The fees applied by the EMA to marketing authorisation applications and to additional services (e.g. protocol assistance, pre- und post-authorisation inspections etc.) are adjusted every year on 1 April. In a press release published on 24 February 2011, the EMA reminded of the coming due changes. The final fees aren't available yet but will be published at the end of March. Yet, the applicants can expect fee increases in line with the EU inflation rate, i.e. around 2.1%.
For all applications the EMA will receive by the 31 March, the actual fee rates will be applied. Applications should be sent on time in order to meet the deadlines for these actual applicable lower rates. The case for marketing authorisations of orphan medicinal products is different, however: from 1 April 2011, fee reductions will come into effect. The special treatment for this group of medicinal products is regulated by an EMA Executive Decision from 15 February 2011 which will come into force on 1 April 2011. Applicants are entitled to these fee reductions when they meet the SME criteria (SME = micro, small and medium-sized enterprises) defined in the Commission Recommendation 2003/362/EC.
You can find the Commission Recommendation published in the Official Journal of the European Union.
The European Commission has elaborated a detailed and informative brochure about the definition of micro, small and medium-sized enterprises (SMEs).
The EMA Executive Decision containing the new charged fees will be effective from 1 April 2011.
Note: You will learn more about the latest authorisation procedures in Europe and the USA during the "Marketing Authorisation Procedures in the EU and US" conference, which will take place on 11 - 13 October 2011 in Berlin.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)