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ARTICLE · 13 DECEMBER 2022

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Medicinal Products – Repackaging Or Relabelling By Parallel Importers?

On 17 November 2022, the Court of Justice of the European Union ("CJEU"), in delivering three rulings in a series of cases in th.e names of Bayer Intellectual Property GmbH v. Kohlpharma

MaltaIntellectual Property

On 17 November 2022, the Court of Justice of the European Union ("CJEU"), in delivering three rulings in a series of cases in the names of Bayer Intellectual Property GmbH v. Kohlpharma, Novartis v. Abacus Medicine A/S, and MSD, Novartis, Ferring and Lundbeck v. Abacus Medicine, Paranova and 2CARE4 ApS (C-204/20, C-147/20 and C-224/20, (the "Three Cases")) clarified that the Member States have no discretion to impose that parallel imported medicinal products must, as a general rule, be repackaged instead of relabelled and it provided for two exceptions to this principle of relabelling rather than repackaging where there is a strong resistance from a significant proportion of consumers in the import market to acquiring (i) relabelled medicinal products or (ii) medicinal products with outer packaging which has visible traces of tampering.

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