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Regulatory Focus™ > News Articles > European Marketing Application Rates Set to Increase in 2013

European Marketing Application Rates Set to Increase in 2013

Posted 25 February 2013 | By Alexander Gaffney, RAC

The European Medicines Agency (EMA) has announced that application fees will go up approximately 2.6% in the coming fiscal year, roughly on par with the EU rate of inflation for the previous year.

The exact fee, set to go into effect on 1 April 2013, is not known, EMA noted. That's because the final fee adjustment must be approved by both EMA's Management Board and the European Commission (EC), a process set to conclude in March 2013.

"The European Commission is currently in the process of adopting a regulation adjusting the fees payable to the Agency in line with the 2012 inflation rate," EMA wrote in a statement on its website. "Although the final adjustment is not yet known, the Agency expects its fees to increase by around 2.6%."

"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."

As of 1 January 2013, fees payable for a basic marketing application were €267,400, with an additional €26,800 for each additional strength or form submitted. Non-dossier applications are charged €172,800, with an additional €10,300 for each additional strength or form.

Based on a 2.6% increase, those fees would be €274,352/€27,497 and €177,272/€10567, respectively. Additional fees, including reduced fees for small- and medium-sized business entities (SMEs), may be found here.

The fees are meant to allow EMA's resources to keep pace with the rate of inflation. Across the EU in 2013, inflation ranged from a low of 2.2% to a high of 3.0%. Early indications for the first half of January 2013 show inflation at just 2.0%, potentially giving EMA a much-needed boost to its purchasing power.

Tags: Fees, MAA, MAH, EU

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