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EMA Will Increase Fees on April 1


Pharmaceutical Executive

March 18, 2016.

You’ve only got another two weeks to submit applications to the European Medicines Agency (EMA) before the fees go up. The new charges for all applications except pharmacovigilance procedures will take effect on April 1.

The European Commission has applied to increase the fees payable to EMA by 0.2%, which in line with the 2015 inflation rate. EMA has said it 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 March 31 will be charged at the current fee and reduction rates, according to EMA. 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 April 1, 2016 will attract the new fee.

Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be updated from July 1, 2016.

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