Adjusted fees for applications to European Medicines Agency on 1 April 2011

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24/02/2011

Adjusted fees for applications to European Medicines Agency on 1 April 2011

The European Medicines Agency reminds applicants and marketing-authorisation holders that adjusted fees will be coming into effect on Friday 1 April.

Every year, the Agency adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year. The European Commission is currently in the process of adopting a regulation adjusting the fees payable to the Agency in line with the 2010 inflation rate. Although the final adjustment is not yet known, the Agency expects its fees to increase by around 2.1%.

The Agency will publish full details of the revised fees at the end of March, once the Commission has adopted the regulation and published it in the Official Journal of the EU, and when the Agency's Management Board has reached a decision on the regulation's implementation.

Revised fee reductions for orphan medicinal products will also be coming into effect on Friday 1 April. The Agency has aligned the fee reductions with the funding received through the special contribution from the EU, whilst maintaining the incentives for small and medium-sized enterprises. The EU contribution in 2011 is €4.9 million.

All applications received at the Agency by Thursday 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 for human medicines, the cut-off point will be the date of validation of the request for advice.

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