he European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a new document called “Stepwise process to get a CEP or having a change approved”.

This document is intended to clarify, for all types of application, the process and steps for obtaining a certificate of suitability (CEP) or having a change approved, from the submission of the application to the communication of the final decision. The steps and the associated timelines are unchanged, but are now explained in greater detail and accompanied by descriptive flowcharts.

This document also clarifies the interactions between evaluation and Good Manufacturing Practice (GMP) inspection activities of the CEP procedure. [EDQM]