The EDQM has revised the document « Guidance for electronic submissions for Certificates of Suitability (CEPs) applications ». The requirements with regards the format of CEP submissions have been updated:
- eCTD is mandatory for new CEP applications.
- EDQM stops accepting PDF submissions for revisions and renewal applications. Therefore, all such submissions need to be either in NeeS (Non-eCTD electronic Submission) or eCTD format.
Changing the electronic format of a dossier should be done at the start of a procedure. Ongoing procedures are not affected.
- Guidance for electronic submissions for Certificates of Suitability (CEP) applications, PA/PH/CEP (09) 108, 5R, January 2018)
Application forms for new applications and for revisions of applications have been updated in order to remove reference to those formats no longer accepted and to introduce small changes.
- Application form “Request for new Certificate of Suitability” (FORM/055 rev15, January 2018)
- Application form “Request for Revision or renewal of Certificate of Suitability (FORM/056 rev12, January 2018)
Implementation: February 2018.