There are multiple ways to report an adverse reaction to Health Canada:

• Complete and submit your report on-line;


• Download and print a paper copy of the reporting form (forms below) to submit a report by mail or fax;


• Report an adverse reaction by phoning one of the Regional Adverse Reaction Monitoring Offices (1-866-234-2345)

Report of Suspected Adverse Reaction due to Health Products Marketed in Canada

Health Canada, through the Canadian Adverse Drug Reaction Monitoring Program, is responsible for collecting and assessing adverse reaction reports for the following health products marketed in Canada: pharmaceuticals, biologics (including fractionated blood products as well as therapeutic and diagnostic vaccines), natural health products and radiopharmaceuticals.

Medical Devices Problem Report Form

Medical Device (as defined in the Food and Drugs Act) covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.

Vaccines

Adverse Events Following Immunization Reporting Form

ADR Expedited Reporting Summary for ADRs occurring during Clinical Trials

ADR Expedited Reporting Summary for ADRs Occuring During Clinical Trials