Guidance on Drug Establishment Licences and Associated Fees (GUI-0002) - Summary

Regulatory Operations and Enforcement Branch

Overview

These guidelines interpret the requirements for drug establishment licensing in Part C, Division 1A of the Food and Drug Regulations (FDR) and the associated fee based on the Fees in Respect of Drugs and Medical Devices Regulations.

Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, so that the rules are enforced in a fair, consistent and effective way across Canada.

This guide is for companies in the drug manufacturing industry. It will help to facilitate understanding and compliance with Part C, Division 1A of the FDR, and the Fees in Respect of Drugs and Medical Devices Regulations with regards to drug establishment licence (DEL) requirements and associated fees.

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 (53 pages, 1.5 MB)

Details and history

Published: [April 08, 2019]

Consulted: N/A

For assistance

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

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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