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Importation & Exportation
The importation and exportation of health products is regulated under the Food and Drugs Act and its associated Regulations includes Human Drugs; Natural Health Products; Medical Devices; Veterinary Drugs; Blood and Blood Components for Transfusion; Human Cells, Tissues and Organs for Transplantation; and Semen for Assisted Conception. This section provides the requirements, policies and guidance documents with respect to importation and exportation of health products.
This section only addresses the requirements under the Food and Drugs Act and its Regulations for health products. Some health products may also have additional restrictions placed on them by other Acts and Legislation, such as the Controlled Drugs and Substances Act and its associated Regulations. Where two different restrictions/requirements exist, such as the quantity allowed for importation, the most restrictive or prescriptive will take precedence.
On this page:
Forms
- Export Certificate (FRM-0176)
- Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products being Exported (FRM-0038)
- Request for Stamping
- Good Manufacturing Practices - Audit Report Form (FRM-0211)
- Good Manufacturing Practices - Audit Report Form (FRM-0211) Instructions for Completing the form
- Good Manufacturing Practices - Foreign Site Submission Form (FRM-0212)
- Good Manufacturing Practices - Request for an Inspection of a Foreign Site Form
(FRM-0213) - Good Manufacturing Practices - Foreign Site Inspection Services Agreement Form
(FRM-0214)
Frequently Asked Questions (FAQ's)
Guidance Documents and Policies
- Guidance Document on the Application for Certificate of a Pharmaceutical Product
(GUI-0024) [2011-02-04] - Border Integrity Approach (POL-0059) [2010-06-01]
- Import and Export Policy for Health Products under the Food and Drugs Act and its Regulations (POL-0060) [2010-06-01]
- Import Requirements for Health Products under the Food and Drug Act and its Regulations (GUI-0084) [2010-06-01]
- Guidance on Evidence to Demonstrate Drug Good Manufacturing Practices (GMP) Compliance of Foreign Sites (GUI-0080) [2009-09-01]
- PIC/S Annex 1: Explanatory Notes for Industry on the Preparation of a Site Master file [2008-01-18]
- Policy for the Importation or Sale of Active Pharmaceutical Ingredients for Veterinary Use (POL-0018) [2007-04-05]
- Conditions for Provision of Packaging/Labelling Services for Drugs under Foreign Ownership (GUI-0067) [2004-05-01]
