The policy of the European Directorate for the Quality of Medicines & HealthCare (EDQM) for the elaboration of documents related to the Certification of suitability (CEP) procedure now involves a consultation phase (public or targeted). This is to inform stakeholders of upcoming proposed and/or potential changes and allow them to provide input or comments, all in a transparent manner.

When a document is made available for public consultation, an announcement will be made on the EDQM home page, and will be featured in the Certification web pages. The documents themselves and the instructions to stakeholders will be available in the dedicated space below.

Detailed information on the types of documents and the different steps in the elaboration process can be found in the following documents:

Open consultations
Document End of consultation
Content of the dossier for sterile substances  15 August 2024