Drugs

The maintenance and enhancement of health and safety is a responsibility that is shared between government and industry, consumers, healthcare professionals and their respective associations.

Regulated parties that market drugs and medical devices have the primary responsibility for the safety of any product they sell, manufacture, import or distribute to the Canadian public. These regulated parties must comply with all legislative and regulatory requirements.

The Health Products and Food Branch Inspectorate (Inspectorate) has the legislative/regulatory authority to conduct compliance and enforcement activities including: the delivery of inspections, investigations, most establishment licensing and related laboratory analysis functions for the HPFB. It also has a responsibility to foster partnerships in the regulatory community, including our international, federal and provincial partners.

On this page:

• Public Warning / Advisories
• Active Pharmaceutical Ingredients
• Adverse Reaction Information
• Canada's Access to Medicines Regime (CAMR)
• Compliance Inspections of Pharmacies
• Disinfectants
• Drug Product Database
• Drug Establishment Licences
• Enforcement Guides and Policies
• Good Clinical Practices
• Good Pharmacovigilance Practices (GVP)
• Importation and Exportation
• Recalls
• Veterinary

Public Warning / Advisories

• Advisories for Health Professionals or Consumers

Active Pharmaceutical Ingredients

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

• Regulations Amending the Food and Drug Regulations (1475 - Good Manufacturing Practices)
• Proposed Regulations Amending the Food and Drug Regulations (1475 - Good Manufacturing Practices)
• Cost-Benefit Analysis: Regulations Amending the Food and Drug Regulations - Good Manufacturing Practices for Active Ingredients
• Cost-Benefit Analysis Supplemental: Small Business Lens under the Cabinet Directive on Regulatory Management
• Consultation on the Creation of a regulatory framework for the implementation of Good Manufacturing Practices for active pharmaceutical ingredients
• Notice of Intent Published in Canada Gazette Part 1, December 7, 2002 and Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients ICH Topic Q7A
•  International Conference on Harmonisation - ICH Q7 Guidance (PDF version - 352 K)

Adverse Reaction Information

• Draft Guidance For Industry - Marketed Health Product Name Assessment: Look-alike Sound-alike (LA/SA) Health Product Names
• Look-alike Sound-alike Health Product Names
• Executive Summary: Look-Alike Sound-Alike (LA/SA) Health Product Names Consultative Workshop

Canada's Access to Medicines Regime (CAMR)

• Inspection Strategy for Canada's Access to Medicines Regime (POL-0055)
• Guidance for Pre-manufacturing and Pre-exportation Notifications (C.07.011) under Canada's Access to Medicines Regime

Compliance Inspections of Pharmacies

• Summary Report of the Compliance Inspections of Canadian Pharmacy Sites Involved in the Sale of Prescription Drugs Via the Internet or Via Distance Dispensing
• Letter to Pharmacists / Obligations of Pharmacists under the Food and Drugs Act and Food and Drug Regulations
• Fact Sheet
• Frequently Asked Questions
• Reminder of obligations with respect to the advertising and sale of drugs

Disinfectants

• Standard for the Fabrication, Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices Version 2 (GUIDE-0049)
• Canada Gazette Part II (December 15, 2004) Regulations Amending the Food and Drug Regulations (1356 - Disinfectants)

Drug Product Database

Drug Establishment Licences

• Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004)
• Drug Establishment Licence Application: Form and Instructions
• Drug Establishment Licence Application:Forms and Instructions (FRM-0033) [2011-04-01]
• Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) [2011-04-01]
• Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080) (August 1, 2009)
  • Cover Letter

Enforcement Guides and Policies

Good Clinical Practices

Good Pharmacovigilance Practices (GVP)

• Notice to Stakeholders: Name change for the Post-Market Reporting Compliance (PMRC) inspection program to Good Pharmacovigilance Practices (GVP)
• Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102)
• Risk Classification of Good Pharmacovigilance Practices (GVP) Observations (GUI-0063)
• Inspection Strategy for Good Pharmacovigilance Practices for Drugs (POL-0041)
• Summary Report of the Post-Market Reporting Compliance Inspections Conducted from September 1, 2005 to March 31, 2008

Importation and Exportation

Recalls

• Health Products and Food Branch Inspectorate - Recall Policy
  (POL-0016)
• Product Recall Procedures
• Request for comments from industry on Draft Guidance Document: HPFBI Guidelines for Recall of Drug and Natural Health Products. (GUIDE-0039)

Veterinary

• Policy for the Importation or Sale of Active Pharmaceutical Ingredients for Veterinary Use