Post-Notice of Compliance (NOC) Changes – Quality Guidance

This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to Section C.08.004 of the Food and Drug Regulations. This may include pharmaceuticals, biologics and radiopharmaceuticals for human use and pharmaceutical, radiopharmaceutical and certain biotechnological products for veterinary use.

Data and Resources

Additional Info

Field Value
Last Updated April 17, 2026, 22:00 (UTC)
Created April 17, 2026, 22:00 (UTC)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2020-08-26 00:00:00
open_canada_keywords {"fr": ["Post-avis de conformité", "changements d'AC", "directives de qualité", "changements aux nouveaux médicaments", "article C.08.004 du Règlement sur les aliments et drogues", "produits pharmaceutiques", "produits biologiques", "radiopharmaceutiques", "médicaments à usage humain", "médicaments biotechnologiques à usage vétérinaire"], "en": ["Post-Notice of Compliance", "NOC Changes", "quality guidance", "changes to new drugs", "section C.08.004 of the Food and Drug Regulations", "pharmaceuticals", "biologics", "radiopharmaceuticals", "drugs for human use", "biotechnological drugs for veterinary use"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Ligne directrice : Changements survenus après l’avis de conformité (AC) : Document sur la qualité
update_frequency as_needed