Federal Administrative Court, Decision C-6605/2018 from 4 November 2021

26. November 2021 – The Court had to decide whether the Federal Office of Public Health (FOPH) had legally reclassified appellant’s preparations into the IT group 10.10 and placed a limitation on them. While a simple classification into an IT group does in principle not constitute an appealable order, the court found in the present case that the contested reclassification order had a direct economic impact on the appellant and constituted a direct interference with the legal position of the marketing authorisation holder. In contrast to FOPH's argumentation, the court also clarified that FOPH could not unquestioningly adopt the IT group provided by Swissmedic for its own classification in the SL. Furthermore, the court held that the medicinal product in question had a broader scope of application and a lower risk profile, and that it therefore ranked higher in terms of appropriateness than the comparator preparations. In addition, the court called attention to the fact that the parties had not compared the medicinal product in question with any of the preparations in IT group 10.10. The court concluded that the reclassification and the introduction of a limitation was not comprehensible.

Therefore, the appeal was upheld and the matter was referred back to the lower court for a new examination.

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