Access to Cannabis for Medical Purposes Regulations

Marginal note:Adverse reactions

• 78 (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)