24.9.2011

Official Journal of the European Union

C 282/2

(Case C-308/11)

2011/C 282/02

Language of the case: German

Referring court

Parties to the main proceedings

Applicant: Chemische Fabrik Kreussler & Co. GmbH

Respondent: John O. Butler GmbH

Questions referred

1.For the purpose of defining the term ‘pharmacological action’ in Article 1(2)(b) of Directive 2001/83/EC, as amended by Directive 2004/27/EC, can recourse be had to the document compiled under the auspices of the European Commission to provide guidance in distinguishing between medicinal products and medical devices (the ‘Medical Devices: Guidance document’), which states that there must be an interaction between the molecules of the substance in question and a cellular constituent, usually referred to as a receptor, which either results in a direct response or blocks the response of another agent?

2.If the first question is answered in the affirmative: does the term ‘pharmacological action’ require that there should be an interaction between the molecules of the substance in question and cellular constituents of the user, or is it sufficient if there is an interaction between the substance in question and a cellular constituent which does not form part of the human body?

3.In the event that the first question is answered in the negative or that neither of the two definitions proposed in the second question is appropriate: which alternative definition should be used instead?

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).

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).