Access to Cannabis for Medical Purposes Regulations
Marginal note:Product label — marihuana or cannabis oil
84 (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.”.
- Date modified: