Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)

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. These new drugs may include pharmaceuticals, biologics, and radiopharmaceuticals for human use, including those submissions for which a NOC has been recommended but issuance of the NOC has been placed on hold.

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Name Format Description Link
Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only) 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/document.html#a1
Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only) 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/document.html#a11

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