2. In the Medicines (Applications for Grant of Product Licences – Products for Human Use) Regulations 1993(1), in regulation 1 (citation, commencement and interpretation), in paragraph 2, in the definition of “the 2001 Directive”, 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”.
S.I. 1993/2538; relevant amending instruments are S.I. 2002/236 and S.I. 2003/2321.