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
Some of the hyperlinks provided are to sites of organizations or other entities that are not subject to the
. 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
- 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 a Certificate of a Pharmaceutical Product (GUI-0024) [2016-04-01]
- 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
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