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As of 1 January 2020 the eCTD is mandatory for ALL CEP applications including notifications, revision, renewal and new applications

15 July 2019
Strasbourg, France

According to the EDQM roadmap for electronic submissions for CEP applications, a major change will be implemented as of 1 January 2020:
• eCTD will become mandatory for all CEP applications.
• 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.

Please find the EDQM roadmap for electronic submissions for CEP applications here.

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