Report a side effect (adverse reaction) to cannabis: Licence holders
On this page
- Requirements for licence holders
- Requirements for research licence holders authorized to conduct non-therapeutic research on cannabis (NTRC) studies
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:
- notify Health Canada of all life-threatening or fatal adverse reactions within 7 days after becoming aware of it
- submit a detailed report on all life-threatening or fatal adverse reactions within 8 days of notifying Health Canada
- submit a detailed report within 15 days of becoming aware of the serious adverse reaction (not life threatening or fatal)
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:
- licence number
- name of the research licence holder
- study category
- name of the principal investigator
- individual responsible for assessing the adverse reaction
- study location if multi-site
The report should include:
- the intended use of the cannabis or cannabis accessory,
- an assessment of the cause of the serious adverse reaction and
- a statement of what further actions, if any, that need to be taken by the research licence holder
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.
Page details
- Date modified: