eCTD is mandatory for CEP Applications From 01 January 2020 to EU
The eCTD is mandatory for ALL CEP applications to EDQM including notifications, revision, renewal and new applications from 1 January 2020.
EDQM will stop accepting NeeS submissions for notifications, revisions and renewal applications. Therefore, all such submissions need to be in eCTD format.
Changing the electronic format of a dossier should be done at the start of a new procedure. Ongoing procedures will not be affected.
• For TSE only submissions PDF will continue to be the accepted.
• For substances for veterinary use only, VNeeS (Veterinary Non-eCTD electronic Submission) will be accepted.
For more detailed information refer below link.