Access to Cannabis for Medical Purposes Regulations (SOR/2016-230)

Regulations are current to 2017-09-14 and last amended on 2017-02-13. Previous Versions

Marginal note:Adverse reactions
  •  (1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil must provide the Minister with a case report for each serious adverse reaction to the substance, within 15 days after the day on which the producer becomes aware of the reaction.

  • Marginal note:Summary report

    (2) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil must prepare annually and maintain a summary report that contains a concise and critical analysis of all adverse reactions to the substance that have occurred during the previous 12 months.

  • Marginal note:Provide Minister with report on request

    (3) If, after reviewing a case report provided under subsection (1) or after reviewing any other safety data relating to the fresh or dried marihuana or cannabis oil, the Minister has reasonable grounds to believe that it may — by reason of the manner in which it was produced, packaged, labelled or stored — pose a risk to the health of a person who in accordance with these Regulations obtains it for their own medical purposes, the Minister may request that, within 30 days after the day on which the request is received, the licensed producer

    • (a) provide the Minister with a copy of any summary report prepared under subsection (2); or

    • (b) prepare and provide the Minister with an interim summary report containing a concise and critical analysis of all adverse reactions to the substance that have occurred since the date of the most recent summary report prepared under subsection (2).

  • Marginal note:Definitions

    (4) The following definitions apply in this section.

    adverse reaction

    adverse reaction means a noxious and unintended response to fresh or dried marihuana or cannabis oil. (réaction indésirable)

    case report

    case report means a detailed record of all relevant data associated with the use of fresh or dried marihuana or cannabis oil by a person. (fiche d’observation)

    serious adverse reaction

    serious adverse reaction means a noxious and unintended response to fresh or dried marihuana or cannabis oil that requires in-patient hospitalization or a prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. (réaction indésirable grave)

SUBDIVISION EDried Marihuana Equivalency Factor

Marginal note:Equivalency factor
  •  (1) A licensed producer who sells or provides fresh marihuana or cannabis oil under subsection 22(4) must determine the quantity of the marihuana or oil that is equivalent to one gram of dried marihuana.

  • Marginal note:Information

    (2) The information about the dried marihuana equivalency factor must be made available on the licensed producer’s website and be provided on request.

SUBDIVISION FPackaging, Labelling and Shipping

Marginal note:Packaging
  •  (1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil under subsection 22(4) must ensure that

    • (a) the substance is packaged in an immediate container

      • (i) that is in direct contact with the substance or, in the case of a substance in a capsule or similar dosage form, that is in direct contact with the capsules or units of that dosage form,

      • (ii) that prevents the contamination of the substance and, in the case of dried marihuana, keeps it dry,

      • (iii) that has a security feature that provides reasonable assurance to consumers that the container has not been opened prior to receipt, and

      • (iv) that is a child resistant package that meets the requirements of subsections C.01.001(2) to (4) of the Food and Drug Regulations; and

    • (b) not more than the equivalent of 30 g of dried marihuana is in the immediate container.

  • Marginal note:Marihuana seeds

    (2) A licensed producer who sells or provides marihuana seeds under subsection 22(5) must ensure that they are packaged in an immediate container that

    • (a) is in direct contact with the seeds;

    • (b) keeps them dry and prevents their contamination; and

    • (c) has a security feature that provides reasonable assurance to consumers that the container has not been opened prior to receipt.

  • Marginal note:Marihuana plants

    (3) A licensed producer who sells or provides marihuana plants under subsection 22(5) must ensure that they are sold or provided in a package that has a security feature that provides reasonable assurance to consumers that the package has not been opened prior to receipt.

Marginal note:Accuracy of weight
  •  (1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil under subsection 22(4) must ensure that the net weight of the substance in the immediate container is not less than 95% and not more than 105% of the net weight specified on the label in accordance with section 84.

  • Marginal note:Accuracy of volume

    (2) A licensed producer who sells or provides cannabis oil under subsection 22(4) must ensure that the net volume of the oil in the immediate container is not less than 95% and not more than 105% of the net volume specified on the label in accordance with section 84.

  • Marginal note:Accuracy — number of capsules or units

    (3) A licensed producer who sells or provides cannabis oil under subsection 22(4) in a capsule or similar dosage form must ensure that number of capsules or units in the container is the same as the number specified on the label in accordance with section 84.

Marginal note:Accuracy — number of seeds

 A licensed producer who sells or provides marihuana seeds under subsection 22(5) must ensure that the number of seeds in the immediate container is the same as the number specified on the label in accordance with section 85.

Marginal note:Accuracy — number of plants

 A licensed producer who sells or provides marihuana plants under subsection 22(5) must ensure that the exact number of plants in the package referred to in subsection 80(3) is indicated on the package.

Marginal note:Product label — marihuana or cannabis oil
  •  (1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil under subsection 22(4) must ensure that a label that contains the following information and the information set out in subsection (2), (3) or (4), as applicable, is affixed to the immediate container:

    • (a) the name, telephone number and email address of the licensed producer;

    • (b) the words “Fresh marihuana / Marihuana fraîche”, “Dried marihuana / Marihuana séchée” or “Cannabis oil / Huile de chanvre indien” (or the equivalent term “Cannabis oil / Huile de cannabis”), as applicable;

    • (c) in respect of the substance in the container,

      • (i) its brand name,

      • (ii) its lot number, preceded by one of the following designations:

        • (A) “Lot number”,

        • (B) “Lot no.”,

        • (C) “Lot”, or

        • (D) “(L)”,

      • (iii) its recommended storage conditions,

      • (iv) its packaging date, and

      • (v) either

        • (A) its expiry date established in accordance with section 91, or

        • (B) a statement that no expiry date has been determined;

    • (d) the symbol “N” set out in the upper left quarter of the label in a colour contrasting with the rest of the label or in type not less than half the size of any other letters used on the label;

    • (e) the warning “KEEP OUT OF REACH OF CHILDREN / TENIR HORS DE LA PORTÉE DES ENFANTS”; and

    • (f) the statement “Important: Please read the Health Canada document provided with this package before using this product. / Important : Veuillez lire le document de Santé Canada qui accompagne ce colis avant d’utiliser ce produit.”.

  • Marginal note:Fresh or dried marihuana

    (2) In the case of fresh or dried marihuana, the label must also contain the following information in respect of the marihuana in the container:

    • (a) its net weight in grams;

    • (b) the percentage of delta-9-tetrahydrocannabinol w/w, followed by the word “delta-9-tetrahydrocannabinol”;

    • (c) the percentage of delta-9-tetrahydrocannabinol w/w that the marihuana could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol;

    • (d) the percentage of cannabidiol w/w, followed by the word “cannabidiol”;

    • (e) the percentage of cannabidiol w/w that the marihuana could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol; and

    • (f) in the case of fresh marihuana, the dried marihuana equivalency factor determined under section 79.

  • Marginal note:Oil other than in dosage form

    (3) In the case of cannabis oil that is not sold in a capsule or similar dosage form, the label must also contain the following information in respect of the oil in the container:

    • (a) its net weight in grams;

    • (b) its net volume in millilitres;

    • (c) the quantity of delta-9-tetrahydrocannabinol, in milligrams per millilitre;

    • (d) the quantity of delta-9-tetrahydrocannabinol, in milligrams per millilitre, that the oil could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol;

    • (e) the quantity of cannabidiol, in milligrams per millilitre;

    • (f) the quantity of cannabidiol, in milligrams per millilitre, that the oil could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol;

    • (g) the dried marihuana equivalency factor determined under section 79;

    • (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 oil; and

    • (j) in the case of cannabis oil that is intended for topical use only, the warning “FOR TOPICAL USE ONLY. DO NOT INGEST. / POUR USAGE TOPIQUE SEULEMENT. NE PAS INGÉRER.”.

  • Marginal note:Oil in dosage form

    (4) In the case of cannabis oil that is sold in a capsule or similar dosage form, the label must also contain the following information in respect of the oil in the container:

    • (a) the number of capsules or units of that dosage form;

    • (b) the net weight in grams as well as the net volume in millilitres of each capsule or unit;

    • (c) the quantity of delta-9-tetrahydrocannabinol, in milligrams, in each capsule or unit;

    • (d) the quantity of delta-9-tetrahydrocannabinol, in milligrams, that each capsule or unit could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol;

    • (e) the quantity of cannabidiol, in milligrams, in each capsule or unit;

    • (f) the quantity of cannabidiol, in milligrams, that each capsule or unit could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol;

    • (g) the dried marihuana equivalency factor determined under section 79;

    • (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 oil; and

    • (j) in the case of cannabis oil that is intended for topical use only, the warning “FOR TOPICAL USE ONLY. DO NOT INGEST. / POUR USAGE TOPIQUE SEULEMENT. NE PAS INGÉRER.”.

 
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