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
- 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]
- 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]