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New EMA fees come into effect

Covers all types of procedures, including marketing-authorisation applications and scientific advice

The European Medicines Agency (EMA) has increased its fees for handling procedures like marketing-authorisation applications, inspections and scientific advice.

The fees, which are paid by applicants and marketing-authorisation holders, rose by 3.1 per cent as of yesterday.

The European regulator said all applications received by March 31 would be charged at the previous fee and reduction rates.

For scientific advice and protocol assistance for human medicines the cut-off point will be the date of validation of the request for advice, while for annual fees their anniversary date will define the applicable fee.

The EMA adjusts its fees every year on April 1, in line with the European Union (EU) inflation rate for the previous year, as published in the Official Journal of the European Union.

• More information on the fees payable to the European Medicines Agency

2nd April 2012

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