New format requirements for Marketing Authorization submissions from 1 January 2019

17 December 2018

The NeeS submission format will be discontinued for all applications submitted under the national procedure (NP), i.e. applications for variations, renewals etc. This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.

From 1 January 2019, it is no longer possible to submit applications under the national procedure (NP) in the NeeS submission format, as outlined in the eSubmission Roadmap. This change forms part of the common European phasing-out plan for the NeeS format. 

Time frame for the phasing-out of nees

The phasing-out of nees in favour of the ectd electronic submission format for medicinal products for human use has been implemented as follows:

  • done: centralised procedure (cp), all types of applications
  • done: decentralised procedure (dcp), all types of applications
  • done: mutual recognition procedure (mrp), all types of applications
  • done: national procedure (np), new marketing authorisation
  • 1 january 2019: national procedure (np), all types of applications

See the link to the esubmission roadmap   

Particular to submissions in the national procedure

We recommend the applicants continue to handle ongoing regulatory activities in non-ectd format, even after the introduction of mandatory ectd in the national procedure by 1 january. when a new regulatory activity (for example an application for a variation) is started within the national procedure after 1 january, 2019, it must be submitted in ectd format and all following submissions for that product dossier must then be submitted in ectd format.

Applicants are referred to additional information in “q&a on how to handle ongoing procedures in relation to mandatory ectd format".

You can contact us at esubmission@dkma.dk

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