CELEX: 62008CA0027
Language: en
Date: 2009-04-30 00:00:00
Title: Case C-27/08: Judgment of the Court (Fifth Chamber) of 30 April 2009 (reference for a preliminary ruling from the Bundesverwaltungsgericht (Germany)) — BIOS Naturprodukte GmbH v Saarland (Directive 2001/83/EC — Article 1(2)(b) — Concept of medicinal product by function — Dosage of the product — Normal conditions of use — Risk to health — Ability to restore, correct or modify physiological functions in human beings)

4.7.2009   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 153/10
            
         Judgment of the Court (Fifth Chamber) of 30 April 2009 (reference for a preliminary ruling from the Bundesverwaltungsgericht (Germany)) — BIOS Naturprodukte GmbH v Saarland
   (Case C-27/08) (1)
   
   (Directive 2001/83/EC - Article 1(2)(b) - Concept of ‘medicinal product by function’ - Dosage of the product - Normal conditions of use - Risk to health - Ability to restore, correct or modify physiological functions in human beings)
   2009/C 153/20
   Language of the case: German
   
      Referring court
   
   Bundesverwaltungsgericht
   
      Parties to the main proceedings
   
   
      Applicant: BIOS Naturprodukte GmbH
   
      Defendant: Saarland
   
      Re:
   
   Reference for a preliminary ruling — Bundesverwaltungsgericht — Interpretation of Article 1(2) of 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 2001 L 311, p. 67), as amended by 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) — Definition of medicinal product — Product containing a substance having a therapeutic effect in high doses, while capable of being harmful in lower doses, like the dose recommended by the manufacturer — Boswellia extract
   
      Operative part of the judgment
   
   Article 1(2) of 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, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, must be interpreted as meaning that a product which includes in its composition a substance which has a physiological effect when used in a particular dosage is not a medicinal product by function where, having regard to its content in active substances and under normal conditions of use, it constitutes a risk to health without, however, being capable of restoring, correcting or modifying physiological functions in human beings.
   
      (1)  OJ C 92, 12.4.2008.