According to the EDQM roadmap for electronic submissions for CEP applications, two major changes will be implemented as of 1 January 2018:
- eCTD will become mandatory for new CEP applications.
- EDQM will stop 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 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.
Please find the EDQM roadmap for electronic submissions for CEP applications via the following link: