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Drugs and Health Products

Adverse Reaction and Medical Device Problem Reporting

Consumers/patients and health professionals can report adverse reactions (also known as side effects) to health products, including prescription and non-prescription medications, biologics, (includes biotechnology products, vaccines, fractionated blood products, human blood and blood components, as well as human cells, tissues and organs), natural health products and radiopharmaceuticals, to the Canada Vigilance Program.

Privacy Statement: Information related to the identity of the patient and/or the reporter of an adverse reaction is protected as per the Privacy Act and in the case of an access to information. Suspected health product-related adverse reaction information is submitted on a voluntary basis, and is maintained in a computerized database. Adverse reaction information is used for the monitoring of marketed health products, and may contribute to the detection of potential product-related safety issues as well as to the benefit-risk assessments of these products.

More details regarding personal information collected under this program can be found in InfoSource's Personal Information Bank, Health Canada; Health Products and Food Branch; Branch Incident Reporting System; PIB# PPU 088.

Reporting by Consumers and Health Professionals

Reporting for Health Products (except Medical Devices)

Reporting for Medical Devices

  • Consumers and health professional are encouraged to report device-related incidents directly to Health Canada by completing a Health Product Complaint Form.

Note to consumers:
Consumers are encouraged to consult their health professional who could offer additional information that may be useful in reporting a side effect.

Reporting by Industry

According to Canada's Food and Drugs Act, it is mandatory for Market Authorization Holders (MAH) (manufacturers and distributors) and for source establishments of human cells, tissues and organs to submit adverse reaction reports to Health Canada, as well as, it is mandatory for manufacturers and importers to submit medical device problems reports to Health Canada. Additional information on the regulatory requirements related to adverse reaction reporting can be found in the Guidance Documents and Guidelines section of the Reports and Publications - MedEffect™ Canada page.

Reporting for Drugs

Market Authorization Holders (manufacturers and distributors) must submit reports to the Canada Vigilance National Office by:

Reporting for Natural Health Products or Cells, Tissues and Organs

Market Authorization Holders for Natural Health Products or Cell, Tissue and Organ (CTO) Source Establishments must submit reports to the Canada Vigilance National Office by:

Reporting for Medical Devices

Manufacturers and importers of medical devices must submit report to the Canada Vigilance - Medical Device Problem Reporting Program by:

If you require further assistance, contact the Canada Vigilance National Office.

Reporting Adverse Reactions to Other Products

To report an adverse reaction to cosmetics, medical devices, pesticides, veterinary drugs, consumer products, foods or any other product on the Canadian market, visit the Adverse Reaction Reporting for Specific Products for details on how to submit an adverse reaction report.

Related Documents


Health Professionals