Certification of Suitability, CEP Submissions, Filing, Process, APIs, EDQM

Certification of Suitability (CEP) Submissions

Freyr helps API Manufacturers in CEP compilation, review & submission to EDQM for all types of APIs as per EDQM guidelines for approval of MAAs/ANDS. CEP adds an advantage for API manufacturers while entering the EU CEP to the monographs of the European Pharmacopoeia.

Filing Active Pharmaceutical Ingredient (API) Information with the European Directorate (ED) for the Quality of Medicines and HealthCare (EDQM) is not mandatory. However, possessing a Certification of Suitability (CEP) is an added advantage for API manufacturers while entering the EU. CEP to the monographs of the European Pharmacopoeia can be filed only for APIs which have monographs in European Pharmacopoeia (Ph. Eur).

Most of the emerging markets, in addition to Australia, Canada and all European Union (EU) countries accept CEP instead of Active Substance Master File (ASMF)/Drug Master File (DMF) submissions. Letter of Access (LoA) of CEP, received from EDQM can be provided to drug product applications like Marketing Authorization Application (MAA) to all EU countries, Therapeutic Goods Administration (TGA) of Australia & most of the emerging markets and Abbreviated New Drug Submission (ANDS) to Health Canada (HC) instead of ASMF/DMF submission.

EDQM has specific requirements for the submission and granting CEP for API/drug substances. Hence, expertise is required in filing CEPs with EDQM for quick approval of MAAs/ANDS.

Know more at Freyr Page - Certification of Suitability (CEP) Submissions

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