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)

On this page

• Purpose
• Scope

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:

• Good manufacturing practices inspection policy for drug establishments (POL-0011)

For more information on Health Canada's on-site assessment of a foreign building, consult:

• How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)

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)