Importation and Exportation - Compliance and Enforcement - Drugs and Health Products - Health Canada

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:

• Notice
• Forms
• Frequently Asked Questions (FAQ's)
• Guidance Documents and Policies

Notice

• Toronto 2015 Pan American and Parapan American Games - Importing and Exporting Controlled Substances, Precursor Chemicals and Therapeutic Products
• Important Information to Stakeholders - Implementation of Advance Notice of Importation Process Pilot for Cosmetics and Drugs

Forms

• Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products being Exported (FRM-0038)
• Good Manufacturing Practices - Audit Report Form (FRM-0211)
• Good Manufacturing Practices - Audit Report Form (FRM-0211) Instructions for Completing the form
• 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)

• Importation and Exportation Questions and Answers
• Frequently Asked Questions - Health Products and Food Branch Inspectorate

Guidance Documents and Policies

• Guidance Document on the Application for Certificate of Pharmaceutical Product (GUI-0024) [2014-04-01]
• 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]
  • Cover Letter
  • Notice to Stakeholders - New for 2012 Drug Establishment Licence (DEL) Annual Review - Evidence to Demonstrate GMP Compliance of Foreign Sites [2011-07-29]
  • Notice to Stakeholders: Foreign Sites - Expiring; Change to Expiry Calculation [2012-08-29]
• 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]