Guidance Documents, Directives and Policies

The Health Products and Food Branch Inspectorate (Inspectorate) is responsible for all activities concerning compliance and enforcement of the Food and Drugs Act (FDA) (with the exception of products regulated as foods which are the responsibility of the Canadian Food Inspection Agency (CFIA)) and the Controlled Drugs and Substances Act (CDSA) and their associated Regulations. These acts and 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 and diversion from illegitimate uses. The Inspectorate provides enforcement and compliance activities such as the delivery of inspections, investigations, most establishment licensing and related laboratory analysis functions.

• Policy on Counterfeit Health Products (POL-0048) [2010-05-14]
• Guidance on Medical Device Compliance and Enforcement (GUI-0073) [2015-06-12]
• Request for comments from industry on Draft Guidance Document: HPFBI Guidelines for Recall of Drug and Natural Health Products. (GUIDE-0039)
• Health Products and Food Branch Inspectorate - Recall Policy (POL-0016)
• 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)
• Compliance and Enforcement Policy (POL-0001)
• Product Recall Procedures
• Guidance Document: Schedule A and Section 3 of the Food and Drugs Act
• Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004)
• GMP Inspection Policy for Canadian Drug Establishments (POL-0011)