EDQM: New CEP Document published

At the beginning of November, the document “Stepwise process to get a CEP/having a change approved” was published on the EDQM website for the first time. This document is intended as a guidance document and clearly outlines the steps and processes required to obtain a CEP. It also sets out timelines for new submissions and changes.

Below you will find an overview of the individual appendices and chapters, some of which contain further subchapters:

1. Introduction
2. New applications for CEPs including via the "sister files" procedure, applications for revisions and renewals
3. Notifications and transfers of holdership
4. File closure for new applications and sister files - rejection of revisions
5. Interactions between evaluation and GMP inspection activities of the CEP procedure
ANNEX I    Flow and timelines for new CEP applications
ANNEX II   Flow and timelines for sister files applications
ANNEX III  Flow and timelines for revisions and renewal applications
ANNEX IV   Table "For some specific data packages (e.g. toxicological data, sterility, TSE) different timelines are applicable as described in the table below."
ANNEX V    Flow and timelines for notification and transfer of holdership

The new document "Stepwise process to get a CEP/having a change approved" can be found in the newsroom of the EDQM website.