EMA Lowers Fees Slightly

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-07-2015 09:00


Fees payable to the European Medicines Agency (EMA) by applicants and marketing-authorization holders decreased by 0.1%, effective April1, 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. These documents include the new fees for all types of procedure handled by the EMA for human and veterinary medicines, including marketing-authorization applications, post-authorization procedures, scientific advice, and inspections.

Every year, the agency adjusts its fees on April 1, 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 EMA by March 31, 2015, 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 April 1, 2015 will attract the new fee.

Source: EMA


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