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EMA cuts fees

Written by | 23 Apr 2015 | All Medical News

by Gary Finnegan: The European Medicines Agency (EMA) has reduced the fees it charges to companies who hold – or apply for – marketing authorisation for medicines.

The modest price cut of 0.1% came into effect in April and affects all types of fees handled by the London-based agency. These include applications relating to new human and veterinary medicines, post-authorisation procedures, scientific advice and inspections.

Changes to fees are routinely made by the drug regulator once a year and are linked to inflation in the European Union for the previous year. On this occasion, the fee reductions reflect slight deflation in Europe in 2014.

The fee for an initial application for marketing authorisation for a new medicine, for which a full dossier is required, is €278,200.

Reduced fees are paid by small and medium-sized enterprises (SMEs) as part of an effort to reduce red tape and costs for smaller players.

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