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Regulatory News and Updates

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

ccording 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.

Ian Abernethy