Compliance and enforcement: Drug and health products
For industry information about COVID-19, visit our COVID-19 health product industry section.
Compliance and enforcement activities are a key element of safeguarding the drugs and health products to which Canadians have access.
As part of its regulatory responsibilities, Health Canada is responsible for compliance monitoring and enforcement activities related to health products in order to verify that regulatory requirements are being applied appropriately. The Regulatory Operations and Enforcement Branch (ROEB) is responsible for health product compliance monitoring activities such as industry inspection and product investigation. ROEB develops and implements enforcement strategies in these areas.
The Compliance and Enforcement Policy for Health Products (POL-0001) applies to Health Canada compliance and enforcement activities conducted in relation to health products that fall under the Food and Drugs Act. These products include:
- Blood for transfusion or for use in the manufacture of a drug
- Cells, Tissues and Organs
- Drugs (Human and Veterinary)
- Medical Devices
- Natural Health Products
Other related policies include:
- Policy on accessing the premises of a regulated party remotely to verify compliance (POL-0138)
- Policy on inspector orders for health products (POL-0139)
- Policy on collection and retention of records related to health products (POL-0140)
- Policy on individual(s) accompanying a health products inspector (POL-0141)
ROEB is also responsible for compliance and enforcement activities in relation to the Assisted Human ReproductionAct (AHR Act). The AHR Act and its regulations establish at the federal level, the framework to help protect the health, safety, dignity and rights of individuals who use or are born of assisted human reproduction (AHR) in Canada. See the Compliance and Enforcement: Assisted Human Reproduction for more information.
The Compliance and Enforcement Policy for the Assisted Human Reproduction Act (POL-0100) describes Health Canada's national compliance and enforcement approach for materials and activities subject to the AHR Act and its regulations.
- Notice: Regulations amending certain regulations concerning drugs and medical devices (shortages) [2022-03-02]
- Canada’s approach to onsite inspections during COVID-19: Notice [2021-04-07]
- Second Interim Order on Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 [2021-03-01]
- Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 [2020-04-05]
- Medical device shortages [2020-04-05]
Registering a complaint for health products and for materials and activities pertaining to assisted human reproduction:
- Health Product Complaint Process - Summary
- Health Product Complaint Form (FRM-0317)
- Questions and Answers
Annual inspection summary reports outline inspection activities conducted by ROEB.
The Canadian Food Inspection Agency provides all federal inspection services related to food and enforces the food safety and nutritional quality standards established by Health Canada.
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