Announcements

Electronic submission formats of medicinal products becoming mandatory in the EU – are you prepared? We are!

EMA published an updated version of the eSubmission Roadmap at the beginning of last year. According to the schedule, the NeeS format for medicinal products for human use will be replaced gradually within the next couple of years. eCTD has been the mandatory format for new MRP/DCP marketing authorisation applications already since the beginning of 2017. Also the variation and renewal applications related to the maintenance of marketing authorisations of MRP/DCP processes have to be submitted in eCTD format from the beginning of 2018.

Additionally, the applications related to national marketing authorisations will be submitted in eCTD format in accordance with the following schedule:

  • • 1.7.2018 new national marketing authorisation applications only in eCTD format
  • • 1.1.2019 all national applications, including variation applications, only in eCTD format

The format of the applications of veterinary medicinal products is also discussed in the Roadmap. All new national marketing authorisation applications have to be submitted in VNeeS format from the beginning of July 2018, and the VNeeS format will be used for all applications from the beginning of 2019.

Medfiles will help you achieve valid eSubmissions on time!

With successful 5000 eSubmissions, Medfiles stands your preferred publishing and submissions partner. The compiling time for small- or medium-sized sequences is 1-2 working days, and for larger sequences it is agreed seperately.

For more information please contact:

Regulatory Affairs Director Minna Haapalahti

Support Operations Manager Jesse Salonen

  • 31.01.2018

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