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29.6.2013 |
EN |
Official Journal of the European Union |
C 187/9 |
COMMISSION DECISION
of 28 June 2013
appointing members and alternates of the Committee for Advanced Therapies to represent clinicians and patients' associations
(Text with EEA relevance)
2013/C 187/08
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (1), and in particular Article 21(1) thereof,
Whereas:
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(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. |
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(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. |
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(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. |
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(4) |
In accordance with Article 21(3) of Regulation (EC) No 1394/2007, the members and alternates of the Committee for Advanced Therapies are appointed for a period of 3 years. The term of office of the members and alternates appointed in 2009 has expired and therefore a new call has been undertaken in 2012. |
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(5) |
In accordance with Article 21(1) of Regulation (EC) No 1394/2007, a public call for expression of interest has been undertaken by the Commission. The European Parliament has been consulted on the results of the evaluation of the applications received, |
HAS ADOPTED THIS DECISION:
Article 1
The following are hereby appointed members and alternates of the Committee for Advanced Therapies to represent clinicians for a term of 3 years, from 1 July 2013:
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Pieter DOEVENDANS (Member) and Esteve TRIAS (Alternate), |
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Bernd GÄNSBACHER (Member) and Ramadan JASHARI (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 3 years, from 1 July 2013:
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Michele LIPUCCI DI PAOLA (Member) and Monica ENSINI (Alternate), |
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Kieran BREEN (Member) and Mariette DRIESSENS (Alternate). |
Done at Brussels, 28 June 2013.
For the Commission
Tonio BORG
Member of the Commission
(1) OJ L 136, 30.4.2004, p. 1.