Regulatory information - adjusted fees for applications to EMA from 1 April 2016

News 01/04/2016

Fees adjusted to 2015 inflation rate

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.

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, 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 2016 will attract the new fee.

Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be updated from 1 July 2016.

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