Facts
On 6 April 2004, the Regional Medicinal Inspectorate of Northwestern Switzerland, on behalf of Swissmedic, conducted an inspection of the business premises of A. AG and B. AG. As a result, Swissmedic prohibited A. AG from distributing various medicinal products in a ruling dated 8 October 2004, as they did not have the required authorisation. A. AG filed a complaint and requested the ruling to be revoked, as they were exempt household specialties under Art. 9 para. 2 lit. c of the Therapeutic Products Act (TPA). The Federal Appeal Commission for Therapeutic Products dismissed the complaint. A. AG filed an administrative court appeal against this judgment with the Federal Supreme Court.Considerations
The Federal Supreme Court dismissed the appeal. It concluded that the medicinal products in question did not fall under the exception for household specialties under Art. 9 para. 2 lit. c TPA. For this, the medicinal products must be manufactured according to a "proprietary formula" of the dispensing site. A "proprietary formula" does not exist if the formula is published or provided by the manufacturer. Even if the commissioned manufacturer complies with stricter regulations than the dispensing site, this does not change the fact that the formula must belong to the dispensing site itself. Furthermore, the…