CEP 2.0: EDQM Updates Guidance on the Use of Certificates of Suitability

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has revised guidance document PA/PH/CEP (14) 06. The document explains how a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) may be used to describe a material included in an application for another CEP.The revision reflects the implementation of CEP 2.0 and brings the guidance into line with the principles outlined in the EMA Questions and Answers document on the use of a CEP in a Marketing Authorisation Application or a Marketing Authorisation Variation (EMA/CHMP/CVMP/QWP/5/2024).

Key points of the revision

The updated guidance provides current regulatory direction for CEP applicants and holders, particularly with regard to:

• the requirements and structure of CEP 2.0;
• the relationship between the EDQM guidance and the relevant EMA principles;
• the use of an existing CEP to describe a material in a further CEP application.

Background to the original document

The original version of PA/PH/CEP (14) 06 was developed to clarify how a CEP could be used to support the description of a material in another CEP application. It provided practical guidance for applicants and CEP holders using an existing certificate in the context of a further CEP procedure. Following the introduction of CEP 2.0 and the development of related EMA guidance, an update of the document became necessary.

Practical implications

CEP applicants and holders should consult the revised guidance when preparing new applications or updating existing CEP documentation. In particular, companies should review the relevant parts of their dossiers where a CEP is used to describe a starting material, intermediate or other material included in another CEP application.