Cannabis Regulations

Marginal note:Adverse reactions

• 248 (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)