Judgment of the Court (Fifth Chamber) of 6 September 2012 (reference for a preliminary ruling from the Oberlandesgericht Frankfurt am Main - Germany) - Chemische Fabrik Kreussler & Co. GmbH v Sunstar Deutschland GmbH, formerly John O. Butler GmbH

(Case C-308/11) 

(Directive 2001/83/EC - Medicinal products for human use - Article 1(2)(b) - Meaning of 'medicinal product by function' - Definition of the term 'pharmacological action')

Language of the case: German

Referring court

Oberlandesgericht Frankfurt am Main

Parties to the main proceedings

Applicant: Chemische Fabrik Kreussler & Co. GmbH

Defendant: Sunstar Deutschland GmbH, formerly John O. Butler GmbH

Re:

Reference for a preliminary ruling - Oberlandesgericht Frankfurt am Main - Interpretation of Article 1(2)(b) 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 of a product as a medicinal product - Mouthwash containing 0.12% chlorhexidine - Definition of 'pharmacological action'

Operative part of the judgment

Article 1(2)(b) 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, for the purpose of defining the term 'pharmacological action' within the meaning of that provision, account may be taken of the definition of that term in the Guidance Document on the demarcation between the Cosmetic Products Directive 76/768 and the Medicinal Products Directive 2001/83 as agreed between the Commission services and the competent authorities of the Member States.

Article 1(2)(b) of Directive 2001/83 must be interpreted as meaning that, for a substance to be regarded as exerting a 'pharmacological action' within the meaning of that provision, it is not necessary for there to be an interaction between the molecules of which it consists and a cellular constituent of the user's body, as an interaction between that substance and any cellular constituent present within the user's body may be sufficient.

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¹ - OJ C 282, 24.9.2011.