Regulatory information – adjusted fees for applications to EMA from 1 April 2017

News 28/02/2017

Fees expected to increase by 1.2%

The European Medicines Agency reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on Friday 1 April 2017.

Every year, the Agency adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year. The European Commission is currently in the process of adopting a regulation adjusting the fees payable to the Agency by 1.2% in line with the 2016 inflation rate.

The Agency 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. The Agency's Management Board will reach a decision on the implementation of the regulation at its March 2017 meeting.

All applications received by 31 March will be charged at the current fee and reduction rates. Applications received after that date will be charged the adjusted fees and be subject to the revised reduction rates, where applicable. For scientific advice and protocol assistance, the cut-off date 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 1 April 2017 will attract the new fee.

Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be updated from 1 July 2017.

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