# C_2007315EN.01000701.xml

| 22.12.2007 | EN | Official Journal of the European Union | C 315/7 |
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Judgment of the Court (Second Chamber) of 8 November 2007 (reference for a preliminary ruling from the Bundesgerichtshof (Germany)) — Gintec International Import-Export GmbH v Verband Sozialer Wettbewerb eV

(Case C-374/05)( 1 )

(Directives 2001/83/EC and 92/28/EEC - National legislation prohibiting advertising of medicinal products by way of statements of third parties or prize draws - Use of generally positive results of a consumer survey and a monthly prize draw to win a pack of the product)

(2007/C 315/11)

Language of the case: German

Referring court

Bundesgerichtshof

Parties to the main proceedings

Applicant: Gintec International Import-Export GmbH

Defendant: Verband Sozialer Wettbewerb eV

Re:

Reference for a preliminary ruling — Bundesgerichtshof — Interpretation of Articles 87(3) and 90(j) 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), and Articles 2(3) and 5(j) of Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use (OJ 1992 L 113, p. 13) — National legislation prohibiting advertising for medicinal products by way of statements of third parties having no specialist knowledge or by lotteries — Use of generally positive results of a customer survey and a monthly prize draw to win a pack of the product

Operative part of the judgment

| 1. | 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, brought about complete harmonisation in the field of advertising of medicinal products and lists expressly the cases in which Member States are authorised to adopt provisions departing from the rules laid down by that directive. The directive must therefore be interpreted to the effect that a Member State may not provide, in its national legislation, for an absolute and unconditional prohibition, in the advertising of medicinal products to the general public, on the use of statements from third parties, whilst their use can be limited, under that same directive, only by reason of their specific content or the type of person making the statement. |
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| 2. | (a)
Directive 2001/83, as amended by Directive 2004/27, requires Member States to provide, in their national legislation, for a prohibition on the use, in the advertising of medicinal products to the general public, of statements from third parties where those refer, in improper, alarming or misleading terms, to claims of recovery within the meaning of Article 90(j) of Directive 2001/83, as amended by Directive 2004/27, the term ‘claims of recovery’ having thus to be interpreted as not including references to the reinforcement of a person's well-being where the therapeutic efficacy of the medicinal product in terms of the elimination of a particular illness is not referred to. Article 90(c) of Directive 2001/83, as amended by Directive 2004/27, also requires Member States to provide, in their national legislation, for a prohibition on the use, in the advertising of medicinal products to the general public, of statements from third parties where they give the impression that the use of the medicinal product contributes to the reinforcement of general well-being. (b)
Articles 87(3), 88(6) and 96(1) of Directive 2001/83, as amended by Directive 2004/27, prohibit the advertising of a medicinal product by means of a prize draw announced on the internet, inasmuch as it encourages the irrational use of that medicinal product and leads to its direct distribution to the general public and to the presentation of free samples. | (a) | Directive 2001/83, as amended by Directive 2004/27, requires Member States to provide, in their national legislation, for a prohibition on the use, in the advertising of medicinal products to the general public, of statements from third parties where those refer, in improper, alarming or misleading terms, to claims of recovery within the meaning of Article 90(j) of Directive 2001/83, as amended by Directive 2004/27, the term ‘claims of recovery’ having thus to be interpreted as not including references to the reinforcement of a person's well-being where the therapeutic efficacy of the medicinal product in terms of the elimination of a particular illness is not referred to. Article 90(c) of Directive 2001/83, as amended by Directive 2004/27, also requires Member States to provide, in their national legislation, for a prohibition on the use, in the advertising of medicinal products to the general public, of statements from third parties where they give the impression that the use of the medicinal product contributes to the reinforcement of general well-being. | (b) | Articles 87(3), 88(6) and 96(1) of Directive 2001/83, as amended by Directive 2004/27, prohibit the advertising of a medicinal product by means of a prize draw announced on the internet, inasmuch as it encourages the irrational use of that medicinal product and leads to its direct distribution to the general public and to the presentation of free samples. |
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| (a) | Directive 2001/83, as amended by Directive 2004/27, requires Member States to provide, in their national legislation, for a prohibition on the use, in the advertising of medicinal products to the general public, of statements from third parties where those refer, in improper, alarming or misleading terms, to claims of recovery within the meaning of Article 90(j) of Directive 2001/83, as amended by Directive 2004/27, the term ‘claims of recovery’ having thus to be interpreted as not including references to the reinforcement of a person's well-being where the therapeutic efficacy of the medicinal product in terms of the elimination of a particular illness is not referred to. Article 90(c) of Directive 2001/83, as amended by Directive 2004/27, also requires Member States to provide, in their national legislation, for a prohibition on the use, in the advertising of medicinal products to the general public, of statements from third parties where they give the impression that the use of the medicinal product contributes to the reinforcement of general well-being. | | | | |
| (b) | Articles 87(3), 88(6) and 96(1) of Directive 2001/83, as amended by Directive 2004/27, prohibit the advertising of a medicinal product by means of a prize draw announced on the internet, inasmuch as it encourages the irrational use of that medicinal product and leads to its direct distribution to the general public and to the presentation of free samples. | | | | |

| 3. | The first and second questions submitted for a preliminary ruling would be answered in the same way if the provisions of Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use applied. |
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( 1 )  OJ C 315, 10.12.2005.

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