# C_2015161EN.01000501.xml

| 14.5.2015 | EN | Official Journal of the European Union | C 161/5 |
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14.5.2015

EN

Official Journal of the European Union

C 161/5

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COMMISSION DECISION

of 13 May 2015

prolonging the appointment of independent scientific experts to the Pharmacovigilance Risk Assessment Committee

(Text with EEA relevance)

(2015/C 161/04)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 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 61a(1) and (4) thereof,

1

Whereas:

| (1) | Article 61a(1) of Regulation (EC) No 726/2004 requires that the Commission appoints six independent scientific experts as members of the Pharmacovigilance Risk Assessment Committee. |
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(1)

Article 61a(1) of Regulation (EC) No 726/2004 requires that the Commission appoints six independent scientific experts as members of the Pharmacovigilance Risk Assessment Committee.

| (2) | Article 61a(1) of Regulation (EC) No 726/2004 provides that the Commission is to appoint those members with a view to ensuring that the relevant expertise is available within the Committee. |
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(2)

Article 61a(1) of Regulation (EC) No 726/2004 provides that the Commission is to appoint those members with a view to ensuring that the relevant expertise is available within the Committee.

| (3) | The members of the Committee are to be appointed for a period of three years, which may be prolonged once. |
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(3)

The members of the Committee are to be appointed for a period of three years, which may be prolonged once.

| (4) | By its decision of 21 June 2012, the Commission appointed six independent scientific experts for a term of three years from 2 July 2012. In view of the continuous and efficient contribution of those experts to the work of the Committee, their mandate should be prolonged in accordance with Article 61a(4) of Regulation (EC) No 726/2004 for a period of three years starting on 2 July 2015. |
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(4)

By its decision of 21 June 2012, the Commission appointed six independent scientific experts for a term of three years from 2 July 2012. In view of the continuous and efficient contribution of those experts to the work of the Committee, their mandate should be prolonged in accordance with Article 61a(4) of Regulation (EC) No 726/2004 for a period of three years starting on 2 July 2015.

| (5) | Where an independent scientific expert appointed by this decision is no longer capable of contributing efficiently to the work of the Committee, or resigns, the Commission may replace this member from the reserve list, for the remaining duration of the member’s mandate, |
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(5)

Where an independent scientific expert appointed by this decision is no longer capable of contributing efficiently to the work of the Committee, or resigns, the Commission may replace this member from the reserve list, for the remaining duration of the member’s mandate,

HAS DECIDED AS FOLLOWS:

Article 1

The appointment of the following members of the Pharmacovigilance Risk Assessment Committee is hereby prolonged for a term of three years from 2 July 2015:

| — | Jane Ahlqvist RASTAD, |
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—

Jane Ahlqvist RASTAD,

| — | Marie Louise DE BRUIN, |
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—

Marie Louise DE BRUIN,

| — | Stephen J. W. EVANS, |
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—

Stephen J. W. EVANS,

| — | Brigitte KELLER-STANISLAWSKI, |
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—

Brigitte KELLER-STANISLAWSKI,

| — | Hervé LE LOUET, |
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—

Hervé LE LOUET,

| — | Lennart WALDENLIND. |
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—

Lennart WALDENLIND.

Article 2

The following are hereby placed on a reserve list by order of merit:

| — | Thierry TRENQUE, |
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—

Thierry TRENQUE,

| — | Michael THEODORAKIS, |
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—

Michael THEODORAKIS,

| — | Marie-Christine PERAULT-POCHAT, |
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—

Marie-Christine PERAULT-POCHAT,

| — | Annemarie HVIDBERG HELLEBEK. |
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—

Annemarie HVIDBERG HELLEBEK.

Done at Brussels, 13 May 2015.

For the Commission,

On behalf of the President,

Vytenis ANDRIUKAITIS

Member of the Commission

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(1)  OJ L 136, 30.4.2004, p. 1.

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