Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions

Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions The purpose of the guidance document is to outline the requirements when preparing submissions that rely on Certificates of Suitability (CEPs) issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM) to support the safety and effectiveness of a drug. 2023-09-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetydrug submissionssupporting-information in Drug-SubmissionsCertificates of SuitabilityCEPs.Use of Certificates-of-Suitabilitysafety-and-effectiveness of drug Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug SubmissionsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/drug-products/draft-guidance-document-use-certificates-suitability-supporting-information-drug-submissions.html Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug SubmissionsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/participation-public-consultations/medicaments/ebauche-ligne-directrice-utilisation-certificats-conformite-titre-information-drogue.html

The purpose of the guidance document is to outline the requirements when preparing submissions that rely on Certificates of Suitability (CEPs) issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM) to support the safety and effectiveness of a drug.

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