Adverse Reaction Reporting
Health Canada monitors health and safety risks related to the sale and use of chemicals, drugs and vaccines, food, pesticides, medical devices and certain consumer products. Health professionals and consumers can report adverse reactions to Health Canada and its partners using the programs listed below.
Clinical Trial Natural Health Products
During clinical trials involving natural health products (NHPs), the sponsor is required to inform the Natural Health Products Directorate Clinical Trial Unit of any serious adverse reactions or serious unexpected adverse reactions to the NHP that has occurred inside or outside Canada.
Clinical Trial Pharmaceutical and Biological Drugs
In relation to the authorized investigational drug, reactions that are serious and / or unexpected that have occurred inside or outside Canada must be reported to Health Canada by the sponsor of the clinical trial.
Consumer Products
To report a product related injury or death, or if you have a safety concern regarding a consumer product, contact your Regional Product Safety Office.
Cosmetics
If an adverse reaction to a cosmetic is suspected, stop using the product and contact the Cosmetics
Program.
Drugs and Natural Health Products Used in Animals
To report any side effects and suspected adverse reactions to drugs and natural health products used in animals, including lack of effect. Please visit this page for important safety information from Health Canada's Veterinary Drugs Directorate's Pharmacovigilance program.
Food
Adverse reactions to food products experienced by consumers or reported to industry should be reported to the local  Canadian Food Inspection Agency Office.
Health Products for Human Use
Suspected adverse reactions to health products marketed in Canada, including prescription and non-prescription drugs, radiopharmaceuticals, medical devices, natural health products, and biologics can be reported to Health Canada by completing the appropriate form available through MedEffect.
Medical Devices
Medical device users are encouraged to report device related incidents directly to Health Canada by completing a Medical Device Problem Report Completed problem reports and general inquiries are to be directed to the Operational Centre of the Health Product and Food Branch Inspectorate in your area
Pesticides
Report any incident related to a pesticide to the Pest Management Regulatory Agency, whether it involves a human, an animal or the environment.
Radiation-Emitting Devices
Report any adverse effect related to a radiation-emitting device (for example: ultrasound equipment, X-ray devices, microwave ovens, tanning equipment, or lasers) to the Consumer and Clinical Radiation Protection Bureau.
Transfusion Transmitted Injuries Surveillance System
Report moderate or severe adverse event related to the transfusion of blood components, plasma derivatives and recombinant products to the Public Health Agency of Canada.
Vaccines in Humans
Health care professionals are encouraged to report adverse events following immunization to their local health unit.
Veterinary Biologics
Notify the Veterinary Biologics Section of the Canadian Food Inspection Agency when you encounter suspected adverse reactions to veterinary biologics (animal vaccines, antibody products or diagnostic kits for infectious animal diseases).
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