Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only)

The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs (ie. changes to a drug that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations). This guidance document provides overarching authorities, a general description of the reporting categories and drug submission filing information.

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Champ	Valeur
Dernière modification	avril 17, 2026, 21:53 (TU)
Créé le	avril 17, 2026, 21:53 (TU)
criticality_level	[]
geographic_scope	[]
open_canada_collection	publication
open_canada_date_published	2020-11-19 00:00:00
open_canada_keywords	{"fr": ["document d'orientation", "sommaire", "modifications", "post-avis", "de conformité", "AC", "document-cadre", "produits pharmaceutiques", "biologiques", "radiopharmaceutiques", "médicaments à usage", "humain uniquement", "cadre", "documents", "d'orientation", "sur l'innocuité", "efficacité", "qualité s'appliquent", "promoteurs", "qui ont l'intention", "de faire", "une approbation", "postérieure", "changements apportés", "aux nouveaux médicaments"], "en": ["summary guidance document", "post-notice-of-compliance-changes", "NOC", "framework document", "Pharmaceutical", "biologic", "radiopharmaceutical", "drugs for human-use-only", "framework", "Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs"]}
open_canada_subject	["health_and_safety"]
sensitivity_level	unrestricted
title_fr	Sommaire : Ligne directrice - Changements survenus après l'avis de conformité (AC) : Document cadre (Médicaments pharmaceutiques, biologiques et radiopharmaceutiques à usage humain seulement)
update_frequency	as_needed