EDQM publishes revised Guideline on requirements for revision and renewal of CEPs
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the updated version of the “Guideline on requirements for revision and renewal of certificates of suitability to the European Pharmacopoeia monographs” (PA/PH/CEP (04) 02).
Regulatory background
The guideline has been substantially revised with the aim of ensuring compliance with the requirements of current EU legislation specified in the following context by holders of a Certificate of Suitability (CEP):
- Regulation (EU) No. 1234/2008 of November 24, 2008, concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products, and the documentation to be submitted pursuant to those procedures;
- Regulation (EU) No. 2024/1701 of March 11, 2024 amending Regulation (EC) No. 1234/2008 as regards the examination of variations to the terms of marketing authorizations for medicinal products for human use.
- Implementing Regulation (EU) 2021/17 of January 8, 2021 establishing a list of variations which, pursuant to Regulation (EU) 2019/6 (veterinary medicinal products), do not require an assessment.
In addition to formal legal alignment, the guideline addresses various points that are relevant from a pragmatic point of view:
- Distinction between “revision” and “new CEP application“: the guideline clarifies in which situations it is not possible to modify an existing CEP and a separate CEP application is instead required.
- Changes in the context of CEP 2.0: the guideline provides guidance on how to classify and manage changes in relation to the implementation of CEP 2.0.
- Risk assessment: the guideline describes when and how a risk assessment should be initiated, updated or adapted in the context of the changes to be implemented.
Transition period and date of full application
Following publication, a two-month transition period is planned. During this period, the application of the new requirements is expressly encouraged but not yet mandatory. The revised guideline will come into full force on July 1, 2026.
SOURCES:
The revised guideline can be found on the EDQM website under “Certification Policy Documents & Guidelines” in the section “Operational documents”.