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In 2018, eCTD mandatory for new CEP applications

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Certification of suitability (CEP)
CEP new application
News
10 October 2017
Strasbourg, France

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.

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 via the following link:

Electronic submissions for CEP applications – Revised Roadmap 2016-2020, PA/PH/CEP (15) 35, 2R, November 2016

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