Certificates of Suitability (CEP/COS)
CEP is granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM). The CEP confirms that pharmaceutical substances or active pharmaceutical ingredients (API) are produced according to the monographs of the EP, and therefore meeting the requirements of EU directives for medicines.
Advantages of the CEP
- Full confidentiality of the submitted data,
- Centralized evaluation by the EDQM,
- Recognized by all Member States of the European Pharmacopoeia Convention (36 countries) as well as by other countries,
- Easing of the management of applications for marketing authorization (MAA) for medicinal products in these countries,
- Simplifies the approbation of a medicinal product compared to the active substance master file (ASMF) or European drug master file (EDMF).