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Procedure : 2008/0045(COD)
Document stages in plenary
Document selected : A6-0346/2008

Texts tabled :

A6-0346/2008

Debates :

PV 22/10/2008 - 2
CRE 22/10/2008 - 2

Votes :

PV 22/10/2008 - 4.6
Explanations of votes
Explanations of votes

Texts adopted :

P6_TA(2008)0510

Texts adopted
PDF 192kWORD 51k
Wednesday, 22 October 2008 - Strasbourg
Variations to the terms of marketing authorisations for medicinal products ***I
P6_TA(2008)0510A6-0346/2008
Resolution
 Text

European Parliament legislative resolution of 22 October 2008 on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products (COM(2008)0123 – C6-0137/2008 – 2008/0045(COD))

(Codecision procedure: first reading)

The European Parliament,

–   having regard to the Commission proposal to the European Parliament and the Council (COM(2008)0123),

–   having regard to Articles 251(2) and 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6-0137/2008),

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

–   having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Agriculture and Rural Development (A6-0346/2008),

1.  Approves the Commission proposal as amended;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

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


Position of the European Parliament adopted at first reading on 22 October 2008 with a view to the adoption of Directive 2008/.../EC of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products
P6_TC1-COD(2008)0045

(As an agreement was reached between Parliament and Council, Parliament's position at first reading corresponds to the final legislative act, Directive 2009/53/EC.)

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