Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only)

Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only) The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs (ie. changes to a drug that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations). This guidance document provides overarching authorities, a general description of the reporting categories and drug submission filing information. 2023-09-30 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetysummary guidance documentpost-notice-of-compliance-changesNOCframework documentPharmaceuticalbiologicradiopharmaceuticaldrugs for human-use-onlyframeworkSafety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only)HTML Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only) - Canada.ca Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (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/cadre-2019.html

The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs (ie. changes to a drug that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations). This guidance document provides overarching authorities, a general description of the reporting categories and drug submission filing information.

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