Reductions in certain fees charged by Fimea

19 Sep Reductions in certain fees charged by Fimea

Posted at 12:09h in News by

The new decree (210/1016) on fees chargeable by Fimea entered into force on 1 April 2016. Most notably, there are no increases in fees.  In addition, the pharmacy dispensary licence fee and the following type IB variation application fees have decreased.

Human medicines, type IB variations

  • National type IB variation fee decreased from EUR 500 to EUR 450.
  • Finland, CMS type IB variation fee decreased from EUR 400 to EUR 360.
  • Finland, RMS type IB variation fee decreased from EUR 1,000 to EUR 900.
  • Parallel imports, type IB variation fee decreased from EUR 300 to EUR 270.

Vet products, type IB variations

  • National type IB variation fee decreased from 400 to EUR 360.
  • Finland, CMS type IB variation fee decreased from EUR 300 to EUR 270.
  • Finland, RMS type IB variation fee decreased from EUR 1,000 to EUR 900.
  • Parallel imports, type IB variation fee decreased from EUR 300 to EUR 270.

If you need help in classification of variation applications or in preparation of application documentation, we are happy to help you at info@dra.fi.

Originally published, 4th April, 2016, by DRA Consulting, Finland at http://www.dra.fi/reductions-certain-fees-charged-fimea/