Fees and fee reductions for scientific advice
There is a fee for scientific advice. The fee varies depending on the scope of the advice.
- Detailed information is available in fees payable to the European Medicines Agency.
There is a reduced scientific-advice fee for these types of medicine:
- orphan medicinal products: these medicines are eligible for fee reductions for protocol assistance. Information on fee reduction for a protocol-assistance application is available in fee reductions for designated orphan medicinal products ;
- medicinal products for paediatric use: scientific advice is free of charge;
- medicinal products under development by registered small or medium-sized enterprises (SMEs): information on the level of fee reductions available to SME applicants, how to apply for SME status and how to submit a letter of intent requesting scientific advice is available in the SME office;
- advanced-therapy medicinal products: these medicines are eligible for a 65% fee reduction for scientific advice.