The European Directorate for the Quality of Medicines & HealthCare (EDQM) has revised the “Guideline on requirements for revision and renewal of certificates of suitability to the European Pharmacopoeia monographs” (PA/PH/CEP (04) 02) to align it with the requirements of the applicable revised EU legislation, i.e.:
- “Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medical products and on the documentation to be submitted pursuant to those procedures”;
- “Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending Commission Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use”;
- “Commission implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (veterinary products)”.
The revised guideline also clarifies situations where revision of an existing CEP is not possible and a separate CEP application is required, and gives guidance on changes related to implementation of CEP 2.0 and on expectations concerning the introduction or modification of a risk assessment.
The draft revised guideline is now available for public consultation in the consultation space. The consultation deadline for this document is 16 January 2026. After the consultation phase, the final guideline will be made available on the EDQM website....[EDQM]
