Reporting requirements for serious adverse reactions during non-therapeutic research with cannabis
Health Canada is currently developing detailed guidance on reporting serious adverse reactions for licence holders conducting non-therapeutic research with cannabis (NTRC). If you have any questions, contact the Office of Cannabis Science and Surveillance at cannabis_oss-cannabis_bss@hc-sc.gc.ca.
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Regulatory obligations under the Cannabis Regulations
If you're a licence holder conducting NTRC and you become aware of a serious adverse reaction during the NTRC study that is fatal or life-threatening, follow these steps:
- Notify the Office of Cannabis Science and Surveillance by email at cannabis_oss-cannabis_bss@hc-sc.gc.ca within 7 days of becoming aware of the serious adverse reaction.
- Complete an adverse reaction report and submit it to the Canada Vigilance Program within 8 days of notifying Health Canada of this serious adverse reaction.
If the serious adverse reaction is not fatal or life-threatening, follow these steps within 15 days of becoming aware of it:
- Complete an adverse reaction report detailing the reaction.
- Submit the report to the Canada Vigilance Program.
These requirements are detailed in subsection 248.2 of the Cannabis Regulations.
Licence holders conducting NTRC are out of the scope of the Cannabis Adverse Reaction Guide. However, we still encourage you to review the good case management practices outlined in section 7 of the guide. This section also describes how to submit an adverse reaction report to Health Canada.
Learn more:
- Defining a serious adverse reaction
- Cannabis Regulations, subsection 248.2
- Cannabis adverse reaction reporting guide
What to include in your report
When you submit your report, include a cover page that provides the following key study identifying details:
- Application ID or licence change ID.
- Name of the research licence holder.
- Risk category of the study.
- Name of the principal investigator or individual responsible for assessing the adverse reaction.
- Study site location, if multi-site.