reg 17
In the Medicines for Human Use (Clinical Trials) Regulations 2004 , in regulation 2 (interpretation), in paragraph (1)— (a) in the definition of “Directive 2001/83/EC ” after “as amended” insert “by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”, (b) in the definition of “marketing authorization”, in paragraph (c), after “Council Regulation (EEC) 2309/93 ”, insert “or Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency”.