Establishment Licences
For industry information about COVID-19, visit our COVID-19 health product industry section.
Establishment Licence Live Listing
Good Manufacturing Practices (GMP) Inspection List
Compliance program bulletins
Notice
- Letter to Stakeholders - Responsibilities and Obligations with Respect with the Good Manufacturing Practices
- Notice to Stakeholders - Establishment Licence Application Deadline - February 8, 2014
- Notice to Stakeholders - Good Manufacturing Practices for Active Pharmaceutical Ingredients - Implementation Pilot Project for Selected Consumer Health Products
- Notice to Stakeholders - Amended Food and Drugs Regulations for Active Ingredients - Coming into force on November 8, 2013
- Notice to Stakeholders: Foreign Sites - Expiring; Change to Expiry Calculation [2012-08-29]
- Notice: Health Products and Food Branch Inspectorate - Establishment Licensing - Important Upcoming Changes [2011-04-01]
Drugs
All Canadian drug establishments must hold, since January 1, 1998 an establishment licence to fabricate, package, label, distribute, import, wholesale, or test a drug.
- Annex 7 to the good manufacturing practices guide, selected non-prescription drugs (GUI-0066) [2023-09-29]
- Consultation opens for the Good manufacturing practices guide: Manufacture of biologics (GUI-0027) [2023-09-20]
- Publication of updated Annex 1 to the Good manufacturing practices guide - Manufacture of sterile drugs - GUI-0119 [2023-08-24]
- Guidance on veterinary antimicrobial sales reporting [2023-03-13]
- Management of Applications and Performance for Drug Establishment Licences (GUI-0127)
- Drug Establishment Licence Application Forms and Instructions (FRM-0033)
- Emergency Contact Information Form
- Drug Establishment Licence Application Completion Checklist
- Drug Establishment Licence - Calculation Chart [2013-03-15]
- How to Pay Fees to Health and Food Branch (HPFBI) [2011-02-18]
- How to pay your establishment licence fees [2018-09-07]
- Guidance on Drug Establishment Licences (GUI-0002)
- Fees for the Review of Human and Veterinary Drug Establishment Licence Applications
- Drug Establishment Good Manufacturing Practices - Pre-Application Package (Importers, Distributors and Wholesalers) [2011-07-22]
- Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004)
- GMP Inspection Policy for Canadian Drug Establishments (POL-0011)
- Guidance on Evidence to Demonstrate Drug Compliance of Foreign Sites (GUI-0080)
- Guidance Document - Alternate Sample Retention Site Guidelines (GUI-0014) [2011-11-18]
- Contract Sterilization Letter
Blood
- Blood Establishment Registration Application: Form and Instructions - (FRM-0353)
- Blood Establishment Licensing Application Form and Instructions - (FRM-0354)
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]
- COVID-19 Medical Device Establishment Licence (MDEL) supensions [Updated 2021-02-11]
- Guidance on Medical Device Establishment Licensing (GUI-0016)
[Updated 2020-04-01] - Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) [Updated 2020-04-01]
- Frequently Ask Questions (FAQ's) - Medical Device Establishment Licensing and Fees [Updated 2020-04-01]
- Fees for the Review of Medical Device Establishment Licence Applications [2019-11-04]
- How to Pay Fees to Health Products and Food Branch (HPFBI) [2011-02-18]
- How to Pay Your Establishment Licence Fees [2018-09-07]
- Application for a Manufacturer's Certificate to Cover Export of Medical Devices (GUI-0097)
- Guidance on Medical Device Compliance and Enforcement (GUI-0073) [2015-11-30]
- How Health Canada inspects medical device establishments (GUI-0064) [2016-11-15]
Export
- Guidance on obtaining electronic certificates of pharmaceutical product and good manufacturing practices (GUI-0024)
- Importation and Exportation
- The Importation and Exportation questions and answers (Q&A)