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 Regulatory Operations and Enforcement Branch (ROEB) 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, organs and assisted human reproductive material), radiopharmaceuticals, and natural health products. ROEB will also verify complaints related to assisted human reproduction activities subject to the Assisted Human Reproduction Act and its Regulations.

Report a complaint

Reporting a Complaint  for the Assisted Human Reproduction Act

Health Canada will also verify complaints regarding  materials,  activities or any matters subject to the Assisted Human Reproduction Act or its Regulations. To submit a complaint please complete the Complaint form for the Assisted Human Reproduction Act.

Complaint form

As ROEB 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 are consistent with ROEB's compliance and enforcement policies for Health Products (POL-0001) and Assisted Human Reproduction (POL-0100) 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 ROEB receives a complaint, the information is reviewed to determine if the report falls within its mandate. If it does, you will be sent an acknowledgement letter that the complaint was received.

If a complaint does not fall within ROEB'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 Regulatory Operations and Enforcement Branch 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.

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

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
(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.

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)

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)

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.

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.

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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