Cannabis Regulations

Marginal note:Voluntary recall

• 247 (1) A holder of a licence must, before commencing a voluntary recall of a cannabis product that has been sold or distributed in Canada, provide the Minister with a document that contains the following information:

  • (a) a description of the cannabis product, including the brand name;

  • (b) the number of each lot or batch of the cannabis product to be recalled, together with, if known, the number of any lot or batch of cannabis that was used to make the cannabis product;

  • (c) if known, the name and address of each person that

    • (i) produced or imported into Canada the cannabis that is, or is contained in, the cannabis product,

    • (ii) packaged or labelled the cannabis referred to in subparagraph (i) before it became, or became part of, the cannabis product,

    • (iii) in the case of a cannabis accessory that is a cannabis product, produced or imported into Canada the cannabis accessory or any component of it, or

    • (iv) packaged or labelled the cannabis product;

  • (d) the reasons for commencing the recall;

  • (e) if the cannabis that is, or is contained in, the cannabis product was produced or imported into Canada by the holder, the quantity of cannabis that was produced or imported;

  • (f) the quantity of the cannabis product that was sold or distributed by the holder in Canada;

  • (g) if applicable, the quantity of the cannabis product that is affected by the problem or potential problem underlying the recall and that remains in the possession of the holder;

  • (h) the number of persons to which the holder sold or distributed the cannabis product in Canada;

  • (i) the period during which the holder sold or distributed the cannabis product in Canada;

  • (j) the time and manner in which the recall is to be carried out, including

    • (i) the expected date for the commencement of the recall,

    • (ii) how and when the Minister will be informed of the progress of the recall, and

    • (iii) the date by which the recall is expected to be completed;

  • (k) a description of any other measure that the holder is taking, or intends to take, in respect of the recall; and

  • (l) contact information for a representative who will be responsible for the recall.

• Marginal note:Recall — exported cannabis

  (2) A holder of a licence must, before commencing a voluntary recall of cannabis that has been exported from Canada, provide the Minister with a document that contains the following information:

  • (a) a description of the cannabis, including,

    • (i) in the case of a drug containing cannabis, other than a prescription drug, the proper name or common name of the drug,

    • (ii) in the case of a prescription drug, the brand name of the drug and its drug identification number,

    • (iii) in any other case, the brand name of the cannabis, if applicable;

  • (b) the number of each lot or batch of the cannabis;

  • (c) if known, the name and address of each person that

    • (i) produced or imported into Canada the cannabis, and, if applicable, packaged or labelled it, and

    • (ii) in the case where the cannabis is contained in a cannabis accessory, produced or imported into Canada the cannabis accessory or any component of it;

  • (d) the reasons for commencing the recall;

  • (e) if applicable, the quantity of the cannabis that was produced or imported into Canada by the holder;

  • (f) the quantity of the cannabis that was sold or distributed by the holder in foreign countries;

  • (g) if applicable, the quantity of the cannabis that is affected by the problem or potential problem underlying the recall and that remains in the possession of the holder;

  • (h) the number of persons to which the holder sold or distributed the cannabis in foreign countries;

  • (i) the period during which the holder sold or distributed the cannabis in foreign countries;

  • (j) the time and manner in which the recall is to be carried out, including

    • (i) the expected date for the commencement of the recall,

    • (ii) how and when the Minister will be informed of the progress of the recall, and

    • (iii) the date by which the recall is expected to be completed;

  • (k) a description of any other measure that the holder is taking, or intends to take, in respect of the recall; and

  • (l) contact information for a representative who will be responsible for the recall.

• Marginal note:Risk evaluation

  (3) The holder must, within 72 hours after providing the Minister with the document referred to in subsection (1) or (2), provide the Minister with a document that contains an evaluation of the risk associated with the problem or potential problem that underlies the recall.

• Marginal note:Report

  (4) The holder must, within 30 days after the day on which the recall is completed, provide the Minister with a written report that sets out the results of the recall and the measures taken to prevent a recurrence of the problem.

• Marginal note:Extension

  (5) Despite subsection (4), the Minister may extend the period for providing the report — to a maximum of 90 days after the day on which the recall is completed — if, for reasons beyond the holder’s control, it is not feasible to provide it within the 30-day period.

• Marginal note:Retention periods

  (6) The holder must retain

  • (a) a copy of the documents that they provide to the Minister under subsections (1) and (3) for at least two years after the day on which their last sale or distribution of any cannabis product that is the subject of the recall takes place;

  • (b) a copy of the documents that they provide to the Minister under subsections (2) and (3) for at least two years after the day on which their last export of any of the cannabis that is the subject of the recall takes place; and

  • (c) a copy of the report that they provide to the Minister under subsection (4) for at least two years after the day on which the recall is completed.