The European Directorate for the Quality of Medicines & HealthCare (EDQM) has drafted a guideline ‘Content of the dossier for sterile substances’ (PA/PH/CEP (23) 54).
The draft document is now available for public consultation in the consultation space. The consultation deadline for this document is 15 August 2024. After the consultation phase the final guideline will be made available on the EDQM website.
Information related to the consultation phase and the dedicated consultation form are accessible from the consultation space.