Increased fees coming into effect on 1 April 2012
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Fees payable to the European Medicines Agency by applicants and marketing-authorisation holders are increasing by 3.1% on 1 April 2012.
Full details of the new fees levels are available in the revised fee regulation, its implementing rules and the corresponding explanatory note on fees, published today.
These documents include the new fees for all types of procedure handled by the Agency for human and veterinary medicines, including marketing-authorisation applications, post-authorisation procedures, scientific advice and inspections.
Every year, the Agency adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year. The current increase reflects the inflation rate for 2011, as published in the Official Journal of the European Union.
All applications received at the Agency by 31 March 2012 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 for human medicines, the cut-off point will be the date of validation of the request for advice. For annual fees, the anniversary date defines the applicable fee. Consequently, any anniversary on or after 1 April 2012 will attract the new increased fee.