Health Canada
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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.
Some of the hyperlinks provided are to sites of organizations or other entities that are not subject to the 
Official Languages Act. The material found there is therefore in the language(s) used by the sites in question.
| 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. |
|
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) |
|
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 |
Food compliance and enforcement activities |
Complaints / ARs to foods should be reported to the 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 |
|
Tobacco compliance |
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 |
|
Consumer products, including cosmetics |
Complaints concerning consumer / cosmetic products should be submitted to the Product Safety Programme. The department monitors and enforces consumer and cosmetic compliance issues. 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) |
|
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. |
|
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. |
|
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. |
|
Medical Marijuana |
The Marihuana Medical Access Program (MMAP) facilitates the medical use of marijuana a substance regulated under the CDSA. |
|
|
The Act that regulates the control and distribution of certain restricted substances and their precursors. |
|
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. |
|
Complaints concerning practice of medicine |
Complaints concerning the practice of medicine should be submitted to the respective provincial College of Physicians and Surgeons |
|
Complaints concerning practice of pharmacy |
Complaints concerning the practice of pharmacy should be submitted to the respective provincial College of Pharmacy |
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