Having regard to Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004(1), and in particular Article 21(1) thereof,

31.12.2008 | EN | Official Journal of the European Union | L 352/31 ---|---|---|--- * * * COMMISSION DECISION of 5 December 2008 appointing members and alternates of the Committee for Advanced Therapies to represent clinicians and patients associations (Text with EEA relevance) (2008/980/EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (1), and in particular Article 21(1) thereof, Whereas: (1) | Regulation (EC) No 1394/2007 lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products. Article 20 of that Regulation lays down that a Committee for Advanced Therapies shall be established within the European Medicines Agency. ---|--- (2) | Subparagraph (c) of Article 21(1) of Regulation (EC) No 1394/2007 lays down that the Committee for Advanced Therapies shall include two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent clinicians. ---|--- (3) | Subparagraph (d) of Article 21(1) of Regulation (EC) No 1394/2007 lays down that the Committee for Advanced Therapies shall include two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent patients associations. ---|--- (4) | In accordance with Article 21(1) of Regulation (EC) No 1394/2007, a public call for expressions of interest has been undertaken by the Commission. The European Parliament has also been consulted on the results of the evaluation of the applications received. ---|--- (5) | The members and alternates of the Committee for Advanced Therapies should be appointed for a period of three years, starting on the date of application of Regulation (EC) No 1394/2007, ---|--- HAS DECIDED AS FOLLOWS: Article 1 The following are hereby appointed members and alternates of the Committee for Advanced Therapies to represent clinicians for a term of three years, from 30 December 2008: — | Dietger Niederwieser (Member) and Per Ljungman (Alternate), ---|--- — | George Dickson (Member) and Thierry VandenDriessche (Alternate). ---|--- Article 2 The following are hereby appointed members and alternates of the Committee for Advanced Therapies to represent patients associations for a term of three years, from 30 December 2008: — | Fabrizia Bignami (Member) and Michele Lipucci di Paola (Alternate), ---|--- — | Alastair Kent (Member) and Nicholas Meade (Alternate). ---|--- Done at Brussels, 5 December 2008. For the Commission Günter VERHEUGEN Vice-President * * * (1) OJ L 324, 10.12.2007, p. 121. * * *