# L_2008352EN.01003101.xml

| 31.12.2008 | EN | Official Journal of the European Union | L 352/31 |
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31.12.2008

EN

Official Journal of the European Union

L 352/31

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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. |
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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.

| (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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(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. |
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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.

| (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. |
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(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, |
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(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), |
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—

Dietger Niederwieser (Member) and Per Ljungman (Alternate),

| — | George Dickson (Member) and Thierry VandenDriessche (Alternate). |
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—

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), |
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—

Fabrizia Bignami (Member) and Michele Lipucci di Paola (Alternate),

| — | Alastair Kent (Member) and Nicholas Meade (Alternate). |
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—

Alastair Kent (Member) and Nicholas Meade (Alternate).

Done at Brussels, 5 December 2008.

For the Commission

Günter VERHEUGEN

Vice-President

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(1)  
  OJ L 324, 10.12.2007, p. 121.

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