Judgment_paragraph 41 · MSD Sharp & Dohme GmbH v Merckle GmbH (C-316/09)

41In that connection, it should be observed that Article 61 of Directive 2001/83 provides that all the information appearing on the packaging and the package leaflet of a medicinal product must have been submitted to the competent authorities when the marketing authorisation was requested and approved by them. Thus, this is information which is not only objective, and without any danger a priori to the consumer, but also approved, and the appearance of which on the packaging and the package leaflet is even obligatory in accordance with Articles 54 and 59 of that directive.

MSD Sharp & Dohme GmbH v Merckle GmbH (C-316/09)

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