Decision 2C_49/2022 dated 8 December 2022

20 gennaio 2023 – The appellant is the authorisation holder of the medicinal products B. (syrup) and B. (lozenges), which contain a single active substance, namely dextromethorphani hydrobromidum monohydricum (hereinafter: dextro-methorphan). In the context of the amendment of the law on medicinal products, distribution category C, to which the two above-mentioned products belonged, was abolished. The appellant objected to the new classification by Swissmedic into distribution category B (Art. 42 of the Ordinance on Medicinal Products (Arzneimittelverordnung, VAM)) and claimed that its two medicinal products belonged to distribution category D (Art. 43 VAM). Distribution category B includes prescription-only medicines, while the distribution of medicines in distribution category D requires specialist advice.

According to the dispatch of 7 November 2012 on the amendment of the Therapeutic Products Act (TPA) (hereinafter: dispatch), special attention must be paid to medicinal products with a risk of misuse, and it is explicitly stated that medicinal products consisting of dextro-methorphan are medicinal products with such a risk and must change from dispensing category C to dispensing category B. Based on the historical interpretation of the amendment to the TPA, the Federal Supreme Court concluded that syrup and lozenges B. fall under Art. 42 lit. f VAM and thus also under Art. 45 para. 1 lit. c VAM, which is directly connected to it. In addition, syrup and lozenges B. also fall under Art. 42 lit. c VAM. The appeal was dismissed.

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