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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Champ Valeur
Dernière modification avril 17, 2026, 21:59 (TU)
Créé le avril 17, 2026, 21:59 (TU)
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