Posted by Michael Wonder on 01 Apr 2019
Regulatory information – 1.7% increase of fees from 1 April 2019
1 April 2019 - General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.7% on 1 April 2019.
Full details of the new fee levels are available in Commission Regulation (EU) No 2019/480 amending Council Regulation (EC) No 297/95 , its implementing rules and the corresponding explanatory note on fees, published on 1 April 2019. These documents include the new fees for all types of procedure handled by the Agency, except for pharmacovigilance procedures.
Every year, the Agency adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year. The current increase reflects the inflation rate for 2018, as published by Eurostat, the European Union’s statistical office.
