European Union

The entry into force of Regulation No 726/2004 (laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency) had no effect on Art 5(1) of Regulation No 141/2000 (on orphan medicinal products).

It was true that, since the entry into force of Regulation No 726/2004, the sponsor of a medicinal product designated as an orphan medicinal product could obtain a marketing authorisation for that medicinal product only by way of the centralised authorisation procedure laid down in that regulation. It was therefore no longer possible for that sponsor to opt for the decentralised procedure under Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), which allowed for recognition of the first marketing authorisation of a medicinal product granted by a Member State in each Member