1. No. 141/2000 of the European Parliament and the Council of the European Union. Regulation (EC) no 141/2000 of the European Parliament and of the council of 16 December 1999 on orphan medicinal products;Regulation;J Eur Communities,2000
2. Regulatory watch: the orphan drug pipeline in Europe;Morel;Nat Rev Drug Discov,2016
3. No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending directive 2001/83/EC and regulation (EC) no 726/2004;Regulation;J Eur Union,2007
4. No. 2049/2005 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises text with EEA relevance;Regulation;J Eur Union,2005