Regulatory

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.
Exceptions:
• 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.
https://www.edqm.eu/en/news/1-january-2020-ectd-mandatory-all-cep-applications-including-notifications-revision-renewal-and

Author

KnetAdmin

Book a Demo