What is CEP No. in Europe?
In the European pharmaceutical regulatory framework, CEP stands for Certificate of Suitability to the monographs of the European Pharmacopoeia. It is a key document issued by the European Directorate for the Quality of Medicines and HealthCare (EDQM). A CEP number, often referred to as CEP No., is a unique identifier assigned to this certificate.
Purpose of a CEP
The main purpose of a CEP is to confirm that the quality of an active substance complies with the specifications of the European Pharmacopoeia (Ph. Eur.). By referencing a CEP in regulatory filings, manufacturers can avoid submitting a full Drug Master File (DMF) or Active Substance Master File (ASMF).
Who Needs a CEP?
- API (Active Pharmaceutical Ingredient) manufacturers
- Excipient suppliers (if applicable)
- Drug product manufacturers using outsourced substances
When the substance is covered by a Ph. Eur. monograph, a CEP helps streamline regulatory approval across EU member states.
What Does the CEP Number Represent?
A CEP No. is an alphanumeric code assigned by EDQM. It typically follows this format:
R0-CEP yyyy-xxx-rev
Where:
yyyyis the year of issuexxxis the sequence/application numberrevdenotes the revision (e.g., R0, R1, etc.)
Benefits of a CEP
- Streamlines pharmaceutical regulatory submissions in the EU
- Confirms compliance with European Pharmacopoeia standards
- Accepted in multiple global markets beyond Europe
- Reduces administrative burden for manufacturers
How to Verify a CEP Number?
EDQM provides a publicly accessible CEP database where you can:
- Search by substance, company, or CEP No.
- Check the validity and revision status
- Download current certificates
CEP vs. ASMF vs. DMF
| Parameter | CEP | ASMF | DMF |
|---|---|---|---|
| Authority | EDQM | EMA / National Agencies | FDA / Others |
| Scope | Ph. Eur. Monograph | Active Substance Details | Active Substance Details |
| Accepted In | EU + other regions | EU | USA + global |
Summary:
A CEP No. is more than a reference — it is an essential part of the European pharmaceutical regulatory landscape. It provides assurance of quality, simplifies the submission process, and supports global market access.
For manufacturers of substances governed by the European Pharmacopoeia, obtaining a valid CEP is a strategic and regulatory asset.
Read More:
2. What is SmPC? A Complete Guide for Regulatory Compliance (2025)
3. Lyophilized Products Process in the Pharmaceutical Industry: A Comprehensive Guide