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The EDQM "Guidance for electronic submissions for CEPs applications" has been revised and application forms have been updated accordingly

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Certification of suitability (CEP)
Certification content of dossier
News
29 January 2018
Strasbourg, France

The EDQM has revised the document « Guidance for electronic submissions for Certificates of Suitability (CEPs) applications ». The requirements with regards the format of CEP submissions have been updated:

  • eCTD is mandatory for new CEP applications.
  • EDQM stops 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 procedure. Ongoing procedures are not affected.

Application forms for new applications and for revisions of applications have been updated in order to remove reference to those formats no longer accepted and to introduce small changes.

Implementation: February 2018.

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