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