Regulatory information – 1.7% increase of fees from 1 April 2018

News 28/03/2018

Revised application fees reflect inflation rate

General, non-pharmacovigilance fees payable to the European Medicines Agency (EMA) by applicants and marketing-authorisation holders are increasing by 1.7% on 1 April 2018.

Full details of the new fee levels are available in PDF iconCommission Regulation (EU) No 2018/471 amending PDF iconCouncil Regulation (EC) No 297/95 , its PDF iconimplementing rules and the corresponding PDF iconexplanatory note on fees , published on 28 March. 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 2017, 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 2018.

In addition, fee reductions have been introduced for second and subsequent multiple marketing authorisations on usage patent grounds for veterinary medicines, similarly to the current principles applied for human medicines.

Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be revised in the second half of the year.

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