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:

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:

Processes not directly related to a DEL application are excluded from this guide. This includes:

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:

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