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EMA application fees set for slower rise in 2013

European regulator expects rate to increase by 2.6 per cent

European Medicines Agency (EMA) - logoThe European Medicines Agency (EMA) expects its marketing application fees will this year rise at a slower pace than last year.

The regulator says it anticipates fee rates, which are adjusted each year in line with the EU's inflation rate for the previous year, will increase by around 2.6 per cent, compared to 3.1 per cent in 2012.

The European Commission is currently in the process of adopting a regulation adjusting the fees payable to the Agency in line with its 2012 inflation rate.

The final adjustment is not yet known, but full details of the revised fees should be published at the end of March.

The EMA said that applications received by March 31 would be charged at the current fee and reduction rates, but later applications would be charged the adjusted fees.

The full fee for a marketing authorisation application of a single strength and form of a pharmaceutical product is €267,400, with reductions offered to, for example, micro, small and medium sized enterprises.

Meanwhile, for scientific advice and protocol assistance, the cut-off date will be the date of validation of the request for advice.

26th February 2013

From: Regulatory

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