Import and export of drugs and health products: Compliance and enforcement 

Importing and exporting health products is regulated under the Food and Drugs Act and its associated Regulations. Some health products may also have additional restrictions placed on them by other Acts and Regulations.

On this page

• Health product import and export laws and regulations
• Notice
• Forms
• Frequently asked questions (FAQs)
• Guidance documents and policies

Health product import and export laws and regulations

The import and export of health products are regulated under the Food and Drugs Act and its associated Regulations. These laws and regulations apply to:

• human drugs
• medical devices
• veterinary drugs
• natural health products
• veterinary health products
• blood and blood components for transfusion
• human cells, tissues and organs for transplant

Some health products have additional restrictions placed on them by other Acts such as the: 

• Controlled Drugs and Substances Act and its associated Regulations
• Convention on International Trade in Endangered Species of Wild Fauna and Flora

Where 2 different restrictions or requirements exist, such as the quantity allowed for importation, the most restrictive or prescriptive rule will apply. The import and export requirements of sperm and ova for assisted conception are outlined in the Assisted Human Reproduction Act.

Notice

• Toronto 2015 Pan American and Parapan American Games - Importing and Exporting Controlled Substances, Precursor Chemicals and Therapeutic Products
• Advance notice of importation process for cosmetics and drugs

Forms

• Intention to Invoke Section 37 of the 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 (FAQs)

• 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]
• 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]
• Conditions for Provision of Packaging/Labelling Services for Drugs under Foreign Ownership (GUI-0067) [2004-05-01]