Slovenian National Assembly

Dossier COD/2008/0256

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use

Subsidiarity deadline: 09/04/2012
 
Scrutiny Information

Scrutiny date: 02/04/2009

Subsidiarity Concern:

No Important information to exchange

No Veto

Information on parliamentary scrutiny

In accordance with Article 4(1) of the Act on Cooperation between the National Assembly and the Government regarding EU Affairs (Official Gazette of the Republic of Slovenia No. 34/04) and Article 154h(5) of the Rules of Procedure of the National Assembly, at its 12th meeting of 6 March 2009 the Committee on EU Affairs adopted, in relation to the proposal for a Directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use, the following Position of the Republic of Slovenia:
The Republic of Slovenia supports the general objectives and definitions laid down in the amendments to Directive 2001/83/EC, deriving from the Council conclusions on information to the patients adopted during the Slovenian Presidency of the EU Council.
The Republic of Slovenia estimates that the proposed solutions could offer the possibilities for providing adequate information to the patients in accordance with their needs, yet certain provisions need to be further discussed with the view of ensuring a clearer definition of the Proposal's provisions. This relates in particular to harmonised understanding of information and its clear separation from advertising, to the manners and procedures of guaranteeing adequate information sources and their use, to the definition of the characteristics of adequate information, and to the improvements to the text which should reduce the possibility of abuse.


Contact points for EU matters

IPEX Correspondents:
Phone: 00 386 4789920  Email Mrs. Aleksandra-Saša Lavrič Phone: 00 386 4789822  Email Ms. Polona Klemenčič
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