Increased fees coming into effect on 1 April 2013
Fees payable to the European Medicines Agency by applicants and marketing-authorisation holders will increase by 2.6% on 1 April 2013 to account for inflation.
These documents include the new fees for all types of procedures 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 2012, as published in the Official Journal of the EU.
All applications received at the Agency by 31 March 2013 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 1 April 2013 will attract the new increased fee.
- Commission Regulation (EU) No 220/2013 of 13 March 2013 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate (27/03/2013)
- Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures (27/03/2013)
- Explanatory note on fees payable to the European Medicines Agency (27/03/2013)