Guidance on Drug Establishment Licences (GUI-0002)

Regulatory Operations and Enforcement Branch

April 1st, 2020 updates

These guidelines have been updated on April 1st, 2020. The update included the removal of all reference to DEL fees. This information is now available in a standalone guide, Fees for the Review of Human and Veterinary Drug Establishment Licence Applications.

The following changes were also made:

• Section 3 was revised to improve the clarity of the requirements that pertain to the Sterilization of Raw Materials and Packaging Material
• Section 6 has been revised to clarify that each DEL foreign building annex (for importers) is specific to one domestic building

Overview

These guidelines interpret the requirements for drug establishment licensing in Part C, Division 1A of the Food and Drug Regulations (FDR) .

These guidelines are meant to help companies in the drug manufacturing industry and health care professionals understand how to comply with regulations, specifically drug establishment licence (DEL) requirements in Part C, Division 1A of the FDR. They also provide guidance to Health Canada staff, so that the rules are enforced in a fair, consistent and effective way across Canada.

Who this guide is for

This guide is for people who work with drugs as:

• Fabricators
• Packagers
• Labelers
• Testers
• Distributors
• Importers
• Wholesalers

In this guide

• About this document
  1. Purpose
  2. Scope
  3. How Guidance Documents Work
• Application of DEL Requirements
  1. Activities to which DEL Requirements Apply
  2. Exemptions
     • Wholesaling Over-the-Counter Pharmaceutical Drugs or Non-Scheduled Drugs Including Non-Scheduled Ethical Drugs
     • Distributing or Wholesaling Active Pharmaceutical Ingredients
     • Wholesaling of a Drug Premix
     • Conducting Activities Related to a Drug that is Used for the Purpose of a Clinical Trial Authorized by Health Canada
     • Storing Drugs
     • Transporting Drugs
     • Importing or Compounding a Drug not Commercially Available for Sale in Canada
     • Assembling Kits and Promotional Material
     • Conducting Activities Related to Antimicrobial Agents
     • Activities Related to Biologicals for Veterinary Use
  3. Inclusions
     • Third Party Performing Testing Required by Part C, Division 2 of the Food and Drug Regulations
     • Sterilization of Raw Materials and Packaging Material
     • Medical Gas Trans-Filling and Curbside Filling
     • Export
  4. Combination Products
• Prohibition and Interpretation
  5. Prohibition
     • Exception - Test
     • Exception – Package/Label for Fabricator
     • Exception – Label for Importers
  6. Drug Establishment Licensing Requirements
  7. Category of Drugs
     • Active Pharmaceutical Ingredients (API)
     • Pharmaceuticals
     • Biologics
     • Vaccines
     • Radiopharmaceutical
     • Prescription Drug List, Schedule G, Drugs Containing Cannabis, and/or Narcotics
     • List A API for Veterinary Use
  8. Storing Drugs as a DEL Holder
  9. Alternate Sample Retention
• DEL Application
  10. Application Types
      • New DEL Application (C.01A.005)
      • Amendment Application (C.01A.006)
      • Annual Licence Review (ALR) Application (C.01A.009)
      • NERBY Application (C.01A.009/C.01A.006)
      • Reinstatement Application (C.01A.018)
      • Cancellation Application
  11. Submitting a DEL Application other than ALR
      • FRM-0033
      • Table A
      • Evidence of Compliance with GMP – Domestic Buildings
      • Evidence of Compliance with GMP – Foreign Buildings
  12. Authority to Request Additional Information, Inspect and Request Samples
      • Additional Information
      • Inspection
      • Samples
  13. Rejection of Application
  14. Refusal to Issue, Amend or Reinstate
  15. Issuance
      • Issuance with Terms and Conditions
  16. The DEL and its Annexes
      • Domestic Buildings
      • DEL Annexes
  17. Submitting an ALR Application
      • ALR Package
      • ALR GMP Evidence Requirements – NERBY
  18. ALR Review Outcomes
  19. Notification Requirements
      • MRA Permits
      • Contravention to GMP that may affect Quality, Safety or Efficacy of a Drug
      • Notifiable Changes
  20. Amalgamations and Changes of Ownership
• Compliance and Enforcement
  21. Suspension Authority
  22. Cancellation
  23. Authority to Add or Amend Terms and Conditions
• Contact Information
• Appendix A - Glossary
  • Acronyms
  • Terms
• Appendix B - References
  • Laws
  • Guidelines
  • Policies
  • Forms
  • Other related documents and tools

View complete guide
Download PDF (45 pages, 1.5 MB)

Details and history

Published: [April 01, 2020]

For assistance

By email
DEL Question <hc.del.questions-leppp.sc@canada.ca>

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