Description

The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs.

Resources

Name	Format	Description	Link
Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/post-notice-compliance-changes/safety-efficacy-2019.html
Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/changements-survenus-apres-avis-conformite/innocuite-efficacite-2019.html

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