4.7.2009

Official Journal of the European Union

C 153/10

(Case C-27/08)

(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

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.