CEP (Certificate of Suitability): what it is and why it matters

What is a CEP?

A Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) is issued by the EDQM (European Directorate for the Quality of Medicines). It certifies that the quality of an active substance is suitably controlled by the relevant Ph. Eur. monograph, and — where applicable — that TSE/BSE risk has been assessed.

Why formulators value a CEP

• Faster qualification. With a valid CEP, the marketing-authorisation applicant can reference the certificate instead of a full Active Substance Master File (ASMF/EDMF) assessment in many cases.
• Regulatory trust. The CEP is issued and periodically re-verified by the EDQM, so authorities already trust the substance's quality.
• Simpler variation filings. A CEP with a stable number eases changes to the marketing authorisation.

CEP vs. DMF/ASMF

• CEP = substance quality conforms to a public Ph. Eur. monograph.
• DMF (US) / ASMF-EDMF (EU) = a confidential dossier describing the manufacturing process, covering substance-specific details not in a public monograph.
• A supplier may hold a CEP and an EDMF; they serve different regulators and purposes.

What we provide

Our CEP applications for selected products are currently under review at EDQM — we do not yet hold an issued CEP. Today we support EU registration through EDMF/ASMF dossiers plus EU Written Confirmation, together with the current CoA and specification and, under NDA, the supporting documentation your RA team needs for filing.

Always verify the current CEP status and number directly with your supplier and the EDQM public list before filing.

Allgemeine Informationen; keine rechtliche oder regulatorische Beratung. Anforderungen ändern sich — bitte stets mit der zuständigen Behörde bestätigen lassen.