Establishment Licences

Establishment Licence Live Listing

• Drug and health product inspections
• Medical Devices Establishment Licence Listing (MDEL)

Good Manufacturing Practices (GMP) Inspection List

• Good Manufacturing Practices (GMP) Inspection List

Compliance program bulletins

• Drug Establishment Licensing Bulletins
• Medical devices 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)
  • Table A: Foreign Building Conducting Active Pharmaceutical Ingredients Related Licensable Activities
• 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)

Cells, Tissues and Organs

• Guidance Document for Cell, Tissue and Organ Establishments - Safety of Human Cells, Tissues and Organs for Transplantation
• Human Cells, Tissues and Organs (CTO) for Transplantation Registration Application Form (FRM-0171)