EMA: Procedural advice on fee reductions for designated orphan medicinal products

Orphan medicinal products designated in accordance with Regulation (EC) No 141/2000 of 22 January 2000, are eligible for reductions on all fees payable under Union rules pursuant to Regulation (EC) No 726/2004. This includes fees for pre-authorisation activities such as protocol assistance (scientific advice), and for products using the centralised procedure: the application for marketing authorisation, inspections and post-authorisation activities such as variations, annual fees, etc.