EN Official Journal of the European Union C 55/2

Judgment of the Court (First Chamber) of 15 January 2009 (reference for a preliminary ruling from the Bundesverwaltungsgericht — Germany) — Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg

(Case C-140/07) (1)

(Directive 2001/83/EC - Articles 1(2) and 2(2) - Concept of ‘medicinal product by function’ - Product in respect of which it has not been established that it is a medicinal product by function - Account taken of the content in active substances)

(2009/C 55/02)

Language of the case: German

Referring court

Bundesverwaltungsgericht

Parties to the main proceedings

Applicant: Hecht-Pharma GmbH

Defendant: Staatliches Gewerbeaufsichtsamt Lüneburg

Intervening Party: Vertreterin des Bundesinteresses beim Bundesverwaltungsgericht

Re:

Reference for a preliminary ruling — Bundesverwaltungsgericht — Interpretation of Articles 1(2) and 2(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 (OJ 2004 L 136, p. 34) — Classification as a medicinal product of a product containing a component capable of producing physiological changes in the event of consumption of a greater dose than intended for normal use — Applicability of Directive 2001/83/EC to a product which could possibly be classified as a medicinal product but whose quality of a medicinal product has not been determined — Concept of medicinal product

Operative part of the judgment

1. Article 2(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 Directive 2001/83, as amended by Directive 2004/27, does not apply to a product in respect of which it has not been scientifically established that it is a medicinal product by function, without its being possible to exclude that possibility.

2. Article 1(2)(b) of Directive 2001/83, as amended by Directive 2004/27, must be interpreted as meaning that the characteristics of the manner in which a product is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail are still relevant to determining whether that product falls within the definition of a medicinal product by function.

3. Article 1(2)(b) of Directive 2001/83, as amended by Directive 2004/27, must be interpreted as meaning that, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, a product cannot be regarded as a medicinal product within the meaning of that provision where, having regard to its composition — including its content in active substances — and if used as intended, it is incapable of appreciably restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.

(1) OJ C 117, 26.5.2007.