Federal Administrative Court, Decision C-5008/2019 of 14 July 2021

12. August 2021 – In this decision, the Federal Administrative Court had to assess whether the reclassification of the appellant's medicines by the Swiss Agency for Therapeutic Products Swissmedic from dispensing category C to dispensing category B was lawful. In its main argumentation, the appellant claimed that the prerequisite for the classification of its medicines in dispensing category B according to art. 42 lit. c in conjunction with art. 40 para. 2 of the Ordinance on Medicinal Products (VAM) was not fulfilled because there was no frequent use of the medicines for purposes other than those for which they were intended. The mere potential for abuse, which exists to a certain extent in every medicine, was not sufficient for a classification in the dispensing category B.

After a comprehensive examination, the Federal Administrative Court found that the notoriety of frequent use not in accordance with the intended purpose, i.e. the misuse of the medicine, could be assumed in the present case. The medicine in question contained an active substance in such a high concentration that the effect desired by abusers could easily be achieved. It was also clear to the court that the medicine in question could have strong effects, particularly in the case of overdose, which could endanger health. Consequently, the Federal Administrative Court considered the reclassification to dispensing category B to be lawful. The appeal was dismissed.

For more information, see here.