EMA to Increase Application Fees 1.2 Percent

March 7, 2017

The European Medicines Agency will increase fees for all applications by 1.2 percent, except for pharmacovigilance procedures, effective April 1.

The annual increase is in line with the European Union’s inflation rate for the previous year. The European Commission is currently in the process of adopting a regulation to adjust the fees. The EMA plans to publish full details of the revised fees at the end of March, once the regulation has been adopted.

All applications received by March 31 will be charged at the current fee and reduction rates. 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. Fees charged for pharmacovigilance procedures are expected to be updated July 1.

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