Scientific advice
Article 16
1. The applicant or holder of a marketing authorisation may request advice from the Agency on the design and conduct of pharmacovigilance and of the risk management system referred to in Article 14. 2. By way of derogation from Article 8(1) of Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products ( 14 ) , a 90 % reduction for small and medium-sized enterprises and 65 % for other applicants shall apply to the fee for scientific advice payable to the Agency for any advice given in respect of advanced therapy medicinal products pursuant to paragraph 1 of this Article and Article 57(1)(n) of Regulation (EC) No 726/2004.