EMA Announces Modest Fee Increases

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-01-2014 20:15


Fees payable to the European Medicines Agency by applicants and marketing-authorization holders will increase by 1.5% on April 1, 2014 to account for inflation.

Full details of the new fee levels are available in the revised fee regulation, its implementing rules and the corresponding explanatory note on fees.

These documents include the new fees for all types of procedures handled by the agency for human and veterinary medicines, including marketing-authorization applications, post-authorization procedures, scientific advice and inspections.

Every year, the agency adjusts its fees on April 1 in line with the European Union (EU) inflation rate for the previous year. The present increase reflects the inflation rate for 2013, as published in the Official Journal of the EU.

All applications received at the agency by March 31, 2014 will be charged at the current fee and reduction rates. Applications received after that date will be charged the adjusted fees.

For scientific advice and protocol assistance, the cut-off point will be the date of validation of the request for advice. For annual fees, the anniversary defines the applicable fee. Consequently, any anniversary on or after April 1, 2014 will attract the new increased fee.

Source: EMA


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