Health Products Compliance Monitoring

 In Regulatory Affairs, Uncategorized

By: Sarah Calder, Regulatory Affairs Specialist, email

Importers, manufacturers, and distributors of health products regulated under the Food and Drugs Act who advertise in Canada must ensure that they are in compliance with applicable Canadian laws.  Health Canada manages the risk posed to public health and safety by these health products through various types of compliance and enforcement activities.

Compliance & Enforcement Activities

  • Inspection of licensed establishments by visual examination of a facility, inventories, and equipment; collection and review of documents and records; and collection of samples for laboratory analysis.
  • Consumer product sampling and testing.
  • Review of complaints, incident reports, and adverse reaction reports and follow-up.

It is important to note that Foreign establishments that conduct regulated activities in Canada or in relation to a product sold, imported or advertised in Canada are also subject to Canadian law.

The Health Product Compliance Directorate Has Planned Compliance Monitoring Events For 2019-2020

  • Natural health product GMP follow-up visits from previous inspection programs to verify corrective actions have taken place.
  • Testing of workout supplements regulated as natural health products to screen for undeclared ingredients or contamination.
  • Products imported by the Advance Notice of importation Process Pilot to verify labeling.
  • Drug Establishment Licenced facility visits to verify compliance of foreign sites.
  • Compliance site visits of Veterinary Health Products (VHPs) and Medically Important Antimicrobial (MIA) for food-producing animals and animals intended to be consumed as food.

Are you aware of all your obligations under the Food and Drugs Act?

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