European Parliament legislative resolution on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards the term of office of the Executive Director of the European Medicines Agency (COM(2005)0190 - C6-0148/2005 - 2005/0083(COD))
Date: 2005-12-13
Institutions: Committee on Legal Affairs, European Parliament
Subjects: European Medicines Agency, administrative procedure, contractual liability, operation of the Institutions

C 286 E/124

Official Journal of the European Union

EN

23.11.2006

Tuesday 13 December 2005

Article 2

This Regulation shall enter into force on the […] day following that of its publication in the Official Journal
of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at …, on …

For the European Parliament
The President

For the Council
The President

P6_TA(2005)0478

The term of office of
Agency ***I

the Executive Director of

the European Medicines

European Parliament legislative resolution on the proposal for a regulation of the European Parlia-
ment and of the Council amending Regulation (EC) No 726/2004 as regards the term of office of
the Executive Director of the European Medicines Agency (COM(2005)0190 — C6-0148/2005 —
2005/0083(COD))

(Codecision procedure: first reading)

The European Parliament,

— having regard to the Commission proposal to the European Parliament and the Council (COM(2005)

0190) (1),

— having regard to Article 251(2) and Articles 95 and 152(4)(b) of the EC Treaty, pursuant to which the

Commission submitted the proposal to Parliament (C6-0148/2005),

— having regard to Rule 51 of its Rules of Procedure,

— having regard to the report of the Committee on Legal Affairs and the opinion of the Committee on

the Environment, Public Health and Food Safety (A6-0359/2005),

1.

Approves the Commission proposal as amended;

Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal

2.
substantially or replace it with another text;

3.

Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in OJ.

P6_TC1-COD(2005)0083

Position of the European Parliament adopted at first reading on 13 December 2005 with a view to
the adoption of Regulation (EC) No …/2006 of the European Parliament and of the Council amend-
ing Regulation (EC) No 726/2004 as regards the term of office of the Executive Director of the
European Medicines Agency

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 and
Article 152(4)(b) thereof,

Having regard to the proposal from the Commission,

23.11.2006

EN

Official Journal of the European Union

C 286 E/125

Tuesday 13 December 2005

Having regard to the opinion of the European Economic and Social Committee (1),

Having regard to the opinion of the Committee of the Regions (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

(1)

It is necessary to harmonise the rules on the conditions and procedures applicable to extending the
term of office of the Director, Deputy Director or President, as appropriate, of certain Community
agencies.

(2) Provision should be made for the Executive Director of the European Medicines Agency to be
appointed on a proposal from the Commission, after hearing the opinion of the representative
appointed by the European Parliament.

(3) Provision should be made to extend this term of office once, after suitable evaluation and after hearing

the opinion of the representative appointed by the European Parliament.

(4) 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 (3) should therefore be amended,

HAVE ADOPTED THIS REGULATION:

Article 1

Article 64(1) of Regulation (EC) No 726/2004 is hereby replaced by the following:

‘1.
The Executive Director shall be appointed by the Management Board, on a proposal from the
Commission, after hearing the opinion of the representative appointed by the European Parliament,
for a period of five years on the basis of a list of candidates proposed by the Commission following a
call for expressions of interest published in the Official Journal of the European Union and else-
where. Before appointment, the candidate nominated by the Management Board shall be invited
forthwith to make a statement to the European Parliament and to answer any questions put by its
Members. The Management Board may, upon a proposal from the Commission, after hearing the
opinion of the representative appointed by the European Parliament, remove the Executive Director
from his post.

After an evaluation and after hearing the opinion of the representative appointed by the European
Parliament, the Management Board may extend the term of office of the Executive Director once for a
period of not more than five years.

In the evaluation, the Management Board shall assess in particular:

— the results achieved in the first term of office and the way in which they have been achieved;

— the Agency's duties and requirements in the coming years.

The evaluation shall be submitted without delay to the Commission and to the European Parliament.’

(1) OJ C …
(2) Position of the European Parliament of 13 December 2005.
(3) OJ L 136, 30.4.2004, p. 1.

C 286 E/126

Official Journal of the European Union

EN

23.11.2006

Tuesday 13 December 2005

Article 2

This Regulation shall enter into force on the […] day following that of its publication in the Official Journal
of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at …, on …

For the European Parliament
The President

For the Council
The President

P6_TA(2005)0479

The term of office of the Director of the European Agency for Health and Safety
at Work ***I

European Parliament legislative resolution on the proposal for a regulation of the European Parlia-
ment and of the Council amending Regulation (EC) No 2062/94 establishing a European Agency for
Health and Safety at Work as regards the Director's term of office (COM(2005)0190 — C6-0149/
2005 — 2005/0085(COD))

(Codecision procedure: first reading)

The European Parliament,

— having regard to the Commission proposal to the European Parliament and the Council (COM(2005)

0190) (1),

— having regard to Article 251(2) and Article 137(1)(a) of the EC Treaty, pursuant to which the Commis-

sion submitted the proposal to Parliament (C6-0149/2005),

— having regard to Rule 51 of its Rules of Procedure,

— having regard to the report of the Committee on Legal Affairs (A6-0360/2005),

1.

Approves the Commission proposal as amended;

Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal

2.
substantially or replace it with another text;

3.

Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in OJ.

P6_TC1-COD(2005)0085

Position of the European Parliament adopted at first reading on 13 December 2005 with a view to
the adoption of Regulation (EC) No …/2006 of the European Parliament and of the Council amend-
ing Council Regulation (EC) No 2062/94 establishing a European Agency for Safety and Health at
Work as regards the Director's term of office

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 137(1)(a)
thereof,

Having regard to the proposal from the Commission,