Report an adverse reaction to a drug: industry

Notice for Industry: Mandatory Reporting Requirement during the COVID-19 Pandemic [2020-03-23]

Canada's Food and Drugs Act and Regulations set out specific reporting requirements and timelines for mandatory reports. These include requiring regulated parties to report serious or unexpected adverse reaction. Reports must be made within 15 calendar days of receiving or becoming aware of the information about the adverse reaction.

Report an adverse reaction

The Canada Vigilance Program (CVP) accepts electronic reports for adverse reactions. CVP's Trading Partner Management Office (TPMO) accepts:

Contact TPMO at to obtain the guidance document on e-reporting or to enrol.

What drugs are included

Drugs include:

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