Enforcement Activities

The Health Products and Food Branch Inspectorate (Inspectorate) is responsible for activities concerning compliance and enforcement of the Food and Drugs Act (with the exception of products regulated as foods which are the responsibility of the Canadian Food Inspection Agency (CFIA)). This act and its associated regulations set standards for quality, health and safety, conditions for sale and the prevention of fraud for human and veterinary drugs, medical devices, natural health products and biological and related biotechnology products. Enforcement and compliance activities include the delivery of inspections, investigations, most establishment licensing and related laboratory analysis functions.

The Inspectorate's decision-making process is guided by the level of risk to the health of Canadians and will follow the risk management decision-making principles outlined in the Health Canada Decision-Making Framework document. Compliance and enforcement activities is directed at the earliest point of distribution to achieve the greatest impact and efficiency. Whether a compliance issue is identified through a trade or consumer complaint or other source, the priority given will be based on the level of risk.

Where non-compliance is brought to the attention of a regulated party by the Inspectorate, it is the regulated party's responsibility to take timely and appropriate action to comply with legislative and regulatory requirements. The Inspectorate evaluates instances of non-compliance to determine the most appropriate action(s) to be taken.

Guidance Documents, Directives and Policies

• Guidance Documents, Directives and Policies
  • Policy on Individual(s) accompanying a health products inspector (POL-0141)
  • Notice to Stakeholders: Expiration Dating for Medical Gases [2021-03-26]
  • Policy on inspector orders for health products [2021-03-17]
  • Policy on collection and retention of records related to health product compliance and enforcement [2021-03-17]
  • Policy on accessing the premises of a regulated party remotely to verify compliance [2021-03-01]
  • Amendments to the Food and Drugs Act Guide to New Authorities [2015-07-31]
  • Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities – What We Heard [2015-07-31]
  • Policy on Counterfeit Health Products (POL-0048) [2010-05-14]
  • Guidance on Medical Device Compliance and Enforcement (GUI-0073) [2015-06-12]
  • Quality System Framework - Summary
  • Guidance Policy - Use of Positron Emitting Radiopharmaceuticals (PERs) in Basic Research Policy (POL-0053)
    • Guidance Document - Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals for Use in Basic Clinical Research Studies [2014-12-30]
  • Drug Identification Number (DIN) Enforcement Policy (POL-0040)
  • Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004)
  • Compliance and Enforcement Policy (POL-0001)
  • Product Recall Procedures
  • GMP Inspection Policy for Canadian Drug Establishments (POL-0011)

Recalls

• Recalls
• Nitrosamine impurities in medications [2020-08-24]

Suspension of Establishment Licence

• Suspension of Establishment Licence