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Section 56 Class Exemption for Licensed Producers Under the Marihuana for Medical Purposes Regulations to Conduct Activities with Cannabis

Nothing in this exemption is intended to affect the rules in the Marihuana for Medical Purposes Regulations (MMPR) that apply in respect of dried marihuana.

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Definitions

The terms used in this exemption have the same meaning as they do in the Controlled Drugs and Substances Act (CDSA) and its regulations, except as defined below.

"cannabis" includes its preparations and derivatives, including

  1. cannabis resin;
  2. cannabis (marihuana) except dried marihuana;
  3. cannabidiol (2-[3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol);
  4. cannabinol (3-n-amyl-6,6,9-trimethyl-6-dibenzopyran-1-ol);
  5. tetrahydrocannabinol (tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol);

    but not including

  6. non-viable cannabis seed, with the exception of its derivatives;
  7. mature cannabis stalks that do not include leaves, flowers, seeds or branches, and fiber derived from such stalks;
  8. similar synthetic preparations;
  9. a drug in dosage form, as defined in subsection C.01.005(3) of the Food and Drug Regulations, that has a drug identification number assigned to it under Division 1 of Part C of those Regulations or that is authorized for sale under Division 5 of that Part.

"cannabis oil" means an oil, in liquid form, that contains cannabis or dried marihuana.

"fresh marihuana" means fresh marihuana buds and leaves, but does not include plant material that can be used to propagate marihuana.

"label" means a label referred to in section 66 of the MMPR or a combined label referred to in section 68 of the MMPR.

Scope of Exemption

Pursuant to section 56 of the CDSA, licensed producers who comply with the terms and conditions set out below are exempted from sections 4, 5 and 7 of the CDSA, subsection 8(1) of the Narcotics Control Regulations (NCR) and the provisions of the MMPR to the extent necessary to allow the licensed producers to

  1. possess, produce or destroy cannabis;
  2. sell, provide, ship, deliver or transport cannabis to another licensed producer, a licensed dealer, the Minister or a person who is specifically named in an exemption relating to cannabis that has been granted under section 56 of the CDSA;
  3. sell, provide, ship, deliver or transport fresh marihuana or cannabis oil to persons described in subparagraph 12(4)(a)(i) or (ii) of the MMPR or a person who is specifically named in an exemption relating to cannabis oil or fresh marihuana that has been granted under section 56 of the CDSA;
  4. ship fresh marihuana or cannabis oil to a person described in paragraph 12(4)(b) of the MMPR.

Terms and Conditions

  1. Fresh marihuana must not have anything added to it other than as permitted under section 54 of the MMPR.

  2. Cannabis oil must not contain any added flavor or scent.

  3. In conducting the activities with cannabis, fresh marihuana and cannabis oil, the licensed producer must comply with the following provisions of the MMPR, with the necessary adaptations:

    1. sections 13 to 20;
    2. sections 41 to 51;
    3. subsection 73(1), if the fresh marihuana or cannabis oil that is being shipped is being sold or provided, or is ultimately to be sold or provided, to a person described in subsection 12(4) without, in the case of oil, further processing;
    4. subsection 73(2), in all other cases where cannabis or cannabis oil is being shipped;
    5. section 102.1;
    6. sections 131 to 149.
  4. The licensed producer must not sell or provide fresh marihuana or cannabis oil to a person described in subsection 12(4) of the MMPR unless the requirements of sections 52 to 72 of the MMPR are met, with the necessary adaptations.

  5. The licensed producer must, for each lot or batch of cannabis oil they produce, keep records of the date on which it was produced, the net weight of cannabis or dried marihuana used, and the lot or batch number of the cannabis or dried marihuana used.

  6. For fresh marihuana or cannabis oil, the licensed producer must determine the quantity of the marihuana or oil that is equivalent to one gram of dried marihuana ("the equivalency factor"). The information must appear on the label. The information about the equivalency factor must also be available at the licensed producer's site and on their website.

  7. The licensed producer must not sell or provide dried marihuana to an "authorized person" within the meaning of the "Section 56 Class Exemption for Individuals Authorized to Possess or to Produce Marihuana for Medical Purposes by Virtue of an Interim Injunction" or a "client" within the meaning of the "Section 56 Class Exemption for Clients and Responsible Persons Under the Marihuana For Medical Purposes Regulations To Conduct Activities With Cannabis" unless that person is a registered client of the licensed producer.

  8. The licensed producer must not sell or provide to a client or an individual responsible for a client in any 30-day period a total quantity of fresh marihuana or cannabis oil that, taking into account the equivalency factor determined in accordance with Term and Condition #6 and any dried marihuana that has been sold or provided during that period, would result in the client or individual obtaining the equivalent of more than 30 times the daily quantity of dried marihuana referred to in the client's medical document in accordance with paragraph 129(1)(d) of the MMPR. Subsections 124(2) to (4) of the MMPR apply, with the necessary adaptations.

  9. The licensed producer must ensure that, for cannabis oil, the label specifies, in mg per ml, the amount of delta-9-tetrahydrocannabinol and the total amount of delta-9-tetrahydrocannabinol that the oil in the container could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol.

  10. The label for cannabis oil must also specify the total amount, in mg, of delta-9-tetrahydrocannabinol that the oil in the container could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol.

  11. The licensed producer must ensure that, for cannabis oil, the label specifies, in mg per ml, the amount of cannabidiol and the total amount of cannabidiol that the oil in the container could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol.

  12. The label for cannabis oil must also specify the total amount, in mg, of cannabidiol that the oil in the container could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol.

  13. The licensed producer must ensure that, for cannabis oil, the label specifies the total volume of the oil, in ml, in the container.

  14. The licensed producer must ensure that, if cannabis oil is sold or provided in a capsule or a similar dosage form, each capsule or unit of the dosage form will not exceed a maximum yield quantity of 10 mg of delta-9-tetrahydrocannabinol, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid to delta-9-tetrahydrocannabinol. The label must specify the amount, in mg, of delta-9-tetrahydrocannabinol in each capsule or unit, as well as the total amount, in mg, of delta-9-tetrahydrocannabinol that each capsule or unit could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol. The label must also specify the amount of cannabidiol, in mg, in each capsule or unit, as well as the total amount, in mg, of cannabidiol that each capsule or unit could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol.

  15. The licensed producer must ensure that the cannabis oil will not exceed a maximum yield quantity of 30 mg of delta-9-tetrahydrocannabinol per ml of the oil in the container, taking into account the potential to convert delta-9-tetrahydrocannabinolic into acid to delta-9-tetrahydrocannabinol.

  16. The label for cannabis oil must specify any allergens contained in the oil.

  17. The following warning must be clearly and prominently displayed on the label for fresh marihuana and cannabis oil: "This product has not been authorized for sale under the Food and Drugs Act. It has not been assessed for safety or efficacy to treat or prevent any disease or symptom. / La vente de ce produit n'est pas autorisée sous le régime de la Loi sur les aliments et drogues. L'innocuité et l'efficacité de ce produit n'ont pas été évaluées eu égard à la prévention ou au traitement des maladies ou de leurs symptômes."

  18. The licensed producer must hold a supplemental licence issued by the Minister of Health for the purpose of authorizing the activities in relation to cannabis, fresh marihuana and cannabis oil that are the subject of this exemption. The licensed producer must provide the Minister with any additional information that is necessary for this purpose. Sections 9, 26 to 29 and 33 to 36 of the MMPR apply, with the necessary adaptations, in respect of this licence.

  19. The licensed producer must allow any inspector duly authorized under the CDSA to enter their site, at any reasonable time, to ensure compliance with this exemption and must allow the inspector to exercise all the powers and functions set out in section 31 of the CDSA, with the necessary adaptations.

  20. The licensed producer must not, by act or omission, obstruct an inspector who is engaged in an inspection under Term and Condition #19.

  21. The licensed producer must not knowingly make any false or misleading statement verbally or in writing to an inspector who is engaged in an inspection under Term and Condition #19.

  22. The licensed producer must not, without the permission of an inspector, remove, alter or interfere in any way with anything seized, detained or taken by an inspector as a result of an inspection under Term and Condition #19.

  23. At the site entered by an inspector for the purpose of ensuring compliance with the exemption, the licensed producer must give the inspector all reasonable assistance and furnish the inspector with any information the inspector may reasonably require for the purpose of the inspection.

Explanatory Note

For greater certainty, nothing in this exemption prevents an applicant for a licence under section 25 of the MMPR from submitting to the Minister information that is necessary to obtain a supplemental licence referred to in Term and Condition #18.

Effective Date: July 8, 2015