The fees required by the EMA of drug marketing authorization holders and those submitting new marketing authorization applications have increased by 3.1% since 1 April 2012. In the revised regulation published online, details on charges are available for all types of procedures managed by the Agency for medicines for human and veterinary use, including the marketing authorization process, post-authorisation procedures, scientific advice and verifications. Every year, in April, the Agency adjusts its 'fees' in line with the inflation rate recorded in the EU in the previous year.
The 3.1% increase reflects the inflation rate for 2011, published in the Official Journal of the European Union. The previous rate will therefore be applied to all applications received by the EMA by 31 March 2012, while applications received after that date will be charged the current fees.
April 3, 2012 – PharmaKronos
