Dear Colleagues,
The European Medicines Agency has just announced new extended fee incentives to support micro, small and medium-sized enterprises (SMEs) developing medicines for human and veterinary use. The new incentives apply to post-authorisation activities. They include total or partial fee exemptions for the following activities:
- extension of a marketing authorisation;
- type-IA, type-IB or type-II variation;
- renewal of a marketing authorisation;
- transfer of a 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;
- post-authorisation annual fee.
Micro-sized enterprises will benefit from a 100% fee reduction, while small and medium-sized enterprises will have a 40% reduction of the total applicable fee.
Do feel free to contact me if you need further information on gaining SME status with EMA.
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Karen Real
Director
Real Regulatory Ltd
Dublin 15
Ireland
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