10 septembre 2020 – In 2015, Swissmedic had restricted the approved indication for a medicinal product and ordered an amendment to the corresponding professional information. This decision was subsequently confirmed by the Federal Administrative Court (C-5649/2015 of 24 July 2018). In its decision of 12 June 2020, the Federal Supreme Court upheld the appeal of the authorization holder. It concluded that the previous instance had not sufficiently addressed the objections of the complainant. The conformity of the evidence for the proof of therapeutic effect with the methodological requirements placed on it is a question of law that the Federal Administrative Court should not have left to Swissmedic. Thus, the case was remitted to the Federal Administrative Court for reassessment.

For the full decision, see here.