Report a side effect (adverse reaction) to cannabis: Licence holders

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Requirements for licence holders

If you have a licence to sell or distribute a cannabis product, you are required to report all serious adverse reactions to Health Canada within 15 days of becoming aware of them.

You are also encouraged to quickly report all medically important adverse reactions on an expedited basis as well.

Report a serious adverse reaction

You may also submit an adverse reaction report using the Council for International Organizations of Medical Sciences (CIOMS) form.

Licence holders are expected to understand and practice the good case management and good vigilance practices, including completeness of reports and follow-ups with reporters.

Cannabis adverse reaction reporting guide

The Mandatory adverse reaction reporting form asks you to select and provide a health product name in Section D, Part 1. You shouldn't select any of the provided options. In the text box portion, provide the cannabis product name, or any available information if the name is unknown (for example, cannabis vape by licence holder name).

Requirements for research licence holders authorized to conduct non-therapeutic research on cannabis studies

Any licence holder authorized to conduct non-therapeutic research on cannabis (NTRC) is required to:

In all cases, the detailed report submitted to Health Canada must contain all information in the possession of the licence holder that is associated with the use of the cannabis or cannabis accessory by the individual who experienced the serious adverse reaction. The report should have a cover page providing key details to identify the study, for example:

The report should include:

Report a serious adverse reaction

You may also submit an adverse reaction report using the Council for International Organizations of Medical Sciences (CIOMS) form.

Research licence holders are expected to understand and practice the good case management and good vigilance practices.

Cannabis adverse reaction reporting guide

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