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.
The Canada Vigilance Program (CVP) accepts electronic reports for adverse reactions. CVP's Trading Partner Management Office (TPMO) accepts:
- reports from enrolled trading partners
- applications for enrolment from market authorization holders
Contact TPMO at tpmo_bgpc@hc-sc.gc.ca to obtain the guidance document on e-reporting or to enrol.
What drugs are included
Drugs include:
- pharmaceutical drugs (prescription and non-prescription drugs)
- biologics (biotechnology products and fractionated blood products)
- radiopharmaceutical drugs
Related links
- MedEffect Canada
- Drugs and health products
- Canada Vigilance Program
- Drug and health product register
- Advisories, warnings and recalls
- Adverse reaction database
- About biologics
- Overview of the reporting adverse reactions to marketed health products - guidance for industry
- Safety of human cells, tissues and organs for transplantation - guidance for cell, tissue and organ establishments
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