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

Overview

Consumers or patients

Health care professionals

Hospitals

Licence holders

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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.

Cannabis adverse reaction reporting guide

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2024-09-20