Description

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.

Resources

Name	Format	Description	Link
Post-Notice of Compliance (NOC) Changes – Quality Guidance	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/post-notice-compliance-changes/quality-document/guidance.html#t1
Post-Notice of Compliance (NOC) Changes – Quality Guidance	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/changements-survenus-apres-avis-conformite/document-qualite/lignes-directrices.html#t1

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