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The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

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5.  In the Prescription Only Medicines (Human Use) Order 1997(1), in article 1 (citation, commencement and interpretation), in paragraph (2)—

(a)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

(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”;

(1)

S.I 1997/1830; relevant amending instrument is S.I.2000/1917.

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