Adjusted fees for EMA applicants from April 1st

The EMA has announced that fees for new drug applications will be different from the beginning of April 2019, taking into account the rate of inflation…


The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders, (the company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States), that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2019.

The EMA’s definition of pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

Every year, the European Commission adopts a regulation adjusting the fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2018 inflation rate was 1.7 percent.

The EMA will publish full details of the revised fees at the end of March, once the regulation has been adopted by the European Commission and published in the Official Journal of the European Union, which publishes legal instruments and other European Union documents. The Agency’s Management Board will decide on the implementation of the regulation at its March 2019 meeting.

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.

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