reg 1
In the Medicines (Pharmacy and General Sale Exemption) Order 1980 in article 1 (citation, commencement and interpretation), in paragraph (2)— (a) in the definition of “Community marketing authorization” after “Regulation (EEC) No. 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”, (a) after the definition of “cosmetic” insert the following definition— “Directive 2001/83/EC ” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as amended 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 “United Kingdom marketing authorization” after “Schedule 6 to those Regulations” insert “or an authorization granted by the licensing authority in accordance with Article 126a of Directive 2001/83/EC ”.