Language of document : ECLI:EU:C:2011:272

Case C-249/09

Novo Nordisk AS

v

Ravimiamet

(Reference for a preliminary ruling from the Tartu ringkonnakohus)

(Medicinal products for human use – Directive 2001/83/EC – Advertising – Medical journal – Information not included in the summary of product characteristics)

Summary of the Judgment

1.        Approximation of laws – Medicinal products for human use – Directive 2001/83 – Advertising – Extent

(European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 87(2))

2.        Approximation of laws – Medicinal products for human use – Directive 2001/83 – Advertising

(European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 87(2))

1.        Article 87(2) 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 extending also to quotations taken from medical journals or other scientific works which are included in advertisements for medicinal products directed at persons qualified to prescribe or supply medicines. It follows, both from the position of Article 87 of Directive 2001/83 in its structure, and from the wording and content of Article 87, that Article 87(2) is a general rule applicable to all advertising for medicinal products, including that directed at persons qualified to prescribe or supply medicinal products. That interpretation is confirmed by the purpose of the directive. Incorrect or incomplete information can clearly endanger people’s health and thus jeopardise the fundamental objective pursued by that directive.

(see paras 30-31, 34-35, operative part 1)

2.        Article 87(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, prohibits the publication, in advertising of medicinal products directed at persons qualified to prescribe or supply them, of claims which conflict with the summary of product characteristics, but it does not lay down a requirement that all the claims in such advertisements should be included in that summary or that it should be possible for them to be deduced from it. Such advertisements may include claims supplementing the information referred to in Article 11 of that directive, provided that those claims:

- confirm or clarify, and are compatible with, that information, and do not distort it, and

- are consistent with the requirements of Articles 87(3) and 92(2) and (3) of that directive.

Accordingly, such information, firstly, may not be misleading and must encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties. Secondly, it must be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned. Finally, quotations, tables and other illustrative matter taken from medical journals or other scientific works are to be clearly identified and the precise sources indicated, so that health professionals are informed of them and can verify them.

(see paras 50-51, operative part 2)