FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Adjusted EMA Application Fees Become Effective April 1

March 12, 2019
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The European Medicines Agency will activate adjusted fees for all applications — with the exception of pharmacovigilance procedures — on April 1.

Full details of the revised fees, such as charges for marketing authorization applications and scientific advice, will be posted at the end of the month, the agency said, after the fees have been adopted by the European Commission and published in the official journal of the EU.

The application fees are updated annually to reflect the EU inflation rate in the prior year. The 2018 inflation rate was 1.7 percent. Pharmacovigilance procedure fees are expected to be revised in 2020, taking into account inflation rates in 2018 and 2019.

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