Guidance on Drug Establishment Licences (GUI-0002)

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 Food and Drug Regulations (FDR) with regards to drug establishment licence (DEL) requirements.

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Last Updated April 17, 2026, 21:59 (UTC)
Created April 17, 2026, 21:59 (UTC)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2020-12-21 00:00:00
open_canada_keywords {"fr": ["Conseils", "industrie de la fabrication de médicaments", "licences d'établissement de médicaments", "GUI-0002", "conditions de licence"], "en": ["Guidance", "drug manufacturing industry", "Drug Establishment Licences", "GUI-0002", "licence requirements"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Document d'orientation sur les licences d'établissement de produits pharmaceutiques (GUI-0002)
update_frequency as_needed