Guidance Document: Notice of Compliance with Conditions (NOC/c)

Guidance Document: Notice of Compliance with Conditions (NOC/c) This guidance document combines and supercedes the policy and guidance documents for Notices of Compliance with Conditions (NOC/c) dated June 12, 2007. The revisions to this document incorporate the provision for the filing of Abbreviated New Drug Submissions (ANDSs) or Supplement to an Abbreviated New Drug Submissions (SANDSs) that reference a Canadian Reference Product (CRP) with NOC/c indications. 2023-09-29 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyguidance documentnotice of complianceNOC with ConditionsNOC/cabbreviated new-drug submissionsANDSssupplement to SANDSsCanadian Reference ProductCRP Guidance Document: Notice of Compliance with Conditions (NOC/c)HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/notice-compliance-conditions.html Guidance Document: Notice of Compliance with Conditions (NOC/c)HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/avis-conformite-conditions.html

This guidance document combines and supercedes the policy and guidance documents for Notices of Compliance with Conditions (NOC/c) dated June 12, 2007. The revisions to this document incorporate the provision for the filing of Abbreviated New Drug Submissions (ANDSs) or Supplement to an Abbreviated New Drug Submissions (SANDSs) that reference a Canadian Reference Product (CRP) with NOC/c indications.

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