2 de abril de 2019

EMA NEWS: Regulatory information – 1.7% increase of fees from 1 April 2019

From: www.ema.europa.eu

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.

All applications received by 31 March will be charged 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 of the decision granting the marketing authorisation defines the applicable fee and consequently a new fee will be applicable at the time of any anniversary on or after 1 April 2019.

In addition, access to SME incentives for regulatory consultancies has been clarified (human and veterinary medicines).

Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be revised in 2020, taking into account the 2018 and 2019 inflation rates.