Annual Review Documents

As of April 1, 2011, establishment licences will no longer expire on December 31 of each year. In order to continue to hold a valid establishment licence, an application for annual review along with the appropriate payment must be submitted to Health Canada before April 1 of each year. Please find below the links to the updated information including letters, application forms and other relevant documents that must be used for preparing your annual review application.

• Drugs
• Medical Devices

Drugs

• How to Pay Fees [2011-02-18]
• Drug Establishment Licences
  • Drug Establishment Licence Application Completion Checklist [2013-03-15]
  • Drug Establishment Licence Application:Forms and Instructions (FRM-0033) [2013-11-08]
    • Table A: Foreign Building Conducting Active Pharmaceutical Ingredients Related Licensable Activities
  • Drug Establishment Licence - Calculation Chart [2013-03-15]
  • Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) [2013-04-01]
• Guidance Document - Alternate Sample Retention Site Guidelines (GUI-0014)
  [2011-11-18]
• Contract Sterilization Letter
• Emergency Contact Information Form
• Drug Establishment Good Manufacturing Practices - Pre-Application Package (Importers, Distributors and Wholesalers) [2011-07-22]
• Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080) - Current Practices letter
• Notice to Stakeholders: Foreign Sites - Expiring; Change to Expiry Calculation
  [2012-08-29]
• Notice to Stakeholders - New for 2012 Drug Establishment Licence (DEL) Annual Review - Evidence to Demonstrate GMP Compliance of Foreign Sites [2011-07-29]
• Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products being Exported

Medical Devices

• Cancellation of MDELs for non-compliance with annual licence review requirements [2024-05-28]
• What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2024 [2023-11-15]
• Frequently Ask Questions (FAQ's) - Medical Device Establishment Licensing and Fees [Updated 2020-04-01]
• How to Pay Fees [2011-02-18]
• Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) [Updated 2020-04-01]
• Guidance on Medical Device Establishment Licensing (GUI-0016)
  [Updated 2020-04-01]