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From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%.
From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%, according to a news report from EMA.
Each year, EMA adjusts its fees according to the European Union (EU) inflation rate for the previous year. The increase in fees for 2019 reflects the increase in inflation rate for 2018 that was published by Eurostat-the EU’s statistical office.
Any applications that had been received by EMA by March 31, 2019 will be subjected to the fee and reduction rates of the prior tax year. Applications received from April 1, 2019 and onwards will incur the adjusted fee.
Full details on the new fee levels are available in Commission Regulation (EU) No 2019/480 amending Council Regulation (EC) No 297/95, the implementing rules and corresponding explanatory note on fees. Within these documents, applicants will be able to find out about fee details for all types of procedure handled by EMA except for pharmacovigilance procedures, which are expected to be revised in 2020, taking into account both 2018 and 2019 inflation rates.