Government of Canada / Gouvernement du Canada
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Cannabis Regulations

Version of section 248 from 2018-10-17 to 2022-12-01:

Marginal note:Adverse reactions

  •  (1) A holder of a licence that sells or distributes a cannabis product must

    • (a) within 15 days after becoming aware of a serious adverse reaction to the cannabis product, provide the Minister with a detailed report containing all information in their possession that is associated with the use of the cannabis product by the individual who experienced the reaction; and

    • (b) prepare an annual summary report that contains a concise and critical analysis of all adverse reactions to the cannabis product that the holder became aware of during the previous 12 months.

  • Marginal note:Retention period

    (2) The holder must retain the reports for at least 25 years after the day on which they are prepared.

  • Marginal note:Definitions

    (3) The following definitions apply in this section.

    adverse reaction

    adverse reaction means a noxious and unintended response to a cannabis product. (réaction indésirable)

    serious adverse reaction

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

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