EMA To Adjust Fees Effective April 1

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-03-2014 14:58


The European Medicines Agency (EMA)  reminds applicants and marketing-authorization holders that adjusted fees will be coming into effect on Tuesday April 1, 2014.

Every year, EMA adjusts its fees on April 1, in line with the European Union 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 2013 inflation rate. Although the final adjustment is not yet known, the agency expects its fees to increase by around 1.5%.

The agency will publish full details of the revised fees at the end of March, once the European Commission has adopted the regulation and published it in the Official Journal of the European Union and the agency's management board has reached a decision on its implementation.

All applications received by March 31 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.

Source: EMA


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