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European Parliament votes against introduction of “Drug-Facts-Box”

Friday, September 14th, 2012 in News

On 11 September 2012 the European Parliament (EP) voted on further additions and changes to the pharmacovigilance rules of Directive 2001/83/EC. There was no majority for introducing the “Drug-Facts-Box”. Find the adopted texts following the link: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7-TA-2012-0313+0+DOC+XML+V0//EN. Some MEPs had come forward with the suggestion of adding a so called “Drug-Facts-Box” ... read more...

ECJ ruling on differentiation between cosmetics and pharmaceuticals

Thursday, September 6th, 2012 in News

On 6 September 2012 the European Court of Justice (ECJ) gave judgment in Case C-308/11 on the definition of and the requirements for the term “pharmacological action” under Article 1(2)(b) of Directive 2001/83/EC. This case was about the potential pharmacological action of a mouthwash solution against bacteria. The Court found ... read more...

Revision of the Clinical Trials Directive 2001/20: Commission Workshop

Thursday, September 6th, 2012 in News

A workshop of the European Commission with European associations on the revision of the Clinical Trials Directive 2001/20/EC (COM 2012 369) took place on 5 September 2012 in Brussels. Discussions in the European Parliament will start in the next few months. The following points were clarified by the Commission: 1. The regulation ... read more...