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Version of document from 2018-12-27 to 2019-01-14:

Cannabis Regulations

SOR/2018-144

CANNABIS ACT

CONTROLLED DRUGS AND SUBSTANCES ACT

FOOD AND DRUGS 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.

Interpretation

Marginal note:Definitions — Act and Regulations

  •  (1) The following definitions apply in the Act and in these Regulations.

    cannabis non-solid concentrates

    cannabis non-solid concentrates means substances that are in non-solid form at a temperature of 22 ± 2°C and that have a maximum yield percentage of greater than 3% w/w of THC, taking into account the potential to convert THCA into THC. (cannabis sous forme d’un concentré qui n’est pas solide)

    cannabis oil

    cannabis oil means an oil that contains anything referred to in item 1 or 3 of Schedule 1 to the Act and that is in liquid form at a temperature of 22 ± 2°C. (huile de cannabis)

    cannabis solid concentrates

    cannabis solid concentrates means substances that are in solid form at a temperature of 22 ± 2°C and that have a maximum yield percentage of greater than 3% w/w of THC, taking into account the potential to convert THCA into THC. (cannabis sous forme d’un concentré solide)

    fresh cannabis

    fresh cannabis means freshly harvested cannabis buds and leaves, 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 maximum yield percentage 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 maximum yield percentage 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 that are set out in Schedule 4 to the Act — or a cannabis accessory if that accessory contains such cannabis — after it has been packaged and labelled for sale to a consumer at the retail level, but does not include 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)

    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 has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (nom usuel)

    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 or that is manufactured or sold for use in a clinical trial as defined in section C.05.001 of those Regulations. (drogue)

    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)

    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)

    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)

    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)

    licence

    licence means a licence issued under subsection 62(1) of the Act in relation to cannabis. (licence)

    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)

    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)

    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)

    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)

    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 )

  • 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.

Non-application

Marginal note:Non-application — Industrial Hemp Regulations

 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

 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

Marginal note:Authorized activities — federal or provincial laboratory

  •  (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 to the extent necessary to conduct the testing:

    • (a) to possess cannabis;

    • (b) to obtain cannabis by altering its chemical or physical properties by any means;

    • (c) in the case of seed viability testing, to obtain cannabis by cultivating it; and

    • (d) to distribute cannabis to another 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 paragraph (1)(b) or (c) is also authorized to offer to conduct that activity.

  • Marginal note:Use of organic solvent

    (3) An individual who conducts an activity referred to in 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) Individuals who are involved in the testing of cannabis as a requirement of their duties at a laboratory that is designated as an accredited laboratory under section 14 of the Canada Agricultural Products Act are authorized to conduct the activities referred to in paragraphs (1)(a) and (c), and to offer to conduct the activity referred to in paragraph (1)(c), to the extent necessary to conduct the testing.

Marginal note:Distribution — analytical testing

 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.

PART 2Licensing

Marginal note:Definition of distribute

 In this Part, distribute does not include administering.

Pre-licensing Requirements

Marginal note:Notice to local authorities

  •  (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

  •  (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

 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

  •  (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, or that is obtained in accordance with these Regulations or from a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act.

  • 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

  •  (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 authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act; 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 authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act, 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

  •  (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

  •  (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

  •  (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 authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act; 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 authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act, 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

  •  (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

  •  (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

  •  (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 cannabis 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) any cannabis that was obtained or produced for the purpose of conducting testing that is necessary to determine the chemical characterization of cannabis;

    • (c) to sell and distribute the following cannabis to a holder of a licence for a nursery:

      • (i) cannabis plants and cannabis plant seeds, or

      • (ii) cannabis that was obtained or produced for the purpose of conducting testing that is necessary to determine the chemical characterization of cannabis;

    • (d) to sell and distribute cannabis products to the following:

      • (i) a holder of a licence for sale, or

      • (ii) a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act; and

    • (e) to send and deliver cannabis products to the purchaser of the products at the request of

      • (i) a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act, 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) 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

  •  (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 and distribution of cannabis products to a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Act; 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

  •  (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 Part 5.

  • 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; and

    • (b) investigating every complaint received in respect of the quality of the cannabis and, if necessary, taking corrective and preventative measures.

  • 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 to a holder of a licence for processing that only manufactures or assembles test kits.

Marginal note:Minister’s approval

  •  (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

  •  (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 1Column 2
    ItemClass of cannabisAmount that is equivalent to 1 kg of dried cannabis
    1dried cannabis1 kg
    2fresh cannabis5 kg
    3solids containing cannabis10 kg
    4non-solids containing cannabis10 kg
    5cannabis solid concentrates0.25 kg
    6cannabis non-solid concentrates0.25 kg

Licence for Analytical Testing

Marginal note:Authorized activities

  •  (1) Subject to the other provisions of these Regulations, a holder of a licence for analytical testing is authorized, for the purpose of testing, to conduct those of the following activities that are authorized by the licence:

    • (a) to possess cannabis; and

    • (b) to obtain cannabis by altering its chemical or physical properties by any means.

  • Marginal note:Offer

    (2) A holder of a licence for analytical testing that is authorized to conduct the activity referred to in 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 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:Head of laboratory

  •  (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 section 91.

  • Marginal note:Qualifications

    (2) The head of laboratory must have sufficient knowledge of the provisions of the Act and these Regulations that apply to the holder of the licence for analytical testing, have knowledge and experience related to the duties of the position and possess a degree in a science related to the work to be carried out that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association.

  • 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

  •  (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

  •  (1) A holder of a licence for analytical testing must destroy all samples of cannabis of a lot or batch that have been distributed to them, and all cannabis obtained from those samples, within 90 days after completing the testing of the samples of the lot or batch.

  • Marginal note:Samples not tested

    (2) If testing of the samples of cannabis distributed to the holder of the licence for analytical testing is not initiated within 120 days of their receipt, the holder must destroy the samples within that period.

Licence for Sale for Medical Purposes

Marginal note:Authorized activities

 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

  •  (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

  •  (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 cannabis drug licence,

      • (iv) the Minister, or

      • (v) 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: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, or

      • (iv) 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 sold or distributed.

Refusal, Suspension and Revocation

Marginal note:Refusal to issue, renew or amend — other grounds

 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; and

  • (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.

Marginal note:Suspension — other circumstance

 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; and

  • (c) 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.

Marginal note:Revocation — other circumstances

 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; and

  • (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.

Changes Relating to Licence

Marginal note:Amendment

 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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

 A holder of a licence must not conduct any activity that is authorized by the licence at a dwelling-house.

Marginal note:Outdoor activities

 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

 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:Destruction

  •  (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

 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

 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

 A holder of a licence 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:Safekeeping during distribution

 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

 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

 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

 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

 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

 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

  •  (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

 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

  •  (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

  •  (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

 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

  •  (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

  •  (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

  •  (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

 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

  •  (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

 The site must be designed in a manner that prevents unauthorized access.

Perimeter of Site

Marginal note:Visual monitoring

  •  (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

 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

  •  (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

 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

  •  (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

 Each operations area and storage area must be surrounded by a physical barrier that prevents unauthorized access.

Marginal note:Visual monitoring

  •  (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

  •  (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

  •  (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

 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

 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

 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

  •  (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

 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

  •  (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 1Column 2
    ItemTerm used in the DirectiveCorresponding term
    1Controlled substanceCannabis
    2Licensed dealer / licenced dealerHolder of a licence
    3Cannabis Sativa, its preparations, derivatives and similar synthetic preparations except NabiloneCannabis
    4Office of Controlled Substances, Therapeutic Products ProgrammeHealth Canada
    5OfficeHealth 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

General Provisions

Marginal note:Sale, distribution and exportation

 A holder of a licence must not sell, distribute or export cannabis unless the applicable requirements set out in sections 80 to 88 have been met.

Marginal note:Standard operating procedures

 Cannabis 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 requirements of this Part.

Marginal note:Pest control product

 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:Storage

 Cannabis must be stored under conditions that maintain its quality.

Marginal note:Distribution

 Cannabis must be distributed in a manner that maintains its quality.

Marginal note:Building or part of building

  •  (1) Cannabis must be produced, packaged, labelled, stored, sampled and tested in a building or part of a building that is 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 cannabis; and

    • (d) prevents the addition of an extraneous substance to the cannabis.

  • Marginal note:Non-application

    (2) Despite subsection (1), cannabis may be obtained by cultivating, propagating or harvesting it outdoors.

Marginal note:Filtration of air

 The building or part of the building where cannabis is produced, packaged, labelled and stored must be equipped with a system that filters air to prevent the escape of odours.

Marginal note:Equipment

  •  (1) Cannabis 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;

    • (c) prevents the contamination of the cannabis; and

    • (d) prevents the addition of an extraneous substance to the cannabis.

  • Marginal note:Non-application

    (2) Paragraph 1(d) does not apply to the outdoor cultivation, propagation or harvesting of cannabis.

Marginal note:Sanitation program

  •  (1) Cannabis must be produced, packaged, labelled, 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 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.

Marginal note:Quality assurance

  •  (1) In the case of a holder of a licence for processing, every complaint received in respect of the quality of the cannabis must be investigated by the quality assurance person referred to in section 19 who must, if necessary, take corrective and preventative measures.

  • Marginal note:Methods and procedures

    (2) In the case of a holder of a licence for processing, the cannabis must be produced, packaged, labelled, distributed, stored, sampled and tested using methods and procedures that, prior to their implementation, have been approved by a quality assurance person.

  • Marginal note:Approval prior to sale

    (3) In the case of a holder of a licence for processing, every lot or batch of cannabis must be approved by a quality assurance person before it is made available for sale.

Testing

Marginal note:Sale and exportation — cannabis product

 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:Validated methods

 The testing conducted under section 91 and further to the requirements in Part 6 must be conducted using validated methods.

Marginal note:Composition

 Testing for the following must be conducted on each lot or batch of cannabis, other than cannabis plants or cannabis plant seeds, that will become a cannabis product or that will be contained in a cannabis accessory that is a cannabis product:

  • (a) the residues of solvents used in the production of cannabis oil;

  • (b) the contaminants referred to in section 94;

  • (c) the dissolution or disintegration referred to in section 95; and

  • (d) the quantity or percentage of THC, THCA, CBD and CBDA, as the case may be.

Marginal note:Representative sample

  •  (1) For the purposes of the testing referred to in section 90, a representative sample of the lot or batch must be taken.

  • Marginal note:Quantity

    (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 and must be of sufficient quantity to enable a determination of

    • (a) whether the lot or batch meets the requirements of section 81, subsection 93(2) and section 94 and, if applicable, subsection 93(3) and sections 95, 97, 101 and 102; and

    • (b) the quantity or percentage of THC, THCA, CBD and CBDA, as the case may be.

PART 6Cannabis Products

General Provisions

Marginal note:Substances

  •  (1) Cannabis that is a cannabis product or that is contained in a cannabis accessory that is a cannabis product must not contain any substance other than the cannabis.

  • Marginal note:Maximum residue limit

    (2) Despite subsection (1), the cannabis may contain residues of a pest control product, its components or derivatives, if they do not exceed any maximum residue limit, in relation to cannabis, specified for the pest control product, its components or derivatives under section 9 or 10 of the Pest Control Products Act.

  • Marginal note:Cannabis oil

    (3) Despite subsection (1), cannabis oil may contain the carrier oil, residues of the solvents listed in the document entitled Limits for Residual Solvents in Cannabis Products, as amended from time to time and published by the Government of Canada on its website that do not exceed the limits established in that document and other substances that are necessary to maintain the oil’s quality and stability.

Marginal note:Microbial and chemical contaminants

  •  (1) Despite subsection 93(1), cannabis that is a cannabis product or that is contained in a cannabis accessory that is a cannabis product may contain microbial or chemical contaminants provided that they are within generally accepted tolerance limits for herbal medicines for human consumption, as established in any publication referred to in Schedule B to the Food and Drugs Act.

  • Marginal note:Non-application — cannabis plant or cannabis plant seeds

    (2) The tolerance limits referred to in subsection (1) do not apply to a cannabis product that is a cannabis plant or cannabis plant seeds.

Marginal note:Dissolution and disintegration

 Each discrete unit of a cannabis product that is intended to be administered orally, rectally or vaginally must meet the requirements of a dissolution or disintegration test that is applicable to its formulation and that is set out in any publication referred to in Schedule B to the Food and Drugs Act.

Marginal note:Components — fit for intended use

 If a cannabis product is intended to be administered orally, rectally, vaginally or topically, all the components of the product must be fit for the intended use.

Marginal note:Maximum yield quantity — discrete unit

 Each discrete unit of a cannabis product that is intended to be administered orally, rectally or vaginally must not exceed a maximum yield quantity of 10 mg of THC, taking into account the potential to convert THCA into THC.

Marginal note:Sale

 The following cannabis products must not be sold or distributed:

  • (a) a cannabis product that is intended to be used in the human eye; and

  • (b) a cannabis product that is administered by disrupting the skin barrier.

Dried and Fresh Cannabis

Marginal note:Addition of THC or THCA

 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

 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 Oil

Marginal note:Maximum yield quantity

 Cannabis oil that is a cannabis product or contained in a cannabis accessory that is a cannabis product must not exceed a maximum yield quantity of 30 mg of THC per millilitre of the oil, taking into account the potential to convert THCA into THC.

Marginal note:Maximum yield quantity — Activation of accessory

 Each activation of a cannabis accessory that dispenses cannabis oil and that is packaged with a cannabis product that is cannabis oil or of a cannabis accessory that contains the oil, if the oil is intended to be taken by ingestion, must not dispense more than a maximum yield quantity of 10 mg of THC, taking into account the potential to convert THCA into THC.

Cannabis Accessory or Component

Marginal note:Flavour

 A cannabis accessory that is a cannabis product or that is packaged together with a cannabis product must not impart a characterizing flavour to the cannabis.

Marginal note:Alteration or enhancement of phytocannabinoid effects

 Any component of a cannabis product, other than the cannabis, as well as any cannabis accessory that is packaged with the cannabis product, must not through chemical means, other than heating or combustion, alter or enhance the effects of the phytocannabinoids.

PART 7Packaging and Labelling

Definitions

Marginal note:Definitions

 The following definitions apply in this Part.

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 surface

exterior surface includes a label or an image. (surfaces extérieures)

immediate container

immediate container means the container that is in direct contact with a cannabis product. (contenant immédiat)

principal display panel

principal display panel has the same meaning as in subsection 2(2) of the Consumer Packaging and Labelling Regulations. (espace principal)

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)

General Provisions

Marginal note:Requirement — sale and distribution of cannabis product

  •  (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

 The requirements set out in this Part do not apply in respect of a shipping container.

Packaging — Cannabis Products

Marginal note:Immediate container

 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

  •  (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

 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

 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

 Except as otherwise provided under the Act, any other Act of Parliament or any provincial Act, the interior surface and exterior surface of any container in which a cannabis product is packaged must not display any image.

Marginal note:Uniform colour

  •  (1) Except as otherwise provided under the Act, any other Act of Parliament or any provincial Act, the colour of the interior surface and exterior surface of any container in which a cannabis product is packaged must be one uniform colour. However, the interior surface may be a different colour than that of the exterior surface.

  • Marginal note:Colour — other requirements

    (2) The colour of the interior surface and exterior surface 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), an interior surface that is made of metal may be the colour of the metal.

Marginal note:Package finish

 Except as otherwise provided under the Act, any other Act of Parliament or any provincial Act, the exterior surface of any container in which a cannabis product is packaged must have a matte finish.

Marginal note:Texture

  •  (1) Except as otherwise provided under the Act, any other Act of Parliament or any provincial Act, the interior surface and exterior surface 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:Features

  •  (1) 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

    • (a) any hidden feature that is designed to change the appearance of the container or covering, such as heat-activated ink or a feature that is visible only through technological means; or

    • (b) any feature that is designed to change the surface area of the container or covering, such as a fold-out panel.

  • Marginal note:Non-application

    (2) Paragraph (1)(a) does not apply to a feature that is used to prevent counterfeiting.

Marginal note:Scent and sound

 The interior surface and exterior surface of any container in which a cannabis product is packaged, and any covering of a container, must not be capable of emitting a scent or sound.

Marginal note:Covering — brand element

 The covering of any container in which a cannabis product is packaged must not display any brand element.

Marginal note:Covering — image or information

 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

 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

 The interior surface and exterior surface of any container in which a cannabis product is packaged must not include any cut-out window.

Marginal note:Bar code

  •  (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.

Labelling — Cannabis Products

Marginal note:Information

  •  (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 or cannabis plant seeds, 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) a health warning message 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 is

      • (i) in the case of dried cannabis, or a cannabis accessory that contains dried cannabis, one of the health warning messages set out in Part 1 of the document, and

      • (ii) in the case of any other cannabis product, one of the health warning messages set out in Part 2 of that document; and

    • (f) in the case of a cannabis product that contains THC in a concentration greater than 10 μg/g, the standardized cannabis symbol that must be obtained from the Minister in the form of an electronic file.

  • Marginal note:Expiry date

    (2) The label of a container 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) it maintains not less than 80% and not more than 120% of its THC content and CBD content; and

    • (b) its microbial and chemical contaminants remain within the limits referred to in section 94.

  • 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:Dried cannabis or fresh cannabis — discrete units

 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, 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”; and

  • (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”.

Marginal note:Dried cannabis or fresh cannabis — not in discrete units

 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 percentage of THC w/w, preceded by “THC”;

  • (c) the percentage of THC w/w 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 percentage of CBD w/w, preceded by “CBD”; and

  • (e) the percentage of CBD w/w that the dried cannabis or fresh cannabis could yield, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD”.

Marginal note:Cannabis oil — discrete unit

 In the case of cannabis oil — or a cannabis accessory that contains cannabis oil — 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, and net volume, in millilitres, of cannabis oil;

  • (b) the number of units;

  • (c) the net weight, in grams, and net volume, in millilitres, of cannabis oil 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) the carrier oil used;

  • (i) the name of any food allergen, within the meaning of subsection B.01.010.1(1) of the Food and Drug Regulations, that is contained in the cannabis oil; and

  • (j) in the case of cannabis oil that is not intended for oral administration, the warning “DO NOT SWALLOW / NE PAS AVALER”.

Marginal note:Cannabis oil — not in discrete units

 In the case of cannabis oil — or a cannabis accessory that contains cannabis oil — 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, and net volume, in millilitres, of cannabis oil;

  • (b) the concentration of THC, in milligrams per millilitre, in the cannabis oil, preceded by “THC”;

  • (c) the concentration of THC, in milligrams per millilitre, that the cannabis oil could yield, taking into account the potential to convert THCA into THC, preceded by “Total THC”;

  • (d) the concentration of CBD, in milligrams per millilitre, preceded by “CBD”;

  • (e) the concentration of CBD, in milligrams per millilitre, that the cannabis oil could yield, taking into account the potential to convert CBDA into CBD, preceded by “Total CBD”;

  • (f) the carrier oil used;

  • (g) the name of any food allergen, within the meaning of subsection B.01.010.1(1) of the Food and Drug Regulations, that is contained in the cannabis oil; and

  • (h) in the case of cannabis oil that is not intended for oral administration, the warning “DO NOT SWALLOW / NE PAS AVALER”.

Marginal note:Cannabis plants

 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

 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 — all information

  •  (1) All information that is included on a label must be in English and in French.

  • 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(d) to (g), 125(b) to (e), 126(d) to (g) and 127(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 parallel with the base of the container; 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,

      • (ii) parallel with the base of the container, and

      • (iii) oriented in such a manner that it is readable from left to right when the container of the cannabis product is displayed; and

    • (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, the surface area must be smaller than or equal to the surface area of the standardized cannabis symbol; 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:Representation resembling standardized cannabis symbol

 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

 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.

Cannabis Product Accuracy Rules

Marginal note:Net weight and volume

 The net weight and net volume that must be included on the label of a cannabis product in accordance with sections 124 to 127 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

 The number of discrete units in a container that is labelled in accordance with sections 124 and 126 must be equal to the number specified on the label.

Marginal note:Number of cannabis plants

 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

 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

 A holder of a licence must not sell, distribute or export cannabis, other than a cannabis product, unless the requirements in section 138 have been met.

Marginal note:Information

 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; 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.

PART 8Drugs Containing Cannabis

Definitions

Marginal note:Definitions

 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)

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

  •  (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.

Marginal note:Eligibility and corresponding activities

  •  (1) Only a holder of an establishment licence that authorizes the following activities may apply for a cannabis drug licence:

    • (a) if the application is for the possession of cannabis, fabricating, packaging/labelling, distributing, importing, wholesaling or testing a drug containing cannabis, including its examination;

    • (b) if the application is with respect to the production of a drug containing cannabis, fabricating the drug; or

    • (c) if the application is with respect to the sale of a drug containing cannabis, packaging/labelling, distributing, importing or wholesaling the drug.

  • Marginal note:Location of activity

    (2) The address of the building where the activity referred to in the application is proposed to be conducted must be the same as the address of the building at which the applicable activity referred to in subsection (1) is authorized by the establishment licence.

Marginal note:Use of organic solvent

 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

  •  (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

 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

 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

  •  (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 the alternate qualified person in charge designated under paragraph 8.3(1)(b) 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

 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

 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

 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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

 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 establishment licence referred to in section 141 is suspended or cancelled;

  • (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

 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 establishment licence referred to in section 141 is suspended; and

  • (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

 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 establishment licence referred to in section 141 is suspended or cancelled; 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

 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

 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

 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

 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.

 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

 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

 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

 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

 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

 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

 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

 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

 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

 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

  •  (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

  •  (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

  •  (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

  •  (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

 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

 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

  •  (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

 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

 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

  •  (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

  •  (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

 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

  •  (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

 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

 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

 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

 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

  •  (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

  •  (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

 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

 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

  •  (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

  •  (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

 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

 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 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)

Marginal note:Authorization

 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

 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

 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

 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

 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

  •  (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

 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

  •  (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

 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) the 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

 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

 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

 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

 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) the 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

 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

 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

 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

  •  (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

 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) the 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

 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

 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

 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

 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) the 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

 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

 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

 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

 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

 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 — cannabis other than oil

  •  (1) A holder of a licence must retain, for each lot or batch of cannabis — other than cannabis oil — 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; and

    • (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.

  • Marginal note:Packaging

    (2) A holder of a licence must retain, for each lot or batch of cannabis — other than cannabis oil — 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 oil

  •  (1) A holder of a licence must retain, for each lot or batch of cannabis oil that they produce, a document that contains the following information:

    • (a) the date on which the cannabis oil is produced and its net weight or volume on that date;

    • (b) if applicable, the date on which the cannabis oil is put into a discrete unit form, the net weight or volume of the oil in each unit and the number of units; and

    • (c) in respect of the cannabis that was used to produce the cannabis oil, its description, its net weight or volume, its lot or batch number and the date on which it was produced.

  • Marginal note:Packaging

    (2) A holder of a licence must retain, for each lot or batch of cannabis oil that they package, a document that contains the following information:

    • (a) a description of the cannabis oil, including the brand name, if applicable;

    • (b) the date on which the cannabis oil 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:Receipt of cannabis

  •  (1) A holder of a licence must, if they receive cannabis, retain a document that contains the following information:

    • (a) the name of the person from which it is received;

    • (b) the address of the location at which it is received and, if known, from which it is received;

    • (c) the date on which it is received;

    • (d) the quantity that is received;

    • (e) a description of the cannabis, including, if applicable, the brand name;

    • (f) if known, 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:Sale, distribution and export of cannabis

  •  (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;

    • (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

  •  (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

  •  (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 in the case of cannabis oil, 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.

Security

Marginal note:Organizational security plan

 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:Good production practices

  •  (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 was produced, packaged, labelled, distributed, stored, sampled and tested in accordance with the provisions of Part 5;

    • (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 any 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 concerning every complaint received in respect of the quality of the cannabis and of any corrective or preventative measures taken; 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: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; and

    • (e) a document referred to in subparagraph (1)(e)(ii), for at least two years after the day on which it is prepared.

  • 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 licence expires or is revoked.

Marginal note:Standard operating procedures and sanitation program

  •  (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

 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

 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

  •  (1) A holder of a licence other than 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 section 46.

  • 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

 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

  •  (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:Retention period

    (2) The document must be retained for at least two years after the day on which it is prepared.

Limit for Micro-processing Licence

Marginal note:Limit — micro-processing licence

 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

 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

 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

  •  (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

 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 of Health under the Cannabis Act, as amended from time to time and published by the Government of Canada on its website.

Marginal note:Request by Minister

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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.

Marginal note:Adverse reactions

  •  (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 cannabis product by the individual who experienced the 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:Definitions

    (3) The following definitions apply in this section.

    adverse reaction

    adverse reaction means a noxious and unintended response to a cannabis product. (réaction indésirable)

    serious adverse reaction

    serious adverse reaction means a noxious and unintended response to a cannabis product 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)

Disclosure of Information to Third Parties

Marginal note:Notices to local authorities

  •  (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

  •  (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

  •  (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

 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

 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

 Part 5 and section 137 do not apply to the cannabis that is contained in a test kit.

Marginal note:Sale, importation and exportation

 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

 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

 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

  •  (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

 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

  •  (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

  •  (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

 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

  •  (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

  •  (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

 This Part does not apply in respect of a drug containing cannabis.

Possession

Marginal note:Possession in public place — adults

  •  (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

  •  (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

 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

  •  (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

 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

 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

  •  (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

  •  (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:Written order

 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

 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

  •  (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

  •  (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

 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

  •  (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

  •  (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

  •  (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

  •  (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

 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 subsection 273(4); or

  • (b) if it is based on a registration certificate, when the registration with the Minister expires.

Marginal note:Refusal to register

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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 cannabis odour, 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

  •  (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

 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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

 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

  •  (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

  •  (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

 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

  •  (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

 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

  •  (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

    • (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

 An individual is not eligible to be registered under this Division more than once at any one time.

Marginal note:Eligibility — designated person

  •  (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

  •  (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 individuals under 18 years of age.

  • 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

  •  (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, the date of which must correspond to the end of the period of validity of the medical document that forms the basis for the registration, as determined in accordance with subsection 273(4);

    • (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:Application to renew registration

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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 cannabis odour, 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

 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

 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

  •  (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

  •  (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 individuals under 18 years of age.

  • 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

  •  (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

  •  (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

 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

 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

  •  (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

 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

 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

  • (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

 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

  •  (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

    • (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

  •  (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

  •  (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

 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

  •  (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

  •  (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

 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

 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

 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

    • (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

  •  (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

  •  (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

 In sections 347, 348, 350 and 351, distribute does not include administering.

Marginal note:Security of cannabis products

 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

  •  (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

 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

  •  (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

  •  (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

 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

  •  (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

    • (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

 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 1Column 2Column 3
ItemLicence issued under section 35 of the former Access to Cannabis for Medical Purposes RegulationsClass of licenceSubclass of licence and requirements
1Licence authorizing the production of fresh or dried marihuana, or marihuana plants or seedsLicence for cultivationLicence 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
2Licence authorizing the production of cannabis oil or cannabis resinLicence for processingLicence 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
3Licence authorizing the activities referred to in subsection 22(4) or (5) of the former Access to Cannabis for Medical Purposes RegulationsLicence for saleLicence for sale for medical purposes

Marginal note:Licences — Narcotic Control Regulations

  •  (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 1Column 2Column 3
    ItemLicence issued under the Narcotic Control Regulations as they read immediately before the day on which these Regulations come into forceClass of licenceSubclass of licence and requirements
    1Licence issued under section 9.2 authorizing the cultivation of marihuana for scientific purposesLicence for research
    2Licence issued under section 9.2 authorizing the obtaining of extracts from samples of cannabis for the analysis of cannabinoidsLicence for analytical testing
    3Licence issued under section 9.2 authorizing the production, making or assembly of a test kit containing cannabisLicence for processingLicence 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
    4Licence issued under section 9.2 authorizing the production of cannabis for the purpose of conducting testing to determine its chemical characterizationLicence for processingLicence 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
    5Licence issued under section 9.2 authorizing the possession, sale or distribution of a drug containing cannabisCannabis drug licence
    6Licence issued under section 67 authorizing the cultivation, gathering or production of cannabis for scientific purposesLicence for research

Marginal note:Non-application — sections 12, 15, 23 and 38

  •  (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

 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

 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

  •  (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

 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

  •  (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

 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

 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

 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

 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

 [Amendment]

 [Amendment]

 [Amendment]

 [Amendment]

 [Amendment]

Medical Devices Regulations

 [Amendment]

Natural Health Products Regulations

 [Amendment]

Cannabis Exemption (Food and Drugs Act) Regulations

 [Amendment]

Cannabis Regulations

The following provision is not in force.

 [Amendment]

Coming into Force

Marginal note:

  • S.C. 2018, c. 16
    • Footnote * (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.]

    
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