Health Product Complaint Process - Summary

Reporting a Complaint Involving a Health Product

Health Canada's mandate is to help Canadians maintain and improve their health. With this in mind, the Inspectorate is committed to verifying complaints from consumers and industry regarding the quality and/or safety of health products. Health products include pharmaceutical drugs, medical devices, biologics (including human blood, cells, tissues, donor semen, and organs), radiopharmaceuticals, and natural health products.

As the Inspectorate deals with numerous product-related issues, all complaints are prioritized according to the health and safety risk. High-risk complaints receive priority attention. Actions taken by the Inspectorate are consistent with the Inspectorate's compliance and enforcement policy (POL-0001) with the objective of achieving compliance using the most appropriate level of intervention. Not all complaints will lead to further action from Health Canada.

A complaint typically relates to the quality and/or safety of a health product and also may include a trade complaint which can relate to the products and/or the activities of a competitor.

When the Inspectorate receives a complaint, the information is reviewed to determine if the report falls within the Inspectorate's mandate. If it does, you will be sent an acknowledgement letter that the complaint was received.

If a complaint does not fall within the Inspectorate's mandate, it will be directed to the appropriate authority or you will be provided with the appropriate authority to contact.

Types of Products / Complaints the Inspectorate does not Address
Products / Complaints Activities Contact

Adverse event in Humans (side effect to prescription and non- prescription medicines (i.e., over-the-counter))

All suspected adverse reactions (ARs) to human drugs marketed in Canada, including prescription and non-prescription drugs, biologics, natural health products, radiopharmaceuticals, disinfectants, and sanitizers should be reported to the Canada Vigilance Program.

Canada Vigilance National Office

Adverse event in Animals (prescription and non-prescription medicines)

All suspected ARs to drugs used in animals should be reported to the Veterinary Drugs Directorate (VDD)

Veterinary Drugs Directorate

Serious and unexpected adverse event related to Clinical trial drugs in Humans

All suspected serious and unexpected ARs related to Clinical trial drugs, for example, biologics, pharmaceutical drugs, radiopharmaceuticals, natural health products should be reported to their respective office of Clinical Trials

Pharmaceutical Drugs, Biologics and Radiopharmaceuticals AR Reporting
Office of Clinical Trial
Natural Health Products
Natural Health Products

Food compliance and enforcement activities

Complaints / ARs to foods should be reported to the Canadian Food Inspection Agency (CFIA).

 Canadian Food Inspection Agency (CFIA)

Adverse event in Animals to biologics

All suspected ARs in animals to biologics, such as vaccines, bacterins etc. should be reported to the CFIA

 Canadian Food Inspection Agency (CFIA)

Tobacco compliance
(Tobacco Control Program)

Complaints concerning tobacco products should be submitted to the Tobacco Control Program. The department is responsible for monitoring and enforcing compliance with tobacco labelling regulations, educating the public and regulating industry on the  Tobacco Act and  Regulations, and in the management of funding related to the Prevention, Cessation and Educational activities.

Health Canada's Tobacco Control Program (TCP)

Consumer products, including cosmetics
(Product Safety Programme)

Complaints concerning consumer / cosmetic products should be submitted to the Product Safety Programme. The department monitors and enforces consumer and cosmetic compliance issues.
Consumer products: (examples: electronics, baby walkers, clothing, toys, children's furniture, small appliances, house wares, household chemicals, bicycles, playground equipment, pools, skates, scooters, hockey helmets, hot tubs, and tents)

Cosmetics products: (examples: include shampoo, tooth whiteners, shaving cream, lipstick, hair dyes and tints, depilatories, soaps, moisturizers, nail polish and removers, and self-tanning products)

Health Canada's Product Safety Programme

Pesticide regulation and registered pesticides

All Complaints / ARs to pesticides, whether it involves a human, an animal, or the environment, should be reported to PMRA.
Pesticides: (examples: insecticides, herbicides, fungicides, and various other substances (or mix of substances) used to control pests, such as insects, fungus, weeds, animal or bacterial organisms)

Pest Management Regulatory Agency (PMRA)

Convention on International Trade in Endangered Species (CITES)

The organization is responsible for ensuring that the international trade in specimens of wild animals and plants does not threaten the survival of indigenous species. Complaints concerning endangered species should be reported to CITES.

 Environment Canada

Biological samples, permits for importation of human pathogens

Please contact either the Public Health Agency of Canada or the Canadian Border Services Agency for additional information.

 Public Health Agency of Canada (PHAC)
 Canadian Border Services Agency (CBSA)

Medical Marijuana

The Marihuana Medical Access Program (MMAP) facilitates the medical use of marijuana a substance regulated under the CDSA.

Drug Strategy and Controlled Substances Programme, Healthy Environments and Consumer Safety Branch (HECSB)

 Controlled Drugs and Substances Act (CDSA) permits or licences, methadone authorization, notification lists

The Act that regulates the control and distribution of certain restricted substances and their precursors.

Office of Controlled Substances, HECSB

Special Access Programme (SAP) to Drugs and Health Products

Health Care Professionals can request access to health products which are unavailable for sale in Canada. Access is limited to life-threatening conditions for which conventional therapies have failed or are unsuitable.  

SAP-Drugs
SAP-Medical Devices
SAP-Donor Semen

Complaints concerning practice of medicine

Complaints concerning the practice of medicine should be submitted to the respective provincial College of Physicians and Surgeons

 Newfoundland and Labrador
 Nova Scotia
 New Brunswick
 Prince Edward Island
 Quebec
 Ontario
 Manitoba
 Saskatchewan
 Alberta
 British Columbia
 Yukon
 Northwest Territories
 Nunavut

Complaints concerning practice of pharmacy

Complaints concerning the practice of pharmacy should be submitted to the respective provincial College of Pharmacy

 Newfoundland and Labrador
 Nova Scotia
 New Brunswick
 Prince Edward Island
 Quebec
 Ontario
 Manitoba
 Saskatchewan
 Alberta
 British Columbia
 Yukon
 Northwest Territories

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: