Federal Administrative Court, Decision C-4368/2019 of 7 September 2021
8. Oktober 2021 – Due to the revision of the Federal Act on Medicinal Products and Medical Devices (TPA), the dispensing category C (medicinal products mainly dispensed by pharmacists) has been abolished. In this context, the court had to assess whether Swissmedic was correct in reclassifying three of appellant’s medicinal products from dispensing category C to dispensing category B instead of category D as requested by the appellant. All of the medicinal products in the present case contained such a concentration of an active substance that they fall under Swiss narcotics legislation. Following an older decision that is not yet final, the court reiterated that the narcotics legislation precludes a classification in dispensing category D. The medicinal products in question, which contain narcotics in reduced concentrations, are explicitly regulated under Swiss narcotics law (Art. 3 para. 2 let. c Ordinance on control of narcotics) and are therefore subject to the more specific narcotics law regulation according to Art. 1b sentence 2 Federal Act on Narcotics and Psychotropic Substances (NarcA). Art. 9 para. 1 NarcA provides for dispensing by solely medical personnel. Swissmedic therefore had no room for manoeuvre in classifying the medicinal products in question in the dispensing category D, especially since, according to the new conception of the TPA, federally certified druggists may dispense all medicinal products in category D, and this without any documentation obligation. The court therefore dismissed the appeal.
For more information, see here.