Cannabis Regulations (SOR/2018-144)
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Regulations are current to 2024-10-30 and last amended on 2024-10-09. Previous Versions
Cannabis Regulations
SOR/2018-144
CONTROLLED DRUGS AND SUBSTANCES ACT
Registration 2018-06-27
Cannabis Regulations
P.C. 2018-948 2018-06-26
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1)Footnote a of the Food and Drugs ActFootnote b, subsection 55(1)Footnote c of the Controlled Drugs and Substances ActFootnote d and subsection 139(1) and section 161 of the Cannabis ActFootnote e, makes the annexed Cannabis Regulations.
Return to footnote aS.C. 2016, c. 9, s. 8
Return to footnote bR.S., c. F-27
Return to footnote cS.C. 2017, c. 7, s. 40
Return to footnote dS.C. 1996, c. 19
Return to footnote eS.C. 2018, c. 16
Interpretation
Marginal note:Definitions — Act and Regulations
1 (1) The following definitions apply in the Act and in these Regulations.
- cannabis beverage
cannabis beverage means edible cannabis that is intended to be consumed by drinking and has a concentration of 3% w/w or less of THC, taking into account the potential to convert THCA into THC. (boisson de cannabis)
- cannabis concentrate
cannabis concentrate means a substance that has a concentration of greater than 3% w/w of THC, taking into account the potential to convert THCA into THC. (cannabis sous forme de concentré)
- cannabis extract
cannabis extract means
(a) a substance produced by
(i) subjecting anything referred to in item 1 of Schedule 1 to the Act to extraction processing, or
(ii) synthesizing a substance that is identical to a phytocannabinoid produced by, or found in, a cannabis plant; or
(b) a substance or mixture of substances that contains or has on it a substance produced in a manner referred to in paragraph (a).
It does not include a cannabis topical or edible cannabis. (extrait de cannabis)
- cannabis non-solid concentrates
cannabis non-solid concentrates[Repealed, SOR/2019-206, s. 1]
- cannabis oil
cannabis oil[Repealed, SOR/2019-206, s. 1]
- cannabis solid concentrates
cannabis solid concentrates[Repealed, SOR/2019-206, s. 1]
- cannabis topical
cannabis topical means a substance or mixture of substances that contains or has on it anything referred to in item 1 or 3 of Schedule 1 to the Act and that is intended for use, directly or indirectly, exclusively on external body surfaces, including hair and nails. (cannabis pour usage topique)
- edible cannabis
edible cannabis means a substance or mixture of substances that contains or has on it anything referred to in item 1 or 3 of Schedule 1 to the Act and that is intended to be consumed in the same manner as food. It does not include dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds. (cannabis comestible)
- fresh cannabis
fresh cannabis means freshly harvested cannabis leaves, flowers or buds, but does not include plant material that can be used to propagate cannabis. (cannabis frais)
- non-solids containing cannabis
non-solids containing cannabis means substances that are in non-solid form at a temperature of 22 ± 2°C and that have a concentration of 3% w/w or less of THC, taking into account the potential to convert THCA into THC. (substances qui ne sont pas solides et qui contiennent du cannabis)
- solids containing cannabis
solids containing cannabis means substances that are in solid form at a temperature of 22 ± 2°C and that have a concentration of 3% w/w or less of THC, taking into account the potential to convert THCA into THC. (solides qui contiennent du cannabis)
Marginal note:Definitions — Regulations
(2) The following definitions apply in these Regulations.
- Act
Act means the Cannabis Act. (Loi)
- cannabis drug licence
cannabis drug licence means a licence for a drug containing cannabis. (Version anglaise seulement)
- cannabis product
cannabis product means cannabis of only one of the classes set out in Schedule 4 to the Act — or a cannabis accessory that contains such cannabis — after it has been packaged and labelled for sale to a consumer at the retail level. It does not include
(a) cannabis that is intended for an animal;
(b) a cannabis accessory that contains cannabis that is intended for an animal; or
(c) a drug containing cannabis. (produit du cannabis)
- CBD
CBD means cannabidiol. (CBD)
- CBDA
CBDA means cannabidiolic acid. (ACBD)
- client
client means, in respect of a holder of a licence for sale for medical purposes, an individual who is registered with that holder of the licence under subsection 282(1). (client)
- combination product
combination product means a product, consisting of a device and a prescription drug, for which a drug identification number has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations. (produit mixte)
- common-law partner
common-law partner means an individual who is cohabiting with an individual in a conjugal relationship, having done so for a period of at least one year. (conjoint de fait)
- common name
common name[Repealed, SOR/2019-206, s. 1]
- constituent
constituent means an individual unit of food that is combined as an individual unit of food with one or more other individual units of food to form an ingredient. (constituant)
- contaminated
contaminated means, in respect of cannabis, a cannabis accessory or an ingredient, containing or having on it anything — including a micro-organism but excluding anything referred to in item 1 or 3 of Schedule 1 to the Act — that may render the cannabis, cannabis accessory or ingredient injurious to human health or unsuitable for human use. (contaminé)
- controlled substance offence
controlled substance offence means
(a) an offence under Part I of the Controlled Drugs and Substances Act, except subsection 4(1) of that Act; or
(b) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraph (a). (infraction relative à une substance désignée)
- device
device has the same meaning as in section 2 of the Food and Drugs Act. (instrument)
- drug
drug has the same meaning as in section 2 of the Food and Drugs Act, but excludes cannabis that is
(a) a natural health product to which the Natural Health Products Regulations apply; or
(b) manufactured or sold — within the meaning of section 2 of the Food and Drugs Act — and is not represented, for use in
(i) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings, or
(ii) restoring, correcting or modifying organic functions in human beings.
It includes cannabis that is an active pharmaceutical ingredient as defined in subsection C.01A.001(1) of the Food and Drug Regulations. It also includes cannabis that is manufactured or sold for use in a clinical trial as defined in section C.05.001 of those Regulations that is not non-therapeutic research on cannabis. (drogue)
- durable life
durable life means the period, commencing on the day on which a cannabis product is packaged for sale to a consumer at the retail level, during which the product, when it is stored under conditions appropriate to that product, will retain, without any appreciable deterioration, normal palatability and any other qualities claimed for it by the holder of a licence for processing that manufactured the product. (durée de conservation)
- durable life date
durable life date means the date on which the durable life of a cannabis product ends. (date limite de conservation)
- export permit
export permit means a permit issued under subsection 62(1) of the Act that authorizes the exportation of cannabis for medical or scientific purposes. (permis d’exportation)
- fish
fish has the same meaning as in section 1 of the Safe Food for Canadians Regulations. (poisson)
- food
food has the same meaning as in section 2 of the Food and Drugs Act. (aliment)
- food additive
food additive means any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of, or affecting the characteristics of, a food or edible cannabis, but does not include
(a) anything referred to in item 1 or 3 of Schedule 1 to the Act; or
(b) anything that is excluded from the definition food additive in subsection B.01.001(1) of the Food and Drug Regulations. (additif alimentaire)
- former Access to Cannabis for Medical Purposes Regulations
former Access to Cannabis for Medical Purposes Regulations means the regulations made by Order in Council P.C. 2016-743 of August 5, 2016 and registered as SOR/2016-230. (ancien Règlement sur l’accès au cannabis à des fins médicales)
- former Industrial Hemp Regulations
former Industrial Hemp Regulations means the regulations made by Order in Council P.C. 1998-352 of March 12, 1998 and registered as SOR/98-156. (ancien Règlement sur le chanvre industriel)
- grow area
grow area means, in respect of a site set out in a licence, an area of the site where cannabis plants are cultivated, harvested or propagated. (zone de culture)
- hospital
hospital means, except in Part 8, a facility
(a) that is licensed, approved or designated by a province under the laws of the province to provide care or treatment to individuals suffering from any form of disease or illness; or
(b) that is owned or operated by the Government of Canada or the government of a province and that provides health services. (hôpital)
- immediate container
immediate container means a container that is in direct contact with cannabis or a cannabis accessory that is a cannabis product or, if a wrapper is in direct contact with the cannabis or the cannabis accessory, with the wrapper. (contenant immédiat)
- import permit
import permit means a permit issued under subsection 62(1) of the Act that authorizes the importation of cannabis for medical or scientific purposes. (permis d’importation)
- ingestion
ingestion includes absorption in the mouth. (ingestion)
- ingredient
ingredient means
(a) in the case of a cannabis extract or a cannabis topical, a substance, other than anything referred to in item 1 or 3 of Schedule 1 to the Act, that is used to produce the cannabis extract or cannabis topical, including any substance used in the manufacture of that substance, and that is present in the final form of the cannabis extract or cannabis topical; and
(b) in the case of edible cannabis,
(i) a substance, other than anything referred to in item 1 or 3 of Schedule 1 to the Act,
(A) that is used to produce the edible cannabis if the use of the substance results, or may reasonably be expected to result, in the substance or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis, or
(B) that is part of a mixture of substances referred to in item 2 of that Schedule that is used to produce the edible cannabis if the use of the mixture results, or may reasonably be expected to result, in the substance or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis, or
(ii) a mixture of substances, other than anything referred to in item 1 or 3 of Schedule 1 to the Act,
(A) that is used to produce the edible cannabis if the use of the mixture results, or may reasonably be expected to result, in the mixture or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis, or
(B) that is part of a mixture of substances referred to in item 2 of that Schedule that is used to produce the edible cannabis if the use of the latter mixture results, or may reasonably be expected to result, in the former mixture or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis. (ingrédient)
- licence
licence means a licence issued under subsection 62(1) of the Act in relation to cannabis. (licence)
- marketing authorization
marketing authorization, except in paragraph 102(2)(a), has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (autorisation de mise en marché)
- meat product
meat product has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (produit de viande)
- mineral nutrient
mineral nutrient has the same meaning as in subsection D.02.001(1) of the Food and Drug Regulations except that it does not include sodium, potassium or chloride or compounds that include those elements. (minéral nutritif)
- non-therapeutic research on cannabis
non-therapeutic research on cannabis means research that involves the distribution of cannabis to human participants by the holder of a licence for research and that is not a clinical trial as defined in section C.05.001 of the Food and Drug Regulations for which the sale of cannabis is authorized in accordance with section C.05.006 of those Regulations. This definition does not include research
(a) related to the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, or the restoration or correction of organic functions, in human beings or animals;
(b) involving the distribution of cannabis that is
(i) represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, or the restoration or correction of organic functions, in human beings or animals,
(ii) manufactured or sold by any person other than a licence holder referred to in paragraph 2(a) of the Cannabis Exemption (Food and Drugs Act) Regulations for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, or in the restoration or correction of organic functions, in human beings or animals,
(iii) referred to in any of paragraphs 1(b) to (d) of the Cannabis Exemption (Food and Drugs Act) Regulations, or
(iv) referred to in paragraph 1(f) of the Cannabis Exemption (Food and Drugs Act) Regulations in respect of an experimental study as defined in subsection C.08.013(2) of the Food and Drug Regulations;
(c) involving the distribution of cannabis that contains any substance that is referred to in column 1 of Schedule 5 to the Act and that
(i) in the case of cannabis that is a cannabis product or that is contained in a cannabis accessory that is a cannabis product, does not meet the requirements set out in subsection 101.3(6) or section 102.2 or 102.3, and
(ii) in the case of any other cannabis, would not meet the requirements set out in subsection 101.3(6) or section 102.2 or 102.3 if it were a cannabis product or if it were contained in a cannabis accessory that is a cannabis product; or
(d) involving the participation of, or relating to, a young person. (recherche non thérapeutique sur le cannabis)
- operations area
operations area means, in respect of a site set out in a licence, an area of the site — other than a storage area — where cannabis is present as a result of any activities conducted under a licence. It includes a grow area. (zone d’exploitation)
- pest control product
pest control product has the same meaning as in subsection 2(1) of the Pest Control Products Act. (produit antiparasitaire)
- pharmacist
pharmacist means an individual who is entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province. (pharmacien)
- point
point means the unit of measurement for type size that is known as a PostScript point and is equal to 0.3527777778 mm. (point)
- potential to convert CBDA into CBD
potential to convert CBDA into CBD means the maximum amount of CBD that would be obtained if CBDA was converted into CBD with no further degradation of CBD. (potentiel de transformation de l’ACBD en CBD)
- potential to convert THCA into THC
potential to convert THCA into THC means the maximum amount of THC that would be obtained if THCA was converted into THC with no further degradation of THC. (potentiel de transformation de l’ATHC en THC)
- poultry product
poultry product has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (produit de volaille)
- prescription
prescription has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (ordonnance)
- prescription drug
prescription drug means a drug
(a) that contains cannabis;
(b) that is a prescription drug, as defined in section A.01.010 of the Food and Drug Regulations; and
(c) for which a drug identification number has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations. (drogue sur ordonnance)
- proper name
proper name has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (nom propre)
- reference standard
reference standard means a standardized form of cannabis that is intended to be used as a measurement base when testing a substance to confirm its identity, concentration, quality or purity for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose. (étalon de référence)
- security clearance
security clearance means, except in paragraph 53(2)(g), a security clearance granted by the Minister under section 67 of the Act and includes, for the purpose of paragraph 53(2)(e), a security clearance granted under section 112 of the former Access to Cannabis for Medical Purposes Regulations. (habilitation de sécurité)
- site
site means, in respect of a holder of a licence, an area that is used exclusively by the holder and that consists of at least one building or one part of a building. (lieu)
- storage area
storage area means, in respect of a site set out in a licence, an area of the site where cannabis is stored. (zone d’entreposage)
- sugars
sugars has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (sucres)
- test kit
test kit means a kit
(a) that contains
(i) cannabis, and
(ii) a reagent system or buffering agent, or both;
(b) that is designed to be used during the course of a chemical or analytical procedure to test for the presence or quantity of cannabis for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and
(c) the contents of which are not intended or likely to be consumed or administered. (nécessaire d’essai)
- THC
THC means delta-9-tetrahydrocannabinol. (THC)
- THCA
THCA means delta-9-tetrahydrocannabinolic acid. (ATHC )
- vitamin
vitamin, except in subsection 101.3(3), has the same meaning as in subsection D.01.002(1) of the Food and Drug Regulations. (vitamine)
- water activity
water activity, except in section 102.5, means the ratio of the water vapour pressure of a meat product, poultry product or fish to the vapour pressure of pure water, at the same temperature and pressure. (activité de l’eau)
Marginal note:Incorporation by reference
(3) For the purpose of the incorporation by reference into these Regulations of any documents published by the Government of Canada, terms that are used but not defined in those documents have the same meaning as in these Regulations.
Marginal note:Deeming — immediate container
(4) For the purposes of these Regulations, a cannabis accessory that contains edible cannabis in liquid form at a temperature of 22 ± 2°C and that is a cannabis product is deemed to be an immediate container.
Non-application
Marginal note:Non-application — Industrial Hemp Regulations
2 These Regulations do not apply to a holder of a licence that is subject to the Industrial Hemp Regulations, or to an applicant for such a licence.
Marginal note:Non-application — holder of cannabis drug licence
3 Subsection 10(1), sections 29 to 48 and Parts 5 and 7 do not apply to a holder of a cannabis drug licence referred to in Part 8, or to an applicant for such a licence.
PART 1General Authorizations and Prohibition
Marginal note:Authorized activities — federal or provincial laboratory
4 (1) Individuals who are involved in the testing of cannabis as a requirement of their duties at a laboratory that is operated by the Government of Canada or the government of a province are authorized to conduct the following activities:
(a) to the extent necessary to conduct the testing,
(i) to possess cannabis,
(ii) to obtain cannabis by altering its chemical or physical properties by any means,
(iii) in the case of seed viability testing, to obtain cannabis by cultivating it, and
(iv) to distribute cannabis to any of the following:
(A) a holder of a licence for analytical testing,
(B) an individual referred to in subsection (4), or
(C) other individuals who are involved in the testing of cannabis as a requirement of their duties at a laboratory that is operated by the Government of Canada or the government of a province;
(b) for the purpose of producing reference standards or manufacturing or assembling test kits, to produce cannabis, other than obtain it by cultivating, propagating or harvesting it; and
(c) to sell or distribute reference standards to any of the following:
(i) a holder of a licence for cultivation,
(ii) a holder of a licence for processing,
(iii) a holder of a licence for research,
(iv) a holder of a licence for analytical testing,
(v) a holder of a cannabis drug licence,
(vi) an individual referred to in subsection (4),
(vii) the Minister,
(viii) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or the class of cannabis that is distributed, or
(ix) other individuals who are involved in the testing of cannabis as a requirement of their duties at a laboratory that is operated by the Government of Canada or the government of a province.
Marginal note:Offer
(2) An individual who conducts an activity referred to in subparagraph (1)(a)(ii) or (iii) or paragraph (1)(b) is also authorized to offer to conduct that activity.
Marginal note:Use of an organic solvent
(3) An individual who conducts an activity referred to in subparagraph (1)(a)(ii) or paragraph (1)(b) is also authorized to alter or offer to alter the chemical or physical properties of cannabis by the use of an organic solvent when conducting that activity.
Marginal note:Authorized activities — accredited laboratory
(4) An individual who is involved in the testing of cannabis as a requirement of their duties at a laboratory that is designated as an accredited laboratory under section 2.1 of the Seeds Act is authorized to conduct the activities referred to in subparagraphs (1)(a)(i), (iii) and (iv), and to offer to conduct the activity referred to in subparagraph (1)(a)(iii), to the extent necessary to conduct the testing.
Marginal note:Distribution — analytical testing
5 An individual is authorized to distribute cannabis to a holder of a licence for analytical testing if the quantity of cannabis does not exceed the equivalent of 30 g of dried cannabis, as determined in accordance with subsection 2(4) of the Act.
Marginal note:Sale of cannabis containing caffeine
5.1 For the purposes of subsection 34(1) of the Act,
(a) a holder of a licence for processing that authorizes the sale of cannabis may, in accordance with the licence, sell edible cannabis that is not a cannabis product and that contains caffeine if the caffeine has been introduced through the use of ingredients that naturally contain caffeine; and
(b) the following persons may, in accordance with their licence or the provincial authorization, as the case may be, sell edible cannabis that is a cannabis product and that contains caffeine if the caffeine has been introduced through the use of ingredients that naturally contain caffeine and the total amount of caffeine in each immediate container of the cannabis product does not exceed 30 mg:
(i) a holder of a licence for processing that authorizes the sale of cannabis,
(ii) a holder of a licence for sale that authorizes the sale of cannabis products, and
(iii) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis.
Marginal note:Sale of cannabis containing ethyl alcohol
5.2 (1) For the purposes of subsection 34(1) of the Act,
(a) a holder of a licence for processing that authorizes the sale of cannabis may, in accordance with the licence, sell a cannabis extract that is not a cannabis product and that contains ethyl alcohol; and
(b) the following persons may, in accordance with their licence or the provincial authorization, as the case may be, sell a cannabis extract that is a cannabis product and that contains ethyl alcohol if the cannabis extract is intended to be ingested and the net weight of the cannabis extract in each immediate container of the cannabis product does not exceed 7.5 g:
(i) a holder of a licence for processing that authorizes the sale of cannabis,
(ii) a holder of a licence for sale that authorizes the sale of cannabis products, and
(iii) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis.
Marginal note:Edible cannabis
(2) For the purposes of subsection 34(1) of the Act,
(a) a holder of a licence for processing that authorizes the sale of cannabis may, in accordance with the licence, sell edible cannabis that is not a cannabis product and that contains ethyl alcohol; and
(b) the following persons may, in accordance with their licence or the provincial authorization, as the case may be, sell edible cannabis that is a cannabis product and that contains ethyl alcohol if the concentration of ethyl alcohol does not exceed 0.5% w/w of the edible cannabis:
(i) a holder of a licence for processing that authorizes the sale of cannabis,
(ii) a holder of a licence for sale that authorizes the sale of cannabis products, and
(iii) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis.
Marginal note:Reference standard
(3) For the purposes of subsection 34(1) of the Act, the following persons are authorized to sell a reference standard that contains any substance that is referred to in column 1 of Schedule 5 to the Act:
(a) a holder of a licence for processing that authorizes the sale of cannabis;
(b) a holder of a licence for analytical testing that authorizes the sale of cannabis; or
(c) the individuals referred to in section 4.
Marginal note:Prohibition to sell — voluntary recall
5.3 A person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis must not sell a cannabis product that they know is the subject of a voluntary recall in Canada that has been commenced for reasons respecting
(a) the quality of the cannabis product; or
(b) the applicable requirements of Part 5 or 6 are otherwise not being met.
Marginal note:Reference standards — prohibition
5.4 A reference standard must not be used as an ingredient, be included in a cannabis product or be packaged and labelled for sale to a consumer at the retail level.
Marginal note:Reference standards appealing to young persons
5.5 For the purposes of section 31 of the Act, the following persons are authorized to sell a reference standard even if it has an appearance, shape or other sensory attribute or a function that there are reasonable grounds to believe could be appealing to young persons:
(a) a holder of a licence for processing that authorizes the sale of cannabis;
(b) a holder of a licence for analytical testing that authorizes the sale of cannabis; and
(c) the individuals referred to in section 4.
PART 2Licensing
Marginal note:Definition of distribute
6 In this Part, distribute does not include administering.
Pre-licensing Requirements
Marginal note:Notice to local authorities
7 (1) Before submitting an application to the Minister for a licence for cultivation, a licence for processing or a licence for sale that authorizes the possession of cannabis, the person that intends to submit the application must provide a written notice to the following authorities in the area in which the site referred to in the application is located:
(a) the local government;
(b) the local fire authority; and
(c) the local police force or the Royal Canadian Mounted Police detachment that is responsible for providing policing services to that area.
Marginal note:Content of notice
(2) The notice must contain the following information:
(a) the person’s name;
(b) the date on which the person expects to submit the application;
(c) the class and the subclass of licence that will be sought, the activity that the person expects to conduct under the licence and an indication that the activity will be conducted in relation to cannabis; and
(d) the address of the site where the person proposes to conduct the activities and, if applicable, of each building within the site.
Marginal note:Senior official
(3) The notice must be addressed to a senior official of the local authority to which it is provided.
Marginal note:Definition of local government
(4) In this section, local government includes
(a) an incorporated city, metropolitan area, town, village or other municipality;
(b) an authority responsible for delivering municipal services that are related to the activities to be conducted under the licence to an unincorporated city, metropolitan area, town, village or other municipality;
(c) a band, as defined in subsection 2(1) of the Indian Act; and
(d) a First Nation, Métis or Inuit government that is party to a self-government or land claims agreement that is given effect by an Act of Parliament, or a First Nation, Métis or Inuit government established under a provincial Act.
Classes of Licences
Marginal note:Classes of licences
8 (1) The following, among others, are established as classes of licences that authorize activities in relation to cannabis:
(a) a licence for cultivation;
(b) a licence for processing;
(c) a licence for analytical testing;
(d) a licence for sale;
(e) a licence for research; and
(f) a cannabis drug licence.
Marginal note:Drug containing cannabis
(2) Despite subsection (1), the licences referred to in paragraphs (1)(a), (b) and (d) authorize activities in relation to cannabis, other than a drug containing cannabis.
Marginal note:Subclasses — cultivation
(3) The following, among others, are established as subclasses of a licence for cultivation:
(a) a licence for micro-cultivation;
(b) a licence for standard cultivation; and
(c) a licence for a nursery.
Marginal note:Subclasses — processing
(4) The following, among others, are established as subclasses of a licence for processing:
(a) a licence for micro-processing; and
(b) a licence for standard processing.
Marginal note:Subclasses — sale
(5) A licence for sale for medical purposes is established as a subclass, among others, of a licence for sale.
Licence Content
Marginal note:Licence — content
9 A licence, other than a licence referred to in paragraph 8(1)(f), must set out the following information:
(a) the name of the holder of the licence;
(b) the licence number;
(c) the class of the licence and, if applicable, the subclass of the licence;
(d) the address of the site where the activity is authorized and, if applicable, of each building within the site;
(e) the authorized activity at the site and, if applicable, the authorized activity that may be conducted at each building within the site;
(f) any conditions that the Minister considers appropriate;
(g) the effective date of the licence; and
(h) the date of expiry of the licence.
Possession
Marginal note:Obtaining cannabis
10 (1) Subject to the other provisions of these Regulations, a holder of a licence that authorizes the possession of cannabis must only possess cannabis that was obtained in accordance with the former Access to Cannabis for Medical Purposes Regulations, the former Industrial Hemp Regulations or the Industrial Hemp Regulations or that is obtained in accordance with these Regulations or from a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis.
Marginal note:Exception — licence for cultivation
(2) A holder of a licence for cultivation is authorized to possess cannabis plants and cannabis plant seeds that were not obtained in accordance with subsection (1) if the holder had submitted to the Minister, with the licence application, a declaration, signed and dated by the individual who signed and dated the application, indicating the quantity of such cannabis plants and cannabis plant seeds that they will have in their possession on the effective date of the licence.
Marginal note:Authorized quantity
(3) The quantity of cannabis plants and cannabis plant seeds that the holder is authorized to possess under subsection (2) must be equal to the amount indicated in the declaration.
Cultivation Licences
Licences for Micro-cultivation and Standard Cultivation
Marginal note:Authorized activities
11 (1) Subject to the other provisions of these Regulations, a holder of a licence for micro-cultivation or standard cultivation is authorized to conduct those of the following activities that are authorized by the licence:
(a) to possess cannabis;
(b) to obtain dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds by cultivating, propagating and harvesting cannabis;
(c) for the purpose of testing, to obtain cannabis by altering its chemical or physical properties by any means; and
(d) to sell cannabis.
Marginal note:Offer
(2) A holder of a licence for micro-cultivation or standard cultivation that is authorized to conduct the activity referred to in paragraph (1)(b) is also authorized to offer to conduct that activity.
Marginal note:Ancillary activities
(3) A holder of a licence for micro-cultivation or standard cultivation that is authorized to conduct the activity referred to in paragraph (1)(b) is also authorized, to the extent necessary to conduct that activity, to conduct ancillary activities such as drying, trimming and milling cannabis.
Marginal note:Use of organic solvent
(4) A holder of a licence for micro-cultivation or standard cultivation that is authorized to conduct the activity referred to in paragraph (1)(c) is also authorized to alter the chemical or physical properties of cannabis by the use of an organic solvent when conducting that activity.
Marginal note:Sale
(5) A holder of a licence for micro-cultivation or standard cultivation whose licence authorizes the sale of cannabis is authorized to conduct the following activities:
(a) to sell and distribute dried cannabis, fresh cannabis, cannabis plants and cannabis plant seeds to any of the following:
(i) a holder of a licence for micro-cultivation or standard cultivation,
(ii) a holder of a licence for processing,
(iii) a holder of a licence for analytical testing,
(iv) a holder of a licence for research,
(v) a holder of a cannabis drug licence,
(vi) the Minister,
(vii) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is sold or distributed; or
(viii) the individuals referred to in section 4;
(b) to sell and distribute cannabis plants and cannabis plant seeds to a holder of a licence for a nursery;
(c) to sell and distribute cannabis plants and cannabis plant seeds, that are cannabis products, to
(i) a holder of a licence for sale, or
(ii) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis; and
(d) to send and deliver cannabis plants and cannabis plant seeds, that are cannabis products, to the purchaser of the products at the request of
(i) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis, or
(ii) a holder of a licence for sale.
Marginal note:Client’s shipping address
(6) If a holder of a licence for micro-cultivation or standard cultivation sends or delivers cannabis plants and cannabis plant seeds under subparagraph (5)(d)(ii) the sale of such products under section 289, the holder must send or deliver the products to the client’s shipping address as indicated by the holder of a licence for sale for medical purposes.
Marginal note:Master grower
12 (1) A holder of a licence for micro-cultivation or standard cultivation must retain the services of one individual as a master grower.
Marginal note:Responsibilities and knowledge
(2) The master grower is responsible for the cultivation, propagation and harvesting of cannabis and must have sufficient knowledge of the provisions of the Act and these Regulations in relation to those activities.
Marginal note:Alternate
(3) A holder of a licence for micro-cultivation or standard cultivation may designate one individual as the alternate master grower who is qualified to replace the master grower.
Marginal note:Micro-cultivation — threshold
13 (1) A holder of a licence for micro-cultivation
(a) must clearly delineate a surface area that does not exceed 200 m2 in which all the cannabis plants, including all the parts of the plants, must be contained; and
(b) must cultivate, propagate or harvest cannabis plants only from that surface area.
Marginal note:Surface area — calculation
(2) If the surface area referred to in paragraph (1)(a) consists of multiple surfaces, such as surfaces arranged above one another, the area of each surface must be included in the calculation of the total surface area.
Licence for Nursery
Marginal note:Authorized activities
14 (1) Subject to the other provisions of these Regulations, a holder of a licence for a nursery is authorized to conduct those of the following activities that are authorized by the licence:
(a) to possess cannabis;
(b) to obtain cannabis plants or cannabis plant seeds by cultivating, propagating and harvesting cannabis;
(c) for the purpose of testing, to obtain cannabis by altering its chemical or physical properties by any means; and
(d) to sell cannabis.
Marginal note:Offer
(2) A holder of a licence for a nursery that is authorized to conduct the activity referred to in paragraph (1)(b) is also authorized to offer to conduct that activity.
Marginal note:Ancillary activity
(3) A holder of a licence for a nursery that is authorized to conduct the activity referred to in paragraph (1)(b) is also authorized, to the extent necessary to conduct that activity, to conduct ancillary activities such as drying cannabis.
Marginal note:Use of organic solvent
(4) A holder of a licence for a nursery that is authorized to conduct the activity referred to in paragraph (1)(c) is also authorized to alter the chemical or physical properties of cannabis by the use of an organic solvent when conducting that activity.
Marginal note:Sale
(5) A holder of a licence for a nursery whose licence authorizes the sale of cannabis is authorized to conduct the following activities:
(a) to sell and distribute cannabis plants and cannabis plant seeds to any of the following:
(i) a holder of a licence for cultivation,
(ii) a holder of a licence for processing,
(iii) a holder of a licence for analytical testing,
(iv) a holder of a licence for research,
(v) a holder of a cannabis drug licence,
(vi) the Minister,
(vii) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is sold or distributed, or
(viii) the individuals referred to in section 4;
(b) to sell and distribute cannabis plants and cannabis plant seeds, that are cannabis products, to the following:
(i) a holder of a licence for sale, or
(ii) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis; and
(c) to send and deliver cannabis plants and cannabis plant seeds, that are cannabis products, to the purchaser of the products at the request of
(i) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis, or
(ii) a holder of a licence for sale.
Marginal note:Client’s shipping address
(6) If a holder of a licence for a nursery sends or delivers cannabis plants and cannabis plant seeds under subparagraph (5)(c)(ii) further to the sale of such products under section 289, the holder must send or deliver the products to the client’s shipping address as indicated by the holder of a licence for sale for medical purposes.
Marginal note:Master grower
15 (1) A holder of a licence for a nursery must retain the services of one individual as a master grower.
Marginal note:Responsibilities and knowledge
(2) The master grower is responsible for the cultivation, propagation and harvesting of cannabis and must have sufficient knowledge of the provisions of the Act and these Regulations in relation to those activities.
Marginal note:Alternate
(3) A holder of a licence for a nursery may designate one individual as the alternate master grower who is qualified to replace the master grower.
Marginal note:Obtaining cannabis plant seeds
16 (1) A holder of a licence for a nursery that cultivates cannabis for the purpose of obtaining cannabis plant seeds must
(a) clearly delineate a total surface area that does not exceed 50 m2 in which all the budding or flowering cannabis plants, including all the parts of those plants, must be contained;
(b) not possess more than 5 kg of flowering heads harvested from the plants referred to in paragraph (a), with the exception of the cannabis plant seeds; and
(c) destroy the flowering heads — with the exception of the cannabis plant seeds — leaves and branches of the plants referred to in paragraph (a) within 30 days of harvesting them.
Marginal note:Surface area — calculation
(2) If the surface area referred to in paragraph (1)(a) consists of multiple surfaces, such as surfaces arranged above one another, the area of each surface must be included in the calculation of the total surface area.
Processing Licences
Marginal note:Authorized activities — licence for standard processing
17 (1) Subject to the other provisions of these Regulations, a holder of a licence for standard processing is authorized to conduct those of the following activities that are authorized by the licence:
(a) to possess cannabis;
(b) to produce cannabis, other than obtain it by cultivating, propagating or harvesting it; and
(c) to sell cannabis.
Marginal note:Authorized activities — licence for micro-processing
(2) Subject to the other provisions of these Regulations, a holder of a licence for micro-processing is authorized to conduct those of the following activities that are authorized by the licence:
(a) to possess cannabis;
(b) to produce cannabis, other than obtain it by
(i) synthesis, or
(ii) cultivating, propagating or harvesting it; and
(c) to sell cannabis.
Marginal note:Offer
(3) A holder of a licence for micro-processing or standard processing that is authorized to conduct the activity referred to in paragraph (1)(b) or (2)(b) is also authorized to offer to obtain cannabis by any method authorized by the licence.
Marginal note:Use of organic solvent
(4) A holder of a licence for micro-processing or standard processing that is authorized to conduct the activity referred to in paragraph 1(b) or (2)(b) is also authorized to alter or offer to alter the chemical or physical properties of cannabis by the use of an organic solvent when conducting that activity.
Marginal note:Sale
(5) A holder of a licence for micro-processing or standard processing whose licence authorizes the sale of cannabis is authorized to conduct the following activities:
(a) to sell and distribute cannabis to any of the following:
(i) a holder of a licence for processing,
(ii) a holder of a licence for analytical testing,
(iii) a holder of a licence for research,
(iv) a holder of a cannabis drug licence,
(v) the Minister,
(vi) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or a class of cannabis that is sold or distributed, or
(vii) the individuals referred to in section 4;
(b) to sell and distribute the following to a holder of a licence for micro-cultivation or standard cultivation:
(i) dried cannabis, fresh cannabis, cannabis plants and cannabis plant seeds, or
(ii) reference standards;
(c) to sell and distribute the following to a holder of a licence for a nursery:
(i) cannabis plants and cannabis plant seeds, or
(ii) reference standards;
(d) to sell and distribute cannabis products to the following:
(i) a holder of a licence for sale, or
(ii) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis; and
(e) to send and deliver cannabis products to the purchaser of the products at the request of
(i) a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis, or
(ii) a holder of a licence for sale.
Marginal note:Client’s shipping address
(6) If a holder of a licence for micro-processing or standard processing sends or delivers cannabis products under subparagraph (5)(e)(ii) further to the sale of such products under section 289, the holder must send or deliver the products to the client’s shipping address as indicated by the holder of a licence for sale for medical purposes.
Marginal note:Consumer information document
18 (1) A holder of a licence for processing must ensure that each shipment of a cannabis product, other than cannabis plants and cannabis plant seeds, is accompanied by copies of the current version of the document entitled Consumer Information — Cannabis, published by the Government of Canada on its website, in a number that is equal to or greater than the number of cannabis products in the shipment in the following cases:
(a) the sale or distribution of cannabis products to a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis; and
(b) the sending or delivering of cannabis products under paragraph 17(5)(e).
Marginal note:Exception
(2) Subsection (1) does not apply if the holder sells or distributes the product to a person referred to in paragraph (1)(a) and that person has notified the holder in writing, that they will obtain the copies through other means and provide it to consumers with their purchase of the product.
Marginal note:No modification
(3) The copies must be identical to the document referred to in subsection (1).
Marginal note:Quality assurance person
19 (1) A holder of a licence for processing must retain the services of one individual as a quality assurance person who has the training, experience and technical knowledge related to the requirements of Parts 5 and 6 that are applicable to the class of cannabis in respect of which activities are conducted under the licence.
Marginal note:Exception — edible cannabis
(1.1) Despite subsection (1), if the quality assurance person does not have the training, experience and technical knowledge related to the requirements of Parts 5 and 6 that are applicable to edible cannabis, the holder of a licence for processing that conducts activities in respect of that class of cannabis must retain the services of another individual who has that training, experience and technical knowledge.
Marginal note:Responsibilities
(2) The quality assurance person is responsible for
(a) assuring the quality of the cannabis before it is made available for sale;
(b) investigating every complaint received in respect of the quality of the cannabis and, if necessary, immediately taking measures to mitigate any risk; and
(c) if they suspect, on reasonable grounds, that the cannabis or anything that will be used as an ingredient presents a risk of injury to human health or that the applicable requirements of Part 5 or 6 are otherwise not being met, immediately investigating the matter and, if necessary, immediately taking measures to mitigate any risk.
Marginal note:Alternate
(3) A holder of a licence for processing may designate up to two individuals as alternate quality assurance persons who are qualified to replace the quality assurance person.
Marginal note:Non-application
(4) Subsections (1) to (3) do not apply in respect of a reference standard or a test kit.
Marginal note:Minister’s approval
20 (1) A holder of a licence for processing must obtain the Minister’s approval before
(a) designating or replacing an alternate quality assurance person; and
(b) replacing the quality assurance person by an individual, other than by the alternate quality assurance person.
Marginal note:Application — content
(2) The holder of a licence for processing must, for the purpose of obtaining the Minister’s approval, submit an application that includes the following:
(a) the name and date of birth of the proposed alternate quality assurance person or the proposed quality assurance person;
(b) a description of the proposed quality assurance person’s or the proposed alternate quality assurance person’s qualifications in respect of the matters referred to in subsection 19(1); and
(c) a declaration, signed and dated by the responsible person referred to in section 37, indicating that all information provided in support of the application is correct and complete to the best of their knowledge.
Marginal note:Additional information
(3) The Minister may, on receiving an application for approval, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to consider the application.
Marginal note:Micro-processing — threshold
21 (1) A holder of a licence for micro-processing must not possess, in a calendar year, cannabis of one or more classes of cannabis — other than cannabis plants and cannabis plant seeds — that has been sold or distributed to them the total amount of which, as determined in accordance with the table to this section, is equivalent to more than 600 kg of dried cannabis.
Marginal note:Equivalency
(2) The cannabis referred to in subsection (1) is exempt from the application of subsection 2(4) of the Act and a quantity referred to in column 2 of the table to this section in respect of any class of cannabis referred to in column 1 is deemed to be equivalent to 1 kg of dried cannabis.
Marginal note:Non-application
(3) Subsection (1) does not apply if the holder also holds a licence for micro-cultivation in relation to the same site and the cannabis that is sold or distributed to them is exclusively from that site.
TABLE
Column 1 Column 2 Item Class of cannabis Amount that is equivalent to 1 kg of dried cannabis 1 dried cannabis 1 kg 2 fresh cannabis 5 kg 3 solids containing cannabis 10 kg 4 non-solids containing cannabis 10 kg 5 cannabis concentrates 0.25 kg 6 [Repealed, SOR/2019-206, s. 10]
Licence for Analytical Testing
Marginal note:Authorized activities
22 (1) Subject to the other provisions of these Regulations, a holder of a licence for analytical testing is authorized to conduct those of the following activities that are authorized by the licence:
(a) for the purpose of testing,
(i) to possess cannabis, and
(ii) to obtain cannabis by altering its chemical or physical properties by any means;
(b) for the purpose of producing reference standards or manufacturing or assembling test kits, to produce cannabis, other than obtain it by cultivating, propagating or harvesting it; and
(c) to sell cannabis.
Marginal note:Offer
(2) A holder of a licence for analytical testing that is authorized to conduct the activity referred to in subparagraph (1)(a)(ii) or paragraph (1)(b) is also authorized to offer to conduct that activity.
Marginal note:Use of organic solvent
(3) A holder of a licence for analytical testing that is authorized to conduct the activity referred to in subparagraph (1)(a)(ii) or paragraph (1)(b) is also authorized to alter or offer to alter the chemical or physical properties of cannabis by the use of an organic solvent when conducting that activity.
Marginal note:Distribution
(4) A holder of a licence for analytical testing is also authorized, for the purpose of testing, to distribute cannabis to another holder of a licence for analytical testing or the individuals referred to in section 4.
Marginal note:Sale
(5) A holder of a licence for analytical testing whose licence authorizes the sale of cannabis is authorized to sell and distribute reference standards to any of the following:
(a) a holder of a licence for cultivation;
(b) a holder of a licence for processing;
(c) a holder of a licence for research;
(d) another holder of a licence for analytical testing;
(e) a holder of a cannabis drug licence;
(f) the individuals referred to in section 4;
(g) the Minister; or
(h) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is sold or distributed.
Marginal note:Head of laboratory
23 (1) A holder of a licence for analytical testing must retain the services of one individual as the head of laboratory who must work at the site set out in the licence and who is responsible for the testing referred to in sections 90 to 91.1.
Marginal note:Qualifications
(2) The head of laboratory must
(a) have sufficient knowledge of the provisions of the Act and these Regulations that apply to the holder of the licence for analytical testing to properly carry out the duties of the position;
(b) have knowledge and experience relevant to the duties of the position; and
(c) hold
(i) a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to the duties of the position, such as chemistry, biology, pharmaceutical or scientific regulatory affairs, laboratory management or laboratory technician, or
(ii) a diploma, certificate or credential awarded by a foreign educational institution in a field or occupation referred to in subparagraph (i) and
(A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or
(B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province.
Marginal note:Alternate
(3) A holder of a licence for analytical testing may designate one or more individuals as the alternate heads of laboratory who are qualified to replace the head of laboratory.
Marginal note:Minister’s approval
24 (1) A holder of a licence for analytical testing must obtain the Minister’s approval before
(a) designating or replacing an alternate head of laboratory; and
(b) replacing the head of laboratory by an individual, other than by an alternate head of laboratory.
Marginal note:Application — content
(2) The holder of a licence for analytical testing must, for the purpose of obtaining the Minister’s approval, submit an application that includes the following:
(a) the name and date of birth of the proposed alternate head of laboratory or the proposed head of laboratory;
(b) a description of the proposed head of laboratory’s or the proposed alternate head of laboratory’s qualifications in respect of the matters referred to in subsection 23(2); and
(c) a declaration, signed and dated by the responsible person referred to in section 37, indicating that all information provided in support of the application is correct and complete to the best of their knowledge.
Marginal note:Additional information
(3) The Minister may, on receiving an application for approval, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to consider the application.
Marginal note:Destruction
25 (1) A holder of a licence for analytical testing must destroy the sample of a lot or batch of cannabis that has been distributed to them, and all cannabis obtained from that sample, within 90 days after completing the testing of the sample of the lot or batch.
Marginal note:Sample not tested
(2) If testing of the sample of a lot or batch of cannabis distributed to the holder of the licence for analytical testing is not initiated within 120 days of its receipt, the holder must, by the end of that period, either destroy the sample or distribute it to another holder of a licence for analytical testing or to the individuals referred to in section 4.
Licence for Sale for Medical Purposes
Marginal note:Authorized activities
26 Subject to the other provisions of these Regulations, a holder of a licence for sale for medical purposes is authorized to conduct those of the following activities that are authorized by the licence:
(a) to possess cannabis products; and
(b) to sell cannabis products.
Marginal note:Sale — other than clients
27 (1) Subject to subsection (2), a holder of a licence for sale for medical purposes that authorizes the sale of cannabis products is authorized to sell or distribute
(a) cannabis products to any of the following:
(i) a holder of a licence, other than a licence for cultivation,
(ii) the Minister, or
(iii) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is, or is contained in, a cannabis product that is sold or distributed;
(b) dried cannabis, fresh cannabis, cannabis plants and cannabis plant seeds, that are cannabis products, to a holder of a licence for micro-cultivation or standard cultivation;
(c) cannabis plants and cannabis plant seeds, that are cannabis products, to a holder of a licence for a nursery; and
(d) cannabis products, other than cannabis plants and cannabis plant seeds, to a hospital employee if the employee’s possession of the cannabis product is for the purpose of, and in connection with, their duties.
Marginal note:Packaging
(2) A holder of a licence for sale for medical purposes must sell the cannabis products referred to in subsection (1) in the packaging in which they were sold or distributed to the holder.
Licence for Research
Marginal note:Authorized activities
28 (1) Subject to the other provisions of these Regulations, a holder of a licence for research is authorized to conduct those of the following activities, that are authorized by the licence:
(a) for the purpose of research,
(i) to possess cannabis,
(ii) to produce cannabis, and
(iii) to transport, send or deliver cannabis between the sites that are set out by the licence; and
(b) to sell cannabis plants and cannabis plant seeds to any of the following:
(i) a holder of a licence for cultivation,
(ii) another holder of a licence for research,
(iii) a holder of a licence for analytical testing,
(iv) a holder of a cannabis drug licence,
(v) the individuals referred to in section 4,
(vi) the Minister, or
(vii) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is sold.
Marginal note:Offer
(2) A holder of a licence for research that is authorized to conduct the activity referred to in subparagraph (1)(a)(ii) is also authorized to offer to obtain cannabis by any method authorized by the licence.
Marginal note:Use of organic solvent
(3) A holder of a licence for research that is authorized to obtain cannabis by altering its chemical or physical properties by any means is also authorized to alter or offer to alter its chemical or physical properties by the use of an organic solvent when conducting that activity.
Marginal note:Administer and distribute — research subject
(4) A holder of a licence for research is also authorized, for the purpose of research, to administer and distribute cannabis to a research subject.
Marginal note:Distribution
(5) A holder of a licence for research is also authorized to distribute
(a) cannabis to any of the following:
(i) another holder of a licence for research,
(ii) a holder of a licence for analytical testing,
(iii) a holder of a cannabis drug licence,
(iv) the individuals referred to in section 4, or
(v) the Minister; and
(b) cannabis plants and cannabis plant seeds to the following:
(i) a holder of a licence for cultivation, or
(ii) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is distributed.
Non-therapeutic Research on Cannabis
Marginal note:Requirements of Part 6
28.1 (1) The requirements of Part 6, other than those set out in subsection 102(6), apply to the following cannabis or cannabis accessory that is administered or distributed to a human participant in the conduct of non-therapeutic research on cannabis as if the cannabis or cannabis accessory were a cannabis product or will become one:
(a) cannabis that is not a cannabis product or is contained in a cannabis accessory that is not a cannabis product; and
(b) a cannabis accessory that contains cannabis and that is not a cannabis product.
Marginal note:References to section 97
(2) For the purposes of subsection (1), any reference in Part 6 to subsection 97(1) or (2) should be read as a reference to paragraph (3)(a) or (b), respectively.
Marginal note:Variability limits
(3) Cannabis that is not a cannabis product — or that is contained in a cannabis accessory that is not a cannabis product — and that is administered or distributed by the holder of a licence for research to human participants in the conduct of non-therapeutic research on cannabis must not contain
(a) in the case of a cannabis extract or a cannabis topical, less than 85% or more than 115% of the quantity or concentration of THC or CBD represented by the holder in the application for the licence, or for its renewal or amendment, related to that research; and
(b) in the case of edible cannabis,
(i) if the quantity of THC or CBD that is represented by the holder in the application exceeds 5 mg, less than 85% or more than 115% of that quantity,
(ii) if the quantity of THC or CBD that is represented by the holder in the application exceeds 2 mg but does not exceed 5 mg, less than 80% or more than 120% of that quantity, and
(iii) if the quantity of THC or CBD that is represented by the holder in the application does not exceed 2 mg, less than 75% or more than 125% of that quantity.
Marginal note:Requirements — edible cannabis
(4) The holder of a licence for research that administers or distributes edible cannabis to human participants in the conduct of non-therapeutic research on cannabis must ensure that
(a) a meat product, poultry product or fish, other than a food additive, was not used as an ingredient to produce the edible cannabis, and was not a constituent of such an ingredient, unless the meat product, poultry product or fish
(i) was produced by a person that is authorized to produce it under the laws of a province or the Safe Food for Canadians Act or was imported in accordance with that Act, and
(ii) had a water activity that did not exceed 0.85 at a temperature of 22 ± 2°C at the time the meat product, poultry product or fish was obtained by the holder that produced the edible cannabis;
(b) food that was produced by a holder of a licence for research and that was used by that holder as an ingredient to produce the edible cannabis, or as a constituent of such an ingredient, was not a meat product, poultry product or fish, and the sale of the food would not have been prohibited under section 4 of the Food and Drugs Act;
(c) a food additive was not used as an ingredient to produce the edible cannabis unless
(i) the edible cannabis would be a food that is the subject of a marketing authorization if the edible cannabis did not contain or have on it anything referred to in item 1 or 3 of Schedule 1 to the Act,
(ii) the marketing authorization would permit the food additive to be in or on the food,
(iii) the conditions under which the marketing authorization would permit the food additive to be in or on the food, including any maximum levels of use, were complied with, and
(iv) the food additive is not caffeine or caffeine citrate; and
(d) the edible cannabis was not irradiated unless
(i) the edible cannabis would be a food that is listed in item 3 or 4, column 1, of the table to Division 26 of Part B of the Food and Drug Regulations if the edible cannabis did not contain or have on it anything that is referred to in item 1 or 3 of Schedule 1 to the Act, and
(ii) the licence holder that produced the edible cannabis satisfied the requirements set out in paragraphs B.26.003(2)(a) and (b) and subsection B.26.004(1) of the Food and Drug Regulations in respect of the edible cannabis.
Marginal note:Vitamins and mineral nutrients
(5) If the conditions set out in subparagraphs (4)(c)(i) to (iv) are met, the holder of a licence for research whose licence authorizes the production of cannabis may use a vitamin or mineral nutrient as an ingredient to produce edible cannabis that is administered or distributed to a human participant in the conduct of non-therapeutic research on cannabis and that is not a cannabis product or is contained in a cannabis accessory that is not a cannabis product.
Marginal note:Irradiated edible cannabis
28.2 The holder of a licence for research that administers or distributes irradiated edible cannabis to human participants in the conduct of non-therapeutic research on cannabis must ensure that the requirements set out in subsection 42(1) have been met in addition to the conditions set out in paragraph 28.1(4)(d).
Marginal note:Return of cannabis
28.3 (1) For the purposes of subparagraph 9(1)(a)(i) or (iii) of the Act, a human participant to whom cannabis was distributed in the conduct of non-therapeutic research on cannabis is authorized to return the cannabis to the holder of the licence for research from which the cannabis was received.
Marginal note:Parcel — requirements
(2) The participant who is returning cannabis under subsection (1) must, if they are sending or having delivered a total quantity of cannabis that exceeds the equivalent of 30 g of dried cannabis,
(a) prepare the parcel in a manner that ensures the security of its contents, such that
(i) it will not open or permit the escape of its contents during handling and transportation,
(ii) it is sealed so that it cannot be opened without the seal being broken, and
(iii) it prevents its contents from being identified without it being opened; and
(b) use a method that ensures the tracking and safekeeping of the parcel during transportation.
Marginal note:Record keeping — returned cannabis
28.4 A holder of a licence for research that receives cannabis from a human participant under section 28.3 must retain a document that contains the following information:
(a) the name of the participant;
(b) the address of the location at which the cannabis is received and, if that location is different from the site or sites at which the cannabis was produced, the address of the site or sites, if known;
(c) the date on which the cannabis is received;
(d) the quantity of cannabis that is received;
(e) a description of the cannabis, including, if applicable, the brand name; and
(f) if applicable, the lot or batch number of the cannabis.
Marginal note:Destruction of returned cannabis
28.5 A holder of a licence for research must destroy any cannabis that has been returned to them by a human participant under section 28.3 no later than 90 days after the day on which the non-therapeutic research on cannabis ends.
Refusal, Suspension and Revocation
Marginal note:Refusal to issue, renew or amend — other grounds
29 For the purpose of paragraph 62(7)(h) of the Act, other grounds for refusing to issue, renew or amend a licence are the following:
(a) an individual who is required to hold a security clearance under section 50 in respect of an application does not hold such a security clearance;
(b) in respect of the renewal or amendment of a licence, the holder of the licence does not hold a cannabis licence issued under subsection 14(1.1) of the Excise Act, 2001, if it is required;
(c) in respect of the issuance or amendment of a licence for cultivation, the site proposed in the application would be authorized by another licence for cultivation;
(d) in respect of the issuance or amendment of a licence for micro-cultivation, the site proposed in the application would be authorized by a licence for standard processing and a licence for micro-cultivation;
(e) in respect of the issuance or amendment of a licence for standard cultivation, the site proposed in the application would be authorized by a licence for micro-processing and a licence for standard cultivation;
(f) in respect of the issuance or amendment of a licence for a nursery, the site proposed in the application would be authorized by a licence for processing and a licence for a nursery;
(g) in respect of the issuance or amendment of a licence for processing, the site proposed in the application would be authorized by another licence for processing;
(h) in respect of the issuance or amendment of a licence for processing, the site proposed in the application would be authorized by a licence for processing and a licence for a nursery;
(i) in respect of the issuance or amendment of a licence for micro-processing, the site proposed in the application would be authorized by a licence for standard cultivation and a licence for micro-processing;
(j) in respect of the issuance or amendment of a licence for standard processing, the site proposed in the application would be authorized by a licence for micro-cultivation and a licence for standard processing;
(k) in respect of a licence for processing, the applicant has, in the past 10 years, been convicted of an offence under the Safe Food for Canadians Act or an Act referred to in subsection 374(2) of the Safe Food for Canadians Regulations; and
(l) in respect of a licence for research that would authorize activities in relation to non-therapeutic research on cannabis, the Minister has reasonable grounds to believe that
(i) the use of the cannabis proposed in the application presents a risk of injury to the health of a human participant or other person that cannot reasonably be mitigated, or
(ii) the objectives of the non-therapeutic research on cannabis that are set out in the application will not be achieved.
Marginal note:Suspension — other circumstance
30 For the purpose of paragraph 64(1)(b) of the Act, other circumstances for the suspension of a licence are the following:
(a) an individual who is required to hold a security clearance under section 50 in respect of the licence does not hold such a security clearance;
(b) the holder of a licence has failed to pay a fee in relation to the licence that is fixed under subsection 142(1) of the Act;
(c) the holder of a licence does not hold a cannabis licence issued under subsection 14(1.1) of the Excise Act, 2001, if it is required;
(d) the cannabis licence issued to the holder under subsection 14(1.1) of the Excise Act, 2001 is suspended under subsection 23(2) of that Act; and
(e) in respect of a licence for research that authorizes activities in relation to non-therapeutic research on cannabis, the Minister has reasonable grounds to believe that
(i) the use of the cannabis in the conduct of the non-therapeutic research on cannabis presents a risk of injury to the health of a human participant or other person that cannot reasonably be mitigated, or
(ii) the objectives of the non-therapeutic research on cannabis will not be achieved.
Marginal note:Revocation — other circumstances
31 For the purpose of paragraph 65(h) of the Act, other circumstances for the revocation of a licence are the following:
(a) the holder of the licence has requested, in writing, the revocation;
(b) the licence has been suspended and not reinstated because the reasons for the suspension still exist or the holder of the licence has not demonstrated to the Minister that the suspension is unfounded;
(c) since the issuance of the licence, a security clearance in respect of the licence has been refused;
(d) the holder of the licence no longer holds the cannabis licence issued under subsection 14(1.1) of the Excise Act, 2001, if it is required;
(e) in the case of a licence for processing, the holder has, since its issuance, been convicted of an offence under the Safe Food for Canadians Act or an Act referred to in subsection 374(2) of the Safe Food for Canadians Regulations; and
(f) in respect of a licence for research that authorizes activities in relation to non-therapeutic research on cannabis, the Minister has reasonable grounds to believe that
(i) the use of the cannabis in the conduct of the non-therapeutic research on cannabis presents a risk of injury to the health of a human participant or other person that cannot reasonably be mitigated, or
(ii) the objectives of the non-therapeutic research on cannabis will not be achieved.
Changes Relating to Licence
Marginal note:Amendment
32 A holder of a licence must submit an application for an amendment to the licence if they propose to make any of the following changes:
(a) a change to the name of the holder of the licence;
(b) a change to the address of the site or building within the site where the activity is authorized; or
(c) a change to the authorized activity at the site or the authorized activity that may be conducted at each building within the site.
Marginal note:Minister’s approval
33 (1) A holder of a licence that proposes to make a change to the site plan that would require physical security measures to be carried out in order to comply with Part 4 must obtain the Minister’s approval before making the change.
Marginal note:Application — content
(2) The holder of a licence must, for the purpose of obtaining the Minister’s approval, submit an application that includes the following:
(a) a description of the change;
(b) the proposed site plan; and
(c) a declaration, signed and dated by the responsible person referred to in section 37, indicating that all information provided in support of the application is correct and complete to the best of their knowledge.
Marginal note:Additional information
(3) The Minister may, on receiving an application for approval, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to consider the application.
Marginal note:Notification — various changes
34 (1) A holder of a licence must notify the Minister of any of the following changes within five days after the change occurs:
(a) a change to the mailing address, telephone number, email address or facsimile number of the holder;
(b) a change to the site plan, other than a change referred to in subsection 33(1);
(c) the replacement of an individual who must hold a security clearance referred to in any of paragraphs 50(b) to (g), (i) and (j) or the addition of another such individual, other than an individual who is designated as an alternate for the position of quality assurance person referred to in section 19; and
(d) in the case of a holder of a licence for cultivation, a licence for processing or a licence for sale, a change to the organizational security plan.
Marginal note:Notification — content
(2) The notification must include the following:
(a) a description of the change; and
(b) a declaration, signed and dated by the responsible person referred to in section 37, indicating that all information provided in support of the notification is correct and complete to the best of their knowledge.
Marginal note:Additional information
(3) In the case of a change referred to in paragraph (1)(c), the notification must also include the following:
(a) the name and date of birth of the individual who replaced an individual referred to in any of paragraphs 50(b) to (g), (i) and (j) or who was added as another such individual; and
(b) if the individual replaced a director or officer referred to in subparagraph 50(b)(i) or (c)(i) or was added as such a director or officer, the certificate of incorporation or other amended incorporating instrument of the corporation or cooperative.
Marginal note:Notification to local authorities
35 (1) A holder of a licence for cultivation, a licence for processing or a licence for sale that authorizes the possession of cannabis must, within 30 days after the issuance, amendment, suspension, reinstatement or revocation of the licence, provide a written notice to the local authorities referred to in paragraphs 7(1)(a) to (c) in the area in which the site set out in the licence is located and provide a copy of the notice to the Minister.
Marginal note:Content of notice
(2) The notice must contain the following information:
(a) the name of the holder of the licence and the address of the site set out in the licence; and
(b) a description of the applicable event referred to in subsection (1) and its effective date and, in the case of an amendment to the licence, details of the amendment.
Marginal note:Senior official
(3) The notice must be addressed to a senior official of the local authority to which it is provided.
Marginal note:Cessation of activities
36 (1) A holder of a licence that intends to cease conducting all the activities authorized by the licence — whether before or on the date of expiry of the licence — must provide the Minister with a written notice to that effect at least 30 days before the day on which those activities cease.
Marginal note:Content of notice
(2) The notice must be signed and dated by the responsible person referred to in section 37 and contain the following information:
(a) the date on which activities are expected to cease;
(b) a description of the manner in which any cannabis remaining at the site as of the date referred to in paragraph (a) will be disposed of by the holder of the licence, including
(i) if the cannabis will be sold or distributed, in whole or in part, the name and address of the person to which it will be sold or distributed, and
(ii) if it will be destroyed, in whole or in part, the day on which and the location at which the destruction is to take place;
(c) the address of the location at which the holder’s records, reports, electronic data and other documents that are required to be retained under the Act by the holder will be retained after activities have ceased; and
(d) the name, address, telephone number and, if applicable, facsimile number and email address of a person from which the Minister may obtain further information after activities have ceased.
Marginal note:Update
(3) After having ceased the activities, the holder must submit to the Minister an update of the information referred to in paragraphs (2)(a) to (d), if it differs from the information submitted in the notice under subsection (1). The update must be signed and dated by the responsible person referred to in section 37.
General Requirements Relating to Authorized Activities
Marginal note:Responsible person
37 (1) A holder of a licence must retain the services of one individual as the responsible person who has the authority to bind the holder.
Marginal note:Responsibilities and knowledge
(2) The responsible person is responsible for the activities conducted under the licence and must have sufficient knowledge of the provisions of the Act and these Regulations that apply to the holder of the licence.
Marginal note:Alternate
(3) A holder of a licence may designate one individual as the alternate responsible person who is qualified to replace the responsible person.
Marginal note:Head of security
38 (1) A holder of a licence, other than a licence for analytical testing or a licence for research, must retain the services of one individual as the head of security who is responsible for
(a) ensuring that the applicable physical security measures set out in Part 4 are complied with; and
(b) the organizational security plan of the holder.
Marginal note:Alternate
(2) A holder of a licence, other than a licence for analytical testing or a licence for research, may designate one individual as the alternate head of security who is qualified to replace the head of security.
Marginal note:Approved site
39 (1) A holder of a licence must only conduct activities that are authorized by the licence at the site and, if applicable, the building within the site, set out in the licence.
Marginal note:Non-application
(2) Subsection (1) does not apply to the possession of cannabis for the purpose of antimicrobial treatment or destruction or the distribution of cannabis.
Marginal note:Dwelling-house
40 A holder of a licence must not conduct any activity that is authorized by the licence at a dwelling-house.
Marginal note:Outdoor activities
41 A holder of a licence must not produce cannabis — other than obtain cannabis by cultivating, propagating or harvesting it — or test, store, package or label cannabis outdoors.
Marginal note:Antimicrobial treatment
42 (1) A holder of a licence, other than a licence for analytical testing, may conduct antimicrobial treatment of cannabis at a location other than the site set out in the licence only if
(a) the holder ensures that the cannabis that is at the location is, at all times, in the presence of at least one individual referred to in paragraph 43(2)(a), or in the case of a holder of a licence for research, an individual referred to in paragraph 43(2)(b); and
(b) the cannabis is subsequently returned to the site set out in the licence or distributed in accordance with these Regulations.
Marginal note:Irradiation of edible cannabis
(2) For greater certainty, in the case of the irradiation of edible cannabis by a holder of a licence for processing, the requirements set out in subsection (1) apply in addition to the conditions set out in paragraphs 102.6(a) and (b).
Marginal note:Destruction
43 (1) A holder of a licence is authorized to destroy cannabis only
(a) in accordance with a method that
(i) complies with all federal, provincial and municipal environmental protection legislation applicable to the location where it is to be destroyed, and
(ii) does not result in any individual being exposed to cannabis smoke or cannabis vapour;
(b) in the presence of at least two individuals who are qualified to witness the destruction and, except in the case of a holder of a licence for analytical testing or a licence for research, one of whom is an individual referred to in paragraph (2)(a); and
(c) in the case where the cannabis is destroyed at a location other than the site set out in the licence, the holder of the licence ensures that the cannabis that is at the location is, at all times, in the presence of at least one individual referred to in paragraph (2)(a) or, in the case of a holder of a licence for analytical testing or a licence for research, an individual referred to in paragraph (2)(b).
Marginal note:Witness to destruction
(2) The following individuals are qualified to witness the destruction of cannabis:
(a) an individual who holds a security clearance; and
(b) an employee of the holder of the licence.
Marginal note:Security clearance holder
44 A holder of a licence, other than a holder of a licence for analytical testing, a licence for research, or a licence for sale that does not authorize the possession of cannabis, must ensure that an individual who holds a security clearance is present at the site when activities are conducted by other individuals in an operations area or a storage area.
Marginal note:Organizational security plan — update
45 A holder of a licence, other than a holder of a licence for analytical testing or a licence for research, must on request of the Minister, update and submit the organizational security plan.
Marginal note:Recall
46 (1) A holder of a licence, other than a licence for analytical testing, must establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of cannabis that has been sold or distributed.
Marginal note:Recall simulation
(2) The holder must
(a) at least once every 12 months, conduct a recall simulation based on the system of control;
(b) after completing the recall simulation, prepare a document that sets out the details of how it was conducted and the results; and
(c) retain the document for at least two years after the day on which the recall simulation is completed.
Marginal note:Safekeeping during distribution
47 A holder of a licence must take any steps that are necessary to ensure the safekeeping of cannabis when distributing it.
Marginal note:Identification of holder of a licence
48 A holder of a licence must include their name, as set out in the licence, in all the means by which they identify themself in relation to cannabis, including advertising, purchase orders, shipping documents and invoices.
PART 3Security Clearances
Marginal note:Definitions
49 The following definitions apply in this Part.
- corporation
corporation does not include a federal or provincial Crown corporation. (personne morale)
- partnership
partnership does not include an incorporated entity. (société de personnes)
Marginal note:Requirement for security clearance
50 The following individuals must hold a security clearance:
(a) an individual who holds a licence for cultivation, processing or sale;
(b) in the case of a corporation that holds a licence for cultivation, processing or sale,
(i) the directors and officers of the corporation,
(ii) any individual who exercises, or is in a position to exercise, direct control over the corporation,
(iii) the directors and officers of any corporation or cooperative that exercises, or is in a position to exercise, direct control over the corporation,
(iv) any individual who is a partner in a partnership that exercises, or is in a position to exercise, direct control over the corporation, and
(v) the directors and officers of any corporation that is a partner in a partnership that exercises, or is in a position to exercise, direct control over the corporation;
(c) in the case of a cooperative that holds a licence for cultivation, processing or sale,
(i) the directors and officers of the cooperative,
(ii) any individual who exercises, or is in a position to exercise, direct control over the cooperative,
(iii) the directors and officers of any corporation or cooperative that exercises, or is in a position to exercise, direct control over the cooperative,
(iv) any individual who is a partner in a partnership that exercises, or is in a position to exercise, direct control over the cooperative, and
(v) the directors and officers of any corporation that is a partner in a partnership that exercises, or is in a position to exercise, direct control over the cooperative;
(d) in the case of a partnership that holds a licence for cultivation, processing or sale,
(i) any individual who is a partner,
(ii) the directors and officers of any corporation or cooperative that is a partner,
(iii) any individual who is a partner in a partnership that exercises, or is in a position to exercise, direct control over the partnership that holds the licence, and
(iv) the directors and officers of any corporation that is a partner in a partnership that exercises, or is in a position to exercise, direct control over the partnership that holds the licence;
(e) in the case of a licence for cultivation, processing or sale, the responsible person referred to in section 37;
(f) in the case of a licence for cultivation, processing or sale, the head of security referred to in section 38;
(g) in the case of a licence for cultivation, the master grower referred to in section 12 or 15;
(h) in the case of a licence for processing, the quality assurance person referred to in section 19;
(i) an individual who has been designated as an alternate for a position referred to in any of paragraphs (e) to (h); and
(j) an individual who has been specified by name by the Minister under subsection 67(2) of the Act or who occupies a position that has been specified by the Minister under that subsection.
Marginal note:Eligibility
51 Only the following individuals may submit an application for a security clearance:
(a) an individual who is required to hold a security clearance;
(b) an individual who will be required to hold a security clearance if an application for a licence, or for its renewal or amendment, that has been filed with the Minister results in the issuance, renewal or amendment of the licence;
(c) an individual who will be required to hold a security clearance if a pending business transaction is completed;
(d) an individual who has been selected for a position referred to in any of paragraphs 50(e) to (h) or as an alternate for such a position; and
(e) an individual who has been selected for a position that has been specified by the Minister under subsection 67(2) of the Act or who has been notified that the Minister intends to specify them, by name or position, under that subsection.
Marginal note:Checks
52 The Minister may, at any time, conduct checks that are necessary to determine whether an applicant for, or the holder of, a security clearance poses a risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity. Such checks include
(a) a check of the applicant’s or holder’s criminal record; and
(b) a check of the relevant files of law enforcement agencies that relate to the applicant or holder, including intelligence gathered for law enforcement purposes.
Marginal note:Grant of security clearance
53 (1) Before granting a security clearance, the Minister must, taking into account any licence conditions that he or she imposes under subsection 62(10) of the Act, determine that the applicant does not pose an unacceptable risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.
Marginal note:Factors
(2) Factors that the Minister may consider to determine the level of risk posed by the applicant include
(a) the circumstances of any events or convictions that are relevant to the determination, the seriousness of those events or convictions, their number and frequency, the date of the most recent event or conviction and any sentence or other disposition;
(b) whether it is known, or there are reasonable grounds to suspect, that the applicant
(i) is or has been involved in, or contributes or has contributed to, an activity that is prohibited by, or conducted in contravention of, any of the provisions of Division 1 of Part 1 of the Act — other than paragraphs 8(1)(a) to (e) — or Subdivision E of Division 2 of Part 1 of the Act,
(ii) is or has been involved in, or contributes or has contributed to, an activity that is prohibited by, or conducted in contravention of, any of the provisions of Part I of the Controlled Drugs and Substances Act — other than subsection 4(1) — or subsection 32(1) or (2) of that Act,
(iii) is or has been involved in, or contributes or has contributed to, an activity that is prohibited by, or conducted in contravention of, any provision of the Criminal Code relating to fraud, corruption of public officials, terrorism financing, counterfeiting or laundering the proceeds of crime,
(iv) is or has been involved in, or contributes or has contributed to, an offence involving an act of violence or the threat of violence,
(v) is or has been a member of a criminal organization as defined in subsection 467.1(1) of the Criminal Code, or is or has been involved in, or contributes or has contributed to, the activities of such an organization,
(vi) is or has been a member of an organization that is known to be involved in or to contribute to — or in respect of which there are reasonable grounds to suspect its involvement in or contribution to — activities directed toward, or in support of, acts of violence or the threat of violence, or is or has been involved in, or contributes or has contributed to, the activities of such an organization,
(vii) is or has been associated with an individual who
(A) is known to be involved in or to contribute to — or in respect of whom there are reasonable grounds to suspect their involvement in or contribution to — activities referred to in subparagraphs (i) to (iii), or
(B) is a member of an organization referred to in subparagraph (v) or (vi), or
(viii) has conspired to commit
(A) an offence under any of the provisions of the Criminal Code referred to in subparagraph (iii),
(B) an offence referred to in subparagraph (iv), or
(C) an offence under any of sections 467.11 to 467.13 of the Criminal Code;
(c) whether there are reasonable grounds to suspect that the applicant could be induced to commit an act — or to aid or abet any person to commit an act — that might constitute a risk to public health or public safety;
(d) whether there are reasonable grounds to believe that the applicant’s activities, including their financial activities, pose a risk to the integrity of the control of the production and distribution of cannabis under the Act;
(e) whether the applicant has had a security clearance suspended or cancelled;
(f) whether there are reasonable grounds to believe the applicant has, now or in the past, submitted false or misleading information, or false or falsified documents, to the Minister; and
(g) whether an entity has refused to issue a security clearance to the applicant — or has suspended or cancelled one — and the reason for the refusal, suspension or cancellation.
Marginal note:Outstanding criminal charge
54 If the Minister refuses to consider an application for a security clearance because there is an outstanding criminal charge against the applicant that may be relevant to the determination of the risk under subsection 53(1), the Minister must provide the applicant, and any affected holder of or applicant for a licence, with notice of the refusal in writing.
Marginal note:Refusal to grant security clearance
55 (1) If the Minister intends to refuse to grant a security clearance, the Minister must provide the applicant with a notice that sets out the reason for the proposed refusal and that specifies the period of time within which they may make written representations to the Minister. The period must start on the day on which the notice is provided and must be not less than 20 days.
Marginal note:Notice of refusal
(2) If the Minister refuses to grant the security clearance, the Minister must provide the applicant, and any affected holder of or applicant for a licence, with notice of the refusal in writing.
Marginal note:Validity period
56 (1) The Minister must establish a validity period for a security clearance in accordance with the level of risk to public health or public safety — including the risk of cannabis being diverted to an illicit market or activity — posed by the applicant, but the period must not exceed five years.
Marginal note:Extension of validity period
(2) If the validity period of a security clearance is less than five years, the Minister may subsequently extend the period to a total of five years if the Minister, taking into account any licence conditions that he or she imposes under subsection 62(10) of the Act, determines that the holder does not pose an unacceptable risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.
Marginal note:Factors
(3) The factors that the Minister may consider to determine the level of risk posed by the holder include those set out in subsection 53(2).
Marginal note:Obligation to notify — offences
57 A holder of a security clearance must, without delay, provide the Minister with notice in writing if they are charged with, or found guilty of, an offence under the Act, the Controlled Drugs and Substances Act or the Criminal Code.
Marginal note:Suspension of security clearance
58 (1) Before suspending a security clearance, the Minister must have reasonable grounds to believe that the risk to public health or public safety posed by the holder, including the risk of cannabis being diverted to an illicit market or activity, has become unacceptable.
Marginal note:Notice of suspension
(2) A suspension takes effect as soon as the Minister provides the holder with a notice in writing that sets out the reasons for the suspension and that specifies the period of time within which they may make written representations to the Minister. The period starts on the day on which the notice is provided and must be not less than 20 days.
Marginal note:Notice to holder of licence
(3) The Minister must, without delay after suspending a security clearance, also provide any affected holder of or applicant for a licence with notice of the suspension in writing.
Marginal note:Reinstatement of security clearance
59 (1) The Minister must reinstate a suspended security clearance if
(a) the reasons for the suspension no longer exist or the holder of the security clearance demonstrates to the Minister that the suspension was unfounded; or
(b) the Minister determines, taking into account any licence conditions that he or she imposes under subsection 62(10) of the Act, that the holder of the security clearance does not pose an unacceptable risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.
Marginal note:Factors
(2) The factors that the Minister may consider to determine the level of risk posed by the holder of the security clearance include those set out in subsection 53(2).
Marginal note:Notice of reinstatement
(3) The Minister must, without delay after reinstating a security clearance, provide the holder of the security clearance, and any affected holder of or applicant for a licence, with notice of the reinstatement in writing.
Marginal note:Cancellation of security clearance
60 (1) A security clearance may not be cancelled unless
(a) it is suspended and the period within which the holder may make representations in respect of the suspension has expired; and
(b) the Minister has determined that the holder poses an unacceptable risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.
Marginal note:Factors
(2) The factors that the Minister may consider to determine the level of risk posed by the holder include those set out in subsection 53(2).
Marginal note:Notice of cancellation
(3) The Minister must, without delay after cancelling a security clearance, provide the holder, and any affected holder of or applicant for a licence, with notice of the cancellation in writing.
Marginal note:Ineligibility — new application
61 If the Minister refuses to grant or cancels a security clearance, the individual who has been refused a security clearance or the former holder may submit a new application for a security clearance only if
(a) a period of five years has elapsed since the day on which the refusal or cancellation occurred; or
(b) a change has occurred in the circumstances that led to the refusal or cancellation.
PART 4Physical Security Measures
DIVISION 1Licences Requiring Increased Security Measures
General Provisions
Marginal note:Security measures
62 (1) The security measures set out in sections 63 to 72 apply in respect of the sites set out in the following licences:
(a) a licence for standard cultivation;
(b) a licence for standard processing;
(c) a licence for sale that authorizes the possession of cannabis; and
(d) a cannabis drug licence if the amount of cannabis that is sold or distributed to the holder of the licence is, as determined in accordance with the table to section 21, equivalent to more than 600 kg of dried cannabis per calendar year.
Marginal note:Compliance with security measures
(2) A holder of a licence referred to in subsection (1) must ensure that the security measures are complied with.
Marginal note:Equivalency
(3) The cannabis referred to in paragraph (1)(d) is exempt from the application of subsection 2(4) of the Act and a quantity referred to in column 2 of the table to section 21 in respect of any class of cannabis referred to in column 1 is deemed to be equivalent to 1 kg of dried cannabis.
Site Design
Marginal note:Site design
63 The site must be designed in a manner that prevents unauthorized access.
Perimeter of Site
Marginal note:Visual monitoring
64 (1) The perimeter of the site must be monitored at all times by visual recording devices to detect any attempted or actual unauthorized access to the site.
Marginal note:Visual recording devices
(2) The devices must, in the conditions under which they are used, be capable of making a visible recording of any attempted or actual unauthorized access.
Marginal note:Intrusion detection system
65 The perimeter of the site must be secured by means of an intrusion detection system that operates at all times and that allows for the detection of any attempted or actual unauthorized access to the site and any attempted or actual tampering with the system.
Marginal note:Monitoring and response
66 (1) The intrusion detection system referred to in section 65 must be monitored at all times.
Marginal note:Appropriate measures
(2) The holder of the licence must determine the appropriate measures to be taken if any occurrence referred to in section 65 is detected.
Marginal note:Record of detected occurrences
(3) If any such occurrence is detected, the holder of the licence must ensure that a document is retained that contains the following information:
(a) the date and time of the occurrence; and
(b) the measures taken in response to it and the date and time when they were taken.
Operations Areas and Storage Areas
Marginal note:Location of storage area
67 Each storage area must be located within an area that satisfies the security measures set out in subsection 68(1), section 69, subsections 70(1) and (3), subsection 71(1) and section 72.
Marginal note:Restricted access
68 (1) Access to each operations area and storage area must be restricted to individuals whose presence in the area is required by their duties.
Marginal note:Record — storage area
(2) A record must be maintained of the identity of every individual entering or exiting a storage area.
Marginal note:Physical barrier
69 Each operations area and storage area must be surrounded by a physical barrier that prevents unauthorized access.
Marginal note:Visual monitoring
70 (1) Each operations area and storage area must be monitored at all times by visual recording devices to detect illicit conduct.
Marginal note:Exception — grow area
(2) For a grow area, only the entry and exit points of the area must be monitored by the devices.
Marginal note:Visual recording devices
(3) The devices must, in the conditions under which they are used, be capable of making a visible recording of any illicit conduct.
Marginal note:Intrusion detection system
71 (1) Each operations area and storage area must be secured by means of an intrusion detection system that operates at all times and that allows for the detection of any attempted or actual unauthorized access to the area, any unauthorized movement in the area and any attempted or actual tampering with the system.
Marginal note:Exception — grow area
(2) The intrusion detection system is not required to detect unauthorized movement in a grow area.
Marginal note:Monitoring and response
72 (1) The intrusion detection system referred to in section 71 must be monitored at all times.
Marginal note:Appropriate measures
(2) The holder of the licence must determine the appropriate measures to be taken if any occurrence referred to in section 70 or 71 is detected.
Marginal note:Record of detected occurrences
(3) If any such occurrence is detected, the holder of the licence must ensure that a document is retained that contains the following information:
(a) the date and time of the occurrence; and
(b) the measures taken in response to it and the date and time when they were taken.
Marginal note:Retention
73 A holder of a licence referred to in subsection 62(1) must retain
(a) a visual recording made under section 64 or 70 for at least one year after the day on which it is made;
(b) a document referred to in subsection 66(3) or 72(3) for at least two years after the day on which it is prepared; and
(c) the information in the record referred to in subsection 68(2) for at least two years after the day on which the information is recorded.
DIVISION 2Other Licences
Marginal note:Micro-cultivation, micro-processing and nurseries
74 A holder of a licence for micro-cultivation, micro-processing or a nursery must ensure that the following security measures are complied with in respect of the site set out in the licence:
(a) the site is designed in a manner that prevents unauthorized access;
(b) the site is surrounded by a physical barrier that prevents unauthorized access;
(c) storage areas are surrounded by a physical barrier that prevents unauthorized access; and
(d) access to each storage area is restricted to individuals whose presence in the area is required by their duties.
Marginal note:Analytical testing
75 A holder of a licence for analytical testing must ensure that the following security measures are complied with in respect of the site set out in the licence:
(a) storage areas are surrounded by a physical barrier that prevents unauthorized access; and
(b) access to each storage area is restricted to individuals whose presence in the area is required by their duties.
Marginal note:Cannabis drug licences
76 (1) If the amount of cannabis that is sold or distributed to the holder of a cannabis drug licence is not equivalent, as determined in accordance with the table to section 21, to more than 600 kg of dried cannabis per calendar year, the holder must ensure that
(a) if they only conduct analytical testing, the security measures set out in paragraphs 75(a) and (b) are complied with in respect of the site set out in the licence; and
(b) in any other case, the security measures set out in paragraphs 74(a) to (d) are complied with in respect of the site set out in the licence.
Marginal note:Equivalency
(2) The cannabis referred to in subsection (1) is exempt from the application of subsection 2(4) of the Act and a quantity referred to in column 2 of the table to section 21 in respect of any class of cannabis referred to in column 1 is deemed to be equivalent to 1 kg of dried cannabis.
Marginal note:Research
77 A holder of a licence for research must ensure that operations areas at the site set out in the licence are designed in a manner that prevents unauthorized access.
DIVISION 3Exemptions
Marginal note:Exemption — storage area
78 (1) A holder of a licence referred to in paragraph 62(1)(a), (b) or (c) is exempt from the application of section 67 in respect of the site set out in the licence if
(a) immediately before the day on which these Regulations come into force, the holder was, in respect of the site,
(i) licensed under Part 1 of the former Access to Cannabis for Medical Purposes Regulations,
(ii) in compliance with their obligations under sections 57 to 60 and 62 of those Regulations, and
(iii) securely storing cannabis, other than cannabis plants and cannabis plant seeds, in accordance with the Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances), as amended in December 1999 and published by the Government of Canada on its website; and
(b) the holder has, since the day on which these Regulations come into force, been securely storing cannabis, other than cannabis plants and cannabis plant seeds, in accordance with the Directive referred to in subparagraph (a)(iii) .
Marginal note:Exemption — application under former Regulations
(2) A holder of a licence referred to in paragraph 62(1)(a), (b) or (c) is exempt from the application of section 67 in respect of the site set out in the licence if
(a) the holder had, before the day on which these Regulations come into force, submitted an application under section 33 of the former Access to Cannabis for Medical Purposes Regulations in respect of the same site;
(b) the application referred to in paragraph (a) was, by virtue of subsection 158(9) of the Act, deemed to be an application for a licence made under section 62 of the Act;
(c) the Minister issued a licence under section 62 of the Act on the basis of the deemed application; and
(d) the holder has, since the licence referred to in paragraph (c) was issued, been securely storing cannabis, other than cannabis plants and cannabis plant seeds, in accordance with the Directive referred to in subparagraph (1)(a)(iii).
Marginal note:Interpretation
(3) For the purposes of paragraphs (1)(b) and (2)(d), a reference in the Directive to a term set out in column 1 of the table to this subsection is deemed to be a reference to the corresponding term set out in column 2.
TABLE
Column 1 Column 2 Item Term used in the Directive Corresponding term 1 Controlled substance Cannabis 2 Licensed dealer / licenced dealer Holder of a licence 3 Cannabis Sativa, its preparations, derivatives and similar synthetic preparations except Nabilone Cannabis 4 Office of Controlled Substances, Therapeutic Products Programme Health Canada 5 Office Health Canada Marginal note:Exemption — cannabis drug licence
(4) The holder of a cannabis drug licence is exempt from the application of this Part in respect of the site set out in the licence if they are securely storing cannabis in accordance with the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis, as amended from time to time and published by the Government of Canada on its website.
PART 5Good Production Practices
Definitions
Marginal note:Definitions
78.1 The following definitions apply in this Part.
- acceptable level
acceptable level means a level of a biological, chemical or physical hazard that does not present a risk of contamination of cannabis or anything that will be used as an ingredient. (niveau acceptable)
- control measure
control measure means a measure that can be applied to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of cannabis or anything that will be used as an ingredient, or to reduce the hazard to an acceptable level. (mesure de contrôle)
- critical control point
critical control point means a step at which the application of a control measure is essential to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of cannabis or anything that will be used as an ingredient, or to reduce the hazard to an acceptable level. (point de contrôle critique)
- sanitary condition
sanitary condition means a condition that does not present a risk of contamination, allergen cross-contamination or introduction of an extraneous substance to cannabis or anything that will be used as an ingredient. (conditions hygiéniques)
General Requirements
Marginal note:Sale, distribution and exportation — cannabis
79 A holder of a licence must not sell, distribute or export cannabis unless the applicable requirements set out in sections 80 to 88.94 have been met.
Marginal note:Non-application — person not holding a licence
79.1 The requirements of this Part do not apply to any activity that a person conducts in respect of anything that will be used as an ingredient unless the activity is conducted by a holder of a licence.
Marginal note:Non-application — holder of licence for analytical testing or research
79.2 Sections 80 to 87.1 do not apply to
(a) a holder of a licence for analytical testing; or
(b) a holder of a licence for research, except in respect of non-therapeutic research on cannabis.
Marginal note:Non-application — reference standard
79.3 The requirements of this Part do not apply in respect of a reference standard and anything that will be used as an ingredient in the production of a reference standard.
Marginal note:Standard operating procedures
80 Cannabis and anything that will be used as an ingredient must be produced, packaged, labelled, distributed, stored, sampled and tested in accordance with standard operating procedures that are designed to ensure that those activities are conducted in accordance with the applicable requirements of this Part and Part 6.
Marginal note:Pest control product
81 (1) Cannabis must not be treated with a pest control product unless the product is registered for use on cannabis under the Pest Control Products Act or is otherwise authorized for use under that Act.
Marginal note:Exception — edible cannabis
(2) Despite subsection (1), edible cannabis may be treated during the course of production with a pest control product referred to in subparagraph 3(1)(b)(ii) of the Pest Control Products Regulations.
Marginal note:Sanitizers, agronomic inputs and non-food chemical agents
81.1 Any sanitizer, agronomic input or non-food chemical agent that is present at a site must
(a) be properly and clearly identified;
(b) be suitable for its intended use and not present a risk of contamination of cannabis or anything that will be used as an ingredient; and
(c) be handled and used in a manner that does not present a risk of contamination of cannabis or anything that will be used as an ingredient and that is in accordance with the manufacturer’s instructions.
Marginal note:Storage
82 Cannabis and anything that will be used as an ingredient must be stored under conditions that maintain their quality.
Marginal note:Distribution
83 Cannabis and anything that will be used as an ingredient must be distributed in a manner that maintains their quality.
Marginal note:Building or part of building
84 Any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled, stored or tested must be designed, constructed and maintained in a manner that permits those activities to be conducted appropriately and under sanitary conditions and, in particular, that
(a) permits the building or part of the building to be kept clean and orderly;
(b) permits the effective cleaning of all surfaces in the building or part of the building;
(c) prevents the contamination of the cannabis or thing that will be used as an ingredient; and
(d) prevents the introduction of an extraneous substance to the cannabis or thing that will be used as an ingredient.
Marginal note:System — filtration and ventilation
85 (1) Any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled, stored or tested must be equipped with a system that
(a) filters air to prevent the escape of odours associated with cannabis plant material to the outdoors;
(b) provides natural or mechanical ventilation with sufficient air exchange to provide clean air and to remove unclean air in order to prevent the contamination of the cannabis or thing that will be used as an ingredient;
(c) is accessible and, if necessary for its cleaning, maintenance or inspection, is capable of being disassembled;
(d) is capable of withstanding repeated cleaning; and
(e) functions in accordance with its intended use.
Marginal note:Exception — cultivation, propagation or harvesting of cannabis
(2) Paragraph (1)(b) does not apply in respect of any building or part of a building where the only activities being conducted in respect of cannabis are its cultivation, propagation or harvesting.
Marginal note:Exception — cultivation, propagation or harvesting of anything used as an ingredient
(3) Paragraphs (1)(b) to (e) do not apply in respect of any building or part of a building where the only activities being conducted in respect of anything that will be used as an ingredient are its cultivation, propagation or harvesting.
Marginal note:Supply of water
85.1 (1) Any system that supplies water to a site must be appropriate for any activity being conducted in respect of cannabis or anything that will be used as an ingredient.
Marginal note:Cross-connection
(2) Any system that supplies potable water to a site must not be cross-connected with any other system, unless measures are taken to eliminate any risk of contamination of cannabis or anything that will be used as an ingredient as a result of the cross-connection.
Marginal note:Lighting
85.2 (1) Any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled, stored or tested must be equipped with natural or artificial lighting that is appropriate for the activity being conducted.
Marginal note:Light fixtures
(2) Any light fixtures in the building or part of the building where the activities referred to in subsection (1) are conducted must
(a) be capable of withstanding repeated cleaning and, if necessary to prevent contamination of the cannabis or thing that will be used as an ingredient, repeated sanitizing; and
(b) not present a risk of contamination of the cannabis or thing that will be used as an ingredient in the event of breakage.
Marginal note:Equipment
86 (1) Cannabis and anything that will be used as an ingredient must be produced, packaged, labelled, stored, sampled and tested using equipment that is designed, constructed, maintained, operated and arranged in a manner that
(a) permits the effective cleaning of its surfaces;
(b) permits it to function in accordance with its intended use;
(b.1) is accessible and, if necessary for its cleaning, maintenance or inspection, is capable of being easily disassembled;
(c) prevents the contamination of the cannabis or thing that will be used as an ingredient;
(d) prevents the introduction of an extraneous substance to the cannabis or thing that will be used as an ingredient; and
(e) protects the cannabis or thing that will be used as an ingredient against allergen cross-contamination.
Marginal note:Conveyances
(1.1) Cannabis and anything that will be used as an ingredient must be distributed using a conveyance that is designed, constructed, maintained and operated in a manner that prevents the contamination of the cannabis or thing that will be used as an ingredient.
Marginal note:Non-application
(2) Paragraphs (1)(d) and (e) do not apply to the outdoor cultivation, propagation or harvesting of cannabis or anything that will be used as an ingredient.
Marginal note:Sanitation program
87 (1) Cannabis and anything that will be used as an ingredient must be produced, packaged, labelled, distributed, stored, sampled and tested in accordance with a sanitation program that sets out
(a) procedures for effectively cleaning the building or part of the building in which those activities are conducted;
(b) procedures for effectively cleaning the equipment and conveyances used in those activities;
(c) procedures for handling any substance used in those activities; and
(d) all requirements, in respect of the health and hygienic behaviour of the personnel who are involved in those activities, that are necessary to ensure that those activities are conducted in sanitary conditions.
Marginal note:Non-application
(2) Paragraph (1)(a) does not apply to the outdoor cultivation, propagation or harvesting of cannabis or anything that will be used as an ingredient.
Marginal note:Hand cleaning and hand sanitizing stations and lavatories
87.1 (1) If necessary to prevent the contamination of cannabis or anything that will be used as an ingredient, a site must be equipped with hand cleaning and hand sanitizing stations and lavatories that
(a) are appropriately equipped and adequate in number and size for the number of individuals using them;
(b) are located so that they are readily accessible to the individuals using them; and
(c) are capable of withstanding repeated cleaning and, as necessary, repeated sanitizing.
Marginal note:Hand cleaning and hand sanitizing stations
(2) The hand cleaning and hand sanitizing stations must permit the effective cleaning and sanitization of hands.
Marginal note:Lavatories
(3) The lavatories must be located and maintained so that they do not present any risk of contamination of cannabis or anything that will be used as an ingredient.
Additional Requirements — Holder of Licence for Processing
Marginal note:Quality assurance
88 A holder of a licence for processing must ensure that
(a) every investigation in respect of the matters referred to in paragraphs 19(2)(b) and (c) is conducted under the responsibility of the quality assurance person referred to in section 19;
(b) if necessary following an investigation, the quality assurance person immediately causes measures to be taken to mitigate any risk;
(c) cannabis and anything that will be used as an ingredient are produced, packaged, labelled, distributed, stored, sampled and tested using methods and procedures that, prior to their implementation, have been approved by the quality assurance person;
(d) in the case of a cannabis extract or edible cannabis, the quality assurance person approves the preventive control plan referred to in section 88.94 prior to its implementation; and
(e) every lot or batch of cannabis is approved by the quality assurance person before it is made available for sale.
Marginal note:Competencies and qualifications
88.1 A holder of a licence for processing must ensure that any individual who conducts activities in relation to edible cannabis or anything that will be used as an ingredient in the production of edible cannabis has the competencies and qualifications that are necessary to conduct those activities at the site set out in the licence.
Marginal note:Temperature and humidity
88.2 (1) A holder of a licence for processing must ensure that the temperature and humidity of any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled, stored or tested are maintained at levels that are appropriate for the activity being conducted with the cannabis or thing that will be used as an ingredient.
Marginal note:Heating, cooling or humidity-control system
(2) If the building or part of the building is equipped with a heating, cooling or humidity-control system, the holder of the licence must ensure that the system
(a) if necessary to prevent contamination of the cannabis or thing that will be used as an ingredient, is equipped with instruments to control and indicate the temperature and humidity levels;
(b) is accessible and, if necessary for its cleaning, maintenance or inspection, is capable of being disassembled;
(c) is capable of withstanding repeated cleaning; and
(d) functions in accordance with its intended use.
Marginal note:Incompatible activities
88.3 (1) A holder of a licence for processing must ensure that physical or other effective means are used to separate incompatible activities in order to prevent contamination of cannabis or anything that will be used as an ingredient.
Marginal note:Production of food
(2) A holder of a licence for processing must not produce, package, label or store cannabis at a site set out in the licence if food that is to be sold is also produced, packaged or labelled at that site.
Marginal note:Exception
(3) Despite subsection (2), a holder of a licence for processing may produce, package, label or store cannabis in a building within a site where food that is to be sold is produced, packaged or labelled if the food is not produced, packaged or labelled in the same building.
Marginal note:Separation of cannabis and ingredients from contaminants
88.4 A holder of a licence for processing must ensure that physical or other effective means are used to separate cannabis or anything that will be used as an ingredient from anything that presents a risk of contamination of the cannabis or thing that will be used as an ingredient.
Marginal note:Ingredients — risk of injury to human health
88.5 A holder of a licence for processing must ensure that anything that will be, or was intended to be, used as an ingredient that presents a risk of injury to human health is identified as such and is stored in a designated area within the site.
Marginal note:Potable water
88.6 (1) A holder of a licence for processing must ensure that any water that might come into contact with a cannabis extract, a cannabis topical, edible cannabis or anything that will be used as an ingredient is potable and, if the water is not potable, must ensure that it does not present a risk of contamination of the cannabis extract, cannabis topical, edible cannabis or thing that will be used as an ingredient.
Marginal note:Steam and ice from potable water
(2) A holder of a licence for processing must ensure that any steam or ice that might come into contact with a cannabis extract, a cannabis topical, edible cannabis or anything that will be used as an ingredient is made from water that meets the requirements of subsection (1) and, if the steam or ice does not meet those requirements, must ensure that it does not present a risk of contamination of the cannabis extract, cannabis topical, edible cannabis or thing that will be used as an ingredient.
Marginal note:No presence of animals
88.7 A holder of a licence for processing must ensure that no animal is present in any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled or stored.
Marginal note:Land — risk of contamination
88.8 If any land that forms part of a site set out in a licence for processing, or any land that is located near such a site, presents a risk of contamination of cannabis or anything that will be used as an ingredient, the holder of the licence must take measures to eliminate the risk.
Marginal note:Removal and disposal of contaminated materials and waste
88.9 (1) A holder of a licence for processing must ensure that any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled or stored has means for the removal and disposal of contaminated materials and waste and, if necessary to prevent contamination of the cannabis or thing that will be used as an ingredient, that the building or part of the building is equipped with a drainage, sewage and plumbing system that functions in accordance with its intended use.
Marginal note:Frequency and manner
(2) The holder of the licence must ensure that contaminated materials and waste are removed and disposed of at a frequency that is sufficient to prevent contamination of the cannabis or thing that will be used as an ingredient and in a manner that does not present a risk of contamination of the cannabis or thing that will be used as an ingredient.
Marginal note:Conveyances and equipment
88.91 A holder of a licence for processing must ensure that any conveyance or equipment that is used at the site set out in the licence to handle any contaminated materials or any waste, unless that conveyance or equipment does not come into contact with those materials or waste,
(a) is used only for that purpose;
(b) is identified as being reserved for that purpose; and
(c) meets the applicable requirements of section 86.
Marginal note:Clothing, footwear and protective coverings
88.92 A holder of a licence for processing must ensure that any individual who enters or is in any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled, stored, sampled or tested wears clothing, footwear and protective coverings, including gloves, a hairnet, a beard net and a smock, that are in good condition, clean and in sanitary condition and that are appropriate for the activity being conducted with the cannabis or thing that will be used as an ingredient.
Marginal note:Identification and analysis of hazards
88.93 (1) A holder of a licence for processing that produces a cannabis extract or edible cannabis must identify and analyze the biological, chemical and physical hazards that present a risk of contamination of the cannabis or anything that will be used as an ingredient in the production of the cannabis extract or edible cannabis.
Marginal note:Prevention, elimination and reduction of hazards
(2) The holder of the licence must prevent, eliminate or reduce to an acceptable level the hazards referred to in subsection (1) by using control measures that are shown by evidence to be effective, including any treatment or process.
Marginal note:Preventive control plan
88.94 (1) A holder of a licence for processing that conducts activities in relation to a cannabis extract or edible cannabis must prepare, retain, maintain and implement a written preventive control plan for any activity they conduct in respect of the cannabis or anything that will be used as an ingredient in the production of the cannabis extract or edible cannabis.
Marginal note:Content of preventive control plan
(2) The preventive control plan must include
(a) a description of the measures for ensuring that the applicable requirements of sections 101.3, 101.4, 102, 102.2, 102.3, 102.5 and 102.6 are met;
(b) in relation to the applicable requirements of these Regulations,
(i) a description of the biological, chemical and physical hazards that are identified under subsection 88.93(1) that present a risk of contamination of the cannabis extract, edible cannabis or anything that will be used as an ingredient in the production of the cannabis extract or edible cannabis,
(ii) a description of the control measures for preventing, eliminating or reducing to an acceptable level the hazards referred to in subparagraph (i) and the evidence that the control measures are effective,
(iii) a description of the critical control points, the related control measures and the evidence that the control measures are effective,
(iv) a description of the critical limits for each critical control point,
(v) the procedures for monitoring the critical control points in relation to their critical limits,
(vi) the corrective action procedures for each critical control point,
(vii) the procedures for verifying that the implementation of the preventive control plan results in compliance with these Regulations, and
(viii) documents that substantiate that the preventive control plan has been implemented with respect to subparagraphs (i) to (vii); and
(c) supporting documents that show evidence of the information recorded under paragraph (a) and subparagraphs (b)(i) to (vii).
Marginal note:Retention period
(3) Each document referred to in subparagraph (2)(b)(viii) must be retained for at least two years after the day on which it is prepared.
Testing
Marginal note:Sale and exportation — cannabis product
89 A holder of a licence must not sell or export a cannabis product unless the applicable requirements set out in sections 90 to 92 have been met.
Marginal note:Testing for phytocannabinoids
90 (1) Testing for the quantity or concentration, as the case may be, of THC, THCA, CBD and CBDA must be conducted on each lot or batch of cannabis, other than cannabis plants or cannabis plant seeds, that
(a) is or will become a cannabis product; or
(b) is or will be contained in a cannabis accessory that is or will become a cannabis product.
Marginal note:Timing of testing
(2) The testing must be conducted on the final form of the cannabis, either before or after it — or the cannabis accessory that contains it — is packaged and labelled as a cannabis product.
Marginal note:Testing for contaminants
91 (1) Testing for microbial and chemical contaminants — other than residues of a pest control product or its components or derivatives — must be conducted on
(a) each lot or batch of cannabis — other than cannabis plants, cannabis plant seeds or edible cannabis — that
(i) is or will become a cannabis product, or
(ii) is or will be contained in a cannabis accessory that is or will become a cannabis product; or
(b) each lot or batch of cannabis — other than cannabis plant seeds — that
(i) is used to produce the cannabis referred to in paragraph (a), or
(ii) is used to produce edible cannabis that is or will become a cannabis product, or that is or will be contained in a cannabis accessory that is or will become a cannabis product.
Marginal note:Timing of testing
(2) The testing on a lot or batch of cannabis must be conducted as follows:
(a) the testing referred to in paragraph (1)(a) must be conducted on the final form of the cannabis, either before or after it — or the cannabis accessory that contains it — is packaged and labelled as a cannabis product; and
(b) the testing referred to in paragraph (1)(b) must be conducted after the final step in the production process during which the contaminants referred to in subsection (1) could have been introduced or could be concentrated, whichever is later.
Marginal note:Tolerance limits
(3) The results of the testing referred to in subsection (1) must enable a determination of whether the contaminants, if any, are or will be within the tolerance limits referred to in subsection 93(3) or 94(2) or section 101.1, as the case may be.
Marginal note:Dissolution and disintegration testing
91.1 (1) If cannabis — or a cannabis accessory that contains cannabis — is or will become a cannabis product to which subsection 95(1) applies, testing must be conducted on each lot or batch of the cannabis or cannabis accessory to determine whether the requirements referred to in that subsection are, or will be, met.
Marginal note:Timing of testing
(2) The testing must be conducted on the final form of the cannabis, either before or after it — or the cannabis accessory that contains it — is packaged and labelled as a cannabis product.
Marginal note:Testing method
92 (1) Testing that is conducted under sections 90 to 91.1 — or to determine whether the applicable requirements in Part 6 are, or will be, met — must be conducted using validated methods on a representative sample of each lot or batch of cannabis or cannabis accessory that contains cannabis.
Marginal note:Retention period
(2) A portion of the sample referred to in subsection (1) must be retained for at least one year after the date of the last sale of any portion of the lot or batch.
Marginal note:Sufficient quantity
(3) The portion of the sample retained under subsection (2) must be of sufficient quantity to enable a determination of
(a) whether the lot or batch meets the requirements of section 81, subsection 93(3), 94(2) or 95(1) or section 101.1, as applicable; and
(b) the quantity or concentration of THC, THCA, CBD and CBDA.
PART 6Cannabis Products
General Provisions
Marginal note:Interpretation — residues of pest control products
92.1 In this Part, a reference to residues of a pest control product includes the residues of any component or derivative of the pest control product.
Marginal note:Residues of pest control products — cannabis plants and seeds
92.2 Cannabis plants or cannabis plant seeds that are cannabis products — or that are contained in a cannabis accessory that is a cannabis product — must not contain or have on them residues of a pest control product that is registered for use on cannabis under the Pest Control Products Act, or that is otherwise authorized for use under that Act, unless the residues are within any maximum residue limits that are specified in relation to cannabis under section 9 or 10 of that Act.
Marginal note:Dried and fresh cannabis
93 (1) Dried cannabis or fresh cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain or have on it anything other than anything referred to in item 1 of Schedule 1 to the Act.
Marginal note:Residues of pest control products
(2) Despite subsection (1), cannabis that is referred to in that subsection may contain or have on it residues of a pest control product that is registered for use on cannabis under the Pest Control Products Act, or that is otherwise authorized for use under that Act, if the residues are within any maximum residue limits that are specified in relation to cannabis under section 9 or 10 of that Act.
Marginal note:Microbial and chemical contaminants
(3) Despite subsection (1), cannabis that is referred to in that subsection may contain or have on it microbial or chemical contaminants if the contaminants are within generally accepted tolerance limits for human use that are
(a) established in a publication referred to in Schedule B to the Food and Drugs Act; and
(b) appropriate for the intended use and any reasonably foreseeable use of the cannabis product.
Marginal note:More stringent limit applies
(4) If there are generally accepted tolerance limits referred to in subsection (3) that apply in respect of the residues of a pest control product referred to in subsection (2) for which a maximum residue limit has been specified in relation to cannabis under the Pest Control Products Act, the more stringent limit applies.
Marginal note:Cannabis used in production
94 (1) Cannabis that is referred to in item 1 or 3 of Schedule 1 to the Act and that is used in the production of the following cannabis must not contain or have on it residues of a pest control product that is registered for use on cannabis under the Pest Control Products Act, or that is otherwise authorized for use under that Act, unless the residues are within any maximum residue limits that are specified in relation to cannabis under section 9 or 10 of that Act:
(a) a cannabis extract that will become a cannabis product or that will be contained in a cannabis accessory that will become a cannabis product;
(b) a cannabis topical that will become a cannabis product or that will be contained in a cannabis accessory that will become a cannabis product; and
(c) edible cannabis that will become a cannabis product or that will be contained in a cannabis accessory that will become a cannabis product.
Marginal note:Edible cannabis — microbial and chemical contaminants
(2) Cannabis that is referred to in item 1 or 3 of Schedule 1 to the Act and that is used in the production of edible cannabis must not, if the edible cannabis will become a cannabis product or will be contained in a cannabis accessory that will become a cannabis product, contain or have on it microbial or chemical contaminants unless the contaminants are within generally accepted tolerance limits for human use that are
(a) established in a publication referred to in Schedule B to the Food and Drugs Act; and
(b) appropriate for a product that is to be ingested.
Marginal note:Dissolution and disintegration
95 (1) Each discrete unit of a cannabis product that is intended for ingestion or nasal, rectal or vaginal use must meet, if the form of the unit is similar to a dosage form for which a dissolution or disintegration test is set out in a publication referred to in Schedule B to the Food and Drugs Act, the requirements of the test or, if there is more than one applicable test, the requirements of any such test that is suitable for demonstrating that the cannabis product will perform as intended.
Marginal note:Exception
(2) Subsection (1) does not apply to edible cannabis.
Marginal note:Maximum quantity of THC — discrete unit
96 (1) Subject to subsection 97(1), each discrete unit of a cannabis product that is intended for ingestion or nasal, rectal or vaginal use must not contain a quantity of THC that exceeds 10 mg, taking into account the potential to convert THCA into THC.
Marginal note:Exception
(2) Subsection (1) does not apply to edible cannabis.
Marginal note:Variability limits
97 (1) A cannabis extract, or a cannabis topical, that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain, in respect of any quantity or concentration of THC or CBD that is displayed on the label, less than 85% or more than 115% of that quantity or concentration.
Marginal note:Edible cannabis
(2) Edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain
(a) if a quantity of THC or CBD that is displayed on the label exceeds 5 mg, less than 85% or more than 115% of that quantity;
(b) if a quantity of THC or CBD that is displayed on the label exceeds 2 mg but does not exceed 5 mg, less than 80% or more than 120% of that quantity; and
(c) if a quantity of THC or CBD that is displayed on the label does not exceed 2 mg, less than 75% or more than 125% of that quantity.
Marginal note:Variability limits — divisible cannabis products
97.1 (1) If a cannabis product that is not in discrete units is represented as being able to be divided into discrete units, each represented unit must not contain
(a) a quantity of THC that is less than 75% or more than 125% of the quantity of THC in each of the other represented units, taking into account the potential to convert THCA into THC; and
(b) a quantity of CBD that is less than 75% or more than 125% of the quantity of CBD in each of the other represented units, taking into account the potential to convert CBDA into CBD.
Marginal note:Divisible units
(2) If a cannabis product is in discrete units that are represented as being able to be divided into discrete sub-units, each represented subunit must not contain
(a) a quantity of THC that is less than 75% or more than 125% of the quantity of THC in each of the other represented subunits, taking into account the potential to convert THCA into THC; and
(b) a quantity of CBD that is less than 75% or more than 125% of the quantity of CBD in each of the other represented subunits, taking into account the potential to convert CBDA into CBD.
Marginal note:Products that must not be sold or distributed
98 The following cannabis products must not be sold or distributed:
(a) a cannabis product that is intended to be used in the area of the human eye bounded by the supraorbital and infraorbital ridges, including the eyebrows, the skin underlying the eyebrows, the eyelids, the eyelashes, the conjunctival sac of the eye, the eyeball and the soft tissue that lies below the eye and within the infraorbital ridge; and
(b) a cannabis product that is intended to be used on damaged or broken skin or to penetrate the skin barrier other than by absorption.
Marginal note:Multiple units
98.1 It is prohibited for a holder of a licence to sell or distribute a cannabis extract, a cannabis topical or edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — if the immediate container contains multiple discrete units, unless the properties of each unit, including size but excluding flavour and colour, as applicable, are consistent.
Dried and Fresh Cannabis
Marginal note:Addition of THC or THCA
99 THC or THCA must not be added to dried or fresh cannabis that will become a cannabis product or that is, or will be, contained in a cannabis accessory that will become a cannabis product.
Marginal note:Consumption by inhalation — net weight of dried cannabis
100 The net weight of dried cannabis that is intended to be consumed by means of inhalation in each discrete unit of a cannabis product must not exceed 1.0 g.
Cannabis Extracts and Cannabis Topicals
Marginal note:Things injurious to health
101 (1) A cannabis extract, or a cannabis topical, that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain or have on it anything that may cause injury to the health of the user when the cannabis product is used as intended or in a reasonably foreseeable way.
Marginal note:Exception
(2) Subsection (1) does not, in respect of a cannabis extract that is intended to be combusted and inhaled, prohibit anything that may cause injury as a result of the intended combustion and inhalation.
Marginal note:Things that do not cause injury
(3) For the purposes of subsection (1), a cannabis extract or a cannabis topical does not contain or have on it anything that may cause injury to the health of the user by reason only that it contains or has on it
(a) anything referred to in item 1 or 3 of Schedule 1 to the Act;
(b) residues of a pest control product that is registered for use on cannabis under the Pest Control Products Act, or that is otherwise authorized for use under that Act, if the residues are within any maximum residue limits that are specified in relation to cannabis under section 9 or 10 of that Act; or
(c) microbial or chemical contaminants — other than residues of a pest control product referred to in paragraph (b) — if the contaminants are within generally accepted tolerance limits for human use that are
(i) established in a publication referred to in Schedule B to the Food and Drugs Act, and
(ii) appropriate for the intended use and any reasonably foreseeable use of the cannabis product.
Marginal note:Microbial and chemical contaminants
101.1 A cannabis extract, or a cannabis topical, that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain or have on it microbial or chemical contaminants unless the contaminants are within generally accepted tolerance limits for human use that are
(a) established in a publication referred to in Schedule B to the Food and Drugs Act; and
(b) appropriate for the intended use and any reasonably foreseeable use of the cannabis product.
Marginal note:Maximum quantity of THC
101.2 A cannabis extract, or a cannabis topical, that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain a quantity of THC that exceeds 1000 mg per immediate container, taking into account the potential to convert THCA into THC.
Marginal note:Cannabis extract — content
101.3 (1) A cannabis extract that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain any ingredients other than
(a) carrier substances;
(b) flavouring agents; and
(c) substances that are necessary to maintain the quality or stability of the cannabis product.
Marginal note:Prohibited ingredients
(2) The following substances must not be used as ingredients to produce a cannabis extract referred to in subsection (1):
(a) substances that are listed in column 1 of the table in Schedule 2 to the Tobacco and Vaping Products Act; or
(b) sugars or sweeteners or sweetening agents, as those terms are defined in subsection B.01.001(1) of the Food and Drug Regulations.
Marginal note:Exception — vitamins
(3) Despite paragraph 2(a), a vitamin may be used as an ingredient to maintain the quality or stability of the cannabis extract referred to in subsection (1) if it is used in an amount that does not exceed what is necessary to maintain the quality or stability of the cannabis product.
Marginal note:Naturally occurring substances
(4) An ingredient that is used to produce the cannabis extract referred to in subsection (1) may contain a substance referred to in subsection (2) only if that substance is naturally present in the ingredient at a level that is not above the naturally occurring level for that ingredient.
Marginal note:Permitted ingredients — inhaled cannabis extract
(5) An ingredient — other than a flavouring agent — must not be used to produce a cannabis extract referred to in subsection (1) that is intended to be consumed by means of inhalation unless
(a) a standard for the ingredient is set out in a publication referred to in Schedule B to the Food and Drugs Act; and
(b) the ingredient complies with the standard.
Marginal note:Ethyl alcohol — ingested cannabis extract
(6) A cannabis extract referred to in subsection (1) must not contain ethyl alcohol unless
(a) the cannabis extract is intended to be ingested; and
(b) the net weight of the cannabis extract in each immediate container of the cannabis product does not exceed 7.5 g.
Marginal note:Uniform distribution — cannabinoids and terpenes
101.4 The cannabinoids and terpenes in a cannabis extract, or a cannabis topical, that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must be uniformly distributed throughout the cannabis extract or cannabis topical.
Marginal note:Cannabis extract — external body surfaces
101.5 A cannabis extract that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not be represented for use, directly or indirectly, on external body surfaces, including hair and nails.
Edible Cannabis
Marginal note:Ingredients — edible cannabis
102 (1) Edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain any ingredients other than food and food additives.
Marginal note:Temporarily marketed foods and supplemented foods
(2) The following foods must not be used as an ingredient to produce edible cannabis referred to in subsection (1) and must not be a constituent of such an ingredient:
(a) a food that is described in a Temporary Marketing Authorization Letter issued under subsection B.01.054(1) of the Food and Drug Regulations;
(b) a supplemented food within the meaning of section B.01.001 of those Regulations; or
(c) a food in respect of which the manufacturer, as defined in section A.01.010 of the Food and Drug Regulations, is exempt from the application of those Regulations in accordance with section 32 or 33 of the Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods), as the case may be.
Marginal note:Meat products, poultry products and fish
(3) A meat product, poultry product or fish, other than a food additive, must not be used as an ingredient to produce edible cannabis referred to in subsection (1) — and must not be a constituent of such an ingredient — unless the meat product, poultry product or fish
(a) has been produced by a person that is authorized to produce it under the laws of a province or the Safe Food for Canadians Act or has been imported in accordance with that Act; and
(b) has a water activity that does not exceed 0.85 at a temperature of 22 ± 2°C at the time the meat product, poultry product or fish is obtained by the holder of the licence for processing that is producing the edible cannabis.
Marginal note:Self-produced food
(4) A holder of a licence for processing that produces a food may use it as an ingredient to produce edible cannabis referred to in subsection (1) — or as a constituent of such an ingredient — if
(a) the food is not a meat product, poultry product or fish; and
(b) the sale of the food would not be prohibited under section 4 of the Food and Drugs Act.
Marginal note:Food additives
(5) A holder of a licence for processing may use a food additive as an ingredient to produce edible cannabis referred to in subsection (1) only if
(a) the edible cannabis would be a food that is the subject of a marketing authorization if the edible cannabis did not contain or have on it anything referred to in item 1 or 3 of Schedule 1 to the Act;
(b) the marketing authorization permits the food additive to be in or on the food;
(c) the conditions under which the marketing authorization permits the food additive to be in or on the food — including any maximum levels of use — are complied with; and
(d) the food additive is not caffeine or caffeine citrate.
Marginal note:Vitamins and mineral nutrients
(6) A vitamin or mineral nutrient must not be used as an ingredient to produce edible cannabis referred to in subsection (1) unless its use is permitted under subsection (5).
(7) [Repealed, SOR/2022-251, s. 15]
Marginal note:Prohibited things
102.1 (1) Edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain or have on it anything in a quantity that would cause the sale of the edible cannabis to be prohibited under any of paragraphs 4(1)(a) to (d) of the Food and Drugs Act if the edible cannabis were a food to which that Act applies.
Marginal note:Not poisonous, harmful or adulterated
(2) Edible cannabis does not have a poisonous or harmful substance in or on it, within the meaning of paragraph 4(1)(a) of the Food and Drugs Act, and is not adulterated, within the meaning of paragraph 4(1)(d) of that Act, by reason only that it contains or has on it
(a) anything referred to in item 1 or 3 of Schedule 1 to the Act;
(b) residues of a pest control product that is registered for use on cannabis under the Pest Control Products Act, or is otherwise authorized for use under that Act, if the residues are within any maximum residue limits that are specified in relation to cannabis under section 9 or 10 of that Act; or
(c) microbial or chemical contaminants — other than residues of a pest control product referred to in paragraph (b) — if the contaminants are within generally accepted tolerance limits for human use that are
(i) established in a publication referred to in Schedule B to the Food and Drugs Act, and
(ii) appropriate for a product that is to be ingested.
Marginal note:Caffeine
102.2 Edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain or have on it caffeine unless
(a) the caffeine has been introduced through the use of ingredients that naturally contain caffeine; and
(b) the total amount of caffeine in each immediate container of the cannabis product does not exceed 30 mg.
Marginal note:Ethyl alcohol
102.3 Edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain or have on it ethyl alcohol unless the concentration of ethyl alcohol does not exceed 0.5% w/w of the edible cannabis.
Marginal note:Cannabis products requiring refrigeration
102.4 It is prohibited for a holder of a licence to sell or distribute edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — if the unopened immediate container must be stored at or below 4°C to prevent the cannabis product from becoming contaminated before its durable life date.
Marginal note:Hermetically sealed containers
102.5 (1) It is prohibited for a holder of a licence to sell or distribute edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — in a hermetically sealed container if any component of the edible cannabis has a pH that exceeds 4.6 and a water activity that exceeds 0.85 at a temperature of 22 ± 2°C.
Marginal note:Definitions
(2) The following definitions apply in subsection (1).
- hermetically sealed container
hermetically sealed container means a container that, due to its design, is secure against the entry of micro-organisms, including spores. (contenant hermétiquement scellé)
- water activity
water activity means the ratio of the water vapour pressure of the component to the vapour pressure of pure water, at the same temperature and pressure. (activité de l’eau)
Marginal note:Irradiation
102.6 A holder of a licence for processing must not irradiate edible cannabis unless
(a) the edible cannabis would be a food that is listed in item 3 or 4, column 1, of the table to Division 26 of Part B of the Food and Drug Regulations if the edible cannabis did not contain or have on it anything that is referred to in item 1 or 3 of Schedule 1 to the Act; and
(b) the holder satisfies the requirements set out in paragraphs B.26.003(2)(a) and (b) and subsection B.26.004(1) of those Regulations in respect of the edible cannabis.
Marginal note:Maximum quantity of THC
102.7 Subject to subsection 97(2), edible cannabis that is a cannabis product — or that is contained in a cannabis accessory that is a cannabis product — must not contain a quantity of THC that exceeds 10 mg per immediate container, taking into account the potential to convert THCA into THC.
Marginal note:Exemption — sale of cannabis beverage
102.8 (1) A person that is authorized to sell cannabis, other than the holder of a licence for processing, is exempt from the application of section 25 of the Act in respect of the sale of a cannabis beverage that is a cannabis product if
(a) the cannabis beverage has been packaged or labelled in accordance with these Regulations, other than paragraph 123(1)(g); and
(b) the label that is applied to any container in which the cannabis beverage is packaged contains the statement set out in paragraph 123(1)(g) but the equivalent quantity of dried cannabis, in grams, that is indicated on the label is, despite that paragraph, determined on the basis that 70 g of cannabis beverage is deemed to be equivalent to 1 g of dried cannabis.
Marginal note:Exemption — distribution of cannabis beverage
(2) A licence holder that is authorized to distribute cannabis, other than the holder of a licence for processing, is exempt from the application of subsection 106(1) in respect of the distribution of a cannabis beverage that is a cannabis product if
(a) the applicable requirements set out in sections 108 to 136, other than paragraph 123(1)(g), have been met in respect of the cannabis beverage; and
(b) the label that is applied to any container in which the cannabis beverage is packaged contains the statement set out in paragraph 123(1)(g) but the equivalent quantity of dried cannabis, in grams, that is indicated on the label is, despite that paragraph, determined on the basis that 70 g of cannabis beverage is deemed to be equivalent to 1 g of dried cannabis.
Cannabis Accessory or Component
Marginal note:Contamination
103 A cannabis accessory that is a cannabis product, or that is packaged with a cannabis product, must not be contaminated.
Marginal note:Flavour
103.1 A cannabis accessory that is a cannabis product, or that is packaged with a cannabis product, must not impart a characterizing flavour to the cannabis.
Marginal note:Dispensing limit
103.2 Subject to subsection 97(1), each activation of the following cannabis accessories must not dispense a quantity of cannabis extract that contains greater than 10 mg of THC, taking into account the potential to convert THCA into THC:
(a) a cannabis accessory that is a cannabis product and that dispenses a cannabis extract that is intended for ingestion or nasal, rectal or vaginal use; or
(b) a cannabis accessory that is packaged with, and that is intended to dispense, a cannabis extract that is a cannabis product and that is intended for ingestion or nasal, rectal or vaginal use.
Marginal note:Psychological effects, abuse liability and toxicity
104 (1) A component of a cannabis product — other than a component that is anything referred to in item 1 or 3 of Schedule 1 to the Act — and a cannabis accessory that is packaged with a cannabis product must not, through any means other than heating or combustion, and when used as intended or in a reasonably foreseeable way,
(a) alter or enhance the psychological effects derived from the cannabis product in a manner that may cause injury to the health of the user;
(b) increase the potential for abuse liability of the cannabis product; or
(c) increase the toxicity of the cannabis product.
Marginal note:Exceptions
(2) Subsection (1) does not prohibit the presence of
(a) ethyl alcohol in or on a cannabis product referred to in subsection 101.3(6) or section 102.3 if the conditions set out in that subsection or section, as the case may be, are met; and
(b) caffeine in or on a cannabis product referred to in section 102.2 if the conditions set out in that section are met.
PART 6.1Promotion
Marginal note:Non-application — prescription drug and combination product
104.1 Sections 104.11 to 104.16 do not apply to a prescription drug or a combination product.
Marginal note:Flavours
104.11 It is prohibited to promote a cannabis extract — or a cannabis accessory that contains a cannabis extract — under subsections 17(2) to (6) of the Act in a manner that could cause a person to believe that the cannabis extract or the cannabis accessory has a flavour set out in column 1 of Schedule 3 to the Tobacco and Vaping Products Act, other than the flavour of cannabis.
Marginal note:Health and cosmetic benefits
104.12 (1) It is prohibited to promote cannabis, a cannabis accessory or a service related to cannabis under subsections 17(2) to (6) of the Act if there are reasonable grounds to believe that the promotion could create the impression that health or cosmetic benefits may be derived from the service or the use of the cannabis or the cannabis accessory.
Marginal note:Non-application — medical devices
(2) Subsection (1) does not apply with respect to a medical device in respect of which a licence has been issued under subsection 36(1) of the Medical Devices Regulations.
Marginal note:Energy value and amount of nutrient
104.13 (1) It is prohibited to promote edible cannabis — or a cannabis accessory that contains edible cannabis — under subsections 17(2) to (6) of the Act by communicating information about the energy value referred to in item 2 of the table to section 132.22 or the amount of any nutrient referred to in items 3 to 15 of that table or in items 5 to 37 of the table to section B.01.402 of the Food and Drug Regulations.
Marginal note:Exception — nutrition facts table
(2) Despite subsection (1), edible cannabis or a cannabis accessory that contains edible cannabis may be promoted by reproducing the nutrition facts table that is required to be included on the label of any container in which the edible cannabis or the cannabis accessory is packaged in accordance with these Regulations using smaller, larger or identical dimensions and spacing.
Marginal note:Dietary requirements
104.14 It is prohibited to promote edible cannabis — or a cannabis accessory that contains edible cannabis — under subsections 17(2) to (6) of the Act if there are reasonable grounds to believe that the promotion could create the impression that the edible cannabis or accessory is intended
(a) to meet the particular dietary requirements of an individual
(i) who has a physical or physiological condition as a result of a disease, disorder or injury, or
(ii) for whom a particular effect, including weight loss, is to be obtained by a controlled intake of food; or
(b) to meet the dietary requirements of young persons.
Marginal note:Alcoholic beverages
104.15 It is prohibited to promote cannabis, a cannabis accessory or a service related to cannabis under subsections 17(2) to (6) of the Act if there are reasonable grounds to believe that the promotion could associate the cannabis, the cannabis accessory or the service with an alcoholic beverage.
Marginal note:Tobacco products and vaping products
104.16 It is prohibited to promote cannabis, a cannabis accessory or a service related to cannabis under subsections 17(2) to (6) of the Act if there are reasonable grounds to believe that the promotion could associate the cannabis, the cannabis accessory or the service with a tobacco product, as defined in section 2 of the Tobacco and Vaping Products Act, or a vaping product to which that Act applies.
Marginal note:Place where young persons are not permitted
104.17 It is prohibited to promote cannabis, a cannabis accessory or a service related to cannabis under paragraphs 17(2)(b) and (3)(b) of the Act in such a manner that the promotion may be audible or visible from outside a place where young persons are not permitted by law.
Marginal note:Number of brand elements
104.18 It is prohibited to promote cannabis, a cannabis accessory or a service related to cannabis under subsection 17(6) of the Act in a manner that results in the same brand element being displayed more than once on a thing referred to in that subsection or in more than one brand element being displayed on the thing.
Marginal note:Public place frequented mainly by young persons
104.19 It is prohibited to promote cannabis, a cannabis accessory or a service related to cannabis under subsection 17(6) of the Act by displaying a brand element of cannabis, of a cannabis accessory or of a service related to cannabis on any thing that is in a school, a public playground, a daycare facility or any other public place frequented mainly by young persons or that is visible from such a place.
Marginal note:Dimensions of brand element
104.2 A brand element referred to in subsection 17(6) of the Act must meet the following requirements:
(a) the surface area must be smaller than or equal to 300 cm2; and
(b) the height of any letter, character or number must be smaller than or equal to 4 cm.
PART 7Packaging and Labelling
Definitions
Marginal note:Definitions
105 (1) The following definitions apply in this Part.
- common name
common name, in respect of edible cannabis, has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (nom usuel)
- Common Names for Ingredients and Components Document
Common Names for Ingredients and Components Document means the document entitled Common Names for Ingredients and Components, prepared by the Canadian Food Inspection Agency and published on its website, as amended from time to time. (Document sur les noms usuels d’ingrédients et de constituants)
- daily value
daily value means
(a) in the case of a nutrient set out in column 1 of Part 1 of the Table of Daily Values, as defined in subsection B.01.001(1) of the Food and Drug Regulations, the quantity set out in column 3; and
(b) in the case of a nutrient set out in column 1 of Part 2 of the table referred to in paragraph (a), the quantity set out in column 4. (valeur quotidienne)
- energy value
energy value means, in respect of a cannabis product, the amount of energy made available to a person’s body when the chemical components of the cannabis product, including protein, fat, carbohydrate and alcohol, are metabolized following ingestion of the cannabis product by the person. (valeur énergétique)
- expiry date
expiry date means the date, expressed at minimum as a year and month, that is the end of the stability period of a cannabis product. (date limite d’utilisation)
- exterior display surface
exterior display surface means the area on the exterior surface of an immediate container to which a label is applied and that is visible under customary conditions of purchase or use. (espace extérieur d’affichage)
- exterior surface
exterior surface includes a label or an image. (surfaces extérieures)
- fat
fat has the same meaning as in subsection B.01.400(1) of the Food and Drug Regulations. (lipides)
- food allergen
food allergen has the same meaning as in subsection B.01.010.1(1) of the Food and Drug Regulations. (allergène alimentaire)
- food allergen source, gluten source and added sulphites statement
food allergen source, gluten source and added sulphites statement means a statement appearing on the label of any container in which edible cannabis — or a cannabis accessory that contains edible cannabis — that is a cannabis product is packaged that indicates the source of a food allergen or gluten that is present in the cannabis product or the presence in the cannabis product of added sulphites in an amount of 10 p.p.m. or more. (mention des sources d’allergènes alimentaires ou de gluten et des sulfites ajoutés)
- gluten
gluten has the same meaning as in subsection B.01.010.1(1) of the Food and Drug Regulations. (gluten)
- immediate container
immediate container[Repealed, SOR/2019-206, s. 30]
- INCI name
INCI name has the same meaning as in subsection 2(1) of the Cosmetic Regulations. (appellation INCI)
- label
label does not include a panel referred to in paragraph 132.27(1)(b). (étiquette)
- p.p.m.
p.p.m. means parts per million by weight. (p.p.m.)
- principal display panel
principal display panel has the same meaning as in subsection 2(2) of the Consumer Packaging and Labelling Regulations. (espace principal)
- saturated fatty acids
saturated fatty acids, saturated fat, saturates or saturated has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (acides gras saturés, graisses saturées, gras saturés, lipides saturés ou saturés)
- standardized cannabis symbol
standardized cannabis symbol means the symbol set out in the document entitled Standardized Cannabis Symbol, as amended from time to time and published by the Government of Canada on its website. (symbole normalisé du cannabis)
- sugars-based ingredient
sugars-based ingredient has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (ingrédient à base de sucres)
- sulphites
sulphites means one or more of the following food additives:
(a) potassium bisulphite;
(b) potassium metabisulphite;
(c) sodium bisulphite;
(d) sodium dithionite;
(e) sodium metabisulphite;
(f) sodium sulphite;
(g) sulphur dioxide; and
(h) sulphurous acid. (sulfites)
- trans fatty acids
trans fatty acids, trans fat or trans has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (acides gras trans, graisses trans, gras trans, lipides trans ou trans)
Marginal note:Definition of panel
(2) For the purposes of sections 112 to 117, 121 and 132.13, subsections 132.27(2) to (7) and (9) and sections 132.28 to 132.32, panel means a panel referred to in paragraph 132.27(1)(b).
General Provisions
Marginal note:Requirement — sale and distribution of cannabis product
106 (1) A holder of a licence must not sell or distribute a cannabis product unless the applicable requirements set out in sections 108 to 136 have been met.
Marginal note:Requirement — exportation of cannabis product
(2) A holder of a licence must not export a cannabis product unless the requirements set out in paragraph 123(1)(a) and subparagraphs 123(1)(c)(ii) and (iv) have been met.
Marginal note:Exception — shipping container
107 The requirements set out in this Part do not apply in respect of a shipping container.
Packaging — Cannabis Products
Marginal note:Immediate container
108 The immediate container in which a cannabis product, other than a cannabis plant or cannabis plant seeds, is packaged must
(a) be opaque or translucent;
(b) prevent contamination of the cannabis;
(c) in the case of dried cannabis, or a cannabis accessory that contains dried cannabis, keep the cannabis dry;
(d) have a security feature that provides reasonable assurance to consumers that it has not been opened prior to receipt;
(e) meet the requirements of a child resistant package under subsections C.01.001(2) to (4) of the Food and Drug Regulations; and
(f) not contain more than the equivalent of 30 g of dried cannabis, as determined in accordance with subsection 2(4) of the Act.
Marginal note:Cannabis plant — not budding or flowering
109 (1) A cannabis plant must not be budding or flowering at the time of packaging.
Marginal note:Cannabis plant — container
(2) The container in which a cannabis plant is packaged must not contain more than four cannabis plants.
Marginal note:Cannabis plant seeds — immediate container
110 The immediate container in which cannabis plant seeds are packaged must
(a) keep the cannabis plant seeds dry; and
(b) not contain more than the equivalent of 30 g of dried cannabis, as determined in accordance with subsection 2(4) of the Act.
Marginal note:Brand element
111 Subject to the other provisions of these Regulations, the interior surface and exterior surface of any container in which a cannabis product is packaged must not display any brand element.
Marginal note:Image
112 Except as otherwise provided under the Act, any other Act of Parliament or any provincial Act, the interior surface, exterior surface and panel of any container in which a cannabis product is packaged must not display any image.
Marginal note:Uniform colour
113 (1) Except as otherwise provided under the Act, any other Act of Parliament or any provincial Act, the colour of the interior surface, exterior surface and panel of any container in which a cannabis product is packaged must be one uniform colour. However, the colour of each surface and the panel may be different.
Marginal note:Colour — other requirements
(2) The colour of the interior surface, exterior surface and panel must meet the following requirements:
(a) it must not have the lustre of metal or have metallic properties in the ink, such as Pantone Metallics or Pantone Premium Metallics;
(b) it must not be fluorescent, have fluorescent properties in the ink or have pigments that absorb ultraviolet energy and transmit it as a longer wavelength, such as the Pantone 800 series; and
(c) it must create a contrast with
(i) the yellow colour of the background of the health warning message, and
(ii) the red colour of the standardized cannabis symbol.
Marginal note:Exception
(3) Despite subsection (2),
(a) an interior surface that is made of metal may be the colour of the metal; and
(b) an exterior surface of an immediate container that is made of metal, excluding the label or any image, may be the colour of the metal.
114 [Repealed, SOR/2019-206, s. 33]
Marginal note:Texture
115 (1) Except as otherwise provided under the Act, any other Act of Parliament or any provincial Act, the interior surface, exterior surface and panel of any container in which a cannabis product is packaged and any covering of such a container must have a smooth texture without any raised features, embossing, decorative ridges, bulges or other irregularities.
Marginal note:Non-application
(2) Subsection (1) does not apply to the features of a container that are necessary to
(a) facilitate the opening and closing of the container; or
(b) assist visually impaired individuals.
Marginal note:Hidden features
116 (1) The interior surface, exterior surface and panel of any container in which a cannabis product is packaged and any covering of such a container must not include any hidden feature that is designed to change the appearance of the container, covering or panel, such as heat-activated ink or a feature that is visible only through technological means, except a feature that is used to prevent counterfeiting.
Marginal note:Feature designed to change surface area
(2) Subject to section 132.27, the interior surface and exterior surface of any container in which a cannabis product is packaged and any covering of such a container must not include any feature that is designed to change the surface area of the container or covering, such as a fold-out panel.
Marginal note:Scent and sound
117 The interior surface, exterior surface and panel of any container in which a cannabis product is packaged and any covering of such a container must not be capable of emitting a scent or sound.
Marginal note:Covering — brand element
118 The covering of any container in which a cannabis product is packaged must not display any brand element.
Marginal note:Covering — image or information
119 Except as otherwise provided under the Act, any other Act of Parliament or any provincial Act, the covering of any container in which a cannabis product is packaged must not display any image or information.
Marginal note:Covering — transparent and colourless
120 Except as otherwise provided under the Act, any other Act of Parliament or any provincial Act, the covering of any container in which a cannabis product is packaged must be transparent and colourless.
Marginal note:Cut-out window
121 The interior surface, exterior surface and panel of any container in which a cannabis product is packaged must not include any cut-out window.
Marginal note:Bar code
122 (1) A bar code may be displayed only once on any container in which a cannabis product is packaged.
Marginal note:Shape and colour
(2) Every bar code must be rectangular in shape and not contain any image or design and must be printed in black and white.
Marginal note:Wrapper
122.1 A wrapper may be used with respect to a cannabis product only if
(a) it is in direct contact with the cannabis or the cannabis accessory and with one or both of the following:
(i) the immediate container of the cannabis product,
(ii) a wrapper that is in direct contact with the cannabis or the cannabis accessory; and
(b) it is required to maintain the quality or stability of the cannabis product.
Marginal note:Packaging requirements — other Regulations
122.2 The following immediate container and wrappers must meet the requirements set out in Division 23 of Part B of the Food and Drug Regulations and subparagraphs 186(a)(i), (ii) and (v) to (vii) of the Safe Food for Canadians Regulations as if the cannabis that the immediate container contains or with which the wrappers are in direct contact were a food for the purposes of that Division and those subparagraphs:
(a) the immediate container in which edible cannabis — or a cannabis accessory that contains edible cannabis — that is a cannabis product is packaged;
(b) any wrapper that is in direct contact with edible cannabis — or a cannabis accessory that contains edible cannabis — that is a cannabis product; and
(c) any wrapper that is in direct contact with a cannabis extract that is intended for ingestion — or a cannabis accessory that contains cannabis extract intended for ingestion — that is a cannabis product.
Marginal note:Maximum quantity — cannabis extract
122.3 The immediate container of a cannabis extract that is a cannabis product must not contain more than 90 mL of extract that is in non-solid form at a temperature of 22 ± 2°C.
Marginal note:Outermost container
122.4 (1) The outermost container in which a cannabis product is packaged must not contain
(a) food;
(b) more than one class of cannabis set out in Schedule 4 to the Act; or
(c) more than one immediate container.
Marginal note:Exception — multiple immediate containers
(2) Despite paragraph (1)(c), the outermost container may contain more than one immediate container of edible cannabis if the following requirements are met:
(a) the outermost container meets the requirements of section 132.18;
(b) the immediate containers meet the requirements of section 132.18, if they contain edible cannabis that is in discrete units, or section 132.19, if they contain edible cannabis that is not in discrete units;
(c) the total quantity of THC in the immediate containers does not exceed 10 mg of THC, taking into account the potential to convert THCA into THC;
(d) the total quantity of cannabis in the immediate containers does not exceed the equivalent of 30 g of dried cannabis, as determined in accordance with subsection 2(4) of the Act;
(e) the statement “Contains the equivalent of (the quantity of dried cannabis, in grams, that is equivalent to the total quantity of cannabis, in grams, as determined in accordance with subsection 2(4) of the Act, in the immediate containers)g of dried cannabis” is displayed on the label of the outermost container; and
(f) the properties of the edible cannabis in all the immediate containers are consistent.
Marginal note:Interpretation — “unit”
(3) For the purposes of paragraph (2)(a), the word “unit” referred to in subsection 132.18(1) is to be read as “immediate container”.
Marginal note:Control measures for dispensing cannabis extract
122.5 (1) The immediate container of a cannabis extract that is a cannabis product and that is not in discrete units must
(a) not permit the extract to be easily poured or drunk directly from the container; and
(b) contain an integrated dispensing mechanism that dispenses no more than 10 mg of THC per activation, taking into account the potential to convert THCA into THC, if the cannabis extract
(i) is in liquid form at a temperature of 22 ± 2°C,
(ii) is not intended to be consumed only by means of inhalation, and
(iii) contains at least 10 mg of THC, taking into account the potential to convert THCA into THC.
Marginal note:Non-application — integrated dispensing mechanism
(2) Paragraph (1)(b) does not apply to an immediate container in which a cannabis accessory referred to in paragraph 103.2(a) is packaged.
Labelling — Cannabis Products
Marginal note:Information
123 (1) The following information must be included on the label that is applied to any container in which a cannabis product is packaged:
(a) the name, telephone number and email address of the following:
(i) in the case of a cannabis plant or cannabis plant seeds, the holder of a licence for cultivation that cultivated the cannabis plant or cannabis plant seeds, or
(ii) in the case of any other cannabis product, the holder of a licence for processing that manufactured the product;
(b) the class of cannabis set out in Schedule 4 to the Act to which the cannabis that is in the immediate container belongs;
(c) in respect of the product
(i) the brand name,
(ii) the lot number, preceded by one of the following designations:
(A) “Lot number”,
(B) “Lot no.”,
(C) “Lot”, or
(D) “(L)”,
(iii) the recommended storage conditions,
(iv) the packaging date, and
(v) except in the case of a cannabis plant, cannabis plant seeds or edible cannabis, either
(A) the expiry date in accordance with subsection (2), or
(B) a statement that no expiry date has been determined;
(d) the warning “KEEP OUT OF REACH OF CHILDREN / TENIR HORS DE LA PORTÉE DES ENFANTS”;
(e) one of the health warning messages set out in the document entitled Cannabis Health Warning Messages, as amended from time to time and published by the Government of Canada on its website, that applies to the cannabis product;
(f) in the case of a cannabis product that contains THC in a concentration greater than 10 μg/g, taking into account the potential to convert THCA into THC, the standardized cannabis symbol that must be obtained from the Minister in the form of an electronic file; and
(g) except in the case of dried cannabis or a cannabis plant, the statement “Contains the equivalent of (the quantity of dried cannabis, in grams, that is equivalent to the quantity of cannabis, in grams or seeds, as the case may be, as determined in accordance with subsection 2(4) of the Act, in the container)g of dried cannabis”.
Marginal note:Expiry date
(2) The label of a container in which cannabis other than edible cannabis is packaged must not include an expiry date unless the holder of the licence for processing that manufactured the cannabis product has data that establishes the stability period during which, after the cannabis is packaged in accordance with these Regulations and stored under its recommended storage conditions,
(a) in the case of dried cannabis or fresh cannabis,
(i) it maintains not less than 80% and not more than 120% of its THC content and CBD content, and
(ii) the microbial and chemical contaminants it contains or has on it remain within the limits referred to subsection 93(3); and
(b) in the case of a cannabis extract or a cannabis topical,
(i) it maintains its THC content and CBD content within the variability limits referred to in subsection 97(1), and
(ii) the microbial and chemical contaminants it contains or has on it remain within the limits referred to in section 101.1.
Marginal note:No expiry date — edible cannabis
(2.1) The label of a container in which edible cannabis is packaged must not include an expiry date.
Marginal note:Stability period — retention of document
(3) The holder of the licence for processing that manufactured the cannabis product must, if they include an expiry date on the label of the container, retain a document that contains the data referred to in subsection (2) for at least two years after the day on which the last sale or distribution of any portion of the lot or batch of the cannabis product with that expiry date takes place, other than for destruction.
Marginal note:Rotation
(4) The health warning messages referred to in paragraph (1)(e) must be displayed in rotation on each type of container of each brand name of the cannabis product that is packaged in a year, so that each health warning message is displayed, to the extent possible, on equal numbers of containers of that product.
Marginal note:Non-application — sections 26 and 27 of Act
(5) Sections 26 and 27 of the Act do not apply with respect to the name and email address that are included on the label in accordance with paragraph (1)(a).
Marginal note:Wrapper
123.1 (1) The interior and exterior surface of a wrapper must
(a) not display any brand element;
(b) not display any image or information;
(c) be one uniform colour, which may be different for each surface;
(d) not be fluorescent, have fluorescent properties in the ink or have pigments that absorb ultraviolet energy and transmit it as a longer wavelength, such as the Pantone 800 series;
(e) have a smooth texture without any embossing or decorative ridges;
(f) not include any hidden feature that is designed to change the appearance of the wrapper, such as heat-activated ink or a feature that is visible only through technological means; and
(g) not be capable of emitting a scent or sound.
Marginal note:Standardized cannabis symbol
(2) Despite paragraph (1)(b), the standardized cannabis symbol that must be obtained from the Minister in the form of an electronic file must be clearly and prominently displayed on the exterior surface of any wrapper if the concentration of THC in the cannabis that is in direct contact with the wrapper or that is in the cannabis accessory that is in direct contact with the wrapper is greater than 10 μg/g, taking into account the potential to convert THCA into THC.
Marginal note:Requirements
(3) The standardized cannabis symbol must meet the following requirements:
(a) it must be at least 1.27 cm by 1.27 cm in size;
(b) it must be displayed with a white border of at least 2 points on all sides; and
(c) if a change is made to the size of the symbol, its dimensions must be proportional vertically and horizontally.
Marginal note:Dried cannabis or fresh cannabis — discrete units and not intended for inhalation
124 (1) In the case of dried cannabis or fresh cannabis — or a cannabis accessory that contains dried cannabis or fresh cannabis — that is in discrete units and is not intended to be consumed by means of inhalation, the label of any container in which the cannabis product is packaged must also include the following information:
(a) the net weight, in grams, of dried cannabis or fresh cannabis;
(b) the number of units;
(c) the net weight, in grams, of dried cannabis or fresh cannabis in each unit;
(d) the quantity of THC, in milligrams, in each unit, preceded by “THC per unit”;
(e) the quantity of THC, in milligrams, that each unit could yield, taking into account the potential to convert THCA into THC, preceded by “Total THC per unit”;
(f) the quantity of CBD, in milligrams, in each unit, preceded by “CBD per unit”;
(g) the quantity of CBD, in milligrams, that each discrete unit could yield, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD per unit”; and
(h) the intended use of the cannabis product.
Marginal note:Maximum quantity of THC on label
(2) The quantity of THC that is included, in accordance with paragraph (1)(e), on the label of a container in which is packaged dried cannabis or fresh cannabis — or a cannabis accessory that contains dried cannabis or fresh cannabis — that is intended for ingestion or nasal, rectal or vaginal use must not exceed 10 mg.
Marginal note:Dried cannabis or fresh cannabis — discrete units and intended for inhalation
124.1 In the case of dried cannabis or fresh cannabis — or a cannabis accessory that contains dried cannabis or fresh cannabis — that is in discrete units and is intended to be consumed by means of inhalation, the label of any container in which the cannabis product is packaged must also include the following information:
(a) the net weight, in grams, of dried cannabis or fresh cannabis;
(b) the number of units;
(c) the net weight, in grams, of dried cannabis or fresh cannabis in each unit;
(d) the concentration of THC, in milligrams per gram, preceded by “THC”;
(e) the concentration of THC, in milligrams per gram, that the dried cannabis or fresh cannabis could yield, taking into account the potential to convert THCA into THC, preceded by “Total THC”;
(f) the concentration of CBD, in milligrams per gram, preceded by “CBD”;
(g) the concentration of CBD, in milligrams per gram, that the dried cannabis or fresh cannabis could yield, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD”; and
(h) the intended use of the cannabis product.
Marginal note:Dried cannabis or fresh cannabis — not in discrete units
125 In the case of dried cannabis or fresh cannabis — or a cannabis accessory that contains dried cannabis or fresh cannabis — that is not in discrete units, the label of any container in which the cannabis product is packaged must also include the following information:
(a) the net weight, in grams, of dried cannabis or fresh cannabis;
(b) the concentration of THC, in milligrams per gram, preceded by “THC”;
(c) the concentration of THC, in milligrams per gram, that the dried cannabis or fresh cannabis could yield, taking into account the potential to convert THCA into THC, preceded by “Total THC”;
(d) the concentration of CBD, in milligrams per gram, preceded by “CBD”; and
(e) the concentration of CBD, in milligrams per gram, that the dried cannabis or fresh cannabis could yield, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD”.
126 [Repealed, SOR/2019-206, s. 43]
127 [Repealed, SOR/2019-206, s. 43]
Marginal note:Cannabis plants
128 In the case of a cannabis plant, the number of plants in the container must be included on the label that is applied to any container in which a cannabis product is packaged.
Marginal note:Cannabis plant seeds
129 In the case of cannabis plant seeds, the number of seeds in the container must be included on the label that is applied to any container in which a cannabis product is packaged.
Marginal note:Presentation of information — general requirement
130 (1) All information that is included on a label must be in English and in French, except for the INCI name and the European Union (EU) technical name.
Marginal note:Presentation — required information
(2) All information that is required to be included on a label must be clearly and prominently displayed and readily discernible under the customary conditions of purchase and use.
Marginal note:Other required information
(3) All information that is required to be included on a label, other than the brand name, the standardized cannabis symbol and the health warning message must meet the following requirements:
(a) subject to subparagraph (e)(ii), it must be in a regular weight and width standard sans serif font, without italics, in the colour black and with leading of at least 7 points;
(b) it must be in one single font type;
(c) it must be in a type size of at least 6 points and smaller than the type size used for the health warning message;
(d) it must be on a white background that extends at least 6 points on all sides away from the information; and
(e) in the case of the information required under paragraphs 124(1)(d) to (g), 124.1(d) to (g), 125(b) to (e), 132.1(1)(d) to (g), 132.11(d) to (g), 132.12(1)(b) to (e), 132.15(d) to (g), 132.16(b) to (e), 132.18(1)(c) to (j) and 132.19(1)(b) to (e), it must be
(i) displayed on the principal display panel, or if there are separate principal display panels for English and French, on each principal display panel,
(ii) in bold type, and
(iii) at least 6 points away from any other information.
Marginal note:Brand name
(4) The brand name that is required to be included on a label must meet the following requirements:
(a) it must be in a type size that is smaller than or equal to the type size used for the health warning message;
(b) it must not be a colour that has the lustre of metal or has metallic properties in the ink, such as Pantone Metallics or Pantone Premium Metallics;
(c) it must not be a colour that is fluorescent, has fluorescent properties in the ink or has pigments that absorb ultraviolet energy and transmit it as a longer wavelength, such as the Pantone 800 series; and
(d) it must be displayed only once on the principal display panel, or if there are separate principal display panels for English and French, only once on each principal display panel.
Marginal note:Standardized cannabis symbol
(5) The standardized cannabis symbol that is required to be included on a label must meet the following requirements:
(a) it must appear in the upper left 25% of the principal display panel, or if there are separate principal display panels for English and French, in the upper left 25% of each principal display panel;
(b) it must be at least 1.27 cm by 1.27 cm in size;
(c) it must be displayed with a white border of at least 2 points on all sides;
(d) it must be oriented in such a manner that its text is readable from left to right when the container is displayed or visible under the customary conditions of purchase and use; and
(e) if a change is made to the size of the symbol, its dimensions must be proportional vertically and horizontally.
Marginal note:Health warning message
(6) The health warning message that is required to be included on a label must meet the following requirements:
(a) it must be displayed on the principal display panel or, if there are separate principal display panels for English and French, on each principal display panel;
(b) subject to paragraphs (c) and (d), it must be in a regular weight and width standard sans serif font, without italics, in the colour black and with leading of at least 8 points;
(c) the word “WARNING” must be in upper case letters and bold type;
(d) the first sentence must be in sentence case letters and bold type;
(e) the second sentence must be in sentence case letters;
(f) it must be in the same font type as that used for the information referred to in subsection (3);
(g) it must be in a type size of at least 7 points and the type size must be equal to or larger than the type size used for the brand name;
(h) it must be within a black border that is a solid line of at least 1 point and that has an inset of at least 6 points on all sides between the message and the border;
(i) the background colour must be yellow with the CMYK value (C=0 M=0 Y=100 K=0);
(j) the message must be
(i) left-justified without hyphenation, and
(ii) oriented in such a manner that its text is readable from left to right when the container is displayed or visible under the customary conditions of purchase and use; and
(iii) [Repealed, SOR/2019-206, s. 44]
(k) in the case where there is one principal display panel, there must be at least 3 points between the English and French message.
Marginal note:Attribution
(7) Any attribution to the source of the health warning message that is included on the label must meet the following requirements:
(a) only the following attributions may be displayed:
(i) if there is one principal display panel, the words “Health Canada / Santé Canada”, and
(ii) if there are separate principal display panels for English and French, the words “Health Canada” for the English display panel and the words “Santé Canada” for the French display panel;
(b) it must be in the same font type as that used for the information referred to in subsection (3);
(c) it must be in a type size of at least 6 points and smaller than the type size used for the health warning message; and
(d) it must be inside the border of the health warning message and be displayed in the bottom right corner below the health warning message text, with leading of at least 7 points.
Marginal note:Other information
(8) Any other information that is included on the label must meet the following requirements:
(a) it must be in regular weight and width standard sans serif font, without italics, and in black or white colour; and
(b) it must be in a type size that is smaller than or equal to the type size used for the information referred to in subsection (3).
Marginal note:Brand element
(9) A label may include only one brand element, other than a brand name, if that brand element meets the following requirements:
(a) it must be displayed only once on the principal display panel or, if there are separate principal display panels for English and French, only once on each principal display panel;
(b) it must not be a colour that has the lustre of metal or has metallic properties in the ink, such as Pantone Metallics or Pantone Premium Metallics;
(c) it must not be a colour that is fluorescent, has fluorescent properties in the ink or has pigments that absorb ultraviolet energy and transmit it as a longer wavelength, such as the Pantone 800 series;
(d) if the brand element is an image, its surface area must be
(i) in the case where the standardized cannabis symbol must be included on the label in accordance with paragraph 123(1)(f), smaller than or equal to the surface area of the standardized cannabis symbol, or
(ii) in any other case, smaller than or equal to 25% of the principal display panel and smaller than or equal to the surface area within the border that surrounds the health warning message that is included on the label in accordance with paragraph (6)(h); and
(e) if the brand element is text only, its type size must be smaller than or equal to the type size used for the health warning message.
Marginal note:Image
(10) The label may include an image that is printed in black and white and that provides instructions on how to open the container.
Marginal note:Location of information on irradiation — edible cannabis
(11) Information that is required to be included on a label under paragraph 132.18(1)(p) or 132.19(1)(k) must be displayed on the principal display panel or, if there are separate principal display panels for English and French, on each principal display panel.
Marginal note:Representation resembling standardized cannabis symbol
131 A representation, such as an illustration, sign, mark, symbol or design, that so closely resembles the standardized cannabis symbol that it is likely to be mistaken for that symbol must not appear on any container in which a cannabis product is packaged.
Marginal note:Insert or leaflet
132 Except as otherwise provided under the Act, any other Act of Parliament or any provincial Act, any container in which a cannabis product is packaged must not include, or be accompanied by, an insert or leaflet.
Marginal note:Cannabis extract — discrete units and not intended for inhalation
132.1 (1) In the case of a cannabis extract — or a cannabis accessory that contains a cannabis extract — that is in discrete units and is not intended to be consumed by means of inhalation, the label of any container in which the cannabis product is packaged must also include the following information:
(a) the net weight, in grams, of the cannabis extract;
(b) the number of units;
(c) the net weight, in grams, of the cannabis extract in each unit;
(d) the quantity of THC, in milligrams, in each unit, preceded by “THC per unit”;
(e) the quantity of THC, in milligrams, that each unit could yield, taking into account the potential to convert THCA into THC, preceded by “Total THC per unit”;
(f) the quantity of CBD, in milligrams, in each unit, preceded by “CBD per unit”;
(g) the quantity of CBD, in milligrams, that each unit could yield, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD per unit”;
(h) a list of the ingredients of the cannabis extract;
(i) the name of any food allergen that is present in the cannabis extract, except as a result of cross-contamination;
(j) the identity of the cannabis product in terms of its common name or in terms of its function; and
(k) the intended use of the cannabis product.
Marginal note:Maximum quantity of THC on label
(2) The quantity of THC that is included on the label, in accordance with paragraph (1)(e), of a container in which is packaged a cannabis extract — or in which is packaged a cannabis accessory that contains a cannabis extract — that is intended for ingestion or nasal, rectal or vaginal use must not exceed 10 mg.
Marginal note:Cannabis extract — discrete units and intended for inhalation
132.11 In the case of a cannabis extract — or a cannabis accessory that contains a cannabis extract — that is in discrete units and is intended to be consumed by means of inhalation, the label of any container in which the cannabis product is packaged must also include the following information:
(a) the net weight, in grams, of the cannabis extract;
(b) the number of units;
(c) the net weight, in grams, of the cannabis extract in each unit;
(d) the concentration of THC, in milligrams per gram, in the cannabis extract, preceded by “THC”;
(e) the concentration of THC, in milligrams per gram, that the cannabis extract could yield, taking into account the potential to convert THCA into THC, preceded by “Total THC”;
(f) the concentration of CBD, in milligrams per gram, in the cannabis extract, preceded by “CBD”;
(g) the concentration of CBD, in milligrams per gram, that the cannabis extract could yield, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD”;
(h) a list of the ingredients of the cannabis extract;
(i) the name of any food allergen that is present in the cannabis extract, except as a result of cross-contamination;
(j) the identity of the cannabis product in terms of its common name or in terms of its function; and
(k) the intended use of the cannabis product.
Marginal note:Cannabis extract — not in discrete units
132.12 (1) In the case of a cannabis extract — or a cannabis accessory that contains a cannabis extract — that is not in discrete units, the label of any container in which the cannabis product is packaged must also include the following information:
(a) the net weight, in grams, of the cannabis extract;
(b) the concentration of THC, in milligrams per gram, in the cannabis extract, preceded by “THC”;
(c) the concentration of THC, in milligrams per gram, that the cannabis extract could yield, taking into account the potential to convert THCA into THC, preceded by “Total THC”;
(d) the concentration of CBD, in milligrams per gram, in the cannabis extract, preceded by “CBD”;
(e) the concentration of CBD, in milligrams per gram, that the cannabis extract could yield, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD”;
(f) in the case of a cannabis accessory that contains a cannabis extract intended for ingestion or nasal, rectal or vaginal use or that is packaged with and is intended to dispense the extract,
(i) the quantity of THC, in milligrams, that each activation of the accessory dispenses, taking into account the potential to convert THCA into THC, preceded by “Total THC per activation”, and
(ii) the quantity of CBD, in milligrams, that each activation of the accessory dispenses, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD per activation”;
(g) a list of the ingredients of the cannabis extract;
(h) the name of any food allergen that is present in the cannabis extract, except as a result of cross-contamination;
(i) the identity of the cannabis product in terms of its common name or in terms of its function; and
(j) the intended use of the cannabis product.
Marginal note:Maximum quantity of THC on label
(2) The quantity of THC that is included on the label in accordance with subparagraph (1)(f)(i) must not exceed 10 mg.
Marginal note:Flavours — cannabis extract
132.13 (1) It is prohibited to display on a cannabis extract that is a cannabis product or on a cannabis accessory that contains a cannabis extract and that is a cannabis product — or on the package of such a cannabis product or on the label or panel of a container in which such a cannabis product is packaged — an indication or illustration, including a brand element, that could cause a person to believe that the cannabis product has a flavour set out in column 1 of Schedule 3 to the Tobacco and Vaping Products Act, other than the flavour of cannabis.
Marginal note:Non-application — name and email address
(2) Subsection (1) does not apply with respect to the name and email address that are included on the label in accordance with paragraph 123(1)(a).
Marginal note:List of ingredients — cannabis extract
132.14 (1) The list of ingredients of a cannabis extract — or of a cannabis accessory that contains a cannabis extract — must meet the following requirements:
(a) the word “Ingredients” in the English version and the word “Ingrédients” in the French version must appear at the beginning of the list;
(b) no intervening printed, written or graphic material is to appear between the word referred to in paragraph (a) and the first ingredient in the list; and
(c) the ingredients must be
(i) set out in descending order of their proportion of the cannabis extract by weight, determined before the ingredients are combined to form the extract,
(ii) in the case of vitamins referred to in subsection 101.3(3), set out by their chemical name,
(iii) in any other case, set out by their common name or chemical name, and
(iv) separated from other ingredients by a comma.
Marginal note:Ingredients in proportion of 1% or less
(2) Despite subparagraph (1)(c)(i), ingredients that are present in a proportion of 1% or less of the cannabis extract may be listed in any order after the ingredients that are present in a proportion of more than 1% of the cannabis extract.
Marginal note:Exception — flavouring agent
(3) Despite paragraph (1)(c), in the case where the cannabis extract contains one flavouring agent, it may be shown individually at the end of the list of ingredients by the name “flavouring agent” and in the case where the cannabis extract contains more than one flavouring agent, they may be shown collectively at the end of the list of ingredients by the name “flavouring agents”.
Marginal note:No individual listing of flavouring agent
(4) If flavouring agents are shown collectively by the name “flavouring agents” under subsection (3), a flavouring agent must not be shown individually in the list of ingredients.
Marginal note:Cannabis topical — discrete units
132.15 In the case of a cannabis topical — or a cannabis accessory that contains a cannabis topical — that is in discrete units, the label of any container in which the cannabis product is packaged must also include the following information:
(a) the net weight, in grams, of the cannabis topical;
(b) the number of units;
(c) the net weight, in grams, of the cannabis topical in each unit;
(d) either the quantity of THC, in milligrams, or the concentration of THC, in milligrams per gram, in each unit, preceded by “THC per unit”;
(e) either the quantity of THC, in milligrams, or the concentration of THC, in milligrams per gram, that each unit could yield, taking into account the potential to convert THCA into THC, preceded by “Total THC per unit”;
(f) either the quantity of CBD, in milligrams, or the concentration of CBD, in milligrams per gram, in each unit, preceded by “CBD per unit”;
(g) either the quantity of CBD, in milligrams, or the concentration of CBD, in milligrams per gram, that each unit could yield, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD per unit”;
(h) a list of the ingredients of the cannabis topical;
(i) the identity of the cannabis product in terms of its common name or in terms of its function; and
(j) the intended use of the cannabis product.
Marginal note:Cannabis topical — not in discrete units
132.16 In the case of a cannabis topical — or a cannabis accessory that contains a cannabis topical — that is not in discrete units, the label of any container in which the cannabis product is packaged must also include the following information:
(a) the net weight, in grams, of the cannabis topical;
(b) either the quantity of THC, in milligrams, or the concentration of THC, in milligrams per gram, in the cannabis topical, preceded by “THC”;
(c) either the quantity of THC, in milligrams, or the concentration of THC, in milligrams per gram, that the cannabis topical could yield, taking into account the potential to convert THCA into THC, preceded by “Total THC”;
(d) either the quantity of CBD, in milligrams, or the concentration of CBD, in milligrams per gram, in the cannabis topical, preceded by “CBD”;
(e) either the quantity of CBD, in milligrams, or the concentration of CBD, in milligrams per gram, that the cannabis topical could yield, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD”;
(f) a list of the ingredients of the cannabis topical;
(g) the identity of the cannabis product in terms of its common name or in terms of its function; and
(h) the intended use of the cannabis product.
Marginal note:List of ingredients – cannabis topical
132.17 (1) The list of ingredients of a cannabis topical — or of a cannabis accessory that contains a cannabis topical — must meet the following requirements:
(a) the word “Ingredients” in the English version and the word “Ingrédients” in the French version must appear at the beginning of the list;
(b) no intervening printed, written or graphic material is to appear between the term referred to in paragraph (a) and the first ingredient in the list; and
(c) the ingredients are to be separated from other ingredients by a comma and shown in descending order of their proportion of the cannabis topical by weight, determined before the ingredients are combined to form the cannabis topical, as follows:
(i) by their INCI name,
(ii) if an ingredient has no INCI name, by its chemical name,
(iii) in the case of a botanical, by specifying at least the genus and species portions of its INCI name or, if it has no INCI name, by its chemical name, or
(iv) if an ingredient is included in the schedule to the Cosmetic Regulations, by its EU technical name set out in column 1 of that schedule, or by the appropriate INCI name set out in column 2 of that schedule and the appropriate French equivalent set out in column 3 of that schedule.
Marginal note:Ingredients in proportion of 1% or less
(2) Despite paragraph (1)(c), ingredients that are present in a proportion of 1% or less and all colouring agents of the cannabis topical may be listed in any order after the ingredients that are present in a proportion of more than 1% of the cannabis topical.
Marginal note:Fragrance and flavour
(3) The word “parfum” or “aroma”, respectively, may be inserted at the end of the list of ingredients to indicate that an ingredient has been added to the cannabis topical to produce a fragrance or flavour.
Marginal note:Definition of botanical
(4) For the purposes of this section, botanical means an ingredient that is directly derived from a plant and that has not been chemically modified before it is used in the production of a cannabis topical.
Marginal note:Edible cannabis — discrete units
132.18 (1) In the case of edible cannabis — or a cannabis accessory that contains edible cannabis — that is in discrete units, the label of any container in which the cannabis product is packaged must also include the following information:
(a) if the edible cannabis is in solid form, its net weight, in grams, and in any other case, its net volume, in millilitres;
(b) the number of units;
(c) the quantity of THC, in milligrams, in each unit, preceded by “THC per unit”;
(d) the quantity of THC, in milligrams, that each unit could yield, taking into account the potential to convert THCA into THC, preceded by “Total THC per unit”;
(e) the quantity of THC, in milligrams, in the edible cannabis, preceded by “THC”;
(f) the quantity of THC, in milligrams, that the edible cannabis could yield, taking into account the potential to convert THCA into THC, preceded by “Total THC”;
(g) the quantity of CBD, in milligrams, in each unit, preceded by “CBD per unit”;
(h) the quantity of CBD, in milligrams, that each unit could yield, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD per unit”;
(i) the quantity of CBD, in milligrams, in the edible cannabis, preceded by “CBD”;
(j) the quantity of CBD, in milligrams, that the edible cannabis could yield, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD”;
(k) a list of the ingredients of the edible cannabis, including constituents, if any;
(l) the source of any food allergen or gluten present in the edible cannabis, except as a result of cross-contamination,
(i) in a food allergen source, gluten source and added sulphites statement, if the food allergen or gluten
(A) is, or is present in, an ingredient that is not shown in the list of ingredients, but is not a constituent of that ingredient or present in a constituent of that ingredient, or
(B) is, or is present in, a constituent and neither the constituent nor the ingredient in which it is present is shown in the list of ingredients, or
(ii) in all other cases, either in the list of ingredients or in a food allergen source, gluten source and added sulphites statement;
(m) the sulphites that are present in the edible cannabis in an amount of 10 p.p.m. or more,
(i) if at least one sulphite is required to be shown in the list of ingredients under these Regulations, in the list of ingredients, or in the list of ingredients and in a food allergen source, gluten source and added sulphites statement, or
(ii) in any other case, in the list of ingredients, in a food allergen source, gluten source and added sulphites statement or in both;
(n) a nutrition facts table that contains only the information set out in column 1 of the table to section 132.22, expressed using a description set out in column 2, in the unit set out in column 3 and in the manner set out in column 4;
(o) the common name of the cannabis product;
(p) if the edible cannabis is irradiated under section 102.6, the symbol set out in subsection B.01.035(5) of the Food and Drug Regulations and one of the following statements or a statement that has the same meaning:
(i) “treated with radiation”,
(ii) “treated by irradiation”, or
(iii) “irradiated”; and
(q) if an irradiated food referred to in column 1 of the table to Division 26 of Part B of the Food and Drug Regulations is an ingredient or constituent of the edible cannabis and constitutes 10% or more of the edible cannabis, the statement “irradiated” preceding any mention of the ingredient or constituent on the label.
Marginal note:Maximum quantity of THC on label
(2) The quantity of THC that is included on the label in accordance with paragraph (1)(f) must not exceed 10 mg.
Marginal note:Ingredient not required to be listed
(3) Despite paragraph (1)(k), if one or more constituents of an ingredient are required by these Regulations to be listed in a list of ingredients, the ingredient is not required to be listed if all constituents of the ingredient are shown in the list by their common names and in accordance with subparagraphs 132.21(1)(c)(i) and (ii).
Marginal note:Risk of cross-contamination
(4) Despite paragraph (1)(l), the source of a food allergen or gluten must be shown on the label if it includes a declaration alerting consumers that, due to a risk of cross-contamination, the edible cannabis may contain the source of a food allergen or gluten.
Marginal note:Edible cannabis — not in discrete units
132.19 (1) In the case of edible cannabis — or a cannabis accessory that contains edible cannabis — that is not in discrete units, the label of any container in which the cannabis product is packaged must also include the following information:
(a) if the edible cannabis is in solid form, its net weight, in grams, and in any other case, its net volume, in millilitres;
(b) the quantity of THC, in milligrams, in the edible cannabis, preceded by “THC”;
(c) the quantity of THC, in milligrams, that the edible cannabis could yield, taking into account the potential to convert THCA into THC, preceded by “Total THC”;
(d) the quantity of CBD, in milligrams, in the edible cannabis, preceded by “CBD”;
(e) the quantity of CBD, in milligrams, that the edible cannabis could yield, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD”;
(f) a list of the ingredients of the edible cannabis, including constituents, if any;
(g) the source of any food allergen or gluten present in the edible cannabis, except as a result of cross-contamination,
(i) in a food allergen source, gluten source and added sulphites statement, if the food allergen or gluten
(A) is, or is present in, an ingredient that is not shown in the list of ingredients, but is not a constituent of that ingredient or present in a constituent of that ingredient, or
(B) is, or is present in, a constituent and neither the constituent nor the ingredient in which it is present is shown in the list of ingredients, or
(ii) in all other cases, either in the list of ingredients or in a food allergen source, gluten source and added sulphites statement;
(h) the sulphites that are present in the edible cannabis in an amount of 10 p.p.m. or more,
(i) if at least one sulphite is required to be shown in the list of ingredients under these Regulations, in the list of ingredients, or in the list of ingredients and in a food allergen source, gluten source and added sulphites statement, or
(ii) in any other case, in the list of ingredients, in a food allergen source, gluten source and added sulphites statement or in both;
(i) a nutrition facts table that contains only the information set out in column 1 of the table to section 132.22, expressed using a description set out in column 2, in the unit set out in column 3 and in the manner set out in column 4;
(j) the common name of the cannabis product;
(k) if the edible cannabis is irradiated under section 102.6, the symbol set out in subsection B.01.035(5) of the Food and Drug Regulations and one of the following statements or a statement that has the same meaning:
(i) “treated with radiation”,
(ii) “treated by irradiation”, or
(iii) “irradiated”; and
(l) if an irradiated food referred to in column 1 of the table to Division 26 of Part B of the Food and Drug Regulations is an ingredient or constituent of the edible cannabis and constitutes 10% or more of the edible cannabis, the statement “irradiated” preceding any mention of the ingredient or constituent on the label.
Marginal note:Maximum quantity of THC on label
(2) The quantity of THC that is included on the label in accordance with paragraph (1)(c) must not exceed 10 mg.
Marginal note:Ingredient not required to be listed
(3) Despite paragraph (1)(f), if one or more constituents of an ingredient are required by these Regulations to be listed in a list of ingredients, the ingredient is not required to be listed if all constituents of the ingredient are shown in the list by their common names and in accordance with subparagraphs 132.21(1)(c)(i) and (ii).
Marginal note:Risk of cross-contamination
(4) Despite paragraph (1)(g), the source of a food allergen or gluten must be shown on the label if it includes a declaration alerting consumers that, due to a risk of cross-contamination, the edible cannabis may contain the source of a food allergen or gluten.
Marginal note:Durable life date required
132.2 (1) In the case of edible cannabis having a durable life of 90 days or less, the durable life date must be shown on the label of any container in which the edible cannabis is packaged.
Marginal note:Format of durable life date
(2) Any durable life date on the label of any container in which edible cannabis is packaged must be shown in accordance with subsections B.01.007(4) and (5) of the Food and Drug Regulations.
Marginal note:List of ingredients – edible cannabis
132.21 (1) The list of ingredients of edible cannabis — or of a cannabis accessory that contains edible cannabis — must meet the following requirements:
(a) the word “Ingredients” in the English version and the word “Ingrédients” in the French version must appear at the beginning of the list;
(b) no intervening printed, written or graphic material is to appear between the word referred to in paragraph (a) and the first ingredient in the list;
(c) the ingredients and constituents must be
(i) set out in descending order of their proportion of the edible cannabis by weight, determined before the ingredients and the constituents are combined to form the edible cannabis,
(ii) separated from other ingredients or constituents by a comma, and
(iii) set out by the applicable name set out in column 2 of Table 1 of the Common Names for Ingredients and Components Document or, if none applies, by their common name;
(d) the constituents of an ingredient must be shown
(i) set out in parentheses, immediately after the ingredient, unless the source of a food allergen or gluten is set out immediately after the ingredient, in which case the constituent of the ingredient must be set out immediately after that source,
(ii) set out in descending order of their proportion of the ingredient by weight, determined before they are combined to form the edible cannabis, and
(iii) separated from other constituents by a comma;
(e) the source of a food allergen or gluten must be
(i) set out in parentheses,
(ii) set out immediately after an ingredient that is shown in that list, if the food allergen or gluten
(A) is the ingredient,
(B) is present in the ingredient, but is not a constituent of or present in a constituent of that ingredient, or
(C) is, or is present in, a constituent of the ingredient and the constituent is not shown in the list of ingredients,
(iii) set out immediately after the constituent that is shown in the list, if the food allergen or gluten is that constituent or is present in that constituent, and
(iv) separated by a comma from other sources of a food allergen or gluten that is shown for the same ingredient or constituent;
(f) sulphites must be shown
(i) set out by one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”, or individually by the applicable name set out in the applicable item, column 1 of the applicable Table of the Common Names for Ingredients and Components Document,
(ii) in the case of the name “sodium dithionite”, “sulphur dioxide” or “sulphurous acid”, set out by that name, followed by one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents” in parentheses, unless
(A) the word “sulfite” or “sulphite” appears in the common name of another sulphite in the list,
(B) one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents” is set out in parentheses following another sulphite in the list, or
(C) one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents” is shown in a food allergen source, gluten source and added sulphites statement on the label, and
(iii) set out at the end of the list where they may be shown in any order with the other ingredients that are shown at the end of that list in accordance with subsection (3) or in parentheses immediately after the ingredient of which they are a constituent; and
(g) if the edible cannabis contains one or more sugars-based ingredients,
(i) the word “Sugars” in the English version of the list and the word “Sucres” in the French version of the list must appear
(A) despite subparagraph (c)(i), in descending order of the proportion of all the sugars-based ingredients in the edible cannabis by weight, determined before they are combined to form the edible cannabis, and
(B) separated from other ingredients by a comma, and
(ii) each sugars-based ingredient must be shown
(A) set out in parentheses, immediately following the word “Sugars” in the English version of the list and the word “Sucres” in the French version of the list,
(B) set out in descending order of its proportion of the edible cannabis by weight, determined before it is combined to form the edible cannabis, and
(C) separated from other sugars-based ingredients by a comma.
Marginal note:Exception — ingredients and constituents shown collectively
(2) Despite paragraph (1)(c), the ingredients and the constituents set out in column 1 of Table 2 of the Common Names for Ingredients and Components Document may be shown collectively in the list of ingredients by the common name set out in column 2 of that Table, unless one of the ingredients or constituents in column 1 is shown separately in the list of ingredients by its common name.
Marginal note:Exception — ingredients at the end of the list
(3) Despite subparagraph (1)(c)(i), the ingredients referred to in subsection B.01.008.2(4) of the Food and Drug Regulations, regardless of their proportion, may be listed at the end of the list of ingredients, in any order.
Marginal note:Exception — source of food allergen or gluten
(4) Despite paragraph (1)(e), the source of the food allergen or gluten is not required to be set out in parentheses immediately after the ingredient or constituent, as the case may be, if the source of the food allergen or gluten appears
(a) in the list of ingredients
(i) as part of the common name of the ingredient or constituent, or
(ii) in parentheses, in accordance with subparagraph (1)(e)(i), immediately after another ingredient or constituent; or
(b) in the food allergen source, gluten source and added sulphites statement.
Marginal note:Nutrition facts table
132.22 (1) The percentage of the daily value for a nutrient shown in the nutrition facts table on the label of any container in which edible cannabis is packaged must be established on the basis of the amount, by weight, of the nutrient per immediate container of edible cannabis, rounded off in the applicable manner set out in column 4 of the table to this section.
Marginal note:Not a significant source of a nutrient
(2) Information with respect to a nutrient set out in column 1 of the table to this section that may be expressed as “0” in the nutrition facts table may be omitted from that table if it includes the statement “Not a significant source of (naming each nutrient that is omitted from the nutrition facts table in accordance with this subsection)”.
Marginal note:Presentation
(3) Despite section 130, the nutrition facts table must be presented in accordance with the format specified in the applicable figure in the Directory of Nutrition Facts Table Formats for Edible Cannabis, as amended from time to time and published by the Government of Canada on its website, having regard to matters such as order of presentation, dimensions, spacing and use of upper and lower case letters and bold type.
TABLE
Information to be Included in the Nutrition Facts Table
Item Column 1 Column 2 Column 3 Column 4 Information Description Unit Manner of expression 1 Immediate container size “Per container (naming the amount of edible cannabis in the immediate container)” The size is expressed per immediate container in grams or millilitres. The size is rounded off
(a) if it is 0.1 g or more or 0.1 mL or more but less than 10 g or 10 mL, to the nearest multiple of 0.1 g or 0.1 mL; and
(b) if it is 10 g or more or 10 mL or more, to the nearest multiple of 1 g or 1 mL.
2 Energy value “Calories”, “Total Calories” or “Calories, Total” The value is expressed in calories per immediate container. The value is rounded off
(a) if it is less than 5 calories, to the nearest multiple of 1 calorie;
(b) if it is 5 calories or more but not more than 50 calories, to the nearest multiple of 5 calories; and
(c) if it is more than 50 calories, to the nearest multiple of 10 calories.
3 Amount of fat “Fat”, “Total Fat” or “Fat, Total” The amount is expressed
(a) in grams per immediate container; and
(b) as a percentage of the daily value per immediate container.
(1) The amount is rounded off
(a) if it is less than 0.5 g, to the nearest multiple of 0.1 g;
(b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and
(c) if it is more than 5 g, to the nearest multiple of 1 g.
(2) The percentage is rounded off
(a) if the amount is declared as “0 g”, to 0%; and
(b) in all other cases, to the nearest multiple of 1%.
4 Amount of saturated fatty acids “Saturated Fat”, “Saturated Fatty Acids”, “Saturated” or “Saturates” The amount is expressed in grams per immediate container. The amount is rounded off
(a) if it is less than 0.5 g, to the nearest multiple of 0.1 g;
(b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and
(c) if it is more than 5 g, to the nearest multiple of 1 g.
5 Amount of trans fatty acids “Trans Fat”, “Trans Fatty Acids” or “Trans” The amount is expressed in grams per immediate container. The amount is rounded off
(a) if it is less than 0.5 g, to the nearest multiple of 0.1 g;
(b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and
(c) if it is more than 5 g, to the nearest multiple of 1 g.
6 The sum of saturated fatty acids and trans fatty acids “Saturated Fat + Trans Fat”, “Saturated Fatty Acids + Trans Fatty Acids”, “Saturated + Trans” or “Saturates + Trans” The sum is expressed as a percentage of the daily value per immediate container. The percentage is rounded off
(a) if the amounts of saturated fatty acids and trans fatty acids are declared as “0 g”, to 0%; and
(b) in all other cases, to the nearest multiple of 1%.
7 Amount of cholesterol “Cholesterol” The amount is expressed in milligrams per immediate container. The amount is rounded off to the nearest multiple of 5 mg. 8 Amount of sodium “Sodium” The amount is expressed
(a) in milligrams per immediate container; and
(b) as a percentage of the daily value per immediate container.
(1) The amount is rounded off
(a) if it is less than 5 mg, to the nearest multiple of 1 mg;
(b) if it is 5 mg or more but not more than 140 mg, to the nearest multiple of 5 mg; and
(c) if it is more than 140 mg, to the nearest multiple of 10 mg.
(2) The percentage is rounded off
(a) if the amount is declared as “0 mg”, to 0%; and
(b) in all other cases, to the nearest multiple of 1%.
9 Amount of carbohydrate “Carbohydrate”, “Total Carbohydrate” or “Carbohydrate, Total” The amount is expressed in grams per immediate container. The amount is rounded off
(a) if it is less than 0.5 g, to 0 g; and
(b) if it is 0.5 g or more, to the nearest multiple of 1 g.
10 Amount of fibre “Fibre”, “Fiber”, “Dietary Fibre” or “Dietary Fiber” The amount is expressed
(a) in grams per immediate container; and
(b) as a percentage of the daily value per immediate container.
(1) The amount is rounded off
(a) if it is less than 0.5 g, to 0 g; and
(b) if it is 0.5 g or more, to the nearest multiple of 1 g.
(2) The percentage is rounded off
(a) if the amount is declared as “0 g”, to 0%; and
(b) in all other cases, to the nearest multiple of 1%.
11 Amount of sugars “Sugars” The amount is expressed
(a) in grams per immediate container; and
(b) as a percentage of the daily value per immediate container.
(1) The amount is rounded off
(a) if it is less than 0.5 g, to 0 g; and
(b) if it is 0.5 g or more, to the nearest multiple of 1 g.
(2) The percentage is rounded off
(a) if the amount is declared as “0 g”, to 0%; and
(b) in all other cases, to the nearest multiple of 1%.
12 Amount of protein “Protein” The amount is expressed in grams per immediate container. The amount is rounded off
(a) if it is less than 0.5 g, to the nearest multiple of 0.1 g; and
(b) if it is 0.5 g or more, to the nearest multiple of 1 g.
13 Amount of potassium “Potassium” The amount is expressed
(a) in milligrams per immediate container; and
(b) as a percentage of the daily value per immediate container.
(1) The amount is rounded off
(a) if it is less than 5 mg, to 0 mg;
(b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg;
(c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and
(d) if it is 250 mg or more, to the nearest multiple of 50 mg.
(2) The percentage is rounded off
(a) if the amount is declared as “0 mg”, to 0%; and
(b) in all other cases, to the nearest multiple of 1%.
14 Amount of calcium “Calcium” The amount is expressed
(a) in milligrams per immediate container; and
(b) as a percentage of the daily value per immediate container.
(1) The amount is rounded off
(a) if it is less than 5 mg, to 0 mg;
(b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg;
(c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and
(d) if it is 250 mg or more, to the nearest multiple of 50 mg.
(2) The percentage is rounded off
(a) if the amount is declared as “0 mg”, to 0%; and
(b) in all other cases, to the nearest multiple of 1%.
15 Amount of iron “Iron” The amount is expressed
(a) in milligrams per immediate container; and
(b) as a percentage of the daily value per immediate container.
(1) The amount is rounded off
(a) if it is less than 0.05 mg, to 0 mg;
(b) if it is 0.05 mg or more but less than 0.5 mg, to the nearest multiple of 0.1 mg;
(c) if it is 0.5 mg or more but less than 2.5 mg, to the nearest multiple of 0.25 mg; and
(d) if it is 2.5 mg or more, to the nearest multiple of 0.5 mg.
(2) The percentage is rounded off
(a) if the amount is declared as “0 mg”, to 0%; and
(b) in all other cases, to the nearest multiple of 1%.
Marginal note:Presentation of source of food allergen
132.23 (1) The source of a food allergen required to be shown in the list of ingredients or in the food allergen source, gluten source and added sulphites statement under paragraph 132.18(1)(l) or 132.19(1)(g) must be set out
(a) for a food allergen from a food referred to in one of paragraphs (a), (b) and (e) of the definition food allergen in subsection B.01.010.1(1) of the Food and Drug Regulations or derived from that food, by the name of the food as shown in the applicable paragraph, expressed in the singular or plural;
(b) for a food allergen from the food referred to in paragraph (c) of the definition food allergen in subsection B.01.010.1(1) of the Food and Drug Regulations or derived from that food, by the name “sesame”, “sesame seed” or “sesame seeds”;
(c) for a food allergen from a food referred to in paragraph (d) or (f) of the definition food allergen in subsection B.01.010.1(1) of the Food and Drug Regulations or derived from that food, by the name of the food as shown in the applicable paragraph;
(d) for a food allergen from the food referred to in paragraph (g) of the definition food allergen in subsection B.01.010.1(1) of the Food and Drug Regulations or derived from that food, by the name “soy”, “soya”, “soybean” or “soybeans”;
(e) for a food allergen from a food referred to in one of paragraphs (h) to (j) of the definition food allergen in subsection B.01.010.1(1) of the Food and Drug Regulations or derived from that food, by the common name of the food set out in the applicable item, column 2 of the applicable Table of the Common Names for Ingredients and Components Document; and
(f) for a food allergen from the food referred to in paragraph (k) of the definition food allergen in subsection B.01.010.1(1) of the Food and Drug Regulations or derived from that food, by the name “mustard”, “mustard seed” or “mustard seeds”.
Marginal note:Presentation of source of gluten
(2) The source of gluten required to be shown in the list of ingredients or in the food allergen source, gluten source and added sulphites statement under paragraph 132.18(1)(l) or 132.19(1)(g) must be set out
(a) for gluten from the grain of a cereal referred to in one of subparagraphs (a)(i) to (v) of the definition gluten in subsection B.01.010.1(1) of the Food and Drug Regulations or derived from that grain, by the name of the cereal as shown in the applicable subparagraph; and
(b) for gluten from the grain of a hybridized strain created from one or more of the cereals referred to in subparagraphs (a)(i) to (v) of the definition gluten in subsection B.01.010.1(1) of the Food and Drug Regulations or derived from that grain, by the names of the cereals as shown in the applicable subparagraphs.
Marginal note:Declaration on risk of cross-contamination
132.24 If the label of the container in which edible cannabis is packaged includes a declaration alerting consumers that, due to a risk of cross-contamination, the edible cannabis may contain the source of a food allergen or gluten, the declaration must meet the following requirements:
(a) it must be shown immediately after the food allergen source, gluten source and added sulphites statement or, if there is none, immediately after the list of ingredients, and must appear on the same continuous surface as the statement, if any, and the list of ingredients; and
(b) no intervening printed, written or graphic material is to appear between it and the list of ingredients or statement that immediately precedes it.
Marginal note:Presentation of food allergen statement
132.25 (1) A food allergen source, gluten source and added sulphites statement must meet the following requirements:
(a) the word “Contains” in the English version and the word “Contient” in the French version must appear at the beginning of the list;
(b) no intervening printed, written or graphic material is to appear between the word referred to in paragraph (a) and the rest of the statement;
(c) it must appear on the same continuous surface as the list of ingredients; and
(d) it must include, even if any of the following information is also shown in the list of ingredients,
(i) the source of each food allergen that is present in the edible cannabis,
(ii) each source of any gluten that is present in the edible cannabis, and
(iii) one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”, if the total amount of sulphites present in the edible cannabis is 10 p.p.m. or more.
Marginal note:No duplication
(2) Despite paragraph (1)(d), the following information is not required to be shown in the statement more than once:
(a) the same source of a food allergen;
(b) the same source of gluten; and
(c) one of the common names “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”.
Marginal note:Constituents not required to be shown on label
132.26 (1) Constituents of ingredients or of classes of ingredients set out in the table to subsection B.01.009(1) of the Food and Drug Regulations are not required to be shown on the label of a container in which edible cannabis — or a cannabis accessory that contains edible cannabis — that is a cannabis product is packaged.
Marginal note:Preparation or mixture
(2) Subject to subsection (3), if a preparation or mixture set out in the table to subsection B.01.009(2) of the Food and Drug Regulations is used to produce edible cannabis, the ingredients and constituents of the preparation or mixture are not required to be shown on the label of the container in which edible cannabis — or a cannabis accessory that contains edible cannabis — that is a cannabis product is packaged.
Marginal note:Common name
(3) If a preparation or mixture set out in the table to subsection B.01.009(2) of the Food and Drug Regulations is used to produce edible cannabis and the preparation or mixture has one or more of the ingredients or constituents listed in subsection B.01.009(3) of the Food and Drug Regulations, those ingredients or constituents must be shown by their common names in the list of the ingredients of the edible cannabis to which they are added as if they were ingredients of that edible cannabis.
Marginal note:Constituents required to be shown in list of ingredients
(4) Despite subsections (1) and (2), if any of the constituents listed in subsection B.01.009(4) of the Food and Drug Regulations is contained in an ingredient of edible cannabis set out in a table referred to in subsection (1) or (2), that constituent must be shown in the list of ingredients.
Marginal note:Small immediate container
132.27 (1) In the case of a cannabis product whose immediate container is too small for all the required information to be displayed on its label in accordance with these Regulations,
(a) the label may extend beyond the exterior display surface; or
(b) either a peel-back or accordion panel may be applied to the container.
Marginal note:Label or panel not easily removed
(2) The label that extends beyond the exterior display surface and the panel must be applied in a manner that they cannot be easily removed from the immediate container.
Marginal note:Panel
(3) The panel must
(a) be able to be resealed;
(b) withstand repeated openings and closings without detaching from the immediate container under customary conditions of use; and
(c) include any of the following information that cannot be included on the label because the immediate container of the cannabis product is too small for all the required information to be displayed in accordance with these Regulations:
(i) the class of cannabis set out in Schedule 4 to the Act to which the cannabis that is in the immediate container belongs,
(ii) the recommended storage conditions,
(iii) the packaging date,
(iv) except in the case of a cannabis plant, cannabis plant seeds or edible cannabis, either
(A) the expiry date in accordance with subsection 123(2), or
(B) a statement that no expiry date has been determined,
(v) except in the case of dried cannabis or a cannabis plant, the statement “Contains the equivalent of (the quantity of dried cannabis, in grams, that is equivalent to the quantity of cannabis, in grams or seeds, as the case may be, as determined in accordance with subsection 2(4) of the Act, in the immediate container)g of dried cannabis”,
(vi) the list of ingredients of the cannabis product, including constituents, if any,
(vii) in the case of dried cannabis or fresh cannabis, the net weight,
(viii) in the case of a cannabis extract,
(A) the net weight, including the net weight of cannabis extract in each unit, if the cannabis extract is in discrete units,
(B) the quantity of THC and CBD that is dispensed with each activation of any cannabis accessory that is packaged with or contains the cannabis extract, and
(C) the name of any food allergen that is present in the product,
(ix) in the case of a cannabis topical, its net weight, including the net weight of cannabis topical in each unit, if the cannabis topical is in discrete units, and
(x) in the case of edible cannabis,
(A) if the edible cannabis is in solid form, its net weight, and in any other case, its net volume,
(B) the durable life date,
(C) the source of any food allergen or gluten present in the edible cannabis, except as a result of cross-contamination,
(D) sulphites that are present in the edible cannabis in an amount of 10 p.p.m. or more, and
(E) the nutrition facts table.
Marginal note:Interpretation — information on panel
(4) The information included on the panel must be shown in accordance with the provisions of these Regulations with respect to a label as if the panel were a label for the purposes of those provisions.
Marginal note:Brand element
(5) The panel must not display any brand element.
Marginal note:Statement on location of information
(6) The label of an immediate container in which a cannabis product is packaged and to which a panel is applied must include a statement that clearly indicates the location of any information required under these Regulations that is not included on the label.
Marginal note:Image
(7) The label referred to in subsection (6) may include an image that is printed in black and white and that provides instructions on how to open the panel.
Marginal note:Information on exterior display surface
(8) In addition to the information that is required under these Regulations, the label referred to in subsection (6) may include
(a) a bar code, in accordance with section 122;
(b) a brand element, in accordance with subsection (9); and
(c) an image, in accordance with subsection 130(10).
Marginal note:Exception — brand element
(9) Despite paragraphs 130(9)(d) and (e), a brand element included on a label that extends beyond the exterior display surface or on a label of a container to which a panel is applied must
(a) if the brand element is an image, be 1.27 cm by 1.27 cm in size or smaller; or
(b) if the brand element is text only, be in a type size that is 7 points or smaller.
Marginal note:Prohibited representation — health and cosmetic benefits
132.28 It is prohibited to make an express or implied representation, including by way of a brand element, on a cannabis product — or on the package of a cannabis product or on the label or panel of a container in which such a cannabis product is packaged — if there are reasonable grounds to believe that the representation could create the impression that health or cosmetic benefits may be derived from the use of the cannabis product.
Marginal note:Prohibited representation — energy value and amount of nutrient
132.29 (1) It is prohibited to make an express or implied representation, including by way of a brand element, on edible cannabis that is a cannabis product or on a cannabis accessory that contains edible cannabis and that is a cannabis product — or on the package of such a cannabis product or on the label or panel of a container in which such a cannabis product is packaged — concerning the energy value referred to in item 2 of the table to section 132.22 or the amount of any nutrient referred to in items 3 to 15 of that table or in items 5 to 37 of the table to section B.01.402 of the Food and Drug Regulations.
Marginal note:Interpretation — nutrition facts table
(2) For greater certainty, subsection (1) does not limit the application of paragraphs 132.18(1)(n) and 132.19(1)(i).
Marginal note:Prohibited representation — dietary requirements
132.3 It is prohibited to make an express or implied representation, including by way of a brand element, on edible cannabis that is a cannabis product or on a cannabis accessory that contains edible cannabis and that is a cannabis product — or on the package of such a cannabis product or on the label or panel of a container in which such a cannabis product is packaged — if there are reasonable grounds to believe that the representation could create the impression that the cannabis product is intended
(a) to meet the particular dietary requirements of an individual
(i) who has a physical or physiological condition as a result of a disease, disorder or injury, or
(ii) for whom a particular effect, including weight loss, is to be obtained by a controlled intake of food; or
(b) to meet the dietary requirements of young persons.
Marginal note:Prohibited representation — alcoholic beverages
132.31 It is prohibited to make an express or implied representation, including by way of a brand element, on a cannabis product — or on the package of a cannabis product or on the label or panel of a container in which such a cannabis product is packaged — if there are reasonable grounds to believe that the representation could associate the cannabis product with an alcoholic beverage.
Marginal note:Prohibited representation — tobacco products and vaping products
132.32 It is prohibited to make an express or implied representation, including by way of a brand element, on a cannabis product — or on the package of a cannabis product or on the label or panel of a container in which such a cannabis product is packaged — if there are reasonable grounds to believe that the representation could associate the cannabis product with a tobacco product, as defined in section 2 of the Tobacco and Vaping Products Act, or a vaping product to which that Act applies.
Marginal note:Non-application — name and email address
132.33 Section 132.28, subsection 132.29(1) and sections 132.3 to 132.32 do not apply with respect to the name and email address that are included on the label in accordance with paragraph 123(1)(a).
Marginal note:Standardized cannabis symbol on cannabis product intended for inhalation
132.34 (1) The standardized cannabis symbol that must be obtained from the Minister in the form of an electronic file must be clearly and prominently displayed on the outer surface of a cannabis accessory that contains a cannabis extract and that is a cannabis product intended to be consumed by means of inhalation if the cannabis extract contains THC in a concentration greater than 10 μg/g, taking into account the potential to convert THCA into THC.
Marginal note:Requirements
(2) The standardized cannabis symbol must meet the following requirements:
(a) it must be at least 1.27 cm by 1.27 cm in size;
(b) it must be displayed with a white border of at least 2 points on all sides; and
(c) if a change is made to the size of the symbol, its dimensions must be proportional vertically and horizontally.
Cannabis Product Accuracy Rules
Marginal note:Net weight and volume
133 The net weight and volume that must be included on the label of a cannabis product in accordance with sections 124, 124.1, 125, 132.1, 132.11, 132.12, 132.15, 132.16, 132.18 and 132.19 must be within the tolerance limits set out for that product in the document entitled Tolerance Limits for the Net Weight and Volume Declared on Cannabis Product Labelling, as amended from time to time and published by the Government of Canada on its website.
Marginal note:Number of discrete units
134 The number of discrete units in a container that is labelled in accordance with sections 124, 124.1, 132.1, 132.11, 132.15 and 132.18 must be equal to the number specified on the label.
Marginal note:Number of immediate containers
134.1 The number of immediate containers in an outermost container that is labelled in accordance with paragraph 122.4(2)(a) must be equal to the number of immediate containers specified on the label.
Marginal note:Number of cannabis plants
135 The number of cannabis plants in a container that is labelled in accordance with section 128 must be equal to the number specified on the label.
Marginal note:Number of cannabis plant seeds
136 The number of cannabis plant seeds in a container that is labelled in accordance with section 129 must be equal to the number specified on the label.
Labelling — Cannabis Other than Cannabis Products
Marginal note:Requirement — cannabis other than a cannabis product
137 Unless the requirements in section 138 have been met,
(a) a holder of a licence for processing, a holder of a licence for analytical testing and the individuals referred to in section 4 must not sell or distribute a reference standard; and
(b) a holder of a licence must not export a reference standard or sell, distribute or export any other cannabis that is not a cannabis product.
Marginal note:Information
138 (1) A label that includes the following information must be applied to any container that contains cannabis, other than a cannabis product:
(a) the name, telephone number and email address of the holder of the licence that sells, distributes or exports the cannabis or, in the case where an individual referred to in section 4 sells or distributes a reference standard, the name, telephone number and email address of the laboratory where that individual carries out their duties; and
(b) in respect of the cannabis,
(i) the lot number, preceded by one of the following designations:
(A) “Lot number”,
(B) “Lot no.”,
(C) “Lot”, or
(D) “(L)”, and
(ii) the packaging date.
Marginal note:Non-application — name and email address
(2) Sections 26 and 27 of the Act do not apply with respect to the name and email address that are included on the label in accordance with paragraph (1)(a).
PART 8Drugs Containing Cannabis
Definitions
Marginal note:Definitions
139 The following definitions apply in this Part.
- brand name
brand name has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (nom commercial)
- common name
common name has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (nom usuel)
- distribute
distribute does not include administering. (distribuer)
- establishment licence
establishment licence means a licence issued under section C.01A.008 of the Food and Drug Regulations. (licence d’établissement)
- hospital
hospital means a facility
(a) that is licensed, approved or designated by a province under the laws of the province to provide care or treatment to individuals or animals suffering from any form of disease or illness; or
(b) that is owned or operated by the Government of Canada or the government of a province and that provides health services. (hôpital)
- licensed dealer
licensed dealer means a licensed dealer, as defined in subsection 2(1) of the Narcotic Control Regulations, that specializes in the destruction of narcotics, as defined in subsection 2(1) of those Regulations. (distributeur autorisé)
- practitioner
practitioner has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (praticien)
- qualified person in charge
qualified person in charge means the individual referred to in section 150. (responsable qualifié)
- Security Directive
Security Directive means the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis, as amended from time to time and published by the Government of Canada on its website. (Directive en matière de sécurité)
- senior person in charge
senior person in charge means the individual referred to in section 149. (responsable principal)
DIVISION 1Licence
Activities
Marginal note:Authorized activities
140 (1) Subject to the other provisions of these Regulations, a holder of a cannabis drug licence is authorized to conduct the following activities if they are authorized by the licence:
(a) possessing cannabis obtained in accordance with these Regulations; and
(b) producing or selling a drug containing cannabis.
Marginal note:Ancillary activities — production
(2) A holder of a cannabis drug licence that authorizes the production of a drug containing cannabis is also authorized to distribute and offer to produce the drug.
Marginal note:Ancillary activities — sale
(3) A holder of a cannabis drug licence that authorizes the sale of a drug is also authorized to distribute the drug.
Marginal note:Definition of produce
(4) For the purpose of this section, produce does not include obtaining cannabis by cultivating, propagating or harvesting it.
141 [Repealed, SOR/2019-206, s. 50]
Marginal note:Use of organic solvent
142 Subject to the other provisions of these Regulations, a holder of a cannabis drug licence that authorizes the production of a drug containing cannabis is also authorized to alter or offer to alter the chemical or physical properties of the cannabis by the use of an organic solvent.
Marginal note:Sale
143 (1) Subject to subsection (2), a holder of a cannabis drug licence that authorizes the sale of a drug containing cannabis may sell or distribute the drug only to
(a) another holder of a cannabis drug licence;
(b) an individual referred to in section 4.
(c) a holder of a research licence;
(d) a holder of an analytical testing licence;
(e) the holder of a licence from which the holder of the cannabis drug licence received the drug, if the drug is sold or distributed for the purpose of its return;
(f) a holder of a licence or a licensed dealer, if the drug is sold or distributed for the purpose of its destruction;
(g) a pharmacist;
(h) a practitioner;
(i) a hospital employee;
(j) a person to which an exemption in relation to the drug has been granted under section 140 of the Act; or
(k) the Minister.
Marginal note:Written order
(2) A holder of a cannabis drug licence that authorizes the sale of a drug containing cannabis may only sell the drug if
(a) they have received a written order that specifies the name and quantity of the drug to be supplied and is signed and dated
(i) in the case of a drug to be provided to a hospital employee or a practitioner in a hospital, by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the individual in charge of the hospital to sign the order, and
(ii) in any other case, by the person to which the drug is to be sold; and
(b) they have verified the signature, if it is unknown to them.
Marginal note:Exception — pharmacist and practitioner
(3) It is prohibited for a holder of a cannabis drug licence to sell or distribute any drug containing cannabis to
(a) a pharmacist who is named in a notice issued under subsection 181(2) or (4); or
(b) a practitioner who is named in a notice issued under subsection 189(2) or (4).
Marginal note:Non-application
(4) Subsection (3) does not apply to a holder of a cannabis drug licence to which the Minister has issued a notice of retraction issued under
(a) subsection 182(1) in respect of the pharmacist referred to in paragraph (3)(a); or
(b) subsection 190(1) in respect of a practitioner referred to in paragraph (3)(b).
Marginal note:Presence of qualified person in charge
144 A holder of a cannabis drug licence may conduct an activity in relation to cannabis, other than its destruction or antimicrobial treatment, at the licensed site only if the qualified person in charge or an alternate qualified person in charge is present at the site.
Marginal note:Antimicrobial treatment
145 A holder of a cannabis drug licence may conduct antimicrobial treatment of cannabis at a location other than the licensed site if
(a) they ensure that the cannabis that is at the location is, at all times, in the presence of an individual referred to in paragraph 146(3)(a); and
(b) the cannabis is subsequently returned to the licensed site or distributed in accordance with this Part.
Marginal note:Destruction — holder of a cannabis drug licence
146 (1) A holder of a cannabis drug licence is authorized to destroy cannabis only
(a) in accordance with a method that
(i) complies with all federal, provincial and municipal environmental protection legislation applicable to the location where it is to be destroyed, and
(ii) does not result in any individual being exposed to cannabis smoke or cannabis vapour;
(b) in the presence of a witness referred to in paragraph (3)(a) and another witness referred to in subsection (3); and
(c) in the case where the cannabis is destroyed at a location other than the licensed site, if the holder ensures that the cannabis that is at the location is, at all times, in the presence of at least one witness referred to in paragraph (3)(a).
Marginal note:Destruction — licensed dealer
(2) The licensed dealer is authorized to destroy cannabis only
(a) in accordance with a method that
(i) complies with all federal, provincial and municipal environmental protection legislation applicable to the location at which it is to be destroyed, and
(ii) does not result in any individual being exposed to cannabis smoke or cannabis vapour; and
(b) in the presence of a witness referred to in paragraph (4)(a) and another witness referred to in subsection (4).
Marginal note:Witness — holder of a cannabis drug licence
(3) The following individuals are qualified to witness the destruction of cannabis by a holder of a cannabis drug licence:
(a) the senior person in charge, the qualified person in charge or the alternate qualified person in charge; and
(b) an employee of the holder.
Marginal note:Witness — licensed dealer
(4) The following individuals are qualified to witness the destruction of cannabis by a licensed dealer:
(a) the qualified person in charge, as defined in subsection 2(1) of the Narcotic Control Regulations, or an alternate qualified person in charge designated under subsection 9.2(2) of those Regulations; and
(b) an employee of the licensed dealer.
Marginal note:Statement by witnesses
(5) For each instance that they destroy cannabis, the holder of a cannabis drug licence or the licensed dealer, as the case may be, must obtain a statement signed and dated by two of the witnesses referred to in paragraph (1)(b) or (2)(b) stating that they witnessed the destruction and that the cannabis was destroyed in accordance with a method referred to in paragraph (1)(a) or (2)(a).
Marginal note:Record
(6) With respect to cannabis that they destroy, the holder of a cannabis drug licence or the licensed dealer, as the case may be, must prepare a record that sets out
(a) a description of the cannabis, its form and quantity;
(b) in the case of a drug containing cannabis, the brand name of the drug and its strength per unit;
(c) the address of the location at which the cannabis is destroyed;
(d) a brief description of the method and the date of destruction; and
(e) the names of the individuals who witnessed the destruction and were qualified to do so under paragraph (1)(b) or (2)(b) and the basis on which they were qualified under subsection (3) or (4).
Marginal note:Retention period
(7) The holder of a cannabis drug licence and the licensed dealer must retain the record and the statement for at least two years after the day on which the cannabis is destroyed.
Licence Issuance
Marginal note:Licence — content
147 A cannabis drug licence must set out the following information:
(a) the name of the holder of the licence;
(b) the licence number;
(c) the address of the site where the activity is authorized and, if applicable, of each building within the site;
(d) the authorized activity at the site and, if applicable, the authorized activity that may be conducted at each building within the site;
(e) the security measures to be implemented to comply with the requirements of either the Security Directive or Part 4;
(f) any conditions that the Minister considers appropriate;
(g) the effective date of the licence; and
(h) the date of expiry of the licence.
Marginal note:Amendment
148 A holder of a cannabis drug licence must submit an application to amend the licence if they propose to make any of the following changes:
(a) a change to the name of the holder;
(b) a change to the authorized activity at the site or the authorized activity at each building within the site; and
(c) a change to the security measures implemented to comply with the requirements of either the Security Directive or Part 4.
Individuals in Charge
Marginal note:Senior person in charge
149 The holder of a cannabis drug licence must retain the services of one individual as a senior person in charge who has overall responsibility for the management of the activities, with respect to cannabis, that are authorized under the licence.
Marginal note:Qualified person in charge
150 (1) A holder of a cannabis drug licence must retain the services of one individual as a qualified person in charge who is responsible for supervising the activities with respect to cannabis that are authorized under the licence and for ensuring, on behalf of the holder, that those activities comply with these Regulations.
Marginal note:Alternate qualified person in charge
(2) A holder of a cannabis drug licence may designate an individual as an alternate qualified person in charge who is authorized to replace the qualified person in charge.
Marginal note:Qualifications
(3) Only an individual who meets the following requirements may be a qualified person in charge or an alternate qualified person in charge:
(a) they work at the site specified in the licence;
(b) they
(i) are entitled to practise a profession that is relevant to their duties, such as that of pharmacist, practitioner, pharmacy technician or laboratory technician,
(ii) hold a diploma, certificate or credential that is awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or
(iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and
(A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or
(B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;
(c) they have sufficient knowledge of and experience with the use and handling of drugs to properly carry out their duties; and
(d) they are familiar with the provisions of the Act and these Regulations that apply to the holder of the licence.
Marginal note:Exception
(4) A holder of a cannabis drug licence may retain the services of an individual as a qualified person in charge or designate an alternate qualified person in charge who does not meet any of the requirements of paragraph (3)(b) if
(a) no other individual working at the site specified in the licence meets those requirements;
(b) those requirements are not necessary for the activities that are authorized under the licence; and
(c) the individual possesses knowledge — acquired from a combination of education, training and work experience — that is sufficient to enable them to properly carry out their duties.
Marginal note:Ineligibility
151 (1) An individual is not eligible to be a senior person in charge, a qualified person in charge or an alternate qualified person in charge if, in the past 10 years,
(a) in respect of a designated offence, a controlled substance offence, or any other offence referred to in subsection (2), the individual
(i) was convicted as an adult, or
(ii) was a young person who received an adult sentence, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act; or
(b) in respect of an offence committed outside Canada that, if committed in Canada, would have constituted a designated offence, a controlled substance offence or any other offence referred to in subsection (2),
(i) the individual was convicted as an adult, or
(ii) if they committed the offence when they were at least 14 years old but less than 18 years old, the individual received a sentence that was longer than the maximum youth sentence that could have been imposed under the Youth Criminal Justice Act for such an offence.
Marginal note:Other offences
(2) The other offences for the purpose of subsection (1) are the following:
(a) an offence involving the financing of terrorism referred to in any of sections 83.02 to 83.04 of the Criminal Code;
(b) an offence involving fraud referred to in any of sections 380 to 382 of the Criminal Code;
(c) the offence of laundering proceeds of crime referred to in section 462.31 of the Criminal Code;
(d) an offence involving a criminal organization referred to in any of sections 467.11 to 467.13 of the Criminal Code; and
(e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (d).
Changes
Marginal note:Minister’s approval
152 (1) A holder of a cannabis drug licence must obtain the Minister’s approval before making the following changes:
(a) replacing the senior person in charge;
(b) replacing the qualified person in charge; or
(c) designating or replacing an alternate qualified person in charge.
Marginal note:Application — content
(2) The holder must, for the purpose of obtaining the Minister’s approval, submit an application that includes the following:
(a) a description of the change;
(b) in the case of the replacement of the senior person in charge,
(i) a declaration signed and dated by the proposed individual attesting that they are not ineligible for a reason specified in section 151,
(ii) a document issued by a Canadian police force indicating whether, during the 10 years before the day on which the application is submitted, the individual was convicted as specified in subparagraph 151(1)(a)(i) or received a sentence as specified in subparagraph 151(1)(a)(ii), and
(iii) if the individual has ordinarily resided in a country other than Canada during the 10 years before the day on which the application is submitted, a document issued by a police force of that country indicating whether in that period that they were convicted as specified in subparagraph 151(1)(b)(i) or received a sentence as specified in subparagraph 151(1)(b)(ii); and
(c) in the case of the designation of an alternate qualified person in charge or in the case of the replacement of the qualified person in charge or an alternate qualified person in charge
(i) the declaration and the documents referred to in subparagraphs (b)(i) to (iii),
(ii) a declaration, signed and dated by the senior person in charge, attesting that the proposed individual has the knowledge and experience required under paragraphs 150(3)(c) and (d), and
(iii) if the proposed individual does not meet the requirement of subparagraph 150(3)(b)(i), either
(A) a copy of the individual’s diploma, certificate or credential referred to in subparagraph 150(3)(b)(ii) or (iii) and a copy of the course transcript for it, or
(B) a detailed description of the individual’s education, training or work experience required under paragraph 150(4)(c), together with supporting evidence, such as a copy of a course transcript or an attestation by the person who provided the training.
Marginal note:Additional information
(3) The Minister may, on receiving an application for approval, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to consider the application.
Marginal note:Approval issued
(4) The Minister must approve the change on completion of the review of the application if the applicable requirements referred to in subsections 150(3) and (4) and section 151 are met.
Marginal note:Notification — various changes
153 (1) A holder of a cannabis drug licence must notify the Minister of any of the following changes within five days after the change occurs:
(a) a change to the mailing address, telephone number, email address and facsimile number of the holder; and
(b) a change to the plan of the licensed site that does not require different security measures to be implemented in order to comply with Part 4.
Marginal note:Notification — content
(2) The notification must include
(a) a description of the change; and
(b) a declaration, signed and dated by the senior person in charge, indicating that all information provided in support of the notification is correct and complete to the best of their knowledge.
Marginal note:Cessation of activities
154 (1) A holder of a cannabis drug licence that intends to cease conducting all the activities authorized by the licence — whether before or on the date of expiry of the licence — must provide to the Minister a written notice to that effect at least 30 days before the day on which those activities cease.
Marginal note:Content of notice
(2) The notice must be signed and dated by the senior person in charge and contain the following information:
(a) the date on which activities are expected to cease;
(b) a description of the manner in which any cannabis remaining at the site as of the date referred to in paragraph (a) will be disposed of by the holder, including
(i) if the cannabis will be sold or distributed, in whole or in part, the name and address of the person to which it will be sold or distributed, and
(ii) if it will be destroyed, in whole or in part, the day on which and the location at which the destruction is to take place;
(c) the address of the location at which the holder’s records, reports, electronic data and other documents that are required to be retained under the Act by the holder, will be retained after activities have ceased; and
(d) the name, address, telephone number and, if applicable, facsimile number and email address of a person from which the Minister may obtain further information after activities have ceased.
Marginal note:Update
(3) After having ceased the activities, the holder must submit to the Minister an update of the information referred to in paragraphs (2)(a) to (d), if it differs from what was set out in the notice submitted under subsection (1). The update must be signed and dated by the senior person in charge.
Refusal, suspension and revocation
Marginal note:Other grounds for refusal
155 For the purpose of paragraph 62(7)(h) of the Act, the other grounds for refusing to issue, renew or amend a cannabis drug licence are as follows:
(a) the applicant does not hold an establishment licence that is necessary to authorize them to conduct, at the site proposed in the application or at a building within the site, the activities in relation to drugs containing cannabis that they intend to conduct there;
(a.1) the Minister of Health suspends, in respect of an activity that the applicant intends to conduct in relation to drugs containing cannabis, an establishment licence that is necessary to authorize the applicant to conduct that activity at the site proposed in the application or at a building within the site;
(b) the holder of the cannabis drug licence applies for an amendment to change the location of the site where an activity that is authorized by the licence may be conducted; and
(c) in respect of the renewal or amendment of the licence, the holder of the licence does not hold the cannabis licence issued under subsection 14(1.1) of the Excise Act, 2001, if it is required;
Marginal note:Suspension — other circumstance
156 For the purpose of paragraph 64(1)(b) of the Act, other circumstances for the suspension of a cannabis drug licence are the following:
(a) the Minister of Health suspends, in respect of an activity that the holder of the cannabis drug licence is authorized to conduct under the licence, an establishment licence that is necessary to authorize the holder to conduct that activity at the site or at a building within the site;
(b) the cannabis licence issued to the holder of the cannabis drug licence under subsection 14(1.1) of the Excise Act, 2001 is suspended under subsection 23(2) of that Act.
Marginal note:Revocation — other circumstances
157 For the purpose of paragraph 65(h) of the Act, other circumstances for the revocation of a cannabis drug licence are the following:
(a) the licence that has been suspended is not reinstated because the reasons for the suspension still exist or the holder of the licence has not demonstrated to the Minister that the suspension is unfounded;
(b) the holder of the licence has requested its revocation in writing;
(c) the holder of the licence no longer holds an establishment licence that is necessary to authorize them to conduct, at the site or at a building within the site, an activity that is authorized under the cannabis drug licence; and
(d) the holder of the licence no longer holds the cannabis licence referred to in subsection 14(1.1) of the Excise Act, 2001, if it is required.
Security
Marginal note:Security obligations
158 A holder of a cannabis drug licence must
(a) take reasonable steps to protect the cannabis they possess against theft or loss;
(b) if they experience a theft of cannabis or a loss of cannabis that cannot be explained on the basis of normally accepted operations,
(i) notify a police force within 24 hours after becoming aware of its theft or loss, and
(ii) notify the Minister, in writing, within 10 days after becoming aware of its theft or loss; and
(c) take any steps that are necessary to ensure the safekeeping of cannabis when distributing it.
DIVISION 2Possession, Pharmacists, Practitioners and Hospitals
General Provisions
Marginal note:Possession — Person
159 The following persons, if they have obtained a drug containing cannabis either in accordance with these Regulations, or from a person that is exempt under section 140 of the Act from the application of subsections 9(1) and (2) and 10(1) and (2) of the Act with respect to that drug, are authorized to possess the drug:
(a) a pharmacist, a practitioner who is entitled to practise in the province in which they possess the drug or a holder of a cannabis drug licence, if they require the drug for their business or profession;
(b) a practitioner who is entitled to practise in a province other than the province in which they possess the drug and their possession is for emergency medical purposes only;
(c) a hospital employee or a practitioner in a hospital;
(d) an individual who possesses a quantity of the drug that exceeds the applicable limit under the Act and has obtained the drug for their own use or for their animal from a practitioner or in accordance with a prescription that was not issued or obtained in contravention of these Regulations;
(e) an individual who possesses a quantity of the drug that exceeds the applicable limit under the Act and has reasonable grounds to believe that the drug was obtained by another individual in accordance with paragraph (d) if the possession is for the purpose of its return or destruction;
(f) a licensed dealer, if the possession is for the purpose of its destruction;
(g) a person to which an exemption has been granted under section 140 of the Act with respect to the possession of that drug, if the possession is for a purpose set out in the exemption; or
(h) the Minister.
Marginal note:Possession — quantity allowed
160 Any quantity of drug containing cannabis that an individual is authorized to possess under paragraph 159(d) or (e) is in addition to any other quantity of cannabis that the individual is authorized to possess under the Act.
Marginal note:Authorization
161 Subject to the other provisions of these Regulations, an individual referred to in paragraph 159(d) or (e) is authorized to distribute a drug containing cannabis to a pharmacist for its destruction.
Marginal note:Promotion — communication of brand name, etc.
162 Subject to the other provisions of these Regulations, a person is authorized to promote a prescription drug by communicating the brand name, the proper name, the common name, the price or the quantity of the drug.
Marginal note:Exemption — section 21 of Act
163 A person is exempt from the application of section 21 of the Act if they display, refer to or otherwise use the brand name of a prescription drug, or the name of the holder of the drug identification number assigned in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations for a prescription drug, directly or indirectly in a promotion that is used in the sponsorship of a person, entity, event, activity or facility.
Marginal note:Exemption — section 22 of Act
164 A person is exempt from the application of section 22 of the Act if they display on a facility, as part of the name of the facility or otherwise, if the facility is used for a sports or cultural event or activity, the brand name of a prescription drug or the name of the holder of the drug identification number assigned in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations for a prescription drug.
Marginal note:Exemption — subsection 23(1) of Act
165 A person is exempt from the application of subsection 23(1) of the Act if they publish, broadcast or otherwise disseminate, on behalf of another person, with or without consideration, any promotion that is authorized under sections 162 to 164.
Marginal note:Authorization – drug for veterinary use
166 Subject to the other provisions of these Regulations, a person that is authorized to sell a prescription drug for veterinary use may sell it in a package or with a label that sets out a depiction of a real or fictional animal that corresponds to the species of the animal for which the drug is intended.
Marginal note:Authorization — drug appealing to young person
167 Subject to the other provisions of these Regulations, a person is authorized to sell a drug containing cannabis that has an appearance, shape or other sensory attribute or a function that there are reasonable grounds to believe could be appealing to young persons.
Marginal note:Authorization — drug not in Schedule 4
168 Subject to the other provisions of these Regulations, a person authorized to sell a drug containing cannabis may sell a drug that is of a class that is not referred to in Schedule 4 to the Act.
Marginal note:Authorization — drug containing a substance in Schedule 5
169 Subject to the other provisions of these Regulations, a person is authorized to sell a drug containing cannabis that contains any substance that is referred to in column 1 of Schedule 5 to the Act.
Pharmacists
Marginal note:Record keeping
170 A pharmacist who receives a prescription drug from a holder of a cannabis drug licence must enter the following in a record retained for such purposes:
(a) the name and quantity of the drug received;
(b) the date the drug was received; and
(c) the name and address of the holder.
Marginal note:Sale, distribution and administration
171 Subject to the other provisions of these Regulations, a pharmacist is authorized to sell, distribute or administer a prescription drug to a person:
(a) if the person is exempted under section 140 of the Act with respect to the possession of that drug; or
(b) if the pharmacist sells, distributes or administers the drug
(i) in accordance with a written order or prescription signed and dated by a practitioner, and
(ii) after verifying the signature, if it is unknown to the pharmacist.
Marginal note:Return and destruction
172 (1) Subject to the other provisions of these Regulations, a pharmacist is authorized to sell or distribute a prescription drug, other than a drug referred to in section 173, in accordance with a written order, to
(a) the holder of a cannabis drug licence from which the pharmacist received the drug, if the drug is sold or distributed for the purpose of its return; and
(b) a holder of a cannabis drug licence or a licensed dealer, if the drug is sold or distributed for the purpose of its destruction.
Marginal note:Written order
(2) The written order must contain
(a) the name, quantity and strength per unit of the drug; and
(b) if the sale or distribution is for the purpose of its destruction, a written statement that affirms that the sole purpose of the order is the destruction of the drug and that is signed and dated by, or on behalf of, the holder of the cannabis drug licence or the licensed dealer, as the case may be.
Marginal note:Record keeping
(3) The pharmacist must prepare a record with respect to the drug that sets out
(a) its brand name, form, quantity and strength per unit;
(b) the address of the person to which it was sold or distributed; and
(c) the date on which it was sold or distributed.
Marginal note:Drug given by individual
173 (1) A pharmacist is authorized to sell or distribute to a licensed dealer a prescription drug that the pharmacist received from an individual referred to in paragraph 159(d) or (e) for the purpose of its destruction, if the drug is in a container that prevents the removal of the drug from the container and is marked in a manner that is sufficient to identify the container.
Marginal note:Record keeping — pharmacist
(2) The pharmacist must prepare a record, with respect to the drug, that sets out
(a) the number of containers distributed;
(b) the date on which each container is distributed;
(c) the identifying mark of each container; and
(d) the name and address of the licensed dealer to which each container is distributed.
Marginal note:Record keeping — licensed dealer
(3) The licensed dealer must prepare a record, with respect to the drug, that sets out
(a) the number of containers received;
(b) the date on which the container is received;
(c) the identifying mark of the container; and
(d) the name and address of the pharmacist from whom the container is received.
Marginal note:Retention period
(4) The pharmacist and the licensed dealer must retain the record for at least two years after the day on which the pharmacist distributes the drug or the licensed dealer receives the drug, as the case may be.
Marginal note:Prohibited activities
174 (1) Despite section 171, subsection 172(1) and section 175, it is prohibited for a pharmacist to
(a) sell or distribute a prescription drug to a pharmacist who is named in a notice issued under subsection 181(2) or (4);
(b) sell or distribute a prescription drug to a practitioner who is named in a notice issued under subsection 189(2) or (4); or
(c) fill a prescription or order for a prescription drug from such a practitioner.
Marginal note:Non-application
(2) Subsection (1) does not apply to a pharmacist to whom the Minister has issued a notice of retraction under
(a) subsection 182(1), in respect of a pharmacist who is named in a notice issued under subsection 181(2) or (4); or
(b) subsection 190(1), in respect of a practitioner who is named in a notice issued under subsection 189(2) or (4).
Marginal note:Distribution — hospital
175 (1) Subject to subsection (2), a pharmacist may distribute a prescription drug to a hospital employee or a practitioner in a hospital in accordance with a written order signed and dated by
(a) the pharmacist in charge of the hospital’s pharmacy; or
(b) a practitioner who is authorized by the individual in charge of the hospital to sign the order.
Marginal note:Signature
(2) Before distributing the prescription drug, the pharmacist receiving the order must verify the signature on the order, if it is unknown to them.
Marginal note:Security obligations
176 A pharmacist must, with respect to a drug containing cannabis on their premises or for which the pharmacist is responsible,
(a) take reasonable steps to protect it against theft or loss; and
(b) notify the Minister, in writing, within 10 days after becoming aware of its theft or loss.
Marginal note:Record keeping
177 If, in accordance with a written order or prescription, a pharmacist dispenses a prescription drug, the pharmacist must retain a record of the following information:
(a) their name or initials;
(b) the name, initials and address of the practitioner who issued the order or prescription;
(c) the name and address of the person for whom the drug was dispensed;
(d) the name, quantity and form of the drug;
(e) the date on which the pharmacist dispensed the drug; and
(f) the number assigned to the order or prescription.
Marginal note:Sale and distribution for emergency purposes
178 (1) A pharmacist may sell or distribute a prescription drug for emergency purposes to another pharmacist in accordance with a written order that is signed and dated by the other pharmacist.
Marginal note:Record keeping — selling and distributing
(2) A pharmacist must, after selling or distributing a prescription drug under subsection (1) or after receiving such a drug under subsection (1) or subsection 193(3), enter the details of the transaction in a record retained for such purposes.
Marginal note:Record keeping — removing, transporting and transferring
(3) A pharmacist must, after removing, transporting or transferring a prescription drug from one place of business operated by the pharmacist to another, enter the details of the transaction in a record retained for such purposes.
Marginal note:Retention period
179 A pharmacist must retain the records which the pharmacist is required to retain under these Regulations for at least two years after the day on which they are prepared.
Marginal note:Factual information
180 The Minister must provide in writing any factual information about a pharmacist with respect to cannabis that has been obtained under the Act or the Controlled Drugs and Substances Act to the provincial professional licensing authority that is responsible for the authorization of individuals to practise their profession
(a) in the province in which the pharmacist is or was entitled to practise if
(i) the authority submits to the Minister a written request that sets out the pharmacist’s name and address, a description of the information being requested and a statement that the information is required for the purpose of assisting an investigation by the authority, or
(ii) the Minister has reasonable grounds to believe that the pharmacist has
(A) contravened, in relation to cannabis, a rule of conduct established by the authority,
(B) been convicted of a designated offence or a controlled substance offence in relation to cannabis,
(C) contravened these Regulations, or
(D) has contravened the Narcotic Control Regulations in relation to cannabis; or
(b) in a province in which the pharmacist is not entitled to practise, if the authority submits to the Minister
(i) a written request that sets out the pharmacist’s name and address and a description of the information requested, and
(ii) a document that shows that
(A) the pharmacist has applied to that authority to practise in that province, or
(B) the authority has reasonable grounds to believe that the pharmacist is practising in that province without being authorized to do so.
Marginal note:Notice — prohibition to sell or distribute
181 (1) A pharmacist may make a written request to the Minister to send a notice advising that the following persons must not sell or distribute any prescription drug to the pharmacist:
(a) all holders of a cannabis drug licence; and
(b) all pharmacies in the province in which the pharmacist who is named in the notice is entitled to practise.
Marginal note:Recipients
(2) The Minister must, in the circumstances set out in subsection (3), issue the notice referred to in subsection (1) to the following persons and authorities:
(a) the pharmacist who is named in the notice;
(b) all holders of a cannabis drug licence;
(c) all pharmacies in the province in which the pharmacist is entitled to practise;
(d) the applicable provincial professional licensing authority for the province in which the pharmacist is entitled to practise; and
(e) on request, the applicable provincial professional licensing authority for any province other than the province referred to in paragraph (d).
Marginal note:Mandatory notice
(3) The notice must be issued if the pharmacist
(a) made a request to the Minister in accordance with subsection (1);
(b) contravened a rule of conduct, in relation to cannabis, established by the provincial professional licensing authority for the province in which the pharmacist is practising and that provincial professional licensing authority has requested the Minister in writing to issue the notice;
(c) has been convicted of any of the following:
(i) a designated offence,
(ii) a controlled substance offence in relation to cannabis, or
(iii) an offence under the Narcotic Control Regulations in relation to cannabis; or
(d) the Minister has reasonable grounds to believe that the pharmacist has contravened this Part or Part 9.
Marginal note:Optional notice
(4) The Minister may issue the notice to the persons and authorities referred to in subsection (2) if the Minister, on reasonable grounds, believes that the pharmacist named in the notice
(a) has contravened section 171, subsection 172(1) or (2) or 173(1), section 174, 175 or 176 or subsection 178(1);
(b) has, on more than one occasion, self-administered a prescription drug contrary to accepted pharmaceutical practice;
(c) has, on more than one occasion, distributed or administered a prescription drug to their spouse, common-law partner, parent or child, including a child adopted in fact, contrary to accepted pharmaceutical practice; or
(d) is unable to account for the quantity of prescription drugs for which the pharmacist was responsible under this Part or Part 9.
Marginal note:Prerequisite
(5) Before issuing a notice under subsection (4), the Minister must
(a) consult with the provincial professional licensing authority for the province in which the pharmacist to whom the notice relates is entitled to practise;
(b) send to the pharmacist a written notice that indicates the reasons why a notice is being considered and give them an opportunity to present reasons why the notice should not be issued; and
(c) consider
(i) any reasons that have been presented by the pharmacist under paragraph (b),
(ii) the compliance history of the pharmacist in respect of the Act and its regulations, the Controlled Drugs and Substances Act and the Narcotic Control Regulations with respect to cannabis, and
(iii) whether the actions of the pharmacist pose a significant risk to public health or public safety, including the risk of any prescription drug being diverted to an illicit market or activity.
Marginal note:Retraction of notice
182 (1) The Minister must retract a notice that was issued under subsection 181(2) or (4) if
(a) the pharmacist who is named in the notice has requested in writing that it be retracted;
(b) the pharmacist has provided a letter from the applicable provincial professional licensing authority for the province in which the pharmacist is entitled to practise that states that the authority consents to the retraction of the notice; and
(c) in the case where the notice was issued at the request of the pharmacist, one year has elapsed since the notice was issued.
Marginal note:Obligation to notify
(2) If the Minister retracts a notice, he or she must notify, in writing, the persons and authorities to which the notice was issued under subsection 181(2) or (4).
Practitioners
Marginal note:Sale, distribution and administration
183 Subject to the other provisions of these Regulations, a practitioner is authorized to administer a drug containing cannabis to an individual or animal, or sell or distribute it for an individual or animal if
(a) the individual or the animal is under their professional treatment; and
(b) the drug is required for the condition for which the individual or animal is receiving treatment.
Marginal note:Return and destruction
184 (1) A practitioner is authorized to sell or distribute a drug containing cannabis, in accordance with a written order, to
(a) the holder of a cannabis drug licence from which the practitioner received the drug, if the drug is sold or distributed for the purpose of its return; and
(b) a holder of a cannabis drug licence or a licensed dealer, if the drug is sold or distributed for the purpose of its destruction.
Marginal note:Written Order
(2) The written order must contain
(a) the name, quantity and strength per unit of the drug; and
(b) if the sale or distribution is for the purpose of its destruction, a written statement that affirms that the sole purpose of the order is the destruction of the drug and that is signed and dated by, or on behalf of, the holder of the cannabis drug licence or the licensed dealer, as the case may be.
Marginal note:Record keeping
(3) The practitioner must prepare a record with respect to the drug that sets out
(a) its brand name, form, quantity and strength per unit;
(b) the address of the person to which it was sold or distributed; and
(c) the date on which it was sold or distributed.
Marginal note:Security obligations
185 A practitioner must, with respect to a drug containing cannabis that they possess,
(a) take reasonable steps to protect it against theft or loss; and
(b) notify the Minister, in writing, within 10 days after becoming aware of its theft or loss.
Marginal note:Record keeping
186 A practitioner who sells or distributes a prescription drug to an individual for self-administration or for administration to an animal must, whether or not the practitioner charges for the drug, retain a record showing the name and quantity of the drug sold or distributed, the name and address of the individual to whom it was sold or distributed and the date on which it was sold or distributed, if the quantity of the drug exceeds
(a) three times the maximum daily dosage set out in the notice of compliance issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations for the drug; or
(b) if the notice of compliance does not set out any maximum daily dosage, three times the generally recognized maximum daily dosage for the drug.
Marginal note:Retention period
187 A practitioner must retain the records which the practitioner is required to retain under these Regulations for at least two years after the day on which they are prepared.
Marginal note:Factual information
188 The Minister must provide in writing any factual information about a practitioner with respect to cannabis that has been obtained under the Act or the Controlled Drugs and Substances Act to the provincial professional licensing authority that is responsible for the authorization of individuals to practise their profession
(a) in a province in which the practitioner is, or was, entitled to practise if
(i) the authority submits to the Minister a written request that sets out the practitioner’s name and address, a description of the information requested and a statement that the information is required for the purpose of assisting a investigation by the authority, or
(ii) the Minister has reasonable grounds to believe that the practitioner has
(A) contravened, in relation to cannabis, a rule of conduct established by the authority,
(B) been convicted of a designated offence or a controlled substance offence in relation to cannabis,
(C) contravened these Regulations, or
(D) contravened the Narcotic Control Regulations in relation to cannabis; or
(b) in a province in which the practitioner is not entitled to practise, if the authority submits to the Minister
(i) a written request that sets out the practitioner’s name and address and a description of the information requested, and
(ii) a document that shows that
(A) the practitioner has applied to that authority to practise in that province, or
(B) the authority has reasonable grounds to believe that the practitioner is practising in that province without being authorized to do so.
Marginal note:Notice — prohibition
189 (1) A practitioner may make a written request to the Minister to send a notice advising that
(a) the following persons must not sell or distribute any prescription drug to the practitioner:
(i) all holders of a cannabis drug licence,
(ii) all pharmacies in the province in which the practitioner who is named in the notice is entitled to practise, and
(iii) all pharmacies in an adjacent province in which a prescription or order from the practitioner who is named in the notice may be filled; and
(b) the following individual must not fill a prescription or order written by the practitioner for a prescription drug:
(i) all pharmacists in the province in which the practitioner who is named in the notice is entitled to practise, and
(ii) all pharmacists in an adjacent province in which a prescription or order from the practitioner who is named in the notice may be filled.
Marginal note:Recipients
(2) The Minister must, in the circumstances set out in subsection (3), issue the notice referred to in subsection (1) to the following persons and authorities:
(a) the practitioner who is named in the notice;
(b) all holders of a cannabis drug licence;
(c) all pharmacies in the province in which the practitioner is entitled to practise;
(d) all pharmacies in an adjacent province in which a prescription or order from the practitioner who is named in the notice may be filled;
(e) the applicable professional licensing authority for the province in which the practitioner is entitled to practise; and
(f) on request, the applicable provincial professional licensing authority for any province other than the province referred to in paragraph (e).
Marginal note:Mandatory notice
(3) The notice must be issued if the practitioner
(a) made a request to the Minister in accordance with subsection (1) to issue the notice;
(b) contravened a rule of conduct, in relation to cannabis, established by the provincial professional licensing authority for the province in which the practitioner is practising and that provincial professional licensing authority has requested the Minister in writing to issue the notice;
(c) been convicted of any of the following:
(i) a designated offence,
(ii) a controlled substance offence in relation to cannabis,
(iii) an offence under the Narcotic Control Regulations in relation to cannabis; or
(d) the Minister has reasonable grounds to believe that the practitioner has contravened this Part or Part 9.
Marginal note:Optional notice
(4) The Minister may issue the notice to the persons and authorities referred to in subsection (2) if the Minister, on reasonable grounds, believes that the practitioner named in the notice
(a) has contravened section 183, subsection 184(1) or (2) or section 185;
(b) has, on more than one occasion, self-administered a prescription drug under a self-directed prescription or order or, in the absence of a prescription or order, contrary to accepted professional practice;
(c) has, on more than one occasion, distributed or administered a prescription drug to their spouse, common-law partner, parent or child, including a child adopted in fact, contrary to accepted professional practice; or
(d) is unable to account for the quantity of prescription drugs for which the practitioner was responsible under this Part or Part 9.
Marginal note:Prerequisite
(5) Before issuing a notice under subsection (4), the Minister must
(a) consult with the applicable provincial professional licensing authority for the province in which the practitioner to whom the notice relates is entitled to practise;
(b) send to the practitioner a written notice that indicates the reasons why a notice is being considered and give them an opportunity to present reasons why the notice should not be issued; and
(c) consider
(i) any reasons that have been presented by the practitioner under paragraph (b),
(ii) the compliance history of the practitioner in respect of the Act and its regulations, the Controlled Drugs and Substances Act and the Narcotic Control Regulations with respect to cannabis, and
(iii) whether the actions of the practitioner pose a significant risk to public health or public safety, including the risk of any prescription drug being diverted to an illicit market or activity.
Marginal note:Retraction of notice
190 (1) The Minister must retract a notice that was issued under subsection 189(2) or (4) if
(a) the practitioner who is named in the notice has requested in writing that it be retracted;
(b) the practitioner has provided a letter from the applicable provincial professional licensing authority for the province in which the practitioner is entitled to practise that states that the authority consents to the retraction of the notice; and
(c) in the case where the notice was issued at the request of the practitioner, one year has elapsed since the notice was issued.
Marginal note:Obligation to notify
(2) If the Minister retracts a notice, the Minister must notify, in writing, the persons and authorities to which the notice was issued under subsection 189(2) or (4).
Hospitals
Marginal note:Record keeping
191 An individual who is in charge of a hospital must retain a record of the following information:
(a) with respect to any prescription drug received by the hospital,
(i) the name and quantity of the drug,
(ii) the name and address of the person from whom the drug was received, and
(iii) the date the drug was received; and
(b) with respect to a prescription drug that is dispensed by the hospital,
(i) the name of the patient for whom or animal for which the drug was dispensed,
(ii) the name of the practitioner who ordered or prescribed the drug, and
(iii) the date on which the drug was ordered or prescribed and the form and quantity of the drug.
Marginal note:Security obligations
192 An individual in charge of a hospital must, with respect to a drug containing cannabis for which the hospital is responsible,
(a) take reasonable steps to protect it against theft or loss; and
(b) notify the Minister, in writing, within 10 days after becoming aware of its theft or loss.
Marginal note:Sale, distribution and administration
193 (1) Subject to the other provisions of these Regulations, it is prohibited for a person to sell, distribute or administer a prescription drug that a hospital possesses without the authorization of the individual in charge of the hospital.
Marginal note:In–patients and out-patients
(2) The individual in charge of a hospital may authorize the sale, distribution or administration of a prescription drug only in accordance with a prescription or a written order, signed and dated by a practitioner and only
(a) in the case of administration, to an individual or an animal under treatment as an in-patient or out-patient of the hospital; or
(b) in the case of sale or distribution, for the individual referred to in paragraph (a) or to the person in charge of the animal referred to in paragraph (a).
Marginal note:Distribution or sale in an emergency
(3) Despite subsection (2), for emergency purposes, the individual in charge of a hospital may authorize the sale or distribution of a prescription drug without a prescription to
(a) an employee of or a practitioner in another hospital, if
(i) the drug is sold or distributed in accordance with a written order signed and dated by a pharmacist in charge of the pharmacy in the other hospital or by a practitioner who is authorized by the individual in charge of the other hospital to sign the order, and
(ii) if the signature of the pharmacist or the practitioner is known to the person who sells or distributes the drug or has been verified by that person;
(b) a pharmacist of another hospital, if
(i) the drug is sold or distributed in accordance with a written order signed and dated by the pharmacist, and
(ii) the signature of the pharmacist or the practitioner who is authorized by the individual in charge of the other hospital to sign the order is known to the person who sells or distributes the drug or has been verified by that person; and
(c) an individual who is exempted under section 140 of the Act with respect to the drug and who is employed in a research laboratory in the hospital for the purpose of research.
Marginal note:Return and destruction
194 (1) Despite subsection 193(2), the individual in charge of a hospital may authorize the sale or distribution of a prescription drug in accordance with a written order to
(a) the holder of a cannabis drug licence from which the drug was received, if the drug is sold or distributed for the purpose of its return; and
(b) a holder of a cannabis drug licence or a licensed dealer, if the drug is sold or distributed for the purpose of its destruction.
Marginal note:Written Order
(2) The written order must contain
(a) the name, the quantity and the strength per unit of the drug; and
(b) if the sale or distribution is for the purpose of its destruction, a written statement that affirms that the sole purpose of the order is the destruction of the drug and that is signed and dated by, or on behalf of, the holder of the cannabis drug licence or the licensed dealer, as the case may be.
Marginal note:Record keeping
(3) The individual in charge of the hospital must prepare a record, with respect to the drug for the purpose of its return or destruction, that sets out
(a) its brand name, form, quantity and strength per unit;
(b) the name and the address of the person to whom it was sold or distributed; and
(c) the date on which it was sold or distributed.
Marginal note:Retention period
195 An individual in charge of a hospital must retain the records that the individual is required to retain under these Regulations for at least two years after the day on which they are prepared.
PART 9Combination Products and Devices
Marginal note:Definitions
196 The following definitions apply in this Part.
- brand name
brand name has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (nom commercial)
- combination product
combination product[Repealed, SOR/2019-206, s. 54]
- common name
common name has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (nom usuel)
Marginal note:Authorization
197 Subject to the other provisions of these Regulations, a person may promote a combination product by communicating the brand name, proper name, common name, price or quantity of the product.
Marginal note:Exemption — section 21 of Act
198 A person is exempt from the application of section 21 of the Act if they display, refer to or otherwise use the brand name of a combination product, or the name of the holder of the drug identification number assigned in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations for the product, directly or indirectly in a promotion that is used in the sponsorship of a person, entity, event, activity or facility.
Marginal note:Exemption — section 22 of Act
199 A person is exempt from the application of section 22 of the Act if they display on a facility, as part of the name of the facility or otherwise, if the facility is used for a sports or cultural event or activity, the brand name of a combination product or the name of the holder of the drug identification number assigned in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations for the product.
Marginal note:Exemption — subsection 23(1) of Act
200 A person is exempt from the application of subsection 23(1) of the Act if they publish, broadcast or otherwise disseminate, on behalf of another person, with or without consideration, any promotion that is authorized under sections 197 to 199.
Marginal note:Authorization — combination product for veterinary use
201 Subject to the other provisions of these Regulations, a person that is authorized to sell a combination product for veterinary use may sell it in a package or with a label that sets out a depiction of a real or fictional animal that corresponds to the species of the animal for which the product is intended.
Marginal note:Authorization — combination product
202 (1) Subject to the other provisions of these Regulations, a person is authorized to sell a combination product to a young person.
Marginal note:Authorization — device
(2) Subject to the other provisions of these Regulations, a person is authorized to sell a device licensed for use with a prescription drug to a young person if the person
(a) has ascertained that there is a written prescription for the young person with respect to the drug; and
(b) is entitled under the laws of a province to dispense a prescription drug.
PART 10Importation and Exportation for Medical or Scientific Purposes
Definitions
Marginal note:Definitions
203 The following definitions apply in this Part.
- customs office
customs office has the same meaning as in subsection 2(1) of the Customs Act. (bureau de douane)
- customs officer
customs officer has the meaning assigned by the definition officer in subsection 2(1) of the Customs Act. (agent des douanes)
Importation
Marginal note:Import permit
204 (1) A holder of a licence is authorized to import cannabis for medical or scientific purposes if they also hold an import permit for each shipment of cannabis that is imported.
Marginal note:Ancillary activities
(2) A holder of an import permit is also authorized to possess, transfer, transport, send or deliver the shipment of cannabis to the extent necessary to import the cannabis.
Marginal note:Import permit — content
205 The import permit must set out the following information:
(a) the name and mailing address of the holder;
(b) the permit number and the licence number;
(c) in respect of the shipment of cannabis to be imported,
(i) a description of the cannabis,
(ii) the intended use of the cannabis,
(iii) if applicable, the brand name of the cannabis,
(iv) quantity of the cannabis, and
(v) the percentage of THC w/w and CBD w/w of the cannabis, except in the case of cannabis plants and cannabis plant seeds;
(d) the name and address of the exporter in the country of export;
(e) the port of entry into Canada;
(f) the address of the customs office to which the shipment is to be delivered;
(g) each mode of transportation used, the country of export and, if applicable, any country of transit or transhipment;
(h) any conditions that the Minister considers appropriate;
(i) the effective date of the permit; and
(j) the date of expiry of the permit.
Marginal note:Refusal to issue — other grounds
206 For the purpose of paragraph 62(7)(h) of the Act, other grounds for refusing to issue an import permit are the following:
(a) the applicant does not hold a licence; and
(b) the Minister has reasonable grounds to believe that
(i) the shipment to which the permit application pertains would contravene these Regulations or the laws of the country of export or any country of transit or transhipment, or
(ii) the importation of the cannabis is for the purpose of exporting it.
Marginal note:Period of validity
207 An import permit is valid until the earliest of the following dates:
(a) the date on which the shipment is imported,
(b) the date of expiry of the permit or the date of its revocation,
(c) the date of expiry of the licence referred to in paragraph 205(b) or the date of its revocation, or
(d) the date of revocation of the permit for exportation issued by the competent authority of the country of export that pertains to the shipment.
Marginal note:Provision of copy of import permit
208 A holder of an import permit must provide a copy of the import permit to the customs office at the time of importation.
Marginal note:Information
209 The holder of an import permit must, within 15 days after the date of release of a shipment of cannabis in Canada, provide the Minister with the following information:
(a) their name, the number of the licence referred to in paragraph 205(b) and the import permit number issued in respect of the shipment;
(b) the date of release of the shipment; and
(c) in respect of the shipment of cannabis that is imported,
(i) a description of the cannabis,
(ii) the intended use of the cannabis,
(iii) if applicable, the brand name of the cannabis,
(iv) the quantity of the cannabis, and
(v) the percentage of THC w/w and CBD w/w of the cannabis, except in the case of cannabis plants and cannabis plant seeds.
Marginal note:Transportation of imported cannabis
210 The holder of an import permit must ensure that, after the imported cannabis is released, it is transported directly to the site set out in the licence referred to in paragraph 205(b).
Marginal note:Revocation — other circumstances
211 For the purpose of paragraph 65(h) of the Act, other circumstances for the revocation of an import permit are the following:
(a) the permit holder has requested, in writing, the revocation;
(b) the licence referred to in paragraph 205(b) has been revoked;
(c) the importation of the cannabis is for the purpose of exporting it; and
(d) a permit that has been suspended is not reinstated because the reasons for the suspension still exist or the permit holder has not demonstrated to the Minister that the suspension is unfounded.
Marginal note:Disclosure of information
212 The Minister may, for the purpose of verifying whether an importation of cannabis complies with these Regulations, provide to a customs officer any information provided in the import permit application or referred to in sections 205 and 209 and inform that customs officer whether the import permit has been suspended or revoked.
Exportation
Marginal note:Export permit
213 (1) A holder of a licence is authorized to export cannabis for medical or scientific purposes if they also hold an export permit for each shipment of cannabis that is exported.
Marginal note:Ancillary activities
(2) A holder of an export permit is also authorized to possess, transfer, transport, send, deliver or sell the shipment of cannabis to the extent necessary to export the cannabis.
Marginal note:Export permit — content
214 The export permit must set out the following information:
(a) the name and mailing address of the holder;
(b) the permit number and the licence number;
(c) in respect of the shipment of cannabis to be exported,
(i) a description of the cannabis,
(ii) the intended use of the cannabis,
(iii) if applicable, the brand name of the cannabis,
(iv) the quantity of the cannabis, and
(v) the percentage of THC w/w and CBD w/w of the cannabis, except in the case of cannabis plants and cannabis plant seeds;
(d) the name and address of the importer in the country of import;
(e) the port of exit from Canada, the country of import and, if applicable, any country of transit or transhipment;
(f) the address of the customs office, sufferance warehouse or bonded warehouse to which the shipment is to be delivered, if applicable;
(g) each mode of transportation used;
(h) any conditions that the Minister considers appropriate;
(i) the effective date of the permit; and
(j) the date of expiry of the permit.
Marginal note:Refusal to issue — other grounds
215 For the purpose of paragraph 62(7)(h) of the Act, other grounds for refusing to issue an export permit are the following:
(a) the applicant does not hold a licence; and
(b) the Minister has reasonable grounds to believe that the shipment to which the permit application pertains
(i) would contravene these Regulations or the laws of the country of import or any country of transit or transhipment, or
(ii) would not comply with the permit for importation issued by a competent authority of the country of import.
Marginal note:Period of validity
216 An export permit is valid until the earliest of the following dates:
(a) the date on which the shipment is exported,
(b) the date of expiry of the permit or the date of its revocation,
(c) the date of expiry of the licence referred to in paragraph 214(b) or the date of its revocation, or
(d) the date of expiry of the permit for importation issued by the competent authority of the country of import that pertains to the shipment or the date of its revocation.
Marginal note:Provision of copy of export permit
217 A holder of an export permit must provide a copy of the export permit to the customs office at the time of exportation.
Marginal note:Information
218 The holder of an export permit must, within 15 days after the date of exportation of a shipment of cannabis, provide the Minister with the following information:
(a) their name and the number of the licence referred to in paragraph 214(b) and the export permit number issued in respect of the shipment;
(b) the date of exportation of the shipment; and
(c) in respect of the shipment of cannabis that is exported,
(i) a description of the cannabis,
(ii) intended use of the cannabis,
(iii) if applicable, the brand name of the cannabis,
(iv) the quantity of the cannabis, and
(v) the percentage of THC w/w and CBD w/w of the cannabis, except in the case of cannabis plants and cannabis plant seeds.
Marginal note:Revocation — other circumstances
219 For the purpose of paragraph 65(h) of the Act, other circumstances for the revocation of an export permit are the following:
(a) the permit holder has requested, in writing, the revocation;
(b) the licence referred to in paragraph 214(b) has been revoked; and
(c) a permit that has been suspended is not reinstated because the reasons for the suspension still exist or the permit holder has not demonstrated to the Minister that the suspension is unfounded.
Marginal note:Disclosure of information
220 The Minister may, for the purpose of verifying whether an exportation of cannabis complies with these Regulations, provide to a customs officer any information provided in the export permit application or referred to in sections 214 and 218 and inform that customs officer whether the export permit has been suspended or revoked.
PART 11Retention of Documents and Information
General Provisions
Marginal note:Manner of retention
221 A person that is required to retain a document or information — or that must ensure that a document or information is retained — under these Regulations must ensure that
(a) the document or information is retained in a manner that will enable an audit of it to be made in a timely manner;
(b) if the person holds a licence, the document or information is available at the site specified in the licence; and
(c) if the person does not hold a licence, the document or information is available at their place of business in Canada or, if they do not have such a place of business, at a place of business in Canada.
Marginal note:Requirement to continue to retain
222 If a person ceases to hold a licence, they must, in respect of any document or information that they were required to retain under these Regulations and for which the retention period has not yet ended,
(a) ensure that the document or information continues to be retained until the end of the retention period; and
(b) provide the Minister with notice in writing of the address of the location at which the document or information is retained and of any subsequent change to the address.
Notices
Marginal note:Retention of notices
223 A holder of a licence, if they send or provide a notice under these Regulations and are not otherwise required to retain a copy, must retain a copy for at least two years after the day on which the notice is sent or provided.
Inventory and Distribution
Marginal note:Inventory
224 (1) A holder of a licence must retain, for each lot or batch of cannabis — other than a cannabis extract, a cannabis topical or edible cannabis — that they produce, a document that contains the following information, as applicable:
(a) the date on which cannabis plants are propagated by means other than sowing seeds and the number of new plants propagated in this manner;
(b) the date on which cannabis plant seeds are sown and their net weight on that date;
(c) the date on which cannabis is harvested and its net weight on that date;
(d) the date on which drying processes are completed for the cannabis and its net weight on that date;
(e) the date on which dried or fresh cannabis is put into a discrete unit form, the net weight of cannabis in each unit and the number of units;
(f) the date on which cannabis that is not of a class of cannabis set out in Schedule 4 to the Act is produced and its net weight or volume on that date; and
(g) except in the case of cannabis plants or cannabis plant seeds, any information that is obtained through testing and that relates to the phytocannabinoid and terpene content of the cannabis.
Marginal note:Packaging
(2) A holder of a licence must retain, for each lot or batch of cannabis — other than a cannabis extract, a cannabis topical or edible cannabis — that they package, a document that contains the following information:
(a) a description of the cannabis, including, if applicable, the brand name;
(b) the date on which the cannabis is packaged and its net weight on that date; and
(c) in the case of a drug containing cannabis, the strength per unit of the drug.
Marginal note:Retention period
(3) The documents must be retained for at least two years after the day on which they are prepared.
Marginal note:Inventory — cannabis extract, etc.
225 (1) A holder of a licence must retain, for each lot or batch of cannabis extract, cannabis topical or edible cannabis that they produce, a document that contains the following information:
(a) the date of production and the net weight or volume of the cannabis extract, cannabis topical or edible cannabis on that date;
(b) if applicable, the date on which the cannabis extract, cannabis topical or edible cannabis is put into a discrete unit form, the net weight or volume of each unit and the number of units;
(c) in respect of the cannabis that is used to produce the cannabis extract, cannabis topical or edible cannabis,
(i) its description,
(ii) its net weight or volume,
(iii) its lot or batch number, and
(iv) the date on which it was produced;
(d) if the cannabis extract, cannabis topical or edible cannabis is or will become a cannabis product or is or will be contained in a cannabis accessory that is or will become a cannabis product,
(i) the list of ingredients that is required to appear on the label of the cannabis product, and
(ii) the net weight, net volume or concentration by weight or volume of each of those ingredients;
(d.1) if the cannabis extract, cannabis topical or edible cannabis is not referred to in paragraph (d) but is or will be distributed in the conduct of non-therapeutic research on cannabis,
(i) the list of ingredients that would be required to appear on the label if the cannabis extract, cannabis topical or edible cannabis were a cannabis product or were contained in a cannabis accessory that is a cannabis product, and
(ii) the net weight, net volume or concentration by weight or volume of each of those ingredients;
(e) if the cannabis extract is or will become a cannabis product or is or will be contained in a cannabis accessory that is or will become a cannabis product,
(i) an indication of whether each ingredient that is required to appear on the label of the cannabis product is a carrier substance, flavouring agent or substance that is necessary to maintain the quality or stability of the cannabis product,
(ii) any additional information in the possession of the holder that relates to the purpose of each ingredient, and
(iii) a description of the flavour, if any, of the cannabis product;
(e.1) if the cannabis extract is not referred to in paragraph (e) but is or will be distributed in the conduct of non-therapeutic research on cannabis,
(i) an indication of whether each ingredient that would be required to appear on the label if the cannabis extract were a cannabis product or were contained in a cannabis accessory that is a cannabis product is a carrier substance, flavouring agent or substance that is necessary to maintain the quality or stability of the cannabis extract,
(ii) any additional information in the possession of the holder that relates to the purpose of each ingredient, and
(iii) a description of the flavour, if any, of the cannabis extract; and
(f) any information that is obtained through testing and that relates to the phytocannabinoid and terpene content of the cannabis extract, cannabis topical or edible cannabis.
Marginal note:Exception to subparagraph (1)(d)(ii) or (d.1)(ii)
(1.1) The document is not required to contain the information referred to in subparagraph (1)(d)(ii) or (d.1)(ii), as the case may be, in respect of an ingredient if
(a) the ingredient is part of a mixture of substances that was used in the production of cannabis referred to in paragraph (1)(d) or (d.1);
(b) the holder obtained the mixture from another person;
(c) the information has not been disclosed to the holder;
(d) the holder has made the necessary arrangements to ensure that the information will be provided to the Minister if, within the retention period referred to in subsection (3), the Minister requires the holder to provide it; and
(e) the document contains the net weight or volume of the mixture at the time it was used to produce the cannabis.
Marginal note:Exception to subparagraph (1)(e)(i) or (e.1)(i)
(1.2) The document is not required to contain the information referred to in subparagraph (1)(e)(i) or (e.1)(i), as the case may be, in respect of an ingredient if
(a) the requirements in paragraphs (1.1)(a) to (d) are met; and
(b) the holder includes in the document an indication of whether the mixture referred to in paragraph (1.1)(a) contains carrier substances, flavouring agents, substances that are necessary to maintain the quality or stability of the cannabis, or a combination of any of these.
Marginal note:Packaging
(2) A holder of a licence must retain, for each lot or batch of cannabis extract, cannabis topical or edible cannabis that they package, a document that contains the following information:
(a) a description of the cannabis extract, cannabis topical or edible cannabis, including the brand name, if applicable;
(b) the date on which the cannabis extract, cannabis topical or edible cannabis is packaged and its net weight or volume on that date; and
(c) in the case of a drug containing cannabis, the strength per unit of the drug.
Marginal note:Retention period
(3) The documents must be retained for at least two years after the day on which they are prepared.
Marginal note:Exception
(4) Despite subsection (3), in the case of cannabis that was distributed to human participants in the conduct of non-therapeutic research on cannabis, the holder of the licence for research that distributed the cannabis must retain the documents for at least two years after the day on which the research ends.
Marginal note:Cannabis obtained from another person
226 (1) A holder of a licence must, if they obtain cannabis from another person, retain a document that contains the following information:
(a) the name of the person from which the cannabis is obtained;
(b) the address of the location at which the cannabis is obtained and, if that location is different from the site or sites at which the cannabis was produced, the address of the site or sites, if known;
(c) the date on which the cannabis is obtained;
(d) the quantity of cannabis that is obtained;
(e) a description of the cannabis, including, if applicable, the brand name;
(f) if applicable, the lot or batch number of the cannabis;
(g) in the case of a drug containing cannabis, the form of the drug and its strength per unit; and
(h) in the case of cannabis plants, cannabis plant seeds or cannabis that is not of a class of cannabis set out in Schedule 4 to the Act, the intended use.
Marginal note:Retention period
(2) The document must be retained for at least two years after the day on which it is prepared.
Marginal note:Things to be used as ingredients
226.1 (1) A holder of a licence for processing must, if they obtain or produce anything that will be used as an ingredient to produce a cannabis extract, a cannabis topical or edible cannabis, retain a document that contains the following information:
(a) the name and business address of the person, if any, that supplies the thing;
(b) the date on which the holder takes possession of the thing or, if the thing is produced by the holder, the date on which production is completed;
(c) a description of the thing, including the name by which it is generally known and, if applicable,
(i) its chemical name,
(ii) its common name, if that name is not the name by which it is generally known,
(iii) its INCI name, and
(iv) its CAS registry number; and
(d) any lot code or other unique identifier that enables the thing to be traced.
Marginal note:Retention period
(2) The document must be retained for at least two years after the day on which it is prepared.
Marginal note:Definitions
(3) The following definitions apply in paragraph (1)(c).
- CAS registry number
CAS registry number means the identification number assigned to a chemical by the Chemical Abstracts Service, a division of the American Chemical Society. (numéro d’enregistrement CAS)
- common name
common name has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (nom usuel)
- INCI name
INCI name has the same meaning as in subsection 2(1) of the Cosmetic Regulations. (appellation INCI)
Marginal note:Sale, distribution and export of cannabis
227 (1) A holder of a licence, if they sell, distribute or export cannabis, must retain a document that contains the following information:
(a) the name of the person to which it is sold, distributed or exported;
(b) the address of the location from which it is sold, distributed or exported and the place to which it is sent or delivered;
(c) the date on which it is sold, distributed or exported;
(d) the quantity that is sold, distributed or exported;
(e) a description of the cannabis, including, if applicable, the brand name;
(f) its lot or batch number;
(f.1) in the case of a cannabis extract, a cannabis topical or edible cannabis that is a cannabis product or that is contained in a cannabis accessory that is a cannabis product, the list of ingredients that appears on the label of the cannabis product;
(g) in the case of a drug containing cannabis, the form of the drug and its strength per unit;
(h) in the case of cannabis plants, cannabis plant seeds or cannabis that is not of a class of cannabis set out in Schedule 4 to the Act, the intended use, if known; and
(i) in the case of a cannabis accessory that is a cannabis product, a description of the cannabis accessory.
Marginal note:Exceptions
(2) The obligation set out in subsection (1) does not apply if the cannabis is sold or distributed to
(a) an individual who has placed a purchase order for it under subsection 289(1); or
(b) an individual, other than an individual referred to in paragraph (a), who does not hold a licence and who is obtaining the cannabis for their personal use.
Marginal note:Retention period
(3) The document must be retained for at least two years after the day on which it is prepared.
Marginal note:Antimicrobial treatment
228 (1) A holder of a licence, if they conduct antimicrobial treatment of cannabis at a location other than the site specified in the licence, must retain a document that contains the following information:
(a) a description of the cannabis, including, if applicable, the brand name;
(b) the date on which the cannabis leaves the site specified in the licence and the quantity that leaves the site;
(c) the name of the person that receives the cannabis at the location where the treatment is to be conducted;
(d) the address of the location referred to in paragraph (c);
(e) the name of the person from which the cannabis is received after the treatment;
(f) the address of the site to which the cannabis is returned, or of the location to which it is distributed, after the treatment; and
(g) the date on which the cannabis is received at the site or location referred to in paragraph (f) and the quantity that is received.
Marginal note:Retention period
(2) The document must be retained for at least two years after the day on which it is prepared.
Destruction
Marginal note:Destruction of cannabis
229 (1) A holder of a licence other than a cannabis drug licence, if they destroy cannabis or cause it to be destroyed, must retain a document that contains the following information:
(a) a description of the cannabis, including, if applicable, the brand name;
(b) the date on which the cannabis is destroyed and its pre-destruction net weight or volume on that date;
(c) the address of the location at which the cannabis is destroyed;
(d) a brief description of the method of destruction; and
(e) the names of the individuals who witness the destruction and are qualified to do so under paragraph 43(1)(b), together with the basis on which they are qualified under subsection 43(2).
Marginal note:Statement by witnesses
(2) The holder must obtain, for each instance in which cannabis is destroyed, a statement signed and dated by two of the witnesses referred to in paragraph (1)(e) stating that they witnessed the destruction and that the cannabis was destroyed in accordance with a method referred to in paragraph 43(1)(a).
Marginal note:Retention period
(3) The document referred to in subsection (1) and the statement referred to in subsection (2) must be retained for at least two years after the day on which the cannabis is destroyed, except if they relate to cannabis destroyed under section 28.5, in which case they must be retained for at least two years after the day on which the non-therapeutic research on cannabis ends.
Security
Marginal note:Organizational security plan
230 A holder of a licence must retain a copy of any organizational security plan that they submit to the Minister — including any updated plan referred to in section 45 — for at least two years after the day on which the plan is replaced by an updated plan or, if the plan has not been replaced, at least two years after the day on which the licence expires or is revoked.
Production
Marginal note:Production
231 (1) A holder of a licence other than a cannabis drug licence must
(a) for each lot or batch of cannabis any portion of which has been sold or exported, retain a document demonstrating that the cannabis and anything that was used as an ingredient was produced, packaged, labelled, distributed, stored, sampled and tested in accordance with the applicable provisions of Parts 5 and 6;
(b) if applicable, maintain a list of the brand names of cannabis — of any class of cannabis set out in Schedule 4 to the Act — that the holder has produced, packaged, labelled, distributed, stored, sampled or tested;
(c) in respect of each instance in which a substance — including a pest control product and a fertilizer but excluding water — is applied directly or indirectly to cannabis, retain a document that contains the following information:
(i) the name of the substance and the quantity used,
(ii) the method and date of application, and
(iii) the rationale for the use of the substance;
(d) in respect of the testing conducted under Part 5 or to meet the requirements set out in Part 6,
(i) maintain a document that describes the validated methods used, and
(ii) for each lot or batch of cannabis that is tested, retain a document that contains the test results;
(e) in the case of a licence for processing, retain
(i) a document that describes the qualifications of the quality assurance person — and of any alternate quality assurance person — in respect of the matters referred to in subsection 19(1), and
(ii) a document that describes every investigation conducted under paragraph 19(2)(b) or (c) and any measures taken under that paragraph; and
(f) in the case of a licence for analytical testing, retain a document that describes the qualifications of the head of laboratory in respect of the matters referred to in subsection 23(2).
Marginal note:Non-therapeutic research on cannabis
(1.1) The holder of a licence for research must also retain a document demonstrating that each lot or batch of cannabis that the holder produced or received from another holder of a licence for research and that has been distributed to human participants in the conduct of non-therapeutic research on cannabis, and anything that was used as an ingredient, was produced, packaged, labelled, distributed, stored, sampled or tested in accordance with sections 28.1 and 28.2 and the provisions of Parts 5 and 6, if applicable.
Marginal note:Retention periods
(2) The following documents must be retained for the following periods:
(a) a document referred to in paragraph (1)(a), for at least two years after the day on which the last sale or export of any portion of the lot or batch takes place;
(b) a document referred to in paragraph (1)(c), for at least two years after the day on which it is prepared;
(c) a document referred to in subparagraph (1)(d)(ii), for at least two years after the day on which the last sale or export of any portion of the lot or batch takes place;
(d) a document referred to in subparagraph (1)(e)(i) or paragraph (f), for the period during which the quality assurance person, the alternate quality assurance person or the head of laboratory acts in that capacity and at least two years after the day on which they cease to do so;
(e) a document referred to in subparagraph (1)(e)(ii), for at least two years after the day on which it is prepared; and
(f) a document referred to in subsection (1.1), for at least two years after the day on which the non-therapeutic research on cannabis ends.
Marginal note:Retention periods — previous versions
(3) The holder must retain
(a) each version of the list referred to in paragraph (1)(b), for at least two years after the day on which it is replaced by a new version or, if it has not been replaced, at least two years after the day on which the licence expires or is revoked; and
(b) each version of the document referred to in subparagraph (1)(d)(i), for at least two years after the day on which the validated methods are replaced or, if the methods have not been replaced, two years after the day on which the licence expires or is revoked.
Marginal note:Standard operating procedures and sanitation program
232 (1) A holder of a licence other than a cannabis drug licence must maintain documentation describing
(a) the standard operating procedures referred to in section 80 that are in use at the site set out in the licence; and
(b) the sanitation program referred to in section 87 that is in use at the site set out in the licence.
Marginal note:Retention period
(2) The holder must retain each version of the documentation for at least two years after the day on which it is replaced by a new version or, if it has not been replaced, at least two years after the day on which the licence expires or is revoked.
Packaging and Labelling
Marginal note:Packages and labels
233 A holder of a licence other than a cannabis drug licence must retain the following samples and copies for at least two years after the day on which they are made:
(a) a sample or copy of each distinct package for a cannabis product that the holder makes available for sale; and
(b) a copy of each distinct label that relates to a cannabis product that the holder makes available for sale.
Cannabis Accessories
Marginal note:Cannabis accessories
234 A holder of a licence must maintain a list of the names and types of the cannabis accessories that they sell and must retain each version of the list for at least two years after the day on which it is replaced by a new version or, if it has not been replaced, at least two years after the day on which the licence expires or is revoked.
System of Control for Recalls
Marginal note:System of control
235 (1) A holder of a licence, other than a licence for analytical testing or a cannabis drug licence must retain, for each lot or batch of cannabis that they sell or distribute, a document that contains the information that is necessary for the system of control referred to in subsection 46(1).
Marginal note:Retention period
(2) The document must be retained for at least two years after the day on which the last sale or distribution of any portion of the lot or batch takes place, other than for destruction.
Marginal note:Documentation
(3) The holder must maintain documentation concerning the system of control and retain each version of the documentation for at least two years after the day on which it is replaced by a new version or, if it has not been replaced, at least two years after the day on which the licence expires or is revoked.
Promotion
Marginal note:Promotion
236 A holder of a licence must retain
(a) a document that contains the information referred to in subparagraphs 245(1)(a)(i) and (ii) and (2)(a)(i) and (ii) for at least two years after the date by which the information must be provided to the Minister;
(b) if applicable, a document that contains any information that is provided to the Minister under subsection 43(4) of the Act for at least two years after the day on which the information is provided; and
(c) a sample or copy of any promotional materials for at least two years after the last day on which the promotion in question takes place.
Research and Development
Marginal note:Research and development
237 (1) A holder of a licence, if they undertake research and development activities, must retain a document that contains the following information:
(a) in respect of any cannabis that is used in the activities,
(i) its description, including, if applicable, its brand name,
(ii) the quantity used and, if applicable, the lot or batch number,
(iii) the date on which it is used, and
(iv) the purpose and a brief description of the activity;
(b) in respect of any cannabis that is produced in the course of the activities,
(i) its description,
(ii) the quantity produced,
(iii) the date on which it is produced,
(iv) if applicable, the date on which it is used for testing and the quantity used, and
(v) if applicable, the date on which it is placed in inventory intended for sale and the quantity placed in inventory; and
(c) any other information that can be used to reconcile the quantities of cannabis referred to in paragraphs (a) and (b).
Marginal note:Non-therapeutic research on cannabis
(1.1) A holder of a licence for research must also retain, in relation to any non-therapeutic research on cannabis that the holder conducts, the following documents:
(a) a copy of the documents submitted to the Minister in relation to that research;
(b) a copy of the documents produced in relation to that research; and
(c) a copy of any document required by licence conditions that the Minister has imposed under subsection 62(10) of the Act.
Marginal note:Retention period — general rule
(2) A document referred to in subsection (1) that does not relate to non-therapeutic research on cannabis must be retained for at least two years after the day on which it is prepared.
Marginal note:Retention period — non-therapeutic research on cannabis
(3) Despite any other provision of these Regulations that specifies a retention period and except in the case of reports and records referred to in section 248.2, every document that the holder of a licence for research must retain under these Regulations in relation to non-therapeutic research on cannabis that the holder conducts or in relation to cannabis that is distributed in the conduct of such research must be retained for at least two years after the day on which the non-therapeutic research on cannabis ends.
Limit for Micro-processing Licence
Marginal note:Limit — micro-processing licence
238 A holder of a licence for micro-processing must maintain documentation that demonstrates that they comply with the limit set out in subsection 21(1) and retain each version of the documentation for at least two years after the day on which it is replaced by a new version or, if it has not been replaced, for at least two years after the day on which the licence expires or is revoked.
Import and Export
Marginal note:Import of cannabis
239 A holder or former holder of an import permit must retain a document that contains the information that they provided to the Minister under section 209 — together with a copy of the relevant export permit that was issued by a competent authority in the country of export — for at least two years after the day on which the information is provided.
Marginal note:Export of cannabis
240 A holder or former holder of an export permit must retain a document that contains the information that they provided to the Minister under section 218 — together with a copy of the relevant import permit issued by a competent authority in the country of final destination — for at least two years after the day on which the information is provided.
Key Investors
Marginal note:Record of key investors
241 (1) A holder of a licence for cultivation, processing or sale must maintain a record that contains the following information in respect of each key investor:
(a) the key investor’s name and mailing address;
(b) a detailed description of the means by which the key investor exercises, or is in a position to exercise, control over the holder;
(c) details regarding the transaction by virtue of which the key investor became such an investor, including
(i) if they provided money directly or indirectly to the holder, the amount provided, the date on which it was provided and the terms and conditions under which it was provided, and if the money was provided in the form of a loan, the interest rate and term, and
(ii) if they provided goods or services directly or indirectly to the holder, a description of the goods or services, their fair market value at the time they were provided, the date on which they were provided and the terms and conditions under which they were provided;
(d) details regarding each instance in which the key investor provides money, goods or services directly or indirectly to the holder, including
(i) in the case of money, the amount provided, the date on which it is provided and the terms and conditions under which it is provided, and if the money is provided in the form of a loan, the interest rate and term, and
(ii) in the case of goods or services, a description of the goods or services, their fair market value at the time at which they are provided, the date on which they are provided and the terms and conditions under which they are provided;
(e) details regarding any benefit that the key investor receives from the holder as a result of
(i) having provided money, goods or services to the holder, or
(ii) holding an ownership interest or other right or interest in, or in respect of, a business operated by the holder or, if the holder is an organization, in or in respect of the organization;
(f) details regarding each instance in which money is repaid or goods are returned to the key investor, including
(i) in the case of money, the amount repaid and the date on which it is repaid, and
(ii) in the case of goods, a description of the goods, their fair market value at the time they are returned and the date on which they are returned;
(g) if known, an indication of whether any ownership interest or other right or interest held by the key investor in, or in respect of, a business operated by the holder — or, if the holder is an organization, in or in respect of the organization — has been assigned, pledged, mortgaged, hypothecated or sold, in whole or in part, to any person;
(h) if known, an indication of whether an agreement has been entered into under which any right or interest referred to paragraph (g) will or could be assigned, pledged, mortgaged, hypothecated or sold, in whole or in part, to any person; and
(i) if known, the name and mailing address of any person referred to in paragraph (g) or (h).
Marginal note:Exception — published market
(2) Subsection (1) does not apply to a holder that is an organization if their equity securities are, or a class of those securities is, listed on a published market.
Marginal note:Exception — key investors before issuance
(3) The holder is not required to include the information referred to in paragraph (1)(c) in respect of a key investor that became such an investor before the day on which the licence was issued.
Marginal note:Exception — continued licences
(4) If the licence has been continued in force by virtue of subsection 158(1) of the Act, the holder is not required to include the information referred to in paragraph (1)(c) in respect of a key investor that became such an investor before the day on which these Regulations come into force.
Marginal note:Requirements regarding content
(5) The holder must not delete any information from the record and must indicate the effective date of the event in respect of which new information is added to the record.
Marginal note:Former key investors
(6) For greater certainty, the information that has been included in the record in respect of a key investor must continue to be retained in the record even if the person ceases to be such an investor.
Marginal note:Annual reporting
(7) The holder must, no later than January 31 in any given year, provide the Minister with
(a) a copy of the record; and
(b) if any person ceased to be a key investor during the previous calendar year, a document containing details regarding how and when they ceased to be such an investor.
Marginal note:Maintenance and retention of record
(8) The holder must ensure that the record is
(a) maintained in a manner that will enable an audit of it to be made in a timely manner;
(b) available at the site specified in the licence; and
(c) retained for at least two years after the day on which the holder ceases to be required to maintain it.
Marginal note:Definitions
(9) The following definitions apply in this section.
- key investor
key investor means, in respect of the holder of a licence, a person that exercises, or is in a position to exercise, direct or indirect control over the holder by virtue of
(a) having provided money, goods or services directly or indirectly to the holder; or
(b) holding an ownership interest or other right or interest in, or in respect of, a business operated by the holder or, if the holder is an organization, in or in respect of the organization. (investisseur-clé)
- published market
published market means a market inside or outside Canada on which equity securities are traded, if the prices at which the securities are traded are regularly published either electronically or in a newspaper or financial or business publication of general circulation. (marché publié)
PART 12Reporting and Disclosure
Documents and Information Provided to Minister
Marginal note:Form and manner
242 Except as otherwise provided in these Regulations, documents that are required to be provided to the Minister under this Part, Part 8, subsection 241(7) or section 297 must be provided in the form and manner specified in the document entitled Form and Manner Requirements – Documents Provided to the Minister for the Purposes of the Cannabis Act, as amended from time to time and published by the Government of Canada on its website.
Marginal note:Request by Minister
243 (1) A person that is required to ensure the retention of documents or information under these Regulations and that is not authorized under the Act to conduct activities in relation to cannabis may be required by the Minister to provide the documents or information to the Minister if the Minister has reasonable grounds to believe that the documents are, or the information is, necessary to address an issue of public health or public safety or to verify compliance or prevent non-compliance with the provisions of the Act or of these Regulations. If the person is required to provide the documents or information to the Minister, they must do so as soon as feasible.
Marginal note:Import and export permits
(2) A person that has ceased to hold a licence and that is required to retain documents — including copies of permits — under section 239 or 240 may be required by the Minister to provide the documents to the Minister if the Minister has reasonable grounds to believe that they are necessary for a purpose specified in subsection (1). If the person is required to provide the documents to the Minister, they must do so as soon as feasible.
Marginal note:Exception — urgent issues
(3) A document or information that must be provided under subsection (1) or (2) to address an issue of public health or public safety must be provided without delay if the Minister has reasonable grounds to believe that the issue must be addressed urgently and so indicates in the request.
Marginal note:Notice — new cannabis product
244 (1) A holder of a licence for processing, at least 60 days before making available for sale a cannabis product — except cannabis plants or cannabis plant seeds — that they have not previously sold in Canada, must provide the Minister with a written notice that contains the following information:
(a) the class of cannabis set out in Schedule 4 to the Act to which the cannabis product belongs;
(b) a description of the cannabis product, including the brand name; and
(c) the date on which the cannabis product is expected to be made available for sale.
Marginal note:Retention period
(2) The holder must retain a copy of the notice for at least two years after the date referred to in paragraph (1)(c).
Marginal note:Information related to promotion
245 (1) For the purpose of subsection 43(1) of the Act,
(a) the information that a person referred to in that subsection must provide to the Minister in respect of the promotion of cannabis is
(i) the total amount of money that the person spent in a given calendar year on promotion that is directed at consumers who purchase cannabis at the retail level in Canada, together with a description of the types of promotion on which the money was spent, and
(ii) the total amount of money that the person spent in a given calendar year on promotion conducted in Canada that is not directed at consumers referred to in subparagraph (i), together with a description of the types of promotion on which the money was spent; and
(b) the information must be provided, in writing, no later than March 31 of the year after the year to which the information relates.
Marginal note:Cannabis accessories and services
(2) For the purpose of subsection 43(2) of the Act,
(a) the information that a person referred to in that subsection must provide to the Minister, in respect of the promotion of cannabis accessories that they sell or distribute or a service related to cannabis that they provide, is
(i) the total amount of money that the person spent in a given calendar year on promotion that is directed at consumers who purchase cannabis at the retail level in Canada, together with a description of the types of promotion on which the money was spent, and
(ii) the total amount of money that the person spent in a given calendar year on promotion conducted in Canada that is not directed at consumers referred to in subparagraph (i), together with a description of the types of promotion on which the money was spent; and
(b) the information must be provided, in writing, no later than March 31 of the year after the year to which the information relates.
Marginal note:Exemption
(3) A person referred to in subsection 43(1) or (2) of the Act is exempt from the requirement to provide the information referred to in subsection (1) or (2) if they do not hold a licence.
Marginal note:Prior promotions
(4) The information referred to in subsections (1) and (2) is not required to be provided in respect of any promotion that is conducted before the day on which these Regulations come into force.
Marginal note:Theft or loss of cannabis
246 (1) A holder of a licence other than a cannabis drug licence must, if they experience a theft of cannabis or a loss of cannabis that cannot be explained on the basis of normally accepted business activities,
(a) notify a police force within 24 hours after becoming aware of its theft or loss; and
(b) provide the Minister with a written notice within 10 days after becoming aware of its theft or loss.
Marginal note:Retention period
(2) The holder must retain a copy of the notice provided to the Minister for at least two years after the day by which the Minister must be notified.
Marginal note:Voluntary recall
247 (1) A holder of a licence must, before commencing a voluntary recall of a cannabis product that has been sold or distributed in Canada, provide the Minister with a document that contains the following information:
(a) a description of the cannabis product, including the brand name;
(b) the number of each lot or batch of the cannabis product to be recalled, together with, if known, the number of any lot or batch of cannabis that was used to make the cannabis product;
(c) if known, the name and address of each person that
(i) produced or imported into Canada the cannabis that is, or is contained in, the cannabis product,
(ii) packaged or labelled the cannabis referred to in subparagraph (i) before it became, or became part of, the cannabis product,
(iii) in the case of a cannabis accessory that is a cannabis product, produced or imported into Canada the cannabis accessory or any component of it, or
(iv) packaged or labelled the cannabis product;
(d) the reasons for commencing the recall;
(e) if the cannabis that is, or is contained in, the cannabis product was produced or imported into Canada by the holder, the quantity of cannabis that was produced or imported;
(f) the quantity of the cannabis product that was sold or distributed by the holder in Canada;
(g) if applicable, the quantity of the cannabis product that is affected by the problem or potential problem underlying the recall and that remains in the possession of the holder;
(h) the number of persons to which the holder sold or distributed the cannabis product in Canada;
(i) the period during which the holder sold or distributed the cannabis product in Canada;
(j) the time and manner in which the recall is to be carried out, including
(i) the expected date for the commencement of the recall,
(ii) how and when the Minister will be informed of the progress of the recall, and
(iii) the date by which the recall is expected to be completed;
(k) a description of any other measure that the holder is taking, or intends to take, in respect of the recall; and
(l) contact information for a representative who will be responsible for the recall.
Marginal note:Recall — exported cannabis
(2) A holder of a licence must, before commencing a voluntary recall of cannabis that has been exported from Canada, provide the Minister with a document that contains the following information:
(a) a description of the cannabis, including, if applicable, the brand name;
(b) the number of each lot or batch of the cannabis;
(c) if known, the name and address of each person that
(i) produced or imported into Canada the cannabis, and, if applicable, packaged or labelled it, and
(ii) in the case where the cannabis is contained in a cannabis accessory, produced or imported into Canada the cannabis accessory or any component of it;
(d) the reasons for commencing the recall;
(e) if applicable, the quantity of the cannabis that was produced or imported into Canada by the holder;
(f) the quantity of the cannabis that was sold or distributed by the holder in foreign countries;
(g) if applicable, the quantity of the cannabis that is affected by the problem or potential problem underlying the recall and that remains in the possession of the holder;
(h) the number of persons to which the holder sold or distributed the cannabis in foreign countries;
(i) the period during which the holder sold or distributed the cannabis in foreign countries;
(j) the time and manner in which the recall is to be carried out, including
(i) the expected date for the commencement of the recall,
(ii) how and when the Minister will be informed of the progress of the recall, and
(iii) the date by which the recall is expected to be completed;
(k) a description of any other measure that the holder is taking, or intends to take, in respect of the recall; and
(l) contact information for a representative who will be responsible for the recall.
Marginal note:Risk evaluation
(3) The holder must, within 72 hours after providing the Minister with the document referred to in subsection (1) or (2), provide the Minister with a document that contains an evaluation of the risk associated with the problem or potential problem that underlies the recall.
Marginal note:Report
(4) The holder must, within 30 days after the day on which the recall is completed, provide the Minister with a written report that sets out the results of the recall and the measures taken to prevent a recurrence of the problem.
Marginal note:Extension
(5) Despite subsection (4), the Minister may extend the period for providing the report — to a maximum of 90 days after the day on which the recall is completed — if, for reasons beyond the holder’s control, it is not feasible to provide it within the 30-day period.
Marginal note:Retention periods
(6) The holder must retain
(a) a copy of the documents that they provide to the Minister under subsections (1) and (3) for at least two years after the day on which their last sale or distribution of any cannabis product that is the subject of the recall takes place;
(b) a copy of the documents that they provide to the Minister under subsections (2) and (3) for at least two years after the day on which their last export of any of the cannabis that is the subject of the recall takes place; and
(c) a copy of the report that they provide to the Minister under subsection (4) for at least two years after the day on which the recall is completed.
Definitions of adverse reaction and serious adverse reaction
248 The following definitions apply in this section and sections 248.1 and 248.2.
- adverse reaction
adverse reaction means a noxious and unintended response to cannabis or a cannabis accessory that contains cannabis. (réaction indésirable)
- serious adverse reaction
serious adverse reaction means an adverse reaction that requires inpatient hospitalization or a prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. (réaction indésirable grave)
Marginal note:Cannabis products
248.1 (1) A holder of a licence that sells or distributes a cannabis product must
(a) within 15 days after becoming aware of a serious adverse reaction to the cannabis product, provide the Minister with a detailed report containing all information in their possession that is associated with the use of the product by the individual who experienced the serious adverse reaction; and
(b) prepare an annual summary report that contains a concise and critical analysis of all adverse reactions to the cannabis product that the holder became aware of during the previous 12 months.
Marginal note:Retention period
(2) The holder must retain the reports for at least 25 years after the day on which they are prepared.
Marginal note:Non-application
(3) This section does not apply in respect of an adverse reaction to cannabis, or a cannabis accessory that contains cannabis, that is distributed to human participants in the conduct of non-therapeutic research on cannabis.
Marginal note:Non-therapeutic research on cannabis
248.2 (1) During the conduct of non-therapeutic research on cannabis, the holder of a licence for research that distributes cannabis, or a cannabis accessory that contains cannabis, to human participants must,
(a) within seven days after becoming aware of a serious adverse reaction to the cannabis or cannabis accessory that is life-threatening or that results in death, notify the Minister of the serious adverse reaction; and
(b) within eight days after notifying the Minister under paragraph (a), provide the Minister with a detailed report containing all information in their possession that is associated with the use of the cannabis or cannabis accessory by the individual who experienced the serious adverse reaction, including the intended use of the cannabis or cannabis accessory, an assessment of the cause of the serious adverse reaction and a statement of what further action, if any, needs to be taken by the holder of the licence.
Marginal note:Serious adverse reaction not life threatening
(2) The holder of the licence must, within 15 days after becoming aware of a serious adverse reaction to the cannabis or cannabis accessory that is not life-threatening and does not result in death, provide the Minister with a detailed report containing all information in their possession that is associated with the use of the cannabis or cannabis accessory by the individual who experienced the serious adverse reaction, including the intended use of the cannabis or cannabis accessory, an assessment of the cause of the serious adverse reaction and a statement of what further action, if any, needs to be taken by the holder of the licence.
Marginal note:Record keeping
(3) The holder must retain a record of each adverse reaction and serious adverse reaction that occurs during the holder’s conduct of non-therapeutic research on cannabis and that the holder becomes aware of.
Marginal note:Retention period
(4) The holder must retain the reports and record for at least 15 years after the day on which they are prepared.
Disclosure of Information to Third Parties
Marginal note:Notices to local authorities
249 (1) The Minister may, at the request of the government of a province or any police force or other law enforcement agency in a province, disclose to the government, police force or agency any information set out in a notice that is referred to in section 7 or 35 and that relates to a site located in that province if the disclosure is for a purpose related to verifying compliance or preventing non-compliance with the provisions of
(a) the Act;
(b) these Regulations;
(c) a provincial Act; or
(d) regulations made under a provincial Act.
Marginal note:Police investigation
(2) The Minister may disclose any information that is set out in a notice referred to in section 7 or 35 to a Canadian police force, or a member of a Canadian police force, that requests the information in the course of an investigation under the Act.
Marginal note:Use of information
(3) Information that is disclosed under subsection (2) must be used only for the purposes of the investigation or the administration or enforcement of the Act or these Regulations.
Marginal note:Disclosure to province
250 (1) For the purpose of paragraph 83(f) of the Act, information contained in the national cannabis tracking system may be disclosed to the government of a province, at its request, if the disclosure is for a purpose related to the implementation of public health programs or activities that are related to cannabis.
Marginal note:Public health programs and activities
(2) The Minister may, at the request of the government of a province, disclose to the government any information obtained under section 297 if the disclosure is for a purpose related to the implementation of public health programs or activities that are related to cannabis.
Marginal note:International Narcotics Control Board
251 (1) In addition to the information that may be disclosed under sections 83, 128 and 129 of the Act, the Minister may disclose to the International Narcotics Control Board other information that is obtained under the Act if the disclosure is necessary to enable Canada to fulfill its international obligations in relation to cannabis.
Marginal note:Former statute
(2) The Minister may also disclose to the International Narcotics Control Board any information relating to cannabis that was obtained under the Controlled Drugs and Substances Act before the day on which these Regulations come into force if the disclosure is necessary to enable Canada to fulfill its international obligations in relation to cannabis.
Marginal note:Competent authorities
252 The Minister may, for the purposes of the administration or enforcement of the Act or these Regulations or if it is necessary to enable Canada to fulfill its international obligations in relation to cannabis, disclose to a competent authority
(a) information obtained from a person that has applied for or that holds an import or export permit;
(b) information relating to an activity authorized by
(i) an import or export permit, or
(ii) a licence held by a person that has applied for or that holds an import or export permit;
(c) any document that the holder or former holder of an import or export permit is required to retain, including any document that relates to a licence that they hold or held; and
(d) a copy of any import or export permit.
PART 13Test Kits
Marginal note:Exemption — Division 2 of Part 1 of Act
253 The cannabis that is contained in a test kit that meets the requirements of paragraphs 255(a) and (b) is exempt from Subdivisions A to D of Division 2 of Part 1 of the Act.
Marginal note:Non-application
254 Part 5 and section 137 do not apply to the cannabis that is contained in a test kit.
Marginal note:Sale, importation and exportation
255 A person is authorized to sell, import or export a test kit if
(a) a registration number has been issued for the test kit and the number has not been cancelled;
(b) the following information is included on the label that is applied to the test kit:
(i) the registration number, and
(ii) in the case of a test kit that is not subject to the labelling requirements of the Medical Devices Regulations,
(A) the name and address of the manufacturer or assembler or, if applicable, the name and address of the person for which the test kit was manufactured or assembled further to a custom order, and
(B) its brand name; and
(c) the test kit is sold, imported or exported for a medical, laboratory, industrial, educational, law administration or enforcement or research purpose.
Marginal note:Individual — possession and distribution
256 An individual is authorized to conduct the following activities, in relation to one or more test kits that contain a total amount of cannabis that, as determined in accordance with subsection 2(4) of the Act, is equivalent to more than the amount the individual may possess under the Act, if the registration number is included on the label of each test kit
(a) possess it in a public place; and
(b) distribute it for a medical, laboratory, industrial, educational, law administration or enforcement or research purpose.
Marginal note:Organization — possession and distribution
257 An organization is authorized to conduct the following activities if the label of a test kit includes its registration number:
(a) possess the test kit; and
(b) distribute the test kit for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.
Marginal note:Application for registration number
258 (1) The manufacturer or assembler of a test kit or, if the test kit is manufactured or assembled further to a custom order, the person for which the test kit was manufactured or assembled, may apply for a registration number for the test kit by submitting an application to the Minister containing the following information:
(a) the brand name of the test kit;
(b) particulars of the design and construction of the test kit;
(c) a statement of the proposed use of the test kit;
(d) a detailed description of the cannabis contained in the test kit, including
(i) the class of cannabis set out in column 1 of Schedule 3 to the Act, and
(ii) the quantity of cannabis;
(e) if applicable, a detailed description of every other substance contained in the test kit, including
(i) the name of each substance,
(ii) if the substance is a salt, the name of the salt, and
(iii) the quantity of each substance; and
(f) the directions for use of the test kit.
Marginal note:Signature and declaration
(2) An application for the registration of a test kit must
(a) be signed and dated by an individual authorized by the applicant for that purpose; and
(b) include a declaration, signed and dated by that individual, indicating that all the information provided in support of the application is correct and complete to the best of their knowledge.
Marginal note:Additional information
259 The Minister may, on receiving an application referred to in section 258, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to consider the application.
Marginal note:Issuance of a registration number
260 (1) Subject to subsection (2), the Minister must, after examining the information and documents required under sections 258 and 259, issue a registration number for the test kit to the applicant if the applicant demonstrates that the test kit is designed to be used solely for a medical, laboratory, industrial, educational, law administration or enforcement or research purpose.
Marginal note:Refusal
(2) The Minister must refuse to issue a registration number if he or she has reasonable grounds to believe that
(a) the test kit is likely to create a risk to public health or safety, including the risk of cannabis being diverted to an illicit market or activity, because
(i) the quantity of cannabis in the test kit is too high, or
(ii) the adulterating or denaturing agent in the test kit is not likely to prevent or deter consumption or administration of the cannabis; or
(b) the test kit is likely to be used for a purpose other than any of those set out in subsection (1).
Marginal note:Cancellation
261 (1) The Minister must cancel the registration number of a test kit if
(a) the Minister receives a notice from the holder of the registration number stating that it has ceased all authorized activities referred to in section 255, 256 or 257 with respect to the test kit;
(b) the Minister has reasonable grounds to believe that
(i) the test kit is likely to create a risk to public health or safety, including the risk of cannabis being diverted to an illicit market or activity, because
(A) the quantity of cannabis in the test kit is too high, or
(B) the adulterating or denaturing agent in the test kit is not likely to prevent or deter consumption or administration of the cannabis, or
(ii) the test kit is likely to be used for a purpose other than any of those set out in subsection 260(1); or
(c) the test kit is a medical device and is no longer authorized for sale in Canada under the Medical Devices Regulations.
Marginal note:Effect of cancellation
(2) When a registration number issued for a test kit is cancelled, the cancelled registration number
(a) must not be displayed on the label of any test kit manufactured or assembled further to a custom order after the cancellation; and
(b) in the case of a cancellation under paragraph (1)(a), must remain on the label of any existing test kit until all of the test kits with that registration number are disposed of.
Marginal note:Refusal or cancellation
262 If the Minister proposes to refuse to issue or to cancel a registration number, the Minister must
(a) send a notice to the applicant or to the holder of the registration number that sets out the reasons for the refusal or cancellation; and
(b) give the applicant or holder an opportunity to be heard in respect of the refusal or cancellation.
Marginal note:Application for new number
263 (1) If a registration number issued for a test kit has been cancelled under section 261, the manufacturer or assembler of the test kit or, if the test kit is manufactured or assembled further to a custom order, the person for which the test kit was manufactured or assembled,
(a) may apply to the Minister for the issuance of a new registration number in accordance with section 258; and
(b) must, in support of the application, provide the Minister with proof that the circumstance that gave rise to the cancellation has been corrected.
Marginal note:New registration number
(2) The Minister, after examining the application and supporting proof referred to in subsection (1), must issue a new registration number for the test kit unless there exists a circumstance set out in paragraph 261(1)(b) or (c).
PART 14Access to Cannabis for Medical Purposes
Interpretation
Marginal note:Definitions
264 (1) The following definitions apply in this Part.
- adult
adult means an individual who is 18 years of age or older. (adulte)
- designated person
designated person means an individual who is designated by a registered person, in accordance with Division 2 of this Part, to produce cannabis for the medical purposes of the registered person. (personne désignée)
- former Marihuana for Medical Purposes Regulations
former Marihuana for Medical Purposes Regulations means the regulations made by Order in Council P.C. 2013-645 of June 6, 2013 and registered as SOR/2013-119. (ancien Règlement sur la marihuana à des fins médicales)
- health care practitioner
health care practitioner means, except as otherwise provided, a medical practitioner or a nurse practitioner. (praticien de la santé)
- licence for sale
licence for sale means a licence for sale for medical purposes. (licence de vente)
- medical document
medical document means a document provided by a health care practitioner to support the use of cannabis for medical purposes. (document médical)
- medical practitioner
medical practitioner means an individual who
(a) is entitled under the laws of a province to practise medicine in that province;
(b) is not restricted, under the laws of the province in which they practise, from authorizing the use of cannabis; and
(c) is not named in a notice issued under section 335 that has not been retracted. (médecin)
- named responsible adult
named responsible adult means, in respect of a client, an adult who is named in the client’s registration document under subparagraph 282(2)(a)(iv) or subsection 285(5). (responsable nommé)
- nurse practitioner
nurse practitioner means an individual who
(a) is entitled under the laws of a province to practise as a nurse practitioner or an equivalent designation and is practising as a nurse practitioner or an equivalent designation in that province;
(b) is not restricted, under the laws of the province in which they practise, from authorizing the use of cannabis; and
(c) is not named in a notice issued under section 335 that has not been retracted. (infirmier praticien)
- provincial professional licensing authority
provincial professional licensing authority means
(a) except in sections 343 to 345, an authority that is responsible for
(i) authorizing the practise of medicine in a province, or
(ii) authorizing individuals to practise as nurse practitioners in a province; and
(b) in sections 343 to 345, an authority that is responsible for authorizing individuals to practise pharmacy in a province. (autorité provinciale attributive de licences en matière d’activités professionelles)
- registered person
registered person means an individual who is registered with the Minister under subsection 313(1). (personne inscrite)
- registration certificate
registration certificate means a certificate issued by the Minister under subsection 313(1). (certificat d’inscription)
- registration document
registration document means a document provided under paragraph 282(2)(a) to a client by a holder of a licence for sale. (document d’inscription)
- written order
written order means a written authorization given by a health care practitioner that a stated amount of cannabis be dispensed for the individual named in the authorization. (commande écrite)
Marginal note:Equivalent designation — nurse practitioner
(2) For the purpose of paragraph (a) of the definition of nurse practitioner, a designation is equivalent when it designates an individual who
(a) is a registered nurse;
(b) possesses additional educational preparation and experience related to health care;
(c) can autonomously make diagnoses, order and interpret diagnostic tests, prescribe drugs and perform other specific procedures under the laws of a province; and
(d) is practising their profession in accordance with one of the following provincial laws, as amended from time to time, or a similar law in another province:
(i) the Extended Practice Regulation, Man. Reg. 43/2005, made under The Registered Nurses Act, C.C.S.M., c. R40,
(ii) Ontario Regulation 275/94, made under the Nursing Act, 1991, S.O. 1991, c. 32, or
(iii) the Regulation respecting the classes of specialization of the Ordre des infirmières et infirmiers du Québec for the activities referred to in section 36.1 of the Nurses Act to be engaged in, CQLR, c. I-8, r. 8, made under the Nurses Act of Quebec, CQLR, c. I-8.
Marginal note:Equivalent quantity — cannabis
(3) In the following provisions, the equivalency of a quantity of cannabis is to be determined in accordance with subsection 2(4) of the Act:
(a) subsections 266(2), (3), (4), (6) and (7);
(b) subsections 267(2) to (5);
(c) paragraph 290(1)(e);
(d) subsection 292(4);
(e) subsection 293(1);
(f) subparagraph 297(1)(e)(iii);
(g) paragraph 322(1)(c);
(h) paragraph 348(3)(a); and
(i) subsection 350(2).
Non-application
Marginal note:Drugs containing cannabis
265 This Part does not apply in respect of a drug containing cannabis.
Possession
Marginal note:Possession in public place — adults
266 (1) The following individuals are authorized to possess, in a public place, cannabis — other than cannabis plants or cannabis plant seeds — that has been obtained under the Act, subject to the applicable maximum amounts and purposes set out in this section:
(a) an adult who is registered with a holder of a licence for sale on the basis of a medical document;
(b) an adult who is a registered person;
(c) an adult who, directly or indirectly, obtained the cannabis as an inpatient or outpatient of a hospital;
(d) an adult who is named in a registration document or a registration certificate as being responsible for an individual referred to in paragraph (a) or (b) or 267(1)(a) or (b) and who possesses the cannabis for the medical purposes of that individual;
(e) an adult who is responsible for an individual referred to in paragraph (c) or 267(1)(c) and who possesses the cannabis for the medical purposes of that individual; and
(f) an adult who possesses the cannabis in the presence of an individual referred to in paragraph (a), (b) or (c) or 267(1)(a), (b) or (c) for the purpose of providing assistance in administering it to the individual.
Marginal note:Client registered on basis of medical document
(2) The maximum amount of cannabis that an adult referred to in paragraph (1)(a) is authorized to possess in a public place, for their own medical purposes, is an amount that is equivalent to the lesser of
(a) 30 times the daily quantity of dried cannabis indicated in their registration document or, if they have more than one registration document, 30 times the total of the daily quantities indicated in the registration documents, and
(b) 150 g of dried cannabis.
Marginal note:Registered person
(3) The maximum amount of cannabis that an adult referred to in paragraph (1)(b) is authorized to possess in a public place, for their own medical purposes, is an amount that is equivalent to the lesser of
(a) 30 times the daily quantity of dried cannabis indicated in their registration certificate, and
(b) 150 g of dried cannabis.
Marginal note:Hospital patient
(4) The maximum amount of cannabis that an adult referred to in paragraph (1)(c) is authorized to possess in a public place, for their own medical purposes, is an amount that is equivalent to the lesser of
(a) 30 times the daily quantity of dried cannabis indicated on the hospital label that is applied to the container in which the cannabis was provided to or for them, and
(b) 150 g of dried cannabis.
Marginal note:Responsible adult
(5) The maximum amount of cannabis that an adult referred to in paragraph (1)(d) or (e) is authorized to possess in a public place, for the medical purposes of the individual for whom they are responsible, is the maximum amount that the individual is authorized to possess under subsection (2), (3) or (4) or 267(2), (3) or (4), as the case may be.
Marginal note:Adult providing assistance
(6) The maximum amount of cannabis that an adult referred to in paragraph (1)(f) is authorized to possess in a public place, for the purpose of providing assistance in administering cannabis to the individual referred to in that paragraph, is an amount equivalent to the lesser of
(a) the daily quantity of dried cannabis indicated in the individual’s registration document or registration certificate or on the hospital label that is applied to the container in which the cannabis was provided to or for the individual, as the case may be, or in the case where the individual has more than one registration document, or one or more registration documents and a registration certificate, the total of the daily quantities, and
(b) 150 g of dried cannabis.
Marginal note:Exception
(7) This section does not authorize an adult who is referred to in more than one of paragraphs (1)(a) to (c) to possess, for their own medical purposes, more than the equivalent of 150 g of dried cannabis.
Marginal note:Possession — young persons
267 (1) The following young persons are authorized to possess cannabis — other than cannabis plants or cannabis plant seeds — that has been obtained under the Act, subject to the applicable maximum amounts and purposes set out in this section:
(a) a young person who is registered with a holder of a licence for sale on the basis of a medical document;
(b) a young person who is a registered person; and
(c) a young person who, directly or indirectly, obtained the cannabis as an inpatient or outpatient of a hospital.
Marginal note:Client registered on basis of medical document
(2) The maximum amount of cannabis that a young person referred to in paragraph (1)(a) is authorized to possess, for their own medical purposes, is an amount that is equivalent to the lesser of
(a) 30 times the daily quantity of dried cannabis indicated in their registration document or, if they have more than one registration document, 30 times the total of the daily quantities indicated in the registration documents, and
(b) 150 g of dried cannabis.
Marginal note:Registered person
(3) The maximum amount of cannabis that a young person referred to in paragraph (1)(b) is authorized to possess, for their own medical purposes, is an amount that is equivalent to the lesser of
(a) 30 times the daily quantity of dried cannabis indicated in their registration certificate, and
(b) 150 g of dried cannabis.
Marginal note:Hospital patient
(4) The maximum amount of cannabis that a young person referred to in paragraph (1)(c) is authorized to possess, for their own medical purposes, is an amount that is equivalent to the lesser of
(a) 30 times the daily quantity of dried cannabis indicated on the hospital label that is applied to the container in which the cannabis was provided to or for them, and
(b) 150 g of dried cannabis.
Marginal note:Exception
(5) This section does not authorize a young person who is referred to in more than one of paragraphs (1)(a) to (c) to possess, for their own medical purposes, more than the equivalent of 150 g of dried cannabis.
Marginal note:Cumulative quantities
268 Any quantity of cannabis that an individual is authorized to possess under section 266 or 267 is in addition to any other quantity of cannabis that the individual may possess under the Act.
Distribution
Marginal note:Distribution of cannabis
269 (1) In addition to any other quantity of cannabis that they may distribute under the Act, an adult referred to in paragraph 266(1)(d) or (e) is authorized to distribute — but not send or otherwise indirectly make available — to the individual for whom they are responsible, or transport for that individual, a quantity of cannabis, other than cannabis plants or cannabis plant seeds, that does not exceed the maximum amount that the adult is authorized to possess under subsection 266(5).
Marginal note:Assistance by adult
(2) In addition to any other quantity of cannabis that they may distribute under the Act, an adult referred to in paragraph 266(1)(f) is authorized to administer, give, transfer, provide or otherwise directly make available to the individual to whom the assistance is being provided a quantity of cannabis, other than cannabis plants or cannabis plant seeds, that does not exceed the maximum amount that the adult is authorized to possess under subsection 266(6).
Non-application of Section 71 of Act
Marginal note:Non-application of section 71 of Act
270 Despite section 71 of the Act, an authorization to possess, sell, distribute or produce cannabis that is conferred by this Part on an adult referred to in paragraphs 266(1)(a) to (f), a young person referred to in paragraphs 267(1)(a) to (c) or a designated person does not authorize an employee or agent or mandatary of the adult, young person or designated person — or a person who is acting under a contract with the adult, young person or designated person — to do anything that is prohibited by a provision of Division 1 of Part 1 of the Act.
Health Care Practitioners
Marginal note:Prohibition
271 A health care practitioner must not provide a medical document or issue a written order except as authorized under this Part.
Marginal note:Authorization — health care practitioner
272 (1) A health care practitioner is authorized, in respect of an individual who is under their professional treatment and if cannabis is required for the condition for which the individual is receiving treatment,
(a) to provide a medical document;
(b) while practising in a hospital, to issue a written order;
(c) to administer to the individual a cannabis product, other than cannabis plants or cannabis plant seeds; or
(d) to transfer to the individual, or to an adult who is responsible for them, a cannabis product, other than cannabis plants or cannabis plant seeds,
(i) that has been received from a holder of a licence for sale or a licence for processing, and
(ii) in respect of which the quantity of cannabis does not exceed the quantity that the individual or adult is authorized to possess under section 266 or 267, as the case may be.
Marginal note:Possession in public place
(2) A health care practitioner is authorized to possess a cannabis product, other than cannabis plants or cannabis plant seeds, in a public place if they have obtained it under the Act and require it for the practice of their profession in the province where they possess it.
Marginal note:Medical document
273 (1) A medical document that is provided under paragraph 272(1)(a) must indicate
(a) the health care practitioner’s given name, surname, profession, business address and telephone number and, if applicable, their facsimile number and email address;
(b) the province in which the health care practitioner is authorized to practise their profession and the number assigned by the province to that authorization;
(c) the given name, surname and date of birth of the individual who is under the professional treatment of the health care practitioner;
(d) the address of the location at which the individual consulted with the health care practitioner;
(e) the daily quantity of dried cannabis, expressed in grams, that the health care practitioner authorizes for the individual; and
(f) a period of use, specified as a number of days, weeks or months.
Marginal note:Maximum period
(2) The period of use specified in a medical document must not exceed one year.
Marginal note:Signature and statement
(3) A medical document must be signed and dated by the health care practitioner who is providing it and must include a statement confirming that the information in the document is correct and complete.
Marginal note:Validity of medical document
(4) A medical document is valid for the period of use specified in it, which period begins on
(a) the date on which the individual referred to in paragraph (1)(c) is registered with a holder of a licence for sale on the basis of the document or, if there have been previous registrations on the basis of the document, the earliest registration date; or
(b) if the individual referred to in paragraph (1)(c) uses the document to register with the Minister under Division 2 of this Part and has not previously been registered with a holder of a licence for sale on the basis of the document, the date of the registration with the Minister.
Marginal note:Additional period of validity
(5) Despite subsection (4), a medical document is valid for an additional period of six months beginning
(a) on the day on which this subsection comes into force, if the document ceases to be valid under subsection (4) on or after March 13, 2020 but before the day on which this subsection comes into force; or
(b) on the day after the day on which the document ceases to be valid under subsection (4) if the day on which the document ceases to be valid is on or after the day on which this subsection comes into force but before October 1, 2020.
Marginal note:Written order
274 A written order that is issued under paragraph 272(1)(b) must be signed and dated by the health care practitioner and must indicate
(a) the health care practitioner’s given name, surname and profession;
(b) the given name and surname of the individual who is under the professional treatment of the health care practitioner; and
(c) the daily quantity of dried cannabis, expressed in grams, that the health care practitioner authorizes for the individual.
General Prohibitions
Marginal note:Alteration of documents
275 It is prohibited to alter or deface a medical document or other document that is issued or provided under this Part.
Marginal note:Obtaining from more than one source
276 (1) It is prohibited to seek or obtain a cannabis product from more than one source at a time on the basis of the same medical document.
Marginal note:Exception
(2) Despite subsection (1), if a medical document forms the basis for a registration with the Minister under Division 2 of this Part, the registration certificate may be used to obtain
(a) cannabis products, other than cannabis plants and cannabis plant seeds, from, or through, a single holder of a licence for sale; and
(b) cannabis plants or cannabis plant seeds from one or more holders of a licence for sale.
DIVISION 1Holders of Licence for Sale
Notice to Licensing Authorities
Marginal note:Notice to licensing authorities
277 (1) A holder of a licence for sale must, within 30 days after the issuance of their licence, provide a written notice to each provincial professional licensing authority and a copy to the Minister.
Marginal note:Content of notice
(2) The notice must contain
(a) the name of the holder, the mailing address of the site specified in the licence and, if applicable, the holder’s email address; and
(b) the effective date of the licence.
Registration of Clients
Marginal note:Eligibility — client
278 An individual is eligible to be a client of a holder of a licence for sale only if the individual ordinarily resides in Canada.
Marginal note:Registration application
279 (1) Before registering an individual as a client, a holder of a licence for sale must receive a registration application, together with the original of the individual’s medical document or a copy of their registration certificate.
Marginal note:Application on basis of medical document
(2) An application that is submitted on the basis of a medical document must include
(a) the applicant’s given name, surname and date of birth;
(b) either
(i) the address of the place in Canada where the applicant ordinarily resides, as well as, if applicable, their telephone number, facsimile number and email address, or
(ii) if the applicant ordinarily resides in Canada but does not ordinarily reside at a specific place, the address as well as, if applicable, the telephone number, facsimile number and email address of a shelter, hostel or similar institution located in Canada that provides them with food, lodging or other social services;
(c) the mailing address of the place referred to in paragraph (b) if different from the address provided under that paragraph;
(d) if the place referred to in subparagraph (b)(i) is an establishment that is not a private residence, the type and name of the establishment;
(e) an indication of whether the shipping address is to be
(i) the address referred to in subparagraph (b)(i),
(ii) the mailing address of the place referred to in subparagraph (b)(i), or
(iii) if the health care practitioner who provided the medical document has consented to receive cannabis products on behalf of the applicant, the address of the health care practitioner;
(f) if applicable, the given name, surname and date of birth of one or more adults who are responsible for the applicant; and
(g) a statement signed and dated by the applicant, or an adult who is named under paragraph (f), confirming that
(i) the applicant ordinarily resides in Canada,
(ii) the information in the application is correct and complete,
(iii) the medical document that forms the basis for the application has not, to the knowledge of the individual signing the statement, been altered,
(iv) the medical document is not being used to seek or obtain cannabis products from another source,
(v) in the case where the applicant is signing the statement, they intend to use any cannabis product that is supplied to them on the basis of the application only for their own medical purposes, and
(vi) in the case where an adult who is named under paragraph (f) is signing the statement, they are responsible for the applicant.
Marginal note:Application on basis of registration certificate
(3) An application that is submitted on the basis of a registration certificate must include
(a) the information referred to in paragraphs (2)(a) to (d), as applicable;
(b) an indication of whether the application is being made to obtain
(i) cannabis products, other than cannabis plants or cannabis plant seeds,
(ii) cannabis plants or cannabis plant seeds, or both, or
(iii) cannabis products referred to in both subparagraphs (i) and (ii);
(c) if the application is being made to obtain cannabis products, other than cannabis plants or cannabis plant seeds, an indication of which of the addresses referred to in paragraph (2)(e) is to be the shipping address;
(d) if the application is being made to obtain cannabis plants or cannabis plant seeds, an indication of whether the shipping address is to be
(i) the address of the place where the applicant ordinarily resides,
(ii) the address of the place where the designated person, if any, ordinarily resides, or
(iii) the address of the site for the production of cannabis that is specified in the registration certificate; and
(e) a statement signed and dated by the applicant, or an adult who is named in the registration certificate under paragraph 313(2)(c), confirming that
(i) the applicant ordinarily resides in Canada,
(ii) the information in the application is correct and complete,
(iii) the copy of the registration certificate is an accurate reproduction of the original,
(iv) if the application is being made to obtain cannabis products other than cannabis plants or cannabis plant seeds, the registration certificate is not being used to seek or obtain the cannabis products from another source,
(v) in the case where the applicant is signing the statement, they intend to use any cannabis product that is supplied to them on the basis of the application only for their own medical purposes, and
(vi) in the case where an adult who is named in the registration certificate is signing the statement, they are responsible for the applicant.
Marginal note:Applicant without ordinary residence
(4) If an institution’s address is included in the application in accordance with subparagraph (2)(b)(ii), the application must include a statement that is signed and dated by a manager of the institution confirming that it provides food, lodging or other social services to the applicant.
Marginal note:Health care practitioner’s consent
280 (1) If an application referred to in section 279 includes, as a shipping address, the address of the health care practitioner who provided the applicant with the medical document, the application must include a statement, signed and dated by the health care practitioner, consenting to receive cannabis products, other than cannabis plants and cannabis plant seeds, on the applicant’s behalf.
Marginal note:Withdrawal of consent
(2) If the applicant becomes a client of a holder of a licence for sale under this Division and the health care practitioner ceases to consent to receive cannabis products on the behalf of the client, the health care practitioner must send a written notice to that effect to the client and the holder.
Marginal note:Verification of medical document
281 (1) A holder of a licence for sale that intends to register an applicant whose application is based on a medical document must
(a) verify that the medical document meets the requirements set out in subsections 273(1) to (3);
(b) verify that, at the time the medical document was provided to the applicant, the individual who provided the document was a health care practitioner who was entitled to practise their profession in the province in which the applicant consulted with them; and
(c) verify with the office of the individual referred to in paragraph (b) that the applicant consulted the individual and that the information set out in the medical document is correct and complete.
Marginal note:Exception
(2) The holder is not required to do the verification referred to in paragraph (1)(c) if the signature of the health care practitioner who provided the medical document is known to the holder.
Marginal note:Uncertainty — previous registration
(3) The holder must, if it appears that the applicant was previously registered on the basis of the medical document but the information referred to in subsection 288(1) does not appear on the medical document,
(a) take reasonable steps to determine whether the applicant was previously registered on the basis of the medical document; and
(b) in the case where they determine that the applicant was previously registered on the basis of the medical document,
(i) take reasonable steps to determine the date on which the applicant was first registered on that basis; and
(ii) if they determine the date referred to in subparagraph (i), ensure that it appears on the medical document in accordance with subsection 288(1).
Marginal note:Date illegible or incomplete
(4) The holder must, if a date of registration appears on the medical document but the date is illegible, incomplete or there is reason to doubt that it is accurate,
(a) take reasonable steps to determine the date on which the applicant was first registered on the basis of the medical document; and
(b) if they determine the date referred to in paragraph (a), ensure that it appears on the medical document in accordance with subsection 288(1) unless there are reasonable grounds to believe that the date that already appears on the medical document has been falsified.
Marginal note:Unknown date
(5) If the holder is, after taking the steps referred to in subparagraph (3)(b)(i) or paragraph (4)(a), unable to determine the date on which the applicant was first registered on the basis of the medical document, they must, if they proceed to register the applicant, indicate on the medical document the information referred to subsection 288(1) in accordance with the requirements set out in that subsection.
Marginal note:Registration of client
282 (1) A holder of a licence for sale may, subject to section 284, register an applicant as a client.
Marginal note:Registration document and other information
(2) A holder that registers an applicant as a client must provide them with
(a) a registration document that contains the following information:
(i) the name of the holder,
(ii) the client’s given name, surname and date of birth,
(iii) the given name and surname of the health care practitioner who provided the client’s medical document,
(iv) the given name, surname and date of birth of any adults named in the application under paragraph 279(2)(f) or in the registration certificate under paragraph 313(2)(c), as the case may be,
(v) an indication of whether the registration is based on a medical document or a registration certificate,
(vi) the daily quantity of dried cannabis, expressed in grams, indicated in the medical document or registration certificate,
(vii) in the case of a registration that is based on a medical document, the shipping address indicated in the application under paragraph 279(2)(e),
(viii) in the case of a registration that is based on a registration certificate, the shipping address or addresses indicated in the application under paragraph 279(3)(c) or (d), or both, as applicable, and
(ix) the date of expiry of the registration;
(b) information that will permit them to use a unique identifier for the purpose of ordering cannabis; and
(c) the current version of the document entitled Consumer Information — Cannabis, published by the Government of Canada on its website.
Marginal note:Expiry of registration
283 A client’s registration with a holder of a licence for sale expires
(a) if it is based on a medical document, at the end of the period of validity of the document, as determined in accordance with subsections 273(4) and (5); or
(b) if it is based on a registration certificate, when the registration with the Minister expires.
Marginal note:Refusal to register
284 (1) A holder of a licence for sale must refuse to register an applicant as a client if
(a) the application does not meet the requirements set out in section 279 or, if applicable, subsection 280(1);
(b) the holder has reasonable grounds to believe that false or misleading information has, or false or falsified documents have, been provided in, or in support of, the application;
(c) the requirements set out in subsection 281(1) have not been met;
(d) the medical document that forms the basis for the application is no longer valid;
(e) the registration with the Minister that forms the basis for the application has expired or been revoked;
(f) the given name, surname or date of birth of the applicant is different from the given name, surname or date of birth that appears on the medical document or the copy of the registration certificate that has been submitted; or
(g) the health care practitioner who provided the medical document to the applicant notifies the holder in writing that the use of cannabis by the applicant is no longer supported for clinical reasons.
Marginal note:Verification requirement
(2) The holder must not refuse to register an applicant on the basis that there are reasonable grounds to believe that the medical document is false or falsified unless the holder has contacted the office of the health care practitioner whose name appears in the medical document to ask about the matters referred to in paragraph 281(1)(c).
Marginal note:Notice of intention to refuse
(3) If the holder proposes to refuse an applicant for a reason referred to in subsection (1) or a business reason, the holder must, without delay, send the applicant a written notice that sets out the reason for the proposed refusal.
Marginal note:Opportunity to be heard
(4) If the holder sends a notice under subsection (3), they must not refuse to register the applicant unless the applicant has had 10 days after the day on which the applicant receives the notice to provide reasons why the refusal is unfounded.
Marginal note:Notice of refusal to register
(5) If the holder is provided with reasons under subsection (4), they must, if they refuse to register the applicant, send the applicant a written notice of the refusal.
Marginal note:Return of medical document
(6) If the holder refuses to register an applicant whose application is based on a medical document, the holder must, without delay, return the medical document unless
(a) it is clear that the document is false or falsified; or
(b) the registration is refused for a reason referred to in paragraph (1)(d) or (g).
Marginal note:Notice to Minister
(7) If the holder refuses to register an applicant whose application is based on a registration certificate, the holder must, as soon as feasible, provide the Minister with a notice that includes the following information:
(a) the given name, surname and date of birth of the registered person named in the certificate;
(b) the registration number indicated in the certificate;
(c) the date of the refusal; and
(d) the reasons for the refusal.
Amendment to Registration
Marginal note:Amendment to registration
285 (1) If there is a change in respect of any of the information provided under section 279, the client — or, if applicable, an adult who is responsible for them — must, without delay, submit an application to amend the registration to the holder of the licence for sale unless the client has ceased to ordinarily reside in Canada.
Marginal note:Content of application
(2) The application must include the following information and documents:
(a) the new information;
(b) if there has been a change to the information referred to in paragraph 279(2)(a), proof of the change;
(c) if applicable, the statement of the health care practitioner consenting to receive cannabis products on behalf of the client, as required by subsection 280(1);
(d) if the application is being submitted by an adult who is responsible for the client but who is not a named responsible adult, the given name, surname and date of birth of the adult; and
(e) a statement, signed and dated by the individual who is submitting the application, confirming that
(i) the client ordinarily resides in Canada,
(ii) the information included in the application is correct and complete,
(iii) in the case where the individual who is signing the statement is not the client, they are responsible for the client, and
(iv) in the case where the individual who is signing the statement is neither the client nor a named responsible adult, the client and any named responsible adults have been notified of the application.
Marginal note:Condition
(3) The new information that is included in the application under paragraph (2)(a) must meet the applicable requirements set out in section 279.
Marginal note:Obligation to amend
(4) The holder of the licence for sale must, if they receive an application that complies with subsections (2) and (3), amend the client’s registration and provide them with an updated registration document.
Marginal note:New responsible adult
(5) If a registration is amended on the basis of an application that is signed by an adult who is neither the client nor a named responsible adult, the name of the adult who signed the application must be included in the updated registration document.
Revocation of Registration
Marginal note:Revocation of registration
286 (1) A holder of a licence for sale must, without delay, revoke a client’s registration if
(a) the client — or, if applicable, a named responsible adult — requests it;
(b) the medical document that forms the basis for the registration is transferred to another holder of a licence for sale under section 287;
(c) the holder has reasonable grounds to believe the client has ceased to ordinarily reside in Canada or ceased to have a shipping address in Canada;
(d) the holder has reasonable grounds to believe that
(i) the registration was made on the basis of false or misleading information provided in, or false or falsified documents provided in support of, the registration application, or
(ii) false or misleading information was, or false or falsified documents were, provided in, or in support of, an amendment application under section 285;
(e) the health care practitioner who provided the medical document notifies the holder in writing that the use of cannabis by the client is no longer supported for clinical reasons;
(f) if the registration is based on a registration certificate, the holder becomes aware that the registration with the Minister has been revoked; or
(g) the client dies.
Marginal note:Revocation for business reason
(2) A holder of a licence for sale may revoke a client’s registration for a business reason.
Marginal note:Revocation of all registrations
(3) A holder of a licence for sale whose licence is revoked must, without delay, revoke the registrations of all of their clients and send each client a written notice that sets out the reason for the revocation.
Marginal note:Notice
(4) Before revoking a registration under subsection (1) or (2), the holder must send the client a written notice that sets out the reason for the proposed revocation unless
(a) the client has requested that the registration be revoked or that the medical document that forms the basis for the registration be transferred;
(b) the named responsible adult, if any, who signed the most recent statement that was included in an application that was submitted under section 279 or 285 to the holder in respect of the client has requested that the registration be revoked or that the medical document that forms the basis for the registration be transferred;
(c) the client — or, if applicable, the named responsible adult referred to in paragraph (b) — has consented to the transfer of the medical document that forms the basis for the registration;
(d) the client has died; or
(e) the holder has received a notice of revocation referred to in subsection 319(1) in respect of the client.
Marginal note:Opportunity to be heard
(5) If the holder sends a notice under subsection (4), the holder must not revoke the registration unless the client has had 10 days after the day on which they receive the notice to provide reasons why the revocation is unfounded.
Marginal note:Medical document
(6) If the holder revokes a registration that is based on a medical document, they must, without delay, return the document to the client unless
(a) it is clear that the document is false or falsified; or
(b) the registration is revoked for a reason referred to in paragraph (1)(b), (e) or (g).
Marginal note:Notice to Minister
(7) If the holder revokes a registration that is based on a registration certificate, they must, as soon as feasible, provide the Minister with a notice that includes the following information:
(a) the given name, surname and date of birth of the registered person named in the certificate;
(b) the registration number indicated in the certificate;
(c) the date of the revocation; and
(d) the reason for the revocation.
Transfer of Medical Documents
Marginal note:Transfer of medical document
287 (1) A holder of a licence for sale must, without delay, transfer the medical document that forms the basis for a client’s registration to another holder of a licence for sale if
(a) the client — or, if applicable, a named responsible adult — requests, or consents to, the transfer;
(b) the holder to which the document is to be transferred consents to the transfer; and
(c) no revocation of the registration is pending for a reason referred to in any of paragraphs 286(1)(c) to (g).
Marginal note:Requirement to send information
(2) The holder that transfers the medical document must send the information contained in the client’s registration document to the holder to which the document is transferred.
Marginal note:Requirement to register
(3) The holder to which the medical document is transferred must, after receiving the information referred to in subsection (2), register the client and comply with the requirements set out in subsection 282(2).
Indication of Date of Registration
Marginal note:Requirement to indicate date of registration
288 (1) A holder of a licence for sale must, before returning a medical document under subsection 286(6) or transferring such a document under section 287, indicate the following information on the document in indelible ink if no date of registration appears on the document:
(a) the date on which the client was registered, in the order of day, month and year, preceded by the words “date of registration” or “date d’inscription”; and
(b) the name of the holder.
Marginal note:Previously registered clients
(2) For greater certainty, the obligation in subsection (1) applies in respect of the medical document of an individual who was not registered under this Part but who is a client of the holder by virtue of subsection 158(7) of the Act.
Sale of Cannabis to Clients
Marginal note:Authorization to sell
289 (1) Subject to the other provisions of these Regulations, a holder of a licence for sale is authorized to sell cannabis products to a client — or, if applicable, to a named responsible adult — if the holder has received from the client or the named responsible adult
(a) a written purchase order that complies with subsection (2); or
(b) a verbal purchase order that has been recorded in accordance with subsection (3).
Marginal note:Written purchase order
(2) A written purchase order must contain the following information:
(a) the date on which it is placed;
(b) the given name, surname and date of birth of the client;
(c) the given name and surname of the individual placing the order;
(d) the shipping address specified in the client’s registration document for the cannabis products that are being ordered;
(e) the client’s unique identifier; and
(f) the names assigned by the holder of the licence for sale to the cannabis products being ordered, the quantities desired and the brand names.
Marginal note:Verbal purchase order
(3) The record of a verbal purchase order must be in writing and contain the following information:
(a) the information referred to in paragraphs (2)(a) to (f);
(b) an order number; and
(c) the name of the individual with whom the order was placed.
Marginal note:New medical document or registration certificate
(4) For greater certainty,
(a) the authorization to sell cannabis products that is conferred by subsection (1) applies only in respect of the medical document or registration certificate that forms the basis for the client’s registration;
(b) if the client wishes to obtain cannabis products from the holder on the basis of a different medical document or registration certificate, they must submit to the holder a new registration application that meets the requirements set out in section 279 and be registered on the basis of that document or certificate; and
(c) sections 280 to 284 apply in respect of a registration application referred to in paragraph (b).
Marginal note:Refusal — purchase order
290 (1) A holder of a licence for sale must refuse to fill a purchase order — and must not ask a holder of a licence for processing or cultivation to fill it — if
(a) the order does not meet the requirements of section 289;
(b) any of the information referred to in paragraph 289(2)(b), (c) or (d) does not correspond to the information set out in the client’s registration document;
(c) the client’s unique identifier referred to in paragraph 289(2)(e) is not correct;
(d) the client’s registration has expired or been revoked;
(e) the order specifies cannabis products, other than cannabis plants or cannabis plant seeds, in respect of which the quantities of cannabis exceed the equivalent of 150 g of dried cannabis;
(f) in the case of a client who is registered on the basis of a medical document, the order specifies a quantity of cannabis plants or cannabis plant seeds;
(g) the order specifies a total quantity of cannabis plants or cannabis plant seeds that, taking into account the seed-to-plant ratio specified in subsection (2), exceeds the maximum number of plants, determined in accordance with section 325, that are authorized to be under production by virtue of the client’s registration with the Minister; or
(h) the order has been previously filled.
Marginal note:Seed-to-plant ratio
(2) For the purpose of paragraph (1)(g), three cannabis plant seeds are equivalent to one cannabis plant.
Marginal note:Notice of refusal
(3) If the holder of the licence refuses to fill a purchase order, they must, except in the case of a refusal for a reason referred to in paragraph (1)(d), send the client a written notice that sets out the reason for the refusal.
Marginal note:Sending or delivery — client
291 (1) A holder of a licence for sale that sells a cannabis product under section 289 is authorized to send or deliver it to the relevant shipping address that is specified in the client’s registration document unless, in the case where the shipping address is the address of a health care practitioner,
(a) the holder has received a written notice from the health care practitioner indicating that they have ceased to consent to receive cannabis products on the client’s behalf; or
(b) the holder has received a notice issued by the Minister under section 335 that names the health care practitioner and that has not been retracted.
Marginal note:Prohibition
(2) A holder of a licence for sale that receives a notice referred to in paragraph (1)(a) or (b) must not ask a holder of a licence for processing to send or deliver cannabis products to a client whose shipping address is the address of the health care practitioner who sent the notice or is named in it, as the case may be.
Marginal note:Notice to holder of processing licence
(3) A holder of a licence for sale that has asked a holder of a licence for processing to send or deliver cannabis products to the address of a health care practitioner must, without delay, provide the holder of the processing licence with a written notice if, within 48 hours after making the request, the holder of the sale licence receives
(a) a notice referred to in paragraph (1)(a) from the health care practitioner; or
(b) a notice referred to in paragraph (1)(b) that names the health care practitioner.
Marginal note:Prohibition — licence for processing
(4) A holder of a licence for processing that receives a notice under subsection (3) must not send or deliver the cannabis products that they had been asked to send or deliver.
Return and Replacement of Cannabis
Marginal note:Return of cannabis products
292 (1) An individual to whom cannabis products are sold under section 289 — or a designated person to whom cannabis plants or cannabis plant seeds are sent or delivered under section 291 — may return the cannabis products if the holder of the licence for sale accepts the return.
Marginal note:Manner of return
(2) The individual who is returning the cannabis products must, subject to subsection (3), send them or have them delivered to the holder of the licence for sale or the holder of a licence for processing or cultivation, as indicated by the holder of the licence for sale.
Marginal note:Health care practitioner
(3) In the case of cannabis products that were transferred to the individual by a health care practitioner who had consented under subsection 280(1) to receive them, the individual who is returning the cannabis products may, with the consent of the health care practitioner, give them, send them or have them delivered to the health care practitioner.
Marginal note:Parcel — requirements
(4) The individual who is returning the cannabis products must, if they are sending or having delivered cannabis plants — or other cannabis products in respect of which the total quantity of cannabis exceeds the equivalent of 30 g of dried cannabis,
(a) prepare the parcel in a manner that ensures the security of its contents, such that
(i) it will not open or permit the escape of its contents during handling and transportation,
(ii) it is sealed so that it cannot be opened without the seal being broken,
(iii) except in the case of cannabis plants, it prevents the escape of odours associated with cannabis plant material, and
(iv) it prevents its contents from being identified without it being opened; and
(b) use a method that ensures the tracking and safekeeping of the parcel during transportation.
Marginal note:Return by health care practitioner
(5) A health care practitioner must ensure that the requirements set out in paragraphs (4)(a) and (b) are met if they are sending or having delivered cannabis products referred to in subsection (4) that have been returned to them under subsection (3).
Marginal note:Replacement of returned cannabis
293 (1) A holder of a licence for sale to which cannabis products, other than cannabis plants or cannabis plant seeds, are returned in accordance with section 292 may replace them with cannabis products, other than cannabis plants or cannabis plant seeds, in respect of which the total quantity of cannabis does not exceed the equivalent of 150 g of dried cannabis.
Marginal note:Plants or seeds
(2) A holder of a licence for sale to which cannabis plants or cannabis plant seeds are returned in accordance with section 292 may replace them with a quantity of cannabis plants or cannabis plant seeds, or both, that does not exceed, taking into account the seed-to-plant ratio specified in subsection 290(2), the maximum number of plants, determined in accordance with section 325, that are authorized to be under production under the client’s registration with the Minister.
Marginal note:Processing licence
(3) A holder of a licence for processing may replace cannabis products that have been returned in accordance with section 292 with cannabis products in respect of which the total quantity of cannabis, according to information provided by the holder of the licence for sale, does not exceed the applicable quantity of cannabis referred to in subsection (1) or (2).
Marginal note:Cultivation licence
(4) A holder of a licence for cultivation may replace cannabis plants or cannabis plant seeds that have been returned in accordance with section 292 with a quantity of cannabis plants or cannabis plant seeds, or both, that, according to information provided by the holder of the licence for sale, does not exceed the quantity of cannabis plants or cannabis plant seeds that could be replaced by the holder of the licence for sale under subsection (2).
Sale, Display and Promotion to Young Persons
Marginal note:Sale of cannabis accessories to young persons
294 A holder of a licence for sale is authorized to sell a cannabis accessory — other than a cannabis accessory referred to in section 31 of the Act or a device referred to in subsection 202(2) — to a young person if the holder takes reasonable steps to ensure that the young person is authorized to possess cannabis under section 267.
Marginal note:Display — young persons
295 (1) A holder of a licence for sale is authorized to display a cannabis product, or a package or label of a cannabis product, in a manner that may result in the cannabis product, package or label being seen by a young person if the holder takes reasonable steps to ensure that any such young person is authorized to possess cannabis under section 267.
Marginal note:Cannabis accessories — young persons
(2) A holder of a licence for sale that sells a cannabis accessory is authorized to display it, or its package or label, in a manner that may result in the cannabis accessory, package or label being seen by a young person if the holder takes reasonable steps to ensure that any such young person is authorized to possess cannabis under section 267.
Marginal note:Promotion of cannabis products — young persons
296 (1) A holder of a licence for sale that promotes a cannabis product by means of informational promotion or brand-preference promotion that is communicated by means of a telecommunication is exempt from the condition set out in paragraph 17(2)(c) of the Act if they have taken reasonable steps to ensure that the promotion cannot be accessed by a young person other than a young person who is authorized to possess cannabis under section 267.
Marginal note:Promotion of cannabis accessories — young persons
(2) A holder of a licence for sale that promotes a cannabis accessory by means of informational promotion or brand-preference promotion that is communicated by means of a telecommunication is exempt from the condition set out in paragraph 17(3)(c) of the Act if they have taken reasonable steps to ensure that the promotion cannot be accessed by a young person other than a young person who is authorized to possess cannabis under section 267.
Reports to Minister
Marginal note:Monthly reports
297 (1) A holder of a licence for sale must, on or before the 15th day of each month, provide the Minister with a report that contains the following information:
(a) the number of clients who had a valid registration on the last day of the previous month;
(b) the number of clients who, in the previous month, had their medical document transferred to another holder of a licence for sale or returned to them at their request or at the request of a named responsible adult;
(c) in respect of the medical documents that formed the basis for registrations that were valid on the last day of the previous month,
(i) the average daily quantity of dried cannabis, expressed in grams,
(ii) the median daily quantity of dried cannabis, expressed in grams, and
(iii) the highest daily quantity of dried cannabis, expressed in grams;
(d) the number of applicants whom the holder refused to register during the previous month, including the number of them who were refused for each of the following reasons:
(i) the application was incomplete,
(ii) the holder had reasonable grounds to believe that false or misleading information was, or false or falsified documents were, provided in, or in support of, the application, and
(iii) the medical document or registration certificate that formed the basis for the application was not valid;
(e) the number of purchase orders referred to in subsection 289(1) that the holder refused to fill during the previous month, including the number of them that were refused for each of the following reasons:
(i) the purchase order was incomplete,
(ii) the client’s registration had expired or been revoked,
(iii) the purchase order specified cannabis products, other than cannabis plants or cannabis plant seeds, in respect of which the quantities of cannabis exceeded the equivalent of 150 g of dried cannabis, and
(iv) the cannabis product specified in the purchase order was unavailable;
(f) the given name, surname, profession and business address of each health care practitioner who provided a medical document referred to in paragraph (c), together with the province in which the health care practitioner was authorized to practise their profession at the time they signed the document and the number assigned by the province to that authorization; and
(g) the number of medical documents referred to in paragraph (c) that were signed by each health care practitioner referred to in paragraph (f).
Marginal note:Definition of health care practitioner
(2) In this section, health care practitioner means an individual who is, or was, a medical practitioner or nurse practitioner.
Disclosure to Third Parties
Marginal note:Disclosure to police
298 (1) A holder of a licence for sale must, if they are provided with an individual’s given name, surname, and date of birth by a member of a Canadian police force who requests information in the course of an investigation under the Act, disclose the following information to the police force as soon as feasible and no later than 72 hours after receiving the request:
(a) an indication of whether the individual is a client of the holder or a named responsible adult in respect of such a client;
(b) in the case where the individual is an individual referred to in paragraph (a),
(i) an indication of whether the client is a registered person and, if so, the classes of cannabis that the client is permitted to obtain by virtue of their registration with the holder, and
(ii) the daily quantity of dried cannabis that is specified in the client’s registration document in accordance with subparagraph 282(2)(a)(vi).
Marginal note:Use of information
(2) Information provided under this section must be used only for the purposes of the investigation or the administration or enforcement of the Act or these Regulations.
Marginal note:Disclosure to licensing authority
299 (1) A holder of a licence for sale must disclose, in writing and as soon as feasible, factual information about a health care practitioner — in relation to cannabis — that they have obtained under the Act or the Controlled Drugs and Substances Act to
(a) the provincial professional licensing authority for a province in which the health care practitioner is, or was, entitled to practise if the licensing authority submits to the holder a written request that sets out the health care practitioner’s name and address, a description of the information being requested and a statement that the information is required for the purpose of assisting an investigation by the authority; or
(b) the provincial professional licensing authority for a province in which the health care practitioner is not entitled to practise if the licensing authority submits to the holder
(i) a written request that sets out the health care practitioner’s name and address and a description of the information being requested, and
(ii) a document that shows that
(A) the health care practitioner has applied to the licensing authority to practise in that province, or
(B) the licensing authority has reasonable grounds to believe that the health care practitioner is practising in that province without being authorized to do so.
Marginal note:Factual information
(2) The factual information that may be requested includes information — including patient information — contained in, or in respect of, any medical document that was signed by the health care practitioner.
Marginal note:Exception
(3) Despite subsection (2), the factual information that may be requested does not include information relating to an individual who
(a) is or was registered as a client of the holder on the basis of a registration with the Minister under Division 2 of this Part; or
(b) in the case where the holder was a licensed producer under the former Access to Cannabis for Medical Purposes Regulations, was registered as a client of the licensed producer under section 133 of those Regulations on the basis of a registration with the Minister under Part 2 of those Regulations.
Marginal note:Secure transmission
(4) The holder must ensure that the information that they disclose under this section is securely transmitted in an electronic format that is accessible to the provincial professional licensing authority.
Marginal note:Definition of health care practitioner
(5) In this section, health care practitioner means an individual who is, or was, a medical practitioner or nurse practitioner.
Marginal note:Quarterly reports
300 (1) A provincial professional licensing authority may submit a written request to a holder of a licence for sale to obtain information, on a quarterly basis, in respect of each client who is registered with the holder on the basis of a medical document that was signed by a health care practitioner who
(a) was, at the time that they signed the medical document, entitled to practise the profession regulated by the licensing authority in the province in question; and
(b) was consulted in that province.
Marginal note:Report
(2) A holder that has received a request referred to in subsection (1) must, after the end of each quarter and in accordance with subsection (3), provide the provincial professional licensing authority with a report containing the following information in respect of each client referred to in subsection (1) who was validly registered at any time during the relevant quarter, together with details of any changes to the information that occurred during the quarter:
(a) the client’s given name, surname and date of birth;
(b) the postal code for the address that was provided under paragraph 279(2)(b), together with the province specified in the address;
(c) the given name, surname and business address of the health care practitioner who signed the medical document, together with the number assigned by the province to the health care practitioner’s authorization to practise;
(d) the daily quantity of dried cannabis specified in the medical document;
(e) the period of use specified in the medical document;
(f) the date on which the medical document was signed by the health care practitioner; and
(g) for each shipment of cannabis products that was sent or delivered during the quarter,
(i) the date it was sent or delivered,
(ii) the quantity of cannabis that was sent or delivered, expressed in grams, and
(iii) the class of cannabis set out in Schedule 4 to the Act to which the cannabis products belong.
Marginal note:Quarterly deadlines
(3) The report must be provided to the provincial professional licensing authority no later than
(a) April 30 of a given year for the quarter beginning on January 1 and ending on March 31 of that year;
(b) July 31 of a given year for the quarter beginning on April 1 and ending on June 30 of that year;
(c) October 31 of a given year for the quarter beginning on July 1 and ending on September 30 of that year; and
(d) January 31 of a given year for the quarter beginning on October 1 and ending on December 31 of the previous year.
Marginal note:First report
(4) For greater certainty, the first quarter in respect of which a report must be provided is the quarter in which the request is received from the provincial professional licensing authority.
Marginal note:Notice
(5) If the holder has no information to include in a report for a quarter, they must send a notice to that effect to the provincial professional licensing authority by the relevant deadline referred to in subsection (3).
Marginal note:Cessation of activities
(6) If the holder ceases to conduct activities, they must, despite subsection (3), provide the provincial professional licensing authority with the report for the quarter in which the activities cease within 30 days after ceasing them.
Marginal note:Cancellation
(7) The provincial professional licensing authority may, at any time, send the holder a notice cancelling the request referred to in subsection (1), in which case the final quarter in respect of which a report must be provided is the one that precedes the quarter in which the notice is received.
Marginal note:Transmission and format
(8) A holder, or former holder, that provides a report to a provincial professional licensing authority under this section must transmit it securely in an electronic format that is accessible to the licensing authority.
Retention of Documents
Marginal note:Verifications
301 (1) A holder of a licence for sale must, each time that they do verifications under subsection 281(1), retain a document that contains details of the verifications and of any measures taken under subsections 281(3) to (5).
Marginal note:Retention period
(2) The document must be retained for at least two years after the day on which it is prepared.
Marginal note:Documents relating to registration
302 (1) A holder of a licence for sale must retain
(a) each registration application that they receive under subsection 279(1), together with
(i) in the case of an application that is based on a medical document, the original of the medical document or, in the case where the medical document has been returned under subsection 284(6) or 286(6) or transferred under subsection 287(1), a copy of it that includes, if applicable, the information referred to in section 288, and
(ii) in the case of an application that is based on a registration certificate, the copy of the certificate;
(b) a copy of each registration document that they provide under paragraph 282(2)(a) and of each updated registration document that they provide under subsection 285(4);
(c) each amendment application referred to in section 285 that they receive;
(d) a copy of each notice that they send or provide under subsection 284(3), (5) or (7), 286(3), (5) or (7), 290(3) or 291(3);
(e) each notice referred to in paragraph 291(1)(a) or (b) that they receive; and
(f) each notification referred to in paragraph 284(1)(g) or 286(1)(e) that they receive.
Marginal note:Retention periods
(2) The documents referred to in subsection (1) must be retained
(a) in the case of documents referred to in paragraphs (1)(a), (c), (e) and (f), for at least two years after the day on which they are received; and
(b) in the case of the copies referred to in paragraphs (1)(b) and (d), for at least two years after the day on which the registration document or notice was provided or sent.
Marginal note:Steps — young persons
303 A holder of a licence for sale must maintain documentation as to the steps that they take to satisfy the conditions set out in sections 294 to 296 and retain each version of the documentation for at least two years after the day on which it is replaced by a new version or, if it has not been replaced, for at least two years after the day on which the licence expires or is revoked.
Marginal note:Purchase orders
304 (1) A holder of a licence for sale must retain, in respect of each purchase order referred to in section 289 that they fill or cause to be filled, a document that contains the following information:
(a) the given name, surname and date of birth of the client;
(b) the given name and surname of the individual who placed the purchase order;
(c) the date on which the purchase order was placed;
(d) the names they have assigned to the cannabis products that are sent or delivered and the brand names;
(e) the quantity of cannabis that is sent or delivered;
(f) the date on which the cannabis products are sent or delivered; and
(g) the address to which the cannabis products are sent or delivered.
Marginal note:Retention period
(2) The holder must retain the document — together with the relevant written purchase order or, in the case of a verbal purchase order, the record referred to in subsection 289(3) — for at least two years after the day on which the document is prepared.
Marginal note:Communications with licensing authorities
305 (1) A holder of a licence for sale must retain
(a) a copy of each notice that they provide to a provincial professional licensing authority under section 277, together with the copy that they provide to the Minister under that section;
(b) in respect of each request that they receive from a provincial professional licensing authority under subsection 299(1),
(i) a copy of the request, together with any supporting documentation received,
(ii) a written record of the date on which the request and any documentation are received,
(iii) a copy of the information that they disclose in response to the request,
(iv) a written record of the date on which the information is disclosed, and
(v) a written record of the steps that are taken to ensure that the information is securely transmitted to the authority;
(c) a copy of each request or notice referred to in section 300 that they receive from a provincial professional licensing authority, together with a written record of the date on which it is received;
(d) a copy of each report that they provide to a provincial professional licensing authority under section 300, together with a written record of the date on which it is provided and the steps that are taken to ensure that it is securely transmitted; and
(e) a copy of any notice that they send to a provincial professional licensing authority under subsection 300(5).
Marginal note:Retention periods
(2) The documents referred to in subsection (1) must be retained for at least two years after
(a) in the case of the documents referred to in paragraph (1)(a), the day on which the notice is provided to the licensing authority;
(b) in the case of the documents referred to in paragraph (1)(b), the day on which the information is disclosed to the licensing authority;
(c) in the case of documents referred to in paragraph (1)(c), the day on which the request or notice is received from the licensing authority;
(d) in the case of documents referred to in paragraph (1)(d), the day by which the holder is required to provide the report to the licensing authority; and
(e) in the case of a notice referred to in paragraph (1)(e), the end of the quarter to which the notice relates.
DIVISION 2Registration with Minister
Interpretation
Marginal note:Adjacent land
306 For the purposes of paragraphs 312(3)(g) and 326(1)(b), a parcel of land is considered to be adjacent to another parcel of land if its boundary has at least one point in common with the boundary of the other parcel of land.
General Provisions
Marginal note:Signature and statement
307 (1) An application that is submitted under this Division must be signed and dated by the individual who is submitting it and must include a statement by the individual confirming that the information included in the application is correct and complete.
Marginal note:Responsible adult
(2) If the application is signed by an adult who is responsible for the applicant, it must include a statement by the adult confirming that they are responsible for the applicant.
Marginal note:Additional information
308 The Minister may, on receiving an application under this Division, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to consider the application.
SUBDIVISION ARegistration, Renewal, Amendment and Revocation
Marginal note:Eligibility – registered person
309 (1) An individual is eligible to be a registered person only if they ordinarily reside in Canada.
Marginal note:Eligibility – production for own medical purposes
(2) An individual is eligible to produce cannabis for their own medical purposes as a registered person only if they are an adult.
Marginal note:Prior offences
(3) An individual is not eligible to produce cannabis for their own medical purposes as a registered person if, within the preceding 10 years, they have been convicted, as an adult, of
(a) a sale, distribution or export offence that was committed while they were authorized to produce cannabis under this Division;
(b) a designated cannabis offence that was committed while they were authorized under the Controlled Drugs and Substances Act — other than under the former Marihuana Medical Access Regulations — to produce a substance that was referred to in item 1 of Schedule II to that Act, as that item read immediately before the coming into force of subsection 204(1) of the Act;
(c) a designated marihuana offence that was committed while they were authorized to produce marihuana
(i) under the Controlled Drugs and Substances Act, other than under the former Access to Cannabis for Medical Purposes Regulations, or
(ii) by virtue of an injunction order issued by a court; or
(d) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in any of paragraphs (a) to (c).
Marginal note:Definitions
(4) The following definitions apply in this section.
- designated cannabis offence
designated cannabis offence means
(a) an offence — in relation to a substance that was referred to in item 1 of Schedule II to the Controlled Drugs and Substances Act, as that item read immediately before the coming into force of subsection 204(1) of the Act — under section 5 of the Controlled Drugs and Substances Act, or under section 6 of that Act except with respect to importation; or
(b) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraph (a). (infraction désignée relativement au chanvre indien)
- designated marihuana offence
designated marihuana offence means
(a) an offence, in relation to marihuana, under section 5 of the Controlled Drugs and Substances Act, or under section 6 of that Act except with respect to importation; or
(b) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraph (a). (infraction désignée relativement à la marihuana)
- former Marihuana Medical Access Regulations
former Marihuana Medical Access Regulations means the regulations made by Order in Council P.C. 2001-1146 of June 14, 2001 and registered as SOR/2001-227. (ancien Règlement sur l’accès à la marihuana à des fins médicales)
- marihuana
marihuana means the substance referred to as “Cannabis (marihuana)” in subitem 1(2) of Schedule II to the Controlled Drugs and Substances Act, as that subitem read immediately before the coming into force of subsection 204(1) of the Act. (marihuana)
- sale, distribution or export offence
sale, distribution or export offence means
(a) an offence under subsection 9(1) or (2), 10(1) or (2) or 11(1) or (2) of the Act, with the exception of an offence under subsection 11(1) with respect to importation;
(b) an offence under subsection 14(1) of the Act in respect of the commission of an offence referred to in paragraph (a); or
(c) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraph (a) or (b). (infraction relative à la vente, à la distribution ou à l’exportation)
Marginal note:Single registration
310 An individual is not eligible to be registered under this Division more than once at any one time.
Marginal note:Eligibility — designated person
311 (1) An individual is eligible to be a designated person only if they are an adult who ordinarily resides in Canada.
Marginal note:Prior offences
(2) An individual is not eligible to be a designated person if, within the preceding 10 years, they
(a) have been convicted, as an adult, of a designated offence or a controlled substance offence;
(b) have been convicted, as an adult, of an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in paragraph (a);
(c) were a young person who received an adult sentence, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act, in respect of an offence referred to in paragraph (a); or
(d) received a sentence — for an offence they committed outside Canada when they were at least 14 years old but less than 18 years old that, if committed in Canada, would have constituted an offence referred to in paragraph (a) — that was longer than the maximum youth sentence that could have been imposed under the Youth Criminal Justice Act for such an offence.
Marginal note:Registration application
312 (1) Before registering an individual under this Division, the Minister must receive an application for registration and the original of the individual’s medical document.
Marginal note:Basic information
(2) The registration application must contain
(a) the applicant’s given name, surname and date of birth;
(b) unless the applicant intends to produce cannabis for their own medical purposes, either
(i) the address of the place in Canada where the applicant ordinarily resides, as well as, if applicable, their telephone number, facsimile number and email address, or
(ii) if the applicant ordinarily resides in Canada but does not ordinarily reside at a specific place, the address, as well as, if applicable, the telephone number, facsimile number and email address of a shelter, hostel or similar institution, located in Canada, that provides them with food, lodging or other social services;
(c) the mailing address of the place referred to in paragraph (b) if different from the address provided under that paragraph;
(d) if the place referred to in subparagraph (b)(i) is an establishment that is not a private residence, the type and name of the establishment;
(e) if applicable, the given name, surname and date of birth of one or more adults who are responsible for the applicant, including any adult who is signing the application;
(f) an indication that the individual who is signing the application will
(i) comply with the possession limit referred to in section 266 that applies to them, and
(ii) if they are not the applicant, take reasonable steps to ensure that the applicant will comply with the possession limits that apply to them;
(g) an indication of whether
(i) the applicant intends to produce cannabis for their own medical purposes,
(ii) cannabis is to be produced for the medical purposes of the applicant by a designated person, or
(iii) cannabis will not be produced under the registration; and
(h) if the applicant intends to produce cannabis for their own medical purposes, or to have it produced by a designated person, an indication that the individual who is signing the application will
(i) take reasonable steps to ensure the security of the cannabis in their possession that they are authorized to produce, or that is produced for the medical purposes of the applicant, under this Division, and
(ii) if they are not the applicant, ensure that the applicant takes reasonable steps to ensure the security of the cannabis in the applicant’s possession that has been produced under this Division.
Marginal note:Production for own medical purposes
(3) If the applicant intends to produce cannabis for their own medical purposes, the application must also include
(a) the address of the place in Canada where they ordinarily reside, as well as, if applicable, their telephone number, facsimile number and email address;
(b) if applicable, the information referred to in paragraphs (2)(c) and (d) as it relates to the place referred to in paragraph (a);
(c) an indication that, within the 10 years preceding the application, they have not been convicted, as an adult, of an offence referred to in subsection 309(3);
(d) an indication that they will comply with the limit on the number of cannabis plants under production, as specified in the registration certificate to be issued under subsection 313(1);
(e) the full address of the site where the proposed production of cannabis plants is to be conducted;
(f) an indication of whether the proposed production area is
(i) entirely indoors,
(ii) entirely outdoors, or
(iii) partly indoors and partly outdoors; and
(g) if there is to be any outdoor production, an indication that the site referred to in paragraph (e) is not adjacent to a school, public playground, daycare facility or other public place frequented mainly by young persons.
Marginal note:Production by designated person
(4) If cannabis is to be produced by a designated person, the application must include a declaration by the designated person that contains
(a) the information referred to in paragraph (2)(a) and subparagraph (2)(b)(i) — and, if applicable, paragraphs (2)(c) and (d) — in respect of that person;
(b) the information referred to in paragraphs (3)(e) to (g);
(c) an indication that
(i) within the 10 years preceding the day on which the declaration is made, they have not been convicted of an offence referred to in paragraph 311(2)(a) or (b) or received a sentence referred to in paragraph 311(2)(c) or (d),
(ii) they will take reasonable steps to ensure the security of the cannabis in their possession that they produce under this Division, and
(iii) they will comply with the limit on the number of cannabis plants under production, as specified in the document to be provided under subsection 313(3); and
(d) a document, issued by a Canadian police force within the 90 days preceding the date on which the application is submitted, establishing that, within the 10 years preceding the date on which the document is issued, the designated person has not been convicted of an offence referred to in paragraph 311(2)(a) or received a sentence referred to in paragraph 311(2)(c).
Marginal note:Signature and statement — designated person
(5) The declaration must be signed and dated by the designated person and must include a statement by them confirming that the information contained in the declaration is correct and complete.
Marginal note:Consent of owner
(6) If the proposed site for the production of cannabis plants is not the ordinary place of residence of, and is not owned by, the applicant or, if applicable, the designated person, the application must include
(a) the full name, address and telephone number of the owner of the site; and
(b) a declaration, signed and dated by the site’s owner — or, if the owner is a corporation, by an authorized representative of the owner — consenting to the production of cannabis at the site.
Marginal note:Applicant without ordinary residence
(7) If an institution’s address is included in the application in accordance with subparagraph (2)(b)(ii), the application must include a statement that is signed and dated by a manager of the institution confirming that it provides food, lodging or other social services to the applicant.
Marginal note:Registration with Minister
313 (1) If the requirements set out in section 312 are met, the Minister must, subject to section 317, register the applicant and issue them a registration certificate.
Marginal note:Registration certificate
(2) The registration certificate must contain the following information:
(a) the given name, surname and date of birth of the registered person and, if applicable, the designated person;
(b) the address specified in the application under paragraph 312(2)(b) and, if applicable, the address of the place where the designated person ordinarily resides;
(c) the given name, surname and date of birth of any adults who are named in the application under paragraph 312(2)(e);
(d) a unique registration number;
(e) the name of the health care practitioner who provided the medical document that forms the basis for the registration;
(f) the daily quantity of dried cannabis, expressed in grams, that is specified in the medical document that forms the basis for the registration;
(g) the maximum quantity of dried cannabis, expressed in grams, that the registered person is authorized to possess by virtue of the registration, as determined in accordance with subsection 266(3) or 267(3), as the case may be;
(h) the effective date of the registration;
(i) the date of expiry of the registration;
(j) if applicable, the type of production that is authorized, namely, production by the registered person or production by a designated person;
(k) if applicable, the full address of the site where the production of cannabis plants is authorized by virtue of the registration;
(l) if applicable, an indication of whether the authorized production area is entirely indoors, entirely outdoors or partly indoors and partly outdoors; and
(m) if applicable, the maximum number of cannabis plants, determined in accordance with section 325, that may be under production at the production site by virtue of the registration and, if applicable, the maximum number of plants for each indoor and outdoor production period.
Marginal note:Document for designated person
(3) If a designated person is named in the registration certificate, the Minister must provide them with a document containing information relating to the production of cannabis that is authorized, including the information referred to in paragraphs (2)(g) to (m) and the given name and surname of any adults who are named in the registration certificate under paragraph (2)(c).
Marginal note:Expiry of registration
313.1 The registration of a registered person expires at the end of the period of validity of the medical document that forms the basis for the registration, as determined in accordance with subsections 273(4) and (5).
Marginal note:Application to renew registration
314 (1) To renew a registration, the registered person, or an adult who is responsible for them, must
(a) submit an application to the Minister that includes the registration number and the information and documents required under subsections 312(2) to (7); and
(b) ensure that a new medical document is sent to the Minister.
Marginal note:Extension of registration
(2) If the Minister has received an application and medical document under subsection (1) but has not notified the applicant of the Minister’s decision in respect of the application before the current registration expires, the registration remains valid until the Minister notifies the applicant — and, in the case of a refusal to renew the registration, the designated person, if any — of the decision.
Marginal note:Renewal
(3) If a renewal application has been submitted in accordance with paragraph (1)(a) and the Minister has received a new medical document under paragraph (1)(b), the Minister must, subject to section 317,
(a) renew the registration;
(b) provide the registered person with a new registration certificate; and
(c) if there is a designated person, provide them with an updated version of the document referred to in subsection 313(3).
Marginal note:Effect of renewal
(4) For greater certainty, a renewed registration replaces the previous one.
Marginal note:Application to amend registration
315 (1) Subject to subsection (2), to amend any of the information in a registration certificate, the registered person, or an adult who is responsible for them, must submit an application to the Minister that includes
(a) the registration number;
(b) a description of the proposed amendment and the supporting reasons for it;
(c) the information and documents referred to in section 312 that are relevant to the proposed amendment;
(d) the effective date of the event that has necessitated the application; and
(e) if there has been a change to the given name or surname of an individual who is named in the registration certificate under paragraph 313(2)(a) or (c), proof of the change.
Marginal note:New medical document
(2) An amendment application cannot be submitted in respect of a new medical document.
Marginal note:Amendment
(3) If an application is submitted in accordance with subsection (1), the Minister must, subject to section 317,
(a) amend the registration;
(b) provide the registered person with an amended registration certificate; and
(c) if there is a designated person, provide them with an updated version of the document referred to in subsection 313(3).
Marginal note:Consequences of renewal or amendment
316 (1) If, as a result of the renewal or amendment of a registration, an individual ceases to be a designated person, the Minister must notify them of the loss of their authorization to produce cannabis under the registration.
Marginal note:Change of location
(2) If, as a result of a renewal or amendment, the location of the authorized site for the production of cannabis plants — or the place of residence of the registered person or designated person — is changed, the Minister may specify the period during which the registered person or, if applicable, the designated person is authorized to transport cannabis from the former site or place of residence to the new site or place of residence.
Marginal note:Refusal to register, renew or amend
317 (1) The Minister must refuse to register an applicant or to renew or amend a registration if
(a) the applicant is not eligible under subsection 309(1) or section 310;
(b) the medical document that forms the basis for the application does not meet all of the requirements of section 273 or is no longer valid;
(c) at the time the medical document was provided to the applicant, the individual who provided it
(i) was not a health care practitioner, or
(ii) was not entitled to practise their profession in the province in which the applicant consulted with them;
(d) the given name, surname or date of birth of the applicant is different from the given name, surname or date of birth that appears on the medical document;
(e) the health care practitioner who provided the medical document notifies the Minister in writing that the use of cannabis by the applicant is no longer supported for clinical reasons;
(f) the Minister has reasonable grounds to believe that false or misleading information has, or false or falsified documents have, been provided in, or in support of, the application;
(g) the registration, renewal or amendment would result in the applicant or, if applicable, the designated person being authorized to produce cannabis plants under more than two registrations;
(h) the registration, renewal or amendment would result in the proposed site for the production of cannabis plants being authorized under more than four registrations;
(i) in the case where the applicant intends to produce cannabis for their own medical purposes, the applicant is not eligible under subsection 309(2) or (3); and
(j) in the case where cannabis is to be produced by a designated person, the individual who has been designated is not eligible under section 311.
Marginal note:Power to refuse
(2) The Minister may refuse to register an applicant or renew or amend a registration if, in the case where cannabis is to be produced by the applicant or a designated person, the registration, renewal or amendment is likely to create a risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.
Marginal note:Notice and opportunity to be heard
(3) Before refusing to register an applicant or refusing to amend or renew a registration, the Minister must send the applicant a written notice that sets out the reason for the proposed refusal and give them an opportunity to be heard.
Marginal note:Revocation of registration
318 (1) The Minister must revoke a registration if
(a) the registered person is not eligible under section 309;
(b) the designated person is not eligible under section 311;
(c) the registration was issued, amended or renewed on the basis of false or misleading information or false or falsified documents;
(d) the health care practitioner who provided the medical document that forms the basis for the registration notifies the Minister in writing that the use of cannabis by the registered person is no longer supported for clinical reasons;
(e) the registered person — or an adult who is named in the registration certificate under paragraph 313(2)(c) — requests, in writing, that the registration be revoked; or
(f) the registered person dies.
Marginal note:Revocation of excess registrations
(2) If a site for the production of cannabis plants is authorized under more than four registrations, the Minister must revoke the excess registrations.
Marginal note:Power to revoke
(3) The Minister may revoke a registration if, in the case where the registered person or designated person is authorized to produce cannabis, the Minister has reasonable grounds to believe that the revocation is necessary to protect public health or public safety, including to prevent cannabis from being diverted to an illicit market or activity.
Marginal note:Conditions of revocation
(4) Before revoking a registration, the Minister must
(a) in the case where it is to be revoked for a reason set out in any of paragraphs (1)(a) to (d) or subsection (2) or (3),
(i) send the registered person a written notice that sets out the reason for the proposed revocation, and
(ii) give them an opportunity to be heard; and
(b) if applicable, send the designated person a written notice of the proposed revocation.
Marginal note:Effect of revocation
(5) For greater certainty, if a registration is revoked, the activities that were previously authorized under Subdivision B by virtue of the registration cease to be authorized.
Marginal note:Notice of revocation
319 (1) If a registration is revoked and the Minister is aware that the registration has formed the basis for a registration with a holder of a licence for sale under Division 1 of this Part, the Minister must provide the holder with a notice of revocation that includes the following information:
(a) the given name, surname and date of birth of the individual whose registration has been revoked;
(b) the registration number of the revoked registration; and
(c) the date of the revocation.
Marginal note:Requirement to notify
(2) A holder of a licence for sale that is notified under subsection (1) must, if within the previous 48 hours they have asked a holder of a licence for processing or cultivation to send or deliver cannabis products to, or for, the individual whose registration has been revoked, notify the holder of the licence for processing or cultivation, in writing, without delay.
Marginal note:Prohibition
(3) A holder of a licence for processing or cultivation that is notified under subsection (2) must not send or deliver the cannabis products that they had been asked to send or deliver.
SUBDIVISION BProduction
Marginal note:Definition of production site
320 (1) In this Subdivision, production site means
(a) in respect of a registered person, the site, if any, for the production of cannabis plants that is specified in their registration certificate under paragraph 313(2)(k); and
(b) in respect of a designated person, the site for the production of cannabis plants that is specified in the document that the person receives under subsection 313(3).
Marginal note:Cumulative quantities
(2) For greater certainty,
(a) the quantities of cannabis that a registered person is authorized to obtain by cultivation, propagation and harvesting, or to send, deliver, transport or possess, by virtue of a registration under this Division are in addition to any other quantities that they are permitted to obtain by cultivation, propagation and harvesting, or to send, deliver, transport or possess, under the Act; and
(b) the quantities of cannabis that a designated person is authorized to obtain by cultivation, propagation and harvesting, or to send, deliver, transport, sell or possess, by virtue of a registration under this Division are in addition to any other quantities that they are permitted to obtain by cultivation, propagation and harvesting, or to send, deliver, transport, sell or possess, under the Act.
Marginal note:Production by registered person
321 (1) A registered person who is registered to produce cannabis for their own medical purposes is, in accordance with the registration and the provisions of this Division, authorized to
(a) obtain by cultivation, propagation and harvesting at the production site a quantity of cannabis plants that does not exceed the maximum number of plants that is specified in the registration certificate under paragraph 313(2)(m);
(b) if the production site is different from the place where the registered person ordinarily resides,
(i) subject to subsection 326(2), transport directly from the place of residence to the production site a total quantity of cannabis plants and cannabis plant seeds that, taking into account the seed-to-plant ratio specified in subsection 290(2), does not exceed the equivalent of the maximum number of plants that is specified in the registration certificate under paragraph 313(2)(m), and
(ii) transport cannabis, other than cannabis plants or cannabis plant seeds, directly from the production site to the place of residence; and
(c) if the registration has been renewed or amended and, as a result, the location of the production site or the place of residence of the registered person is changed, transport cannabis directly from the former production site or place of residence to the new production site or place of residence within any period that the Minister may specify under subsection 316(2).
Marginal note:Possession of cannabis
(2) A registered person referred to in subsection (1) is authorized to possess the cannabis that they are authorized to obtain by cultivation, propagation and harvesting or to transport under that subsection.
Marginal note:Production by designated person
322 (1) A designated person is, in accordance with the registration and the provisions of this Division, authorized to
(a) obtain by cultivation, propagation and harvesting at the production site a quantity of cannabis plants that does not exceed the maximum number of plants that is specified in the document that the designated person receives under subsection 313(3);
(b) if the production site is different from the place where the designated person ordinarily resides,
(i) subject to subsection 326(2), transport directly from the place of residence to the production site a total quantity of cannabis plants and cannabis plant seeds that, taking into account the seed-to-plant ratio specified in subsection 290(2), does not exceed the equivalent of the maximum number of plants that is specified in the document that the designated person receives under subsection 313(3), and
(ii) transport cannabis, other than cannabis plants or cannabis plant seeds, directly from the production site to the place of residence;
(c) send, deliver, transport or sell to the registered person — or an adult who is named in the document that the designated person receives under subsection 313(3) — a quantity of cannabis, other than cannabis plants or cannabis plant seeds, that does not exceed the equivalent of the maximum quantity of dried cannabis that is specified in the document; and
(d) if the registration has been renewed or amended and, as a result, the location of the production site or the place of residence of the designated person is changed, transport cannabis directly from the former production site or place of residence to the new production site or place of residence within any period that the Minister may specify under subsection 316(2).
Marginal note:Parcel — requirements
(2) A designated person who sends or has cannabis delivered under paragraph (1)(c) must
(a) prepare the parcel in a manner that ensures the security of its contents, such that
(i) it will not open or permit the escape of its contents during handling or transportation,
(ii) it is sealed so that it cannot be opened without the seal being broken,
(iii) it prevents the escape of odours associated with cannabis plant material, and
(iv) it prevents the contents from being identified without it being opened; and
(b) use a method that ensures the tracking and safekeeping of the parcel during transportation.
Marginal note:Possession of cannabis
(3) A designated person is authorized to
(a) possess the cannabis plants and cannabis plant seeds that they are authorized to obtain by cultivation, propagation and harvesting or to transport under paragraph (1)(a), (b) or (d); and
(b) possess in a public place the cannabis, other than cannabis plants or cannabis plant seeds, that they are authorized to send, deliver, transport or sell under paragraphs (1)(b) to (d).
Marginal note:Participation by registered person
323 If a designated person is specified in a registration certificate, the registered person may, if they are an adult, participate in the activities that the designated person is authorized to conduct under subsection 322(1).
Marginal note:Former designated person
324 An individual who ceases to be a designated person may, within seven days after ceasing to be designated, conduct the activities referred to in paragraph 322(1)(c) in accordance with that paragraph unless the registration has expired or has been revoked.
Marginal note:Maximum number of plants
325 (1) If the production area is entirely indoors, the maximum number of cannabis plants that may be under production at a production site by virtue of a registration is determined by the formula
[(A × 365) ÷ (B × 3C)] × 1.2
where
- A
- is the daily quantity of dried cannabis, expressed in grams, indicated in the medical document that forms the basis for the registration;
- B
- is 30 g, being the expected yield of dried cannabis per plant; and
- C
- is a constant equal to 1, representing the growth cycle of a cannabis plant from seeding to harvesting.
Marginal note:Outdoor production only
(2) If the production area is entirely outdoors, the maximum number of cannabis plants that may be under production at a production site by virtue of a registration is determined by the formula
[(A × 365) ÷ (B × C)] × 1.3
where
- A
- is the daily quantity of dried cannabis, expressed in grams, indicated in the medical document that forms the basis for the registration;
- B
- is 250 g, being the expected yield of dried cannabis per plant; and
- C
- is a constant equal to 1, representing the growth cycle of a cannabis plant from seeding to harvesting.
Marginal note:Indoor and outdoor production
(3) If the production area is partly indoors and partly outdoors, the maximum number of cannabis plants that may be under production at a production site by virtue of a registration is determined
(a) for the indoor production period, by the formula
[(A × 182.5) ÷ (B × 2C)] × 1.2
where
- A
- is the daily quantity of dried cannabis, expressed in grams, indicated in the medical document that forms the basis for the registration,
- B
- is 30 g, being the expected yield of dried cannabis per plant, and
- C
- is a constant equal to 1, representing the growth cycle of a cannabis plant from seeding to harvesting; and
(b) for the outdoor production period, by the formula
[(A × 182.5) ÷ (B × C)] × 1.3
where
- A
- is the daily quantity of dried cannabis, expressed in grams, indicated in the medical document that forms the basis for the registration,
- B
- is 250 g, being the expected yield of dried cannabis per plant, and
- C
- is a constant equal to 1, representing the growth cycle of a cannabis plant from seeding to harvesting.
Marginal note:Rounding
(4) If the maximum number of cannabis plants determined under this section is not a whole number, it is to be rounded to the next highest whole number.
Marginal note:Prohibition — production of plants
326 (1) An individual who is authorized to produce cannabis plants under this Division must not cultivate, propagate or harvest them
(a) indoors and outdoors at the same time; or
(b) outdoors if the production site is adjacent to a school, public playground, daycare facility or other public place frequented mainly by young persons.
Marginal note:Time limit — transportation of plants
(2) If the production site of an individual who is authorized to produce cannabis plants under this Division is different from the place where the individual ordinarily resides, the individual must not transport to the production site cannabis plants that were ordered in accordance with section 289 if it has been more than seven days after the individual received the plants at their place of residence.
SUBDIVISION CSecurity Obligations
Marginal note:Security of cannabis and documents
327 (1) A registered person who is authorized to produce cannabis, or for whom cannabis may be produced by a designated person, under this Division — or, if applicable, any adult who is named in the registration certificate of the registered person — must
(a) take reasonable steps to ensure the security of
(i) the cannabis in their possession that was produced under this Division, and
(ii) the registration certificate, if they possess it;
(b) report the theft or loss of anything referred to in paragraph (a) to a police force within 24 hours after becoming aware of the theft or loss; and
(c) report the theft or loss of anything referred to in paragraph (a) to the Minister, in writing, within 72 hours after becoming aware of the theft or loss and include confirmation that the requirement set out in paragraph (b) has been complied with.
Marginal note:Designated person
(2) The requirements set out in subsection (1) also apply to a designated person in respect of
(a) cannabis in their possession that they produced under this Division; and
(b) the document referred to in subsection 313(3).
SUBDIVISION DDisclosure of Information
Marginal note:Disclosure to licensing authorities
328 (1) At any time after receiving a medical document that forms the basis for an application under this Division, the Minister may disclose, in respect of the health care practitioner who is named in the medical document, the following information to the provincial professional licensing authority for the province identified in the medical document under paragraph 273(1)(b):
(a) the given name, surname and business address of the health care practitioner, together with the number assigned by the province to the health care practitioner’s authorization to practise;
(b) the daily quantity of dried cannabis that is specified in the medical document; and
(c) the name of the province that is specified in the application under paragraph 312(2)(b).
Marginal note:Disclosure after registration
(2) At any time after registering an individual under this Division, the Minister may disclose, in respect of the health care practitioner who is named in the medical document that forms the basis for the registration, the following information to the provincial professional licensing authority for the province identified in the document under paragraph 273(1)(b):
(a) the given name, surname and date of birth of the individual who is or was registered with the Minister;
(b) the postal code for the address of the place indicated in the medical document as the place where the individual ordinarily resides;
(c) the period of use that is specified in the medical document; and
(d) the date on which the medical document was signed by the health care practitioner.
Marginal note:Definition of health care practitioner
(3) In this section, health care practitioner means an individual who is, or was, a medical practitioner or nurse practitioner.
Marginal note:Disclosure to police
329 The Minister may disclose any of the following information to a Canadian police force, or a member of a Canadian police force, that requests the information in the course of an investigation under the Act, on condition that the information is used only for the purposes of the investigation or the administration and enforcement of the Act or these Regulations:
(a) in respect of a named individual, whether the individual is a registered person, a designated person or an adult who is named in a registration certificate under paragraph 313(2)(c);
(b) in respect of a specified address, whether the address is
(i) the place where a registered person or designated person ordinarily resides and, if so, the name of that person and the registration number, or
(ii) the site where the production of cannabis plants is authorized under a registration and, if so, the registration number, the name of the individual who is authorized to produce and, if that individual is a designated person and the registered person is an adult, the name of the registered person; and
(c) in respect of a registration,
(i) the given name, surname and date of birth of the registered person and, if applicable, the designated person and any adult who is named in the registration certificate under paragraph 313(2)(c),
(ii) the full address of the place where the registered person and, if applicable, the designated person ordinarily reside,
(iii) the registration number,
(iv) the maximum quantity of dried cannabis that the registered person is authorized to possess, as indicated in the registration certificate,
(v) the effective date and date of expiry of the registration,
(vi) if the registration remains valid by virtue of subsection 314(2), the status of the renewal application,
(vii) the full address of the site where the production of cannabis plants is authorized,
(viii) whether the authorized production area is indoors, outdoors or partly indoors and partly outdoors, and
(ix) the maximum number of cannabis plants that may be produced at the production site and, if applicable, the maximum number of cannabis plants that may be produced for each indoor and outdoor production period.
DIVISION 3Health Professionals and Hospitals
Health Care Practitioners
Marginal note:Security of cannabis products
330 A health care practitioner must, in respect of cannabis products that they possess for the practice of their profession,
(a) take reasonable steps to protect them from theft or loss; and
(b) report any theft or loss to the Minister within 10 days after becoming aware of the theft or loss.
Marginal note:Returned cannabis products
331 (1) A health care practitioner must, if they accept cannabis products that are returned under subsection 292(3), retain a document that contains the following information:
(a) the name of the individual who is returning the cannabis products;
(b) the address of the location at which the cannabis products are received;
(c) the date on which they are received;
(d) the quantity of cannabis that is received; and
(e) a description of the cannabis products, including their brand names.
Marginal note:Exceptions
(2) The health care practitioner is not required to include the information referred to in paragraphs (1)(d) and (e) if
(a) they are unable to ascertain the information without unsealing a parcel that meets the requirements of paragraph 292(4)(a) and the parcel is subsequently sent or delivered to the holder of the licence that originally sold or distributed the cannabis products to or for the client; or
(b) in the case of a cannabis accessory that contains cannabis, they are unable to ascertain the information.
Marginal note:Retention period
(3) The document must be retained for at least two years after the day on which it is prepared.
Marginal note:Former health care practitioner
332 If an individual ceases to be a health care practitioner, they must, in respect of any document that they were required to retain under this Part and for which the retention period has not yet ended,
(a) ensure that the document continues to be retained until the end of the retention period; and
(b) notify the Minister, in writing, of the address of the place of business at which the document is retained and of any subsequent change to the address.
Marginal note:Disclosure to licensing authority
333 The Minister must disclose, in writing, factual information about a health care practitioner — in relation to cannabis — that has been obtained under the Act or the Controlled Drugs and Substances Act to
(a) the provincial professional licensing authority for a province in which the health care practitioner is, or was, entitled to practise if
(i) the licensing authority submits to the Minister a written request that sets out the health care practitioner’s name and address, a description of the information being requested and a statement that the information is required for the purpose of assisting an investigation by the authority,
(ii) the Minister has reasonable grounds to believe that the health care practitioner has contravened, in relation to cannabis, a rule of conduct established by the licensing authority,
(iii) the Minister becomes aware that the health care practitioner has been convicted of
(A) a designated offence,
(B) a controlled substance offence in relation to cannabis,
(C) a contravention of the former Access to Cannabis for Medical Purposes Regulations or the former Marihuana for Medical Purposes Regulations, or
(D) a contravention of the Narcotic Control Regulations in relation to cannabis, or
(iv) the Minister has reasonable grounds to believe that the health care practitioner has contravened this Part or the former Access to Cannabis for Medical Purposes Regulations, the former Marihuana for Medical Purposes Regulations or — in relation to cannabis — the Narcotic Control Regulations; and
(b) the provincial professional licensing authority for a province in which the health care practitioner is not entitled to practise if the licensing authority submits to the Minister
(i) a written request that sets out the health care practitioner’s name and address and a description of the information being requested, and
(ii) a document that shows that
(A) the health care practitioner has applied to the licensing authority to practise in that province, or
(B) the licensing authority has reasonable grounds to believe that the health care practitioner is practising in that province without being authorized to do so.
Marginal note:Definition of health care practitioner
334 In sections 335 to 337, health care practitioner means
(a) an individual who is entitled under the laws of a province to practise medicine in that province; or
(b) an individual who meets the requirements of paragraph (a) of the definition nurse practitioner in subsection 264(1).
Marginal note:Notice from Minister
335 (1) The Minister must, in the circumstances set out in subsection (2), issue a notice to the persons and pharmacies specified in subsection (3) advising them, as applicable, that
(a) the holders of a licence for sale and the holders of a licence for processing that receive the notice must not send cannabis products to the health care practitioner who is named in the notice;
(b) any medical document that is signed by the health care practitioner who is named in the notice must not form the basis for registering a client if the medical document is signed after the day on which the notice is issued; and
(c) pharmacists practising in the notified pharmacies must not distribute or sell cannabis products on the basis of a medical document signed by, or a written order issued by, the health care practitioner who is named in the notice if the medical document is signed, or the written order is issued, after the day on which the notice is issued.
Marginal note:Circumstances — mandatory issuance
(2) The notice must be issued if
(a) the health care practitioner who is named in the notice has asked the Minister, in writing, to issue it;
(b) the health care practitioner who is named in the notice has contravened, in relation to cannabis, a rule of conduct established by the provincial professional licensing authority for the province in which the health care practitioner is practising and the licensing authority has asked the Minister, in writing, to issue the notice;
(c) the health care practitioner who is named in the notice has been convicted of
(i) a designated offence,
(ii) a contravention of these Regulations,
(iii) a controlled substance offence in relation to cannabis,
(iv) a contravention of the former Access to Cannabis for Medical Purposes Regulations or the former Marihuana for Medical Purposes Regulations, or
(v) a contravention of the Narcotic Control Regulations in relation to cannabis; or
(d) the health care practitioner who is named in the notice has been named in a notice issued under subsection 189(2) or (4).
Marginal note:Recipients of notice
(3) A notice that is issued under this section must be issued to
(a) the health care practitioner who is named in the notice;
(b) all holders of a licence for sale and holders of a licence for processing;
(c) all hospital pharmacies in the province in which the health care practitioner who is named in the notice is entitled to practise and is practising;
(d) the provincial professional licensing authority for the province in which the health care practitioner who is named in the notice is entitled to practise; and
(e) on request, the provincial professional licensing authority for any province other than the province referred to in paragraph (d).
Marginal note:Power to issue notice
(4) The Minister may issue a notice referred to in subsection (1) if he or she has reasonable grounds to believe that the health care practitioner who is named in the notice
(a) has conducted an activity referred to in section 272 other than in accordance with that section;
(b) has provided a medical document, or issued a written order, that contains false or misleading information;
(c) has, on more than one occasion, provided themselves with a medical document or issued a written order for themselves, contrary to accepted medical practice;
(d) has, on more than one occasion, conducted an activity referred to in section 272 in respect of their spouse, common-law partner, parent or child, including a child adopted in fact, contrary to accepted medical practice; or
(e) is unable to account for a quantity of cannabis for which they were responsible under this Part, the Narcotic Control Regulations or the former Access to Cannabis for Medical Purposes Regulations.
Marginal note:Preconditions
(5) Before issuing a notice under subsection (4), the Minister must
(a) consult with the provincial professional licensing authority for the province in which the health care practitioner to whom the notice relates is entitled to practise;
(b) send to the health care practitioner a written notice that sets out the reasons why a notice is being considered and give him or her an opportunity to present reasons why the notice should not be issued; and
(c) consider
(i) any reasons that have been presented by the health care practitioner under paragraph (b),
(ii) the compliance history of the health care practitioner in respect of the Act, the Controlled Drugs and Substances Act and the regulations made or continued under either Act, and
(iii) whether the actions of the health care practitioner pose a significant risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.
Marginal note:Retraction of notice
336 (1) The Minister must retract a notice that was issued under section 335 if
(a) the health care practitioner who is named in the notice has requested in writing that it be retracted;
(b) the health care practitioner has provided a letter from the provincial professional licensing authority for the province in which the health care practitioner is entitled to practise that states that the authority consents to the retraction of the notice;
(c) in the case where the notice was issued at the request of the health care practitioner, one year has elapsed since the notice was issued; and
(d) in the case where the notice was issued in the circumstance referred to in paragraph 335(2)(d), the notice that was issued under subsection 189(2) or (4) has been retracted under subsection 190(1).
Marginal note:Requirement to notify
(2) If the Minister retracts a notice issued under section 335, he or she must notify, in writing, the persons and pharmacies to which it was issued.
Pharmacists
Marginal note:Prohibitions — notified pharmacies
337 (1) A pharmacist who is practising in a pharmacy that has received a notice issued under section 335 must not distribute or sell cannabis products on the basis of a medical document signed, or a written order issued, by the health care practitioner who is named in the notice unless the medical document is signed, or the written order is issued, before the day on which the notice is issued.
Marginal note:Prohibition — pharmacist named in notice
(2) A pharmacist who is practising in a pharmacy that has received a notice issued under section 344 must not distribute or sell cannabis products to the pharmacist who is named in the notice.
Marginal note:Effect of retraction
(3) The prohibitions referred to in subsections (1) and (2) cease to apply if the notice is retracted.
Marginal note:Prohibition — dispensing
338 A pharmacist must not use an order — including a written order — to dispense a cannabis product if the quantity of cannabis that would be dispensed, when added to the quantity of cannabis that has already been dispensed under the order, would exceed the quantity of cannabis specified in the order.
Marginal note:Hospital pharmacists
339 (1) Subject to section 337, a pharmacist who is practising in a hospital may, if authorized by the individual in charge of the hospital,
(a) distribute, sell or return, in accordance with paragraph 348(2)(b) or subsection 348(4) or (7), cannabis products, other than cannabis plants or cannabis plant seeds, that have been received from a holder of a licence for sale or a holder of a licence for processing; or
(b) distribute — but not send — or sell cannabis products, other than cannabis plants or cannabis plant seeds, to an employee of the hospital or a health care practitioner practising in the hospital, on receipt of an order, in writing, that has been signed and dated by
(i) the pharmacist in charge of the hospital’s pharmacy, or
(ii) a health care practitioner who is authorized by the individual in charge of the hospital to sign the order.
Marginal note:Verification of signature
(2) Before distributing or selling cannabis products under paragraph (1)(b), the pharmacist receiving the order must verify the signature on the order, if it is unknown to them.
Marginal note:Prohibition
(3) A pharmacist must not conduct the activities referred to in subsection (1) if the pharmacist has been named in a notice that has been issued under section 344 and that has not been retracted.
Marginal note:Definition of distribute
(4) In this section, distribute does not include administering.
Marginal note:Retention of documents
340 (1) A pharmacist who receives cannabis products from a person must retain a document that contains the following information:
(a) the quantity of cannabis that is received;
(b) a description of the cannabis products, including their brand names;
(c) the date on which the cannabis products are received; and
(d) the name and mailing address of the person from which the cannabis products are received.
Marginal note:Sale or distribution
(2) A pharmacist who distributes or sells cannabis products on the basis of a medical document or written order must retain a document that contains the following information:
(a) the pharmacist’s name or initials;
(b) the name, initials and address of the health care practitioner who provided the medical document or issued the written order;
(c) the name and mailing address of the individual for whom the cannabis products are distributed or sold;
(d) the quantity of cannabis that is distributed or sold;
(e) a description of the cannabis products, including their brand names;
(f) the date on which the cannabis products are distributed or sold; and
(g) the number that the pharmacist has assigned to the medical document or written order.
Marginal note:Emergency transfer
(3) A pharmacist who distributes or sells cannabis products for emergency purposes on the basis of an order made in accordance with subsection 348(4) must retain a document that contains the following information:
(a) the name and address of the pharmacist or health care practitioner who signed the order;
(b) the name and address of the individual to whom the cannabis products are distributed or sold;
(c) the quantity of cannabis that is distributed or sold;
(d) a description of the cannabis products, including their brand names; and
(e) the date on which the cannabis products are distributed or sold.
Marginal note:Return of cannabis products
(4) A pharmacist who returns cannabis products must retain a document that contains the following information:
(a) the name and address of the person to which the cannabis products are returned;
(b) the quantity of cannabis that is returned;
(c) a description of the cannabis products, including their brand names; and
(d) the date on which the cannabis products are returned.
Marginal note:Retention period
(5) The documents must be retained for at least two years after the day on which they are prepared.
Marginal note:Former pharmacists
341 If an individual ceases to be a pharmacist, they must, in respect of any document that they were required to retain under this Part and for which the retention period has not yet ended,
(a) ensure that the document continues to be retained until the end of the retention period; and
(b) notify the Minister, in writing, of the address of the place of business at which the document is retained and of any subsequent change to the address.
Marginal note:Security of cannabis products
342 The pharmacist in charge of a hospital’s pharmacy must, in respect of cannabis products that are on the pharmacy premises or for which the pharmacist is responsible,
(a) take reasonable steps to protect them from theft or loss; and
(b) report any theft or loss to the Minister within 10 days after becoming aware of the theft or loss.
Marginal note:Disclosure to licensing authority
343 The Minister must disclose, in writing, factual information about a pharmacist — in relation to cannabis — that has been obtained under the Act or the Controlled Drugs and Substances Act to
(a) the provincial professional licensing authority for a province in which the pharmacist is, or was, entitled to practise if
(i) the licensing authority submits to the Minister a written request that sets out the pharmacist’s name and address, a description of the information being requested and a statement that the information is required for the purpose of assisting an investigation by the authority,
(ii) the Minister has reasonable grounds to believe that the pharmacist has contravened, in relation to cannabis, a rule of conduct established by the licensing authority,
(iii) the Minister becomes aware that the pharmacist has been convicted of
(A) a designated offence,
(B) a controlled substance offence in relation to cannabis,
(C) a contravention of the former Access to Cannabis for Medical Purposes Regulations, or
(D) a contravention of the Narcotic Control Regulations in relation to cannabis, or
(iv) the Minister has reasonable grounds to believe that the pharmacist has contravened these Regulations, the former Access to Cannabis for Medical Purposes Regulations or — in relation to cannabis — the Narcotic Control Regulations; and
(b) the provincial professional licensing authority for a province in which the pharmacist is not entitled to practise if the licensing authority submits to the Minister
(i) a written request that sets out the pharmacist’s name and address and a description of the information being requested, and
(ii) a document that shows that
(A) the pharmacist has applied to the licensing authority to practise in that province, or
(B) the licensing authority has reasonable grounds to believe that the pharmacist is practising in that province without being authorized to do so.
Marginal note:Notice from Minister
344 (1) The Minister must, in the circumstances set out in subsection (2), issue a notice to the following persons and pharmacies advising them that holders of a licence for sale, holders of a licence for processing and pharmacists practising in the notified pharmacies must not distribute or sell cannabis products to the pharmacist who is named in the notice:
(a) the pharmacist who is named in the notice;
(b) all holders of a licence for sale and all holders of a licence for processing;
(c) all hospital pharmacies in the province in which the pharmacist who is named in the notice is entitled to practise and is practising;
(d) the provincial professional licensing authority for the province in which the pharmacist who is named in the notice is entitled to practise; and
(e) on request, the provincial professional licensing authority for any province other than the province referred to in paragraph (d).
Marginal note:Circumstances — mandatory issuance
(2) The notice must be issued if
(a) the pharmacist who is named in the notice asks the Minister, in writing, to issue the notice;
(b) the pharmacist who is named in the notice has contravened, in relation to cannabis, a rule of conduct established by the provincial professional licensing authority for the province in which the pharmacist is practising and the licensing authority has asked the Minister, in writing, to issue the notice;
(c) the pharmacist who is named in the notice has been convicted of an offence referred to in subparagraph 343(a)(iii); or
(d) the pharmacist who is named in the notice has been named in a notice issued under subsection 181(2) or (4).
Marginal note:Power to issue notice
(3) The Minister may issue a notice referred to in subsection (1) if he or she has reasonable grounds to believe that the pharmacist who is named in the notice
(a) has conducted an activity referred to in section 339 other than in accordance with that section;
(b) has, on more than one occasion, distributed or sold a cannabis product to their spouse, common-law partner, parent or child, including a child adopted in fact, contrary to accepted pharmaceutical practice; or
(c) is unable to account for a quantity of cannabis products for which they were responsible under this Part, the Narcotic Control Regulations or the former Access to Cannabis for Medical Purposes Regulations.
Marginal note:Preconditions
(4) Before issuing a notice under subsection (3), the Minister must
(a) consult with the provincial professional licensing authority for the province in which the pharmacist to whom the notice relates is entitled to practise;
(b) send to the pharmacist a written notice that sets out the reasons why a notice is being considered and give him or her an opportunity to present reasons why the notice should not be issued; and
(c) consider
(i) any reasons that have been presented by the pharmacist under paragraph (b),
(ii) the compliance history of the pharmacist in respect of the Act, the Controlled Drugs and Substances Act and the regulations made or continued under either Act, and
(iii) whether the actions of the pharmacist pose a significant risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.
Marginal note:Retraction of notice
345 (1) The Minister must retract a notice that was issued under section 344 if
(a) the pharmacist who is named in the notice has requested in writing that it be retracted;
(b) the pharmacist has provided a letter from the provincial professional licensing authority for the province in which the pharmacist is entitled to practise that states that the authority consents to the retraction of the notice;
(c) in the case where the notice was issued at the request of the pharmacist, one year has elapsed since the notice was issued; and
(d) in the case where the notice was issued in the circumstance referred to in paragraph 344(2)(d), the notice that was issued under subsection 181(2) or (4) has been retracted under subsection 182(1).
Marginal note:Requirement to notify
(2) If the Minister retracts a notice issued under section 344, he or she must notify, in writing, the persons and pharmacies to which it was issued.
Hospitals
Marginal note:Definition of distribute
346 In sections 347, 348, 350 and 351, distribute does not include administering.
Marginal note:Security of cannabis products
347 An individual in charge of a hospital must, in respect of cannabis products that they permit to be administered, distributed or sold,
(a) take reasonable steps to protect them from theft or loss; and
(b) report any theft or loss to the Minister within 10 days after becoming aware of the theft or loss.
Marginal note:Administration, distribution and sale
348 (1) An individual in charge of a hospital must not permit cannabis products to be administered, distributed or sold, except in accordance with this section.
Marginal note:Hospital patients
(2) An individual in charge of a hospital may permit cannabis products, other than cannabis plants and cannabis plant seeds, received from a holder of a licence for sale or a holder of a licence for processing to be
(a) administered, on receipt of a medical document or written order, to an inpatient or outpatient of the hospital; or
(b) distributed — but not sent — or sold, on receipt of a medical document or written order, to an individual referred to in paragraph (a) or an adult who is responsible for them.
Marginal note:Requirements — distribution or sale
(3) An individual in charge of a hospital must, if they permit cannabis products to be distributed or sold under paragraph (2)(b), ensure that
(a) the quantity of cannabis that is distributed or sold does not exceed the equivalent of the lesser of
(i) 30 times the daily quantity of dried cannabis that is specified in the medical document or written order, and
(ii) 150 g of dried cannabis;
(b) the cannabis products are distributed or sold in the container in which they were received from the holder of the licence for sale or the holder of the licence for processing;
(c) a label is applied to the container in which the cannabis products were received indicating
(i) the given name, surname and profession of the health care practitioner who signed the medical document or written order,
(ii) the given name and surname of the patient,
(iii) the daily quantity of dried cannabis that is specified in the medical document or written order, and
(iv) the date on which the cannabis products are distributed or sold;
(d) the patient or responsible adult is provided with the current version of the document entitled Consumer Information — Cannabis, published by the Government of Canada on its website; and
(e) the patient or responsible adult is provided with a separate document containing the information referred to in paragraph (c).
Marginal note:Emergency purposes
(4) An individual in charge of a hospital may permit cannabis products, other than cannabis plants and cannabis plant seeds, received from a holder of a licence for sale or a holder of a licence for processing to be distributed or sold for emergency purposes to an employee of or a health care practitioner in another hospital on receipt of an order, in writing, that has been signed and dated by a pharmacist in the other hospital or a health care practitioner who is authorized by the individual in charge of the other hospital to order cannabis products.
Marginal note:Verification of signature
(5) An individual in charge of a hospital must not permit cannabis products to be distributed or sold under subsection (4) unless the signature on the order has been verified by the individual who distributes or sells the cannabis products, if it is unknown to them.
Marginal note:Distribution for research purposes
(6) An individual in charge of a hospital may permit cannabis products, other than cannabis plants and cannabis plant seeds, to be distributed for research purposes to an individual who is employed in a research laboratory in the hospital and who holds a licence for those purposes.
Marginal note:Return or destruction
(7) An individual in charge of a hospital may permit cannabis products to be
(a) returned to the holder of the licence for sale or the holder of the licence for processing from which the cannabis products were received, on receipt of a written request for the cannabis products that has been signed and dated by, or on behalf of, the holder; or
(b) distributed or sold, for destruction, to a holder of a licence for sale, or a holder of a licence for processing, that is authorized to destroy cannabis that they did not produce, sell or distribute, on receipt of a written request for the cannabis products that has been signed and dated by, or on behalf of, the holder.
Marginal note:Possession — hospital employees
349 A hospital employee is authorized to possess cannabis products, other than cannabis plants or cannabis plant seeds, if
(a) the cannabis products have been obtained in accordance with section 348 or 350; and
(b) the employee requires the cannabis products for the purposes of, and in connection with, their employment.
Marginal note:Return and replacement
350 (1) An individual to whom cannabis products are distributed or sold under paragraph 348(2)(b) may return them to a hospital employee who is authorized to distribute or sell cannabis products if the employee accepts the return.
Marginal note:Return of more than 30 g
(2) The individual returning the cannabis products must comply with the requirements set out in subsection 292(4) if they are returning more than the equivalent of 30 g of dried cannabis and are sending the cannabis products or having them delivered to the hospital.
Marginal note:Replacement of cannabis products
(3) The individual in charge of the hospital may, subject to the limit referred to in paragraph 348(3)(a), permit cannabis products that have been returned to be replaced.
Marginal note:Retention of documents
351 (1) An individual who is in charge of a hospital must ensure that documents that contain the following information are retained:
(a) in respect of cannabis products that are received at the hospital,
(i) the class of cannabis set out in Schedule 4 to the Act to which the cannabis products belong and their brand names,
(ii) the quantity of cannabis that is received,
(iii) the name and address of the person from which the cannabis products are received, and
(iv) the date on which the cannabis products are received;
(b) in respect of cannabis products that are distributed or sold for a patient,
(i) the given name and surname of the patient,
(ii) the given name, surname and profession of the health care practitioner who signed the relevant medical document or written order, together with the date on which it was signed,
(iii) the daily quantity of dried cannabis that is specified in the medical document or written order referred to in subparagraph (ii) and, if applicable, the period of use that is specified,
(iv) the class of cannabis set out in Schedule 4 to the Act to which the cannabis products belong,
(v) the quantity of cannabis that is distributed or sold, and
(vi) the date on which the cannabis products are distributed or sold; and
(c) in respect of cannabis products that are distributed or sold to a person that is authorized to sell or distribute such products — other than an adult referred to in paragraph 266(1)(d) or (e) — or that are returned under subsection 348(7),
(i) the name of the person to which the cannabis products are distributed, sold or returned,
(ii) the date on which the cannabis products are distributed, sold or returned,
(iii) the quantity of cannabis that is distributed, sold or returned,
(iv) the brand names of the cannabis products, and
(v) in the case of cannabis products that are distributed, sold or returned under subsection 348(7), the address of the person to which they are distributed, sold or returned.
Marginal note:Retention period
(2) The individual in charge of the hospital must ensure that the documents are retained for at least two years after the day on which they are prepared.
Marginal note:Cessation of operations — hospital
352 If a hospital ceases operations, the individual who was in charge of the hospital must, in respect of any document that they were required to retain under this Part and for which the retention period has not yet ended,
(a) ensure that the document continues to be retained until the end of the retention period; and
(b) notify the Minister, in writing, of the address of the place of business at which the document is retained and of any subsequent change to the address.
Nurses
Marginal note:Disclosure to nursing statutory body
353 (1) The Minister must disclose, in writing, factual information about a nurse — in relation to cannabis — that has been obtained under the Act or the Controlled Drugs and Substances Act to
(a) the nursing statutory body for a province in which the nurse is, or was, entitled to practise if
(i) the nursing statutory body submits to the Minister a written request that sets out the nurse’s name and address, a description of the information being requested and a statement that the information is required for the purpose of assisting an investigation by the body,
(ii) the Minister has reasonable grounds to believe that the nurse has contravened, in relation to cannabis, a rule of conduct established by the nursing statutory body,
(iii) the Minister becomes aware that the nurse has been convicted of
(A) a designated offence,
(B) a controlled substance offence in relation to cannabis,
(C) a contravention of the former Access to Cannabis for Medical Purposes Regulations or the former Marihuana for Medical Purposes Regulations, or
(D) a contravention of the Narcotic Control Regulations in relation to cannabis, or
(iv) the Minister has reasonable grounds to believe that the nurse has contravened this Part, the former Access to Cannabis for Medical Purposes Regulations, the former Marihuana for Medical Purposes Regulationsor — in relation to cannabis — the Narcotic Control Regulations; and
(b) the nursing statutory body for a province in which the nurse is not entitled to practise if the nursing statutory body submits to the Minister
(i) a written request that sets out the nurse’s name and address and a description of the information being requested, and
(ii) a document that shows that
(A) the nurse has applied to the nursing statutory body to practise in that province, or
(B) the nursing statutory body has reasonable grounds to believe that the nurse is practising in that province without being authorized to do so.
Marginal note:Definitions
(2) The following definitions apply in this section.
- nurse
nurse means an individual — other than a nurse practitioner — who is authorized by a nursing statutory body to practise nursing. (infirmier)
- nursing statutory body
nursing statutory body means the authority that is responsible for authorizing individuals to practise nursing in a province. (organisme régissant la profession d’infirmier)
PART 15Transitional Provisions
Marginal note:Licences — former Access to Cannabis for Medical Purposes Regulations
354 A licence issued under the former Access to Cannabis for Medical Purposes Regulations, as set out in column 1 of the table to this section, is deemed to be a licence of the class set out in column 2, and one of the licences of the subclass set out in column 3 if the holder of the licence meets the requirements, if any, in that column for that subclass.
TABLE
| Column 1 | Column 2 | Column 3 | |
|---|---|---|---|
| Item | Licence issued under section 35 of the former Access to Cannabis for Medical Purposes Regulations | Class of licence | Subclass of licence and requirements |
| 1 | Licence authorizing the production of fresh or dried marihuana, or marihuana plants or seeds | Licence for cultivation | Licence for standard cultivation if the requirements in Division 1 of Part 4 are met |
| Licence for micro-cultivation if the requirements in sections 13 and 74 are met | |||
| Licence for a nursery if the requirements in sections 16 and 74 are met | |||
| 2 | Licence authorizing the production of cannabis oil or cannabis resin | Licence for processing | Licence for standard processing if the requirements in Division 1 of Part 4 are met |
| Licence for micro-processing if the requirements in sections 21 and 74 are met | |||
| 3 | Licence authorizing the activities referred to in subsection 22(4) or (5) of the former Access to Cannabis for Medical Purposes Regulations | Licence for sale | Licence for sale for medical purposes |
Marginal note:Licences — Narcotic Control Regulations
355 (1) A licence issued under the Narcotic Control Regulations as they read immediately before the day on which these Regulations come into force, as set out in column 1 of the table to this section, is deemed to be a licence of the class set out in column 2 and, if applicable, one of the licences of the subclass set out in column 3 if the holder of the licence meets the requirements in that column and, despite subsections 159(1) and (4) of the Act, continues in force until December 31, 2019, unless it is revoked before that date.
Marginal note:Licences not set out in table
(2) A licence issued under section 9.2 of the Narcotic Control Regulations, as they read immediately before the day on which these Regulations come into force, that is not set out in column 1 of the table to this section is deemed to be a licence for processing.
Marginal note:Sale
(3) The holder of a licence referred to in subsection (2) is not authorized to sell cannabis to any person unless they are authorized to do so as a condition of their licence.
TABLE
Column 1 Column 2 Column 3 Item Licence issued under the Narcotic Control Regulations as they read immediately before the day on which these Regulations come into force Class of licence Subclass of licence and requirements 1 Licence issued under section 9.2 authorizing the cultivation of marihuana for scientific purposes Licence for research 2 Licence issued under section 9.2 authorizing the obtaining of extracts from samples of cannabis for the analysis of cannabinoids Licence for analytical testing 3 Licence issued under section 9.2 authorizing the production, making or assembly of a test kit containing cannabis Licence for processing Licence for standard processing if the requirements in Division 1 of Part 4 are met Licence for micro-processing if the requirements in sections 21 and 74 are met 4 Licence issued under section 9.2 authorizing the production of cannabis for the purpose of conducting testing to determine its chemical characterization Licence for processing Licence for standard processing if the requirements in Division 1 of Part 4 are met Licence for micro-processing if the requirements in sections 21 and 74 are met 5 Licence issued under section 9.2 authorizing the possession, sale or distribution of a drug containing cannabis Cannabis drug licence 6 Licence issued under section 67 authorizing the cultivation, gathering or production of cannabis for scientific purposes Licence for research
Marginal note:Non-application — sections 12, 15, 23 and 38
356 (1) For a three-month period that begins on the day on which these Regulations come into force, sections 12, 15, 23 and 38 do not apply to a holder of a licence set out in column 3 of the table to section 354 or in items 1 to 4 and 6, column 2, of the table to section 355.
Marginal note:Name of individuals to Minister
(2) The holder of the licence must, within that period, provide the Minister with the names of the individuals who will be designated for the positions referred to in section 12, 15, 23 or 38, as the case may be.
Marginal note:Quality assurance person
357 Every quality assurance person designated under paragraph 75(1)(a) of the former Access to Cannabis for Medical Purposes Regulations by the holder of a licence set out in column 1 of the table to section 354 is deemed to be a quality assurance person under subsection 19(1).
Marginal note:Senior person in charge
358 Every senior person in charge designated under paragraph 32(1)(a) of the former Access to Cannabis for Medical Purposes Regulations by the holder of a licence set out in column 1 of the table to section 354 is deemed to be a responsible person under subsection 37(1).
Marginal note:Security clearance
359 (1) A holder of a licence set out in column 3 of the table to section 354 or in column 2 of the table to section 355 must, within three months after the day on which these Regulations come into force,
(a) provide the Minister with the name and position of any individual who does not hold a security clearance, but is required to do so under section 50; and
(b) ensure that any individual referred to in paragraph (a) submits an application for a security clearance.
Marginal note:Non-application — section 50
(2) An individual referred to in paragraph (1)(a) who is not ineligible to apply for a security clearance by virtue of section 61 is not required to comply with section 50 until the occurrence of one of the following events:
(a) the three-month period that begins on the day on which these Regulations come into force expires without the individual having submitted an application for a security clearance;
(b) the Minister grants a security clearance to the individual;
(c) the individual is notified under subsection 55(2) that the Minister has refused to grant the security clearance; or
(d) the individual withdraws their application for the security clearance before the Minister makes a decision in respect of it.
Marginal note:Packaging and labelling
360 For a six-month period that begins on the day on which these Regulations come into force, section 106 does not apply to a holder of a licence for sale for medical purposes, as set out in item 3, column 3, of the table to section 354, that sells, sends or delivers a cannabis product under section 289 or 291, if the holder complies with sections 80 to 86 and sections 90 and 91 of the former Access to Cannabis for Medical Purposes Regulations and the sale of that cannabis product would have been permitted under those Regulations.
Marginal note:Individual in charge of premises
361 (1) Every individual in charge of the premises to which a licence that is referred to in item 5, column 1, of the table to section 355 applies is deemed to be a senior person in charge under section 149.
Marginal note:Qualified person in charge
(2) Every qualified person in charge designated under paragraph 8.3(1)(a) of the Narcotic Control Regulations, as they read immediately before the day on which these Regulations come into force, by a holder of a licence referred to in item 5, column 1, of the table to section 355 is deemed to be the qualified person in charge under subsection 150(1).
Marginal note:Alternate qualified person in charge
(3) Every alternate qualified person in charge designated under to paragraph 8.3(1)(b) of the Narcotic Control Regulations, as they read immediately before the day on which these Regulations come into force, by a holder of a licence referred to in item 5, column 1, of the table to section 355 is deemed to be an alternate qualified person in charge under subsection 150(2).
Marginal note:Registration document
362 For a six-month period that begins on the day on which these Regulations come into force, paragraph 282(2)(a) does not apply to a holder of a licence for sale for medical purposes, as set out in item 3, column 3, of the table to section 354, that registers an applicant as a client, if the holder complies with section 87 and paragraph 133(2)(a) of the former Access to Cannabis for Medical Purposes Regulations.
Marginal note:Exemptions — Controlled Drugs and Substances Act
363 Despite subsection 156(1) of the Act, an exemption referred to in that subsection that expires before December 31, 2018 continues in force until December 31, 2018, unless it is revoked before that date.
Marginal note:Retention — Controlled Drugs and Substances Act
364 A person referred to in section 157 of the Act must
(a) ensure that any record, report, electronic data or other document referred to in that section is retained until the end of the applicable retention period imposed under the Controlled Drugs and Substances Act; and
(b) if the person is or was the holder of a licence that was issued under the Controlled Drugs and Substances Act, notify the Minister, in writing, of any change to the address of the location at which the document is retained.
Marginal note:Extension of time for compliance
365 For the purposes of subsection 241(1), the information that the holder of a licence that is deemed by section 354 or 355 to be a licence for cultivation, processing or sale would otherwise be required to include in the record referred to in that subsection in the first 90 days after the day on which these Regulations come into force is not required to be included until the 91st day after that day.
PART 16Consequential Amendments and Coming into Force
Consequential Amendments
Food and Drug Regulations
366 [Amendment]
367 [Amendment]
368 [Amendment]
369 [Amendment]
370 [Amendment]
Medical Devices Regulations
371 [Amendment]
Natural Health Products Regulations
372 [Amendment]
Cannabis Exemption (Food and Drugs Act) Regulations
373 [Amendment]
Cannabis Regulations
374 [Amendment]
Coming into Force
Marginal note:
Footnote *375 (1) Subject to subsections (2) to (4), these Regulations come into force on the day on which subsection 204(1) of the Cannabis Act comes into force, but if they are registered after that day, they come into force on the day on which they are registered.
Marginal note:Bill C-74
(2) If Bill C-74, introduced in the 1st session of the 42nd Parliament and entitled Budget Implementation Act, 2018, No. 1, has not received royal assent on the day on which these Regulations are in force, then paragraphs 29(b), 30(c), 31(d), 155(c), 156(b) and 157(d) of these Regulations come into force on the day on which Bill C-74 receives royal assent.
Marginal note:Six months after registration
(3) Section 102 comes into force on the day that, in the sixth month after the month in which these Regulations are registered, has the same calendar number as the day on which they are registered or, if that sixth month has no day with that number, the last day of that sixth month.
Marginal note:
- S.C. 2012, c. 24
(4) Section 374 comes into force on the day on which section 90 of the Safe Food for Canadians Act comes into force.
Return to footnote *[Note: Regulations, except sections 102 and 374, in force October 17, 2018, see SI/2018-52; section 102 in force December 27, 2018; section 374 in force January 15, 2019, see SI/2018-39.]
RELATED PROVISIONS
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