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Cannabis Regulations (SOR/2018-144)

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Regulations are current to 2023-01-11 and last amended on 2022-12-02. Previous Versions

PART 2Licensing (continued)

Processing Licences (continued)

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 or distribution of cannabis products to a person that is authorized under a provincial Act referred to in subsection 69(1) of the Act to sell cannabis; and

    • (b) the sending or delivering of cannabis products under paragraph 17(5)(e).

  • Marginal note:Exception

    (2) Subsection (1) does not apply if the holder sells or distributes the product to a person referred to in paragraph (1)(a) and that person has notified the holder in writing, that they will obtain the copies through other means and provide it to consumers with their purchase of the product.

  • Marginal note:No modification

    (3) The copies must be identical to the document referred to in subsection (1).

Marginal note:Quality assurance person

  •  (1) A holder of a licence for processing must retain the services of one individual as a quality assurance person who has the training, experience and technical knowledge related to the requirements of Parts 5 and 6 that are applicable to the class of cannabis in respect of which activities are conducted under the licence.

  • Marginal note:Exception — edible cannabis

    (1.1) Despite subsection (1), if the quality assurance person does not have the training, experience and technical knowledge related to the requirements of Parts 5 and 6 that are applicable to edible cannabis, the holder of a licence for processing that conducts activities in respect of that class of cannabis must retain the services of another individual who has that training, experience and technical knowledge.

  • Marginal note:Responsibilities

    (2) The quality assurance person is responsible for

    • (a) assuring the quality of the cannabis before it is made available for sale;

    • (b) investigating every complaint received in respect of the quality of the cannabis and, if necessary, immediately taking measures to mitigate any risk; and

    • (c) if they suspect, on reasonable grounds, that the cannabis or anything that will be used as an ingredient presents a risk of injury to human health or that the applicable requirements of Part 5 or 6 are otherwise not being met, immediately investigating the matter and, if necessary, immediately taking measures to mitigate any risk.

  • Marginal note:Alternate

    (3) A holder of a licence for processing may designate up to two individuals as alternate quality assurance persons who are qualified to replace the quality assurance person.

  • Marginal note:Non-application

    (4) Subsections (1) to (3) do not apply in respect of a reference standard or a test kit.

Marginal note:Minister’s approval

  •  (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 concentrates0.25 kg
    6[Repealed, SOR/2019-206, s. 10]

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 to conduct those of the following activities that are authorized by the licence:

    • (a) for the purpose of testing,

      • (i) to possess cannabis, and

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

    • (b) for the purpose of producing reference standards or manufacturing or assembling test kits, to produce cannabis, other than obtain it by cultivating, propagating or harvesting it; and

    • (c) to sell cannabis.

  • Marginal note:Offer

    (2) A holder of a licence for analytical testing that is authorized to conduct the activity referred to in subparagraph (1)(a)(ii) or paragraph (1)(b) is also authorized to offer to conduct that activity.

  • Marginal note:Use of organic solvent

    (3) A holder of a licence for analytical testing that is authorized to conduct the activity referred to in subparagraph (1)(a)(ii) or paragraph (1)(b) is also authorized to alter or offer to alter the chemical or physical properties of cannabis by the use of an organic solvent when conducting that activity.

  • Marginal note:Distribution

    (4) A holder of a licence for analytical testing is also authorized, for the purpose of testing, to distribute cannabis to another holder of a licence for analytical testing or the individuals referred to in section 4.

  • Marginal note:Sale

    (5) A holder of a licence for analytical testing whose licence authorizes the sale of cannabis is authorized to sell and distribute reference standards to any of the following:

    • (a) a holder of a licence for cultivation;

    • (b) a holder of a licence for processing;

    • (c) a holder of a licence for research;

    • (d) another holder of a licence for analytical testing;

    • (e) a holder of a cannabis drug licence;

    • (f) the individuals referred to in section 4;

    • (g) the Minister; or

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

Marginal note:Head of laboratory

  •  (1) A holder of a licence for analytical testing must retain the services of one individual as the head of laboratory who must work at the site set out in the licence and who is responsible for the testing referred to in sections 90 to 91.1.

  • Marginal note:Qualifications

    (2) The head of laboratory must

    • (a) have sufficient knowledge of the provisions of the Act and these Regulations that apply to the holder of the licence for analytical testing to properly carry out the duties of the position;

    • (b) have knowledge and experience relevant to the duties of the position; and

    • (c) hold

      • (i) a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to the duties of the position, such as chemistry, biology, pharmaceutical or scientific regulatory affairs, laboratory management or laboratory technician, or

      • (ii) a diploma, certificate or credential awarded by a foreign educational institution in a field or occupation referred to in subparagraph (i) and

        • (A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or

        • (B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province.

  • Marginal note:Alternate

    (3) A holder of a licence for analytical testing may designate one or more individuals as the alternate heads of laboratory who are qualified to replace the head of laboratory.

Marginal note:Minister’s approval

  •  (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 the sample of a lot or batch of cannabis that has been distributed to them, and all cannabis obtained from that sample, within 90 days after completing the testing of the sample of the lot or batch.

  • Marginal note:Sample not tested

    (2) If testing of the sample of a lot or batch of cannabis distributed to the holder of the licence for analytical testing is not initiated within 120 days of its receipt, the holder must, by the end of that period, either destroy the sample or distribute it to another holder of a licence for analytical testing or to the individuals referred to in section 4.

Licence for Sale for Medical Purposes

Marginal note:Authorized activities

 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.

 
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