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
ASMF:
- 1.1.2018 eCTD compulsory for ASMF submissions in NP, MRP and DCP
- 1.1.2018 vNeeS or NeeS compulsory for Veterinary ASMF submissions