# The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005, Paragraph 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”.

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Source: https://www.legislation.gov.uk/uksi/2005/2759/schedule/paragraph/17 (the official version)
Page: https://openlegislation.uk/medicines-marketing-authorisations-etc-amendment-regulations-2005/schedule/paragraph-17
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.