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

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Certification of suitability (CEP)
Procedure of certification (general)
News
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.
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.

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

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