Paragraph 5

in the definition of “Community marketing authorization”, after “Council 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”, and

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”;