Description

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.

Resources

Name	Format	Description	Link
Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/chemical-entity-products-quality/guidance-document-use-certificates-suitability-supporting-information-drug-submissions.html
Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/qualite-entites-chimique/ligne-directrice-utilisation-certificats-conformite-titre-information-drogue.html

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