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


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

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

Details and history

Published: [April 01, 2020]

For assistance

By email
DEL Question <>

Service standards: We answer to mail within 10 business days. If we cannot answer your question within the service standard, we will inform you and we will aim to get you a response as soon as possible.

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