21.1.2010 |
EN |
Official Journal of the European Union |
CE 15/140 |
Wednesday 22 October 2008
Variations to the terms of marketing authorisations for medicinal products ***I
P6_TA(2008)0510
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))
2010/C 15 E/45
(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. |
Wednesday 22 October 2008
P6_TC1-COD(2008)0045
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
(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.)