LS&R 344

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Polen: voorstel clinical trails regulation niet conform subsidiariteitsbeginsel

Reasoned opinion of the Polish Sejm of the Republic of Poland on the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
 (COM(2012)0369 – C7-0194/2012 – 2012/0192(COD))


Polish Foreign Policy for 2011 01DECISION of the Sejm of the Republic of Poland of 10 October 2012  on non-compliance with the subsidiarity principle of the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Pursuant to Rule 148cc of its Rules of Procedure, the Sejm of the Republic of Poland finds that the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (COM(2012)0369) does not comply with the principle of subsidiarity as laid down in Article 5(3) of the Treaty on European Union. The proposal breaches the principle of subsidiarity in that it fails to demonstrate that the objectives of the proposed action can be achieved more effectively at EU level, by means of a regulation – a legislative act directly applicable and binding in its entirety in  all Member States – than at national level. A reasoned opinion stating why the Sejm considers that the draft legislative act does not comply with the principle of subsidiarity is attached to this decision.

Marshal of the Sejm