The European Medicines Agency has introduced new fee incentives to support micro, small and medium-sized enterprises (SMEs) developing medicines for human and veterinary use.
The Agency has taken this initiative in response to concerns raised by SMEs about the burden of fees for post-authorisation procedures for small businesses. The new incentives apply to post-authorisation activities and include total or partial fee exemptions for extension of a marketing authorisation; type-IA, type-IB or type-II variation; renewal of a marketing authorisation; transfer of marketing authorisation between two SMEs; referral procedure initiated by the marketing-authorisation holder as laid down in Article 30(1) or the first sub-paragraph of Article 31(1) of Directive 2001/83/EC and post-authorisation annual fee.
According the the EMA micro-sized enterprises benefit from a 100% fee reduction, while small and medium-sized enterprises have a 40% reduction of the total applicable fee. At the moment, there are more than 1,100 SMEs in the Agency’s public SME register. 44% of these are micro-sized (fewer than 10 staff members), 39% are small-sized (fewer than 50 staff members) while 17% are medium-sized companies (fewer than 250 staff members).