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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
- Frequently Asked Questions - Drug Establishment Licensing and Fees [Updated 2013-04-01]
- Drug Establishment Licence Application Completion Checklist [2013-03-15]
- Drug Establishment Licence Application: Forms and Instructions (FRM-0033) [2011-04-01]
- Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) [2013-04-01]
- Drug Establishment Licence - Calculation Chart [2013-03-15]
- Part C: Canadian Warehouse Form [2013-03-15]
- Good Manufacturing Practices - Foreign Site Submission Form - Section 5 (FRM-0212) [2013-03-15]
- Guidance Document - Alternate Sample Retention Site Guidelines (GUI-0014) [2011-11-18]
- Contract Sterilization Letter
- Emergency Contact Information Form
- Export Certificate (FRM-0176)
- Good Manufacturing Practices (GMP) and Establishment Licences (EL) Issues [2010-07-01]
- 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
- 2011 Drug Establishment Fee Remission Applicants in Respect to Veterinary Use Only (Letter and Form)
Medical Devices
- How to Pay Fees [2011-02-18]
- Medical Device Establishment Licence Annual Review 2013 [New 2012-12]
- Medical Device Establishment Licence Application: Form and Instructions (FRM-0292) [Updated 2012-12-12]
- Medical Device Establishment Licence Application Completion Checklist [Updated 2012-12-12]
- Medical Device Establishment Licence: Calculation Chart [Updated 2012-12-12]
- Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016) [Updated 2013-04-01]
- Frequently Ask Questions (FAQ's) - Medical Device Establishment Licensing and Fees [Updated 2013-04-01]
