Regulatory information - adjusted fees for applications to EMA from 1 April 2016
General, non-pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing-authorisation holders are increasing by 0.2% on 1 April 2016.
Full details of the new fee levels are available in the revised Commission Regulation (EU) No 2016/461 amending Council Regulation (EC) No 297/95, its implementing rules and the corresponding explanatory note on fees, published today. 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 2015, as published in the Official Journal of the European Union.
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