Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions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

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Title (French) Ébauche de la ligne directrice: Utilisation de certificats de conformité à titre d'information à l'appui des présentations de drogue
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Open Canada Date Published 2017-05-18 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["présentations de médicaments", "informations à l'appui dans les présentations de médicaments", "certificats de conformité", "CEP", "utilisation des certificats de conformité", "innocuité et efficacité du médicament"], "en": ["drug submissions", "supporting-information in Drug-Submissions", "Certificates of Suitability", "CEPs", ".Use of Certificates-of-Suitability", "safety-and-effectiveness of drug"]}
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