What's new

Moving to eCTD format (hum):

Fimea follows the guideline of HMA eSubmission Roadmap.

According to guideline, it is compulsory for the national processes to move to eCTD format accordingly:

  • 1.7.2018 New National MA applications only in eCTD
  • 1.1.2019 All National applications in eCTD

 

Please remember the timetable for MRP and DCP processes:

  • 1.1.2017 New MRP/DCP MA applications only in eCTD
  • 1.1.2018 all MRP/DCP processes only in eCTD

 

Moving to vNeeS format (vet):

  • 2017 vNeeS compulsory in CP, MRP and DCP
  • 1.7.2018 New National MA applications only in vNeeS
  • 1.1.2019 All National applications in vNeeS

Read more:

eSubmission Roadmap