Sch 7 para 8
In the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003 , in regulation 1 (citation, commencement and interpretation), in paragraph (2)— (a) in the definition of “unlicensed product”— (i) in sub-paragraph (a)(ii) after “Medicinal Products” insert “or under 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”, (ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (iii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (b) in the definition of “the TSE Guideline” after “for human use” insert “as substituted by Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”.