Regulatory information - adjusted fees for applications to European Medicines Agency from 1 April 2016

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09/03/2016

Regulatory information - adjusted fees for applications to European Medicines Agency from 1 April 2016

Fees expected to increase by 0.2%

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 2016.

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 0.2% in line with the 2015 inflation rate.

The Agency will publish full details of the revised fees at the end of March, once the European Commission has adopted the regulation and published it in the Official Journal of the European Union and the Agency's Management Board has reached a decision on its implementation.

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 2016 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 2016.

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