Health Canada
www.hc-sc.gc.ca
Common menu bar links
Institutional links
Drugs and Health Products
International
Cooperative Agreements and Activities
- Closer ties on medicines safety between European and Canadian regulatory authorities
MRA - Mutual Recognition Agreements on Drugs/Medicinal Products Good Manufacturing Practices Compliance Programmes
- Background
- MRAs Updates
- Internationally Harmonized Requirements for Batch Certification
- Standard Operational Procedure for the Determination of Equivalency of Inspection Methods
Some of the hyperlinks provided are to sites of organizations or other entities that are not subject to the 
Official Languages Act. The material found there is therefore in the language(s) used by the sites in question.
Partnerships
- PIC/S - Pharmaceutical Inspection Co-operation Scheme
- WHO - World Health Organization
- ICH - International Conference on Harmonization
- GHTF - Global Harmonization Task Force
- OMCL - Official Medicines Control Laboratories
Regulatory Agencies
- FDA - Food and Drug Administration - United States of America
- TGA - Therapeutic Goods Administration - Australia
- AGENCE Francaise de Securite Sanitaire des Produits de Sante - France
(available in French only) - Läkemedelsverket Medical Product Agency - Sweden
(available in Swedish only) - Medicines Control Agency - United Kingdom
- European Commission
- European Agency for the Evaluation of Medicinal Products
Export and Import
- Guidance Document on the Application for Certificate of a Pharmaceutical Product (GUIDE-0024) [2011-02-04]
- Export Certificate (FRM-0176)
- Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080) (August 1, 2009)
- Cover Letter
- Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products being Exported
- PIC/S Annex 1: Explanatory Notes for Industry on the Preparation of a Site Master file (January 18, 2008)
- Policy for the Importation or Sale of Active Pharmaceutical Ingredients for Veterinary Use
- Request for Stamping
