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Valentina R., lawyer
EN
2013/C 325/13
Language of the case: German
Is Article 1(2)(b) of Directive 2001/83/EC of 6 November 2001, as amended by Directive 2004/27/EC of 31 March 2004, to be interpreted as meaning that substances or combinations of substances within the meaning of that provision which merely modify — that is, do not restore or correct — human physiological functions are to be regarded as medicinal products only if they are of therapeutic benefit or at any rate bring about a modification of bodily functions along positive lines? Consequently, do substances or combinations of substances which are consumed solely for their — intoxication-inducing — psychoactive effects, and in the process also have an effect which at least poses a risk to health, fall under the definition of ‘medicinal product’ contained in the directive?
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2011 L 311, p. 67).
Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ 2004 L 136, p. 34).