Certificate of Suitability to the Monographs of the European Pharmacopoeia
A certification issued by EDQM confirming that an active substance from a named manufacturing route complies with the relevant Ph. Eur. monograph. A CEP can be referenced in a marketing-authorisation application in place of a full active-substance master file, across the signatory states.
API manufacturers supplying substances into Europe, and the finished-product manufacturers who reference their CEPs.
- 01A valid, current CEP covering the actual route and site of manufacture
- 02Change notification to EDQM where the certified conditions change
- 03Finished-product holders monitoring the status of every referenced CEP
CEP (EDQM Certification): frequently asked questions
Quick answers to common questions about CEP (EDQM Certification).
What is CEP (EDQM Certification)?
CEP (EDQM Certification) — Certificate of Suitability to the Monographs of the European Pharmacopoeia — is a certification issued by the European Directorate for the Quality of Medicines & HealthCare (Council of Europe). A certification issued by EDQM confirming that an active substance from a named manufacturing route complies with the relevant Ph. Eur. monograph. A CEP can be referenced in a marketing-authorisation application in place of a full active-substance master file, across the signatory states.
Who does CEP (EDQM Certification) apply to?
API manufacturers supplying substances into Europe, and the finished-product manufacturers who reference their CEPs.
What are the key requirements of CEP (EDQM Certification)?
EDQM CEP (EDQM Certification) requires, among other things: A valid, current CEP covering the actual route and site of manufacture; Change notification to EDQM where the certified conditions change; Finished-product holders monitoring the status of every referenced CEP.
When was CEP (EDQM Certification) last updated?
The current version of CEP (EDQM Certification) dates from January 2023.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When CEP (EDQM Certification) — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.