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

Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only) 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. 2021-07-07 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGuidance documentpost-notice of complianceNOC Changeschanges to new drugssafety and efficacy documentpharmaceuticalbiologicradiopharmaceuticaldrugs for human usesection C.08.004 of the Food and Drug Regulations 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

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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