Cannabis Regulations (SOR/2018-144)

Licence for Research

Marginal note:Authorized activities

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

  • (a) for the purpose of research,

    • (i) to possess cannabis,

    • (ii) to produce cannabis, and

    • (iii) to transport, send or deliver cannabis between the sites that are set out by the licence; and

  • (b) to sell cannabis plants and cannabis plant seeds to any of the following:

    • (i) a holder of a licence for cultivation,

    • (ii) another holder of a licence for research,

    • (iii) a holder of a licence for analytical testing,

    • (iv) a holder of a cannabis drug licence,

    • (v) the individuals referred to in section 4,

    • (vi) the Minister, or

    • (vii) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is sold.

• Marginal note:Offer

  (2) A holder of a licence for research that is authorized to conduct the activity referred to in subparagraph (1)(a)(ii) is also authorized to offer to obtain cannabis by any method authorized by the licence.

• Marginal note:Use of organic solvent

  (3) A holder of a licence for research that is authorized to obtain cannabis by altering its chemical or physical properties by any means is also authorized to alter or offer to alter its chemical or physical properties by the use of an organic solvent when conducting that activity.

• Marginal note:Administer and distribute — research subject

  (4) A holder of a licence for research is also authorized, for the purpose of research, to administer and distribute cannabis to a research subject.

• Marginal note:Distribution

  (5) A holder of a licence for research is also authorized to distribute

  • (a) cannabis to any of the following:

    • (i) another holder of a licence for research,

    • (ii) a holder of a licence for analytical testing,

    • (iii) a holder of a cannabis drug licence,

    • (iv) the individuals referred to in section 4, or

    • (v) the Minister; and

  • (b) cannabis plants and cannabis plant seeds to the following:

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

    • (ii) a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is distributed.

Non-therapeutic Research on Cannabis

Marginal note:Requirements of Part 6

• 28.1 (1) The requirements of Part 6, other than those set out in subsection 102(6), apply to the following cannabis or cannabis accessory that is administered or distributed to a human participant in the conduct of non-therapeutic research on cannabis as if the cannabis or cannabis accessory were a cannabis product or will become one:

  • (a) cannabis that is not a cannabis product or is contained in a cannabis accessory that is not a cannabis product; and

  • (b) a cannabis accessory that contains cannabis and that is not a cannabis product.

• Marginal note:References to section 97

  (2) For the purposes of subsection (1), any reference in Part 6 to subsection 97(1) or (2) should be read as a reference to paragraph (3)(a) or (b), respectively.

• Marginal note:Variability limits

  (3) Cannabis that is not a cannabis product — or that is contained in a cannabis accessory that is not a cannabis product — and that is administered or distributed by the holder of a licence for research to human participants in the conduct of non-therapeutic research on cannabis must not contain

  • (a) in the case of a cannabis extract or a cannabis topical, less than 85% or more than 115% of the quantity or concentration of THC or CBD represented by the holder in the application for the licence, or for its renewal or amendment, related to that research; and

  • (b) in the case of edible cannabis,

    • (i) if the quantity of THC or CBD that is represented by the holder in the application exceeds 5 mg, less than 85% or more than 115% of that quantity,

    • (ii) if the quantity of THC or CBD that is represented by the holder in the application exceeds 2 mg but does not exceed 5 mg, less than 80% or more than 120% of that quantity, and

    • (iii) if the quantity of THC or CBD that is represented by the holder in the application does not exceed 2 mg, less than 75% or more than 125% of that quantity.

• Marginal note:Requirements — edible cannabis

  (4) The holder of a licence for research that administers or distributes edible cannabis to human participants in the conduct of non-therapeutic research on cannabis must ensure that

  • (a) a meat product, poultry product or fish, other than a food additive, was not used as an ingredient to produce the edible cannabis, and was not a constituent of such an ingredient, unless the meat product, poultry product or fish

    • (i) was produced by a person that is authorized to produce it under the laws of a province or the Safe Food for Canadians Act or was imported in accordance with that Act, and

    • (ii) had a water activity that did not exceed 0.85 at a temperature of 22 ± 2°C at the time the meat product, poultry product or fish was obtained by the holder that produced the edible cannabis;

  • (b) food that was produced by a holder of a licence for research and that was used by that holder as an ingredient to produce the edible cannabis, or as a constituent of such an ingredient, was not a meat product, poultry product or fish, and the sale of the food would not have been prohibited under section 4 of the Food and Drugs Act;

  • (c) a food additive was not used as an ingredient to produce the edible cannabis unless

    • (i) the edible cannabis would be a food that is the subject of a marketing authorization if the edible cannabis did not contain or have on it anything referred to in item 1 or 3 of Schedule 1 to the Act,

    • (ii) the marketing authorization would permit the food additive to be in or on the food,

    • (iii) the conditions under which the marketing authorization would permit the food additive to be in or on the food, including any maximum levels of use, were complied with, and

    • (iv) the food additive is not caffeine or caffeine citrate; and

  • (d) the edible cannabis was not irradiated unless

    • (i) the edible cannabis would be a food that is listed in item 3 or 4, column 1, of the table to Division 26 of Part B of the Food and Drug Regulations if the edible cannabis did not contain or have on it anything that is referred to in item 1 or 3 of Schedule 1 to the Act, and

    • (ii) the licence holder that produced the edible cannabis satisfied the requirements set out in paragraphs B.26.003(2)(a) and (b) and subsection B.26.004(1) of the Food and Drug Regulations in respect of the edible cannabis.

• Marginal note:Vitamins and mineral nutrients

  (5) If the conditions set out in subparagraphs (4)(c)(i) to (iv) are met, the holder of a licence for research whose licence authorizes the production of cannabis may use a vitamin or mineral nutrient as an ingredient to produce edible cannabis that is administered or distributed to a human participant in the conduct of non-therapeutic research on cannabis and that is not a cannabis product or is contained in a cannabis accessory that is not a cannabis product.

Marginal note:Irradiated edible cannabis

28.2 The holder of a licence for research that administers or distributes irradiated edible cannabis to human participants in the conduct of non-therapeutic research on cannabis must ensure that the requirements set out in subsection 42(1) have been met in addition to the conditions set out in paragraph 28.1(4)(d).

Marginal note:Return of cannabis

• 28.3 (1) For the purposes of subparagraph 9(1)(a)(i) or (iii) of the Act, a human participant to whom cannabis was distributed in the conduct of non-therapeutic research on cannabis is authorized to return the cannabis to the holder of the licence for research from which the cannabis was received.

• Marginal note:Parcel — requirements

  (2) The participant who is returning cannabis under subsection (1) must, if they are sending or having delivered a total quantity of cannabis that exceeds the equivalent of 30 g of dried cannabis,

  • (a) prepare the parcel in a manner that ensures the security of its contents, such that

    • (i) it will not open or permit the escape of its contents during handling and transportation,

    • (ii) it is sealed so that it cannot be opened without the seal being broken, and

    • (iii) it prevents its contents from being identified without it being opened; and

  • (b) use a method that ensures the tracking and safekeeping of the parcel during transportation.

Marginal note:Record keeping — returned cannabis

28.4 A holder of a licence for research that receives cannabis from a human participant under section 28.3 must retain a document that contains the following information:

• (a) the name of the participant;

• (b) the address of the location at which the cannabis is received and, if that location is different from the site or sites at which the cannabis was produced, the address of the site or sites, if known;

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

• (d) the quantity of cannabis that is received;

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

• (f) if applicable, the lot or batch number of the cannabis.

Marginal note:Destruction of returned cannabis

28.5 A holder of a licence for research must destroy any cannabis that has been returned to them by a human participant under section 28.3 no later than 90 days after the day on which the non-therapeutic research on cannabis ends.

Refusal, Suspension and Revocation

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

29 For the purpose of paragraph 62(7)(h) of the Act, other grounds for refusing to issue, renew or amend a licence are the following:

• (a) an individual who is required to hold a security clearance under section 50 in respect of an application does not hold such a security clearance;

• (b) in respect of the renewal or amendment of a licence, the holder of the licence does not hold a cannabis licence issued under subsection 14(1.1) of the Excise Act, 2001, if it is required;

• (c) in respect of the issuance or amendment of a licence for cultivation, the site proposed in the application would be authorized by another licence for cultivation;

• (d) in respect of the issuance or amendment of a licence for micro-cultivation, the site proposed in the application would be authorized by a licence for standard processing and a licence for micro-cultivation;

• (e) in respect of the issuance or amendment of a licence for standard cultivation, the site proposed in the application would be authorized by a licence for micro-processing and a licence for standard cultivation;

• (f) in respect of the issuance or amendment of a licence for a nursery, the site proposed in the application would be authorized by a licence for processing and a licence for a nursery;

• (g) in respect of the issuance or amendment of a licence for processing, the site proposed in the application would be authorized by another licence for processing;

• (h) in respect of the issuance or amendment of a licence for processing, the site proposed in the application would be authorized by a licence for processing and a licence for a nursery;

• (i) in respect of the issuance or amendment of a licence for micro-processing, the site proposed in the application would be authorized by a licence for standard cultivation and a licence for micro-processing;

• (j) in respect of the issuance or amendment of a licence for standard processing, the site proposed in the application would be authorized by a licence for micro-cultivation and a licence for standard processing;

• (k) in respect of a licence for processing, the applicant has, in the past 10 years, been convicted of an offence under the Safe Food for Canadians Act or an Act referred to in subsection 374(2) of the Safe Food for Canadians Regulations; and

• (l) in respect of a licence for research that would authorize activities in relation to non-therapeutic research on cannabis, the Minister has reasonable grounds to believe that

  • (i) the use of the cannabis proposed in the application presents a risk of injury to the health of a human participant or other person that cannot reasonably be mitigated, or

  • (ii) the objectives of the non-therapeutic research on cannabis that are set out in the application will not be achieved.

Marginal note:Suspension — other circumstance

30 For the purpose of paragraph 64(1)(b) of the Act, other circumstances for the suspension of a licence are the following:

• (a) an individual who is required to hold a security clearance under section 50 in respect of the licence does not hold such a security clearance;

• (b) the holder of a licence has failed to pay a fee in relation to the licence that is fixed under subsection 142(1) of the Act;

• (c) the holder of a licence does not hold a cannabis licence issued under subsection 14(1.1) of the Excise Act, 2001, if it is required;

• (d) the cannabis licence issued to the holder under subsection 14(1.1) of the Excise Act, 2001 is suspended under subsection 23(2) of that Act; and

• (e) in respect of a licence for research that authorizes activities in relation to non-therapeutic research on cannabis, the Minister has reasonable grounds to believe that

  • (i) the use of the cannabis in the conduct of the non-therapeutic research on cannabis presents a risk of injury to the health of a human participant or other person that cannot reasonably be mitigated, or

  • (ii) the objectives of the non-therapeutic research on cannabis will not be achieved.