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    The Court of Justice of the European Union has made a decision regarding the case Novo Nordisk A/S versus the Estonian State Agency of Medicines

    07.07.2011
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    On the 5th of May 2011 the Court of Justice of the European Union (ECJ) has made a judgment concerning the reference for a preliminary ruling from the Tartu Circuit Court which concerns the question of interpreting Article 87(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6th of November 2001 on the Community code relating to medicinal products for human use.

    The reference for preliminary ruling was made in proceedings between Novo Nordisk A/S and the Estonian State Agency of Medicines concerning the latter’s order requiring Novo Nordisk to withdraw its advertisement for Levemir (insulin detemir). Since the argument concerned the interpretation of the referred directive and because the ECJ had not taken a uniform position on the concerned article Tartu Circuit Court turned to the ECJ.

    The ECJ stated in its judgment from the 5th of May 2011 that the article 87(2) of the Directive 2001/83/EC must be interpreted as prohibiting the publication in advertising medicinal products of claims which conflict with the summary of product characteristics, but it does not require that all the claims in such advertisements are included in that summary or can be derived from it. The advertisement may contain additional claims that supplement the summary of product characteristics provided that the information:

    - confirms or clarifies the information in the summary of product characteristics;
    - does not distort it;
    - encourages the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties;
    - is not misleading;
    - is 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;
    - quotations as well as tables and other illustrative matter taken from medical journals or other scientific works must be faithfully reproduced and their precise sources indicated.

    The ECJ does not resolve the argument in its essence but only provides interpretations to EU legislation with the purpose of guaranteeing their unified implementation in all Member States. The reference of the preliminary ruling is one step of the in-process case and the argument between Novo Nordisk A/S and the Estonian State Agency of Medicines will continue in the national court.

    The reference for a preliminary ruling by the Tartu Circuit Court and the Judgment of the European Court of Justice from the 5th of May 2011 with arguments and reasoning can be found on the home page of the Court of Justice of the European Union: http://curia.europa.eu/jurisp/cgi-bin/form.pl?lang=et

    The number of the case is C-249/09.

    For further information please contact: info@ravimiamet.ee