Applications and service standards for drug establishment licences (GUI-0127): Overview
Date implemented: December 4, 2024
Replaces: Management of applications and performance for drug establishment licences (GUI-0127) (March 18, 2020)
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Purpose
This document outlines:
- the responsibilities of applicants in the drug establishment licence (DEL) application process
- how Health Canada manages DEL applications and service standards
This guide is for companies in the pharmaceutical industry requiring a DEL. It will help you understand the DEL requirements and comply with Part C, Division 1A of the Food and Drug Regulations (regulations).
Scope
This document applies to all DEL applications submitted under Part C, Division 1A of the regulations. It covers:
- DEL application concepts
- an overview of the application streams
- processes that Health Canada uses to manage DEL applications
Processes not directly related to a DEL application are excluded from this guide. This includes:
- regular domestic good manufacturing practices (GMP) inspections, which verify the ongoing compliance of DEL holders with GMP requirements
- requests for an on-site assessment of a foreign building by a Health Canada inspector
For more information on domestic GMP inspections, consult:
For more information on Health Canada's on-site assessment of a foreign building, consult:
For information on how to cancel an existing DEL, follow the:
- instructions in the Drug establishment licence application form (FRM-0033)
- guidance in Guidance on drug establishment licences (GUI-0002)
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