5 February 2026

Company A, authorisation holder for the sleeping aid B. (containing substance C.), challenged a decision by Swissmedic requiring the reclassification of the medicinal product from the former dispensing category C to the stricter category B as a consequence of the 2019 revision of Swiss pharmaceutical law. The company sought classification in the less restrictive category D, arguing that the risk profile did not justify such reclassification and that only a rare misuse in suicidal intent existed. Swissmedic justified its decision by referring to the potential for abuse, in particular the life-threatening risks associated with intentional overdoses and documented cases of misuse. It also highlighted specific risks for elderly patients and the possibility of serious adverse effects.

Before the Federal Administrative Court, the company raised several complaints, including violations of the right to be heard, an infringement of economic freedom, and unequal treatment compared with similar medicinal products. The court found that Swissmedic had sufficiently based its decision on scientific reports and the applicable legal criteria, and that a significant risk of misuse and health hazards associated with substance C had been established. The restriction on distribution was therefore considered justified in the interest of public health. The court also rejected the argument of unequal treatment with other medicinal products, noting significant differences in formulation and indication.

In conclusion, the Federal Administrative Court dismissed the appeal and held that the reclassification of medicinal product C into category B was lawful and proportionate in light of the potential health risks.

For more information, see here.