EDQM publishes revised CEP Guideline

The EDQM has published the guideline "Guideline on requirements for revision and renewal of certificates of suitability to the European Pharmacopoeia monographs" (PA/PH/CEP (04) 02) in a revised version. The update is intended to support CEP holders in managing changes to approved CEP dossiers in a consistent and traceable manner and in line with the current EU regulations.

Background: Alignment with updated EU requirements

The EDQM guideline has been revised to ensure compliance with the following already updated EU legislation:

• Regulation (EU) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of authorisations for medicinal products for human use and veterinary medicinal products, as well as the documentation to be submitted in the context of these procedures.
• Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 regarding the examination of variations to the terms of marketing authorisations for medicinal products for human use.
• Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations which, in accordance with Regulation (EU) 2019/6 (veterinary medicinal products), do not require an assessment.

This brings the expectations regarding the type, scope and documentation of CEP-related changes more closely in line with the classification of the EU variation logic.

Important additional clarifications in the revised guideline

Beyond the formal legal alignment, the guideline addresses several practice relevant points:

• Distinction between "revision" and "new CEP application": It clarifies in which situations a revision of an existing CEP is not possible and a separate CEP application is required instead.
• Changes in the context of CEP 2.0: The guideline provides guidance on how to classify and handle changes in connection with the implementation of CEP 2.0.
• Risk assessment: It describes when and how a risk assessment should be introduced, updated or adapted in the context of changes (e.g. to justify the impact on quality and to derive corresponding measures).

Transition period and date of full application

Following publication, a two month transition period applies. During this period, application of the new requirements is explicitly recommended but not yet mandatory. The revised guideline will become effective on 1 July 2026.

Recommendation for CEP holders

Companies should use the transition period to implement the following:

• Review internal regulatory (revision/renewal) and change control processes against the new expectations.
• Update templates/checklists for CEP 2.0-related changes.
• Harmonise the risk assessment approach (content and level of documentation).
• Assess ongoing or planned changes at an early stage to determine whether a revision is possible or whether a separate application is advisable/required.

The revised guideline can be found on the EDQM website under "Certification Policy Documents & Guidelines" in the section "Operational documents".