Adjusted fees for applications to European Medicines Agency from 1 April 2015

31/03/2015

Fees adjusted to 2014 inflation rate

Fees payable to the European Medicines Agency by applicants and marketing-authorisation holders are decreasing by 0.1% on 1 April 2015.

Full details of the new fee levels are available in the revised Commission Regulation (EU) No 2015/490 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 for human and veterinary medicines, including marketing-authorisation applications, post-authorisation procedures, scientific advice and inspections.

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 decrease reflects the inflation rate for 2014, as published in the Official Journal of the European Union.

All applications received at the Agency by 31 March will be charged at the current fee and reduction rates. Applications received after that date will be charged the adjusted fees. For scientific advice and protocol assistance for human medicines, the cut-off point will be the date of validation of the request for advice. For annual fees the anniversary date defines the applicable fee and consequently any anniversary on or after 1 April 2015 will attract the new fee.