Facts
On 6 April 2004, the Regional Medicinal Inspectorate of Northwestern Switzerland, on behalf of the Swiss Agency for Therapeutic Products (Swissmedic), conducted an inspection of the business premises of X AG. Subsequently, on 2 November 2004, Swissmedic issued a decision prohibiting X AG from distributing 31 preparations, as they did not have the required marketing authorisation. X AG filed an appeal against this decision with the Federal Appeal Commission for Therapeutic Products. Ultimately, 11 preparations of X AG were still in dispute in the appeal proceedings. The Appeal Commission dismissed the appeal with regard to these preparations. Thereupon, X AG filed an administrative court appeal with the Federal Supreme Court.Considerations
The Federal Supreme Court had to assess whether the disputed preparations were exempt from the marketing authorisation requirement as so-called magistral formulations pursuant to Art. 9 para. 2 lit. a of the Therapeutic Products Act (TPA). The Appeal Commission had denied this, as the preparations were not manufactured on a case-by-case basis upon a medical prescription, but were pre-produced in series and stored in stock.
The Federal Supreme Court followed the reasoning of the Appeal Commission. It stated that Art. 9 para. 2 lit. a TPA must be interpreted restrictively and only covers medicinal products that are manufactured in temporal proximity to a medical prescription and based…