Case C-308/11

Chemische Fabrik Kreussler & Co. GmbH

v

Sunstar Deutschland GmbH, formerly John O. Butler GmbH

(Reference for a preliminary ruling from the Oberlandesgericht Frankfurt am Main)

‛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’’

Summary — Judgment of the Court (Fifth Chamber), 6 September 2012

1. Approximation of laws — Medicinal products for human use — Directive 2001/83 — Classification of a product as a medicinal product by function — Concept of pharmacological action — Possibility of taking into account the definition in the Commission’s Guidance Document on the demarcation between the Cosmetic Products Directive and the Medicinal Products Directive — Whether permissible

   (European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 1(2)(b))

2. Approximation of laws — Medicinal products for human use — Directive 2001/83 — Classification of a product as a medicinal product by function — Concept of pharmacological action — Necessity for an interaction between the molecules of the substance and a cellular constituent of the user’s body — None

   (European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 1(2)(b))

1.  Article 1(2)(b) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, 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 Directive 76/768 on the approximation of the laws of the Member States relating to cosmetic products and Directive 2001/83 as agreed between the Commission services and the competent authorities of the Member States.

   It is true that, in itself, that guidance document, which is not one of the legal acts of the European Union referred to in Article 288 TFEU, cannot be of a legally binding nature or enforceable against individuals. However, it may provide useful information for the interpretation of the relevant provisions of European Union law and therefore contribute to ensuring that they are applied uniformly. Consequently, a national court may, in order to apply the term ‘pharmacological action’ within the meaning of Article 1(2)(b) of Directive 2001/83, take account of that document. In doing so, it must nevertheless ensure that the interpretation thus derived was derived in a manner consistent with the criteria laid down by the case-law relating to the interpretation of European Union legal acts, including those concerning the division of jurisdiction between the national courts and the Court in the context of preliminary ruling proceedings.

   (see paras 23, 25-27, operative part 1)

2.  Article 1(2)(b) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, 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.

   (see para. 36, operative part 2)

Case C-308/11

Chemische Fabrik Kreussler & Co. GmbH

v

Sunstar Deutschland GmbH, formerly John O. Butler GmbH

(Reference for a preliminary ruling from the Oberlandesgericht Frankfurt am Main)

‛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’’

Summary — Judgment of the Court (Fifth Chamber), 6 September 2012

1. Approximation of laws — Medicinal products for human use — Directive 2001/83 — Classification of a product as a medicinal product by function — Concept of pharmacological action — Possibility of taking into account the definition in the Commission’s Guidance Document on the demarcation between the Cosmetic Products Directive and the Medicinal Products Directive — Whether permissible

   (European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 1(2)(b))

2. Approximation of laws — Medicinal products for human use — Directive 2001/83 — Classification of a product as a medicinal product by function — Concept of pharmacological action — Necessity for an interaction between the molecules of the substance and a cellular constituent of the user’s body — None

   (European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 1(2)(b))

1.  Article 1(2)(b) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, 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 Directive 76/768 on the approximation of the laws of the Member States relating to cosmetic products and Directive 2001/83 as agreed between the Commission services and the competent authorities of the Member States.

   It is true that, in itself, that guidance document, which is not one of the legal acts of the European Union referred to in Article 288 TFEU, cannot be of a legally binding nature or enforceable against individuals. However, it may provide useful information for the interpretation of the relevant provisions of European Union law and therefore contribute to ensuring that they are applied uniformly. Consequently, a national court may, in order to apply the term ‘pharmacological action’ within the meaning of Article 1(2)(b) of Directive 2001/83, take account of that document. In doing so, it must nevertheless ensure that the interpretation thus derived was derived in a manner consistent with the criteria laid down by the case-law relating to the interpretation of European Union legal acts, including those concerning the division of jurisdiction between the national courts and the Court in the context of preliminary ruling proceedings.

   (see paras 23, 25-27, operative part 1)

2.  Article 1(2)(b) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, 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.

   (see para. 36, operative part 2)