New format requirements for marketing authorisation applications from 1 January 2018

10 November 2017

The NeeS submission format will be discontinued for applications submitted under the mutual recognition procedure (MRP). This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.

From 1 January 2018, it is no longer possible to submit applications under the mutual recognition procedure (MRP) in the NeeS submission format, as outlined in the eSubmission Roadmap. From this date, the NeeS format is only accepted for purely national applications (NP). 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 will be implemented as follows:

  • Done: Centralised procedure (CP), all types of applications
  • Done: Decentralised procedure (DCP)
  • Done: Mutual recognition procedure (MRP), new marketing authorisation
  • 1 January 2018: MRP, other cases
  • 1 July 2018: National procedure (NP), new marketing authorisation
  • 1 January 2019: National procedure (NP), other cases

See the link to the eSubmission Roadmap in the External links box. We have updated our page about the eSubmission Roadmap.

Reducing assessment times

We would like to encourage applicants to switch to the eCTD format as soon as possible for all procedures and types of applications as this would help us to reduce the overall assessment time.

For information and guidelines on the change to the eCTD format, please see our format requirements (particularly the technical details about baseline and the first eCTD submission) as well as EMA’s eSubmission page and CMDh’s eSubmission page.