Facts
[A. AG], a Swiss company, holds a wholesale license for the sale of medicinal products in Switzerland. It wants to deliver medicinal products directly from its warehouse in Singen (Germany) to customers in Switzerland. The Swiss Agency for Therapeutic Products (Swissmedic) has issued a ruling that does not permit direct delivery from a German warehouse. [A. AG] has lodged an appeal against this ruling.
The Federal Administrative Court has dismissed the appeal. [A. AG] has subsequently filed a complaint with the Federal Supreme Court.
The Federal Supreme Court has upheld the complaint and overturned the decision of the lower court. It has established that the mere fact that customers are delivered directly from the German warehouse does not constitute sufficient grounds for refusing the license.
Considerations
The Federal Supreme Court has dealt with the question of whether direct delivery to customers in Switzerland from a warehouse abroad is admissible. It has established that Swiss law does not explicitly require a warehouse within Switzerland as a licensing requirement. However, this requirement arises indirectly from the fact that the warehouse must be accessible to inspection by the Swiss authorities.
The court has further established that the lower court wrongly assumed that direct delivery from a warehouse abroad was not admissible. It has also established that the Agreement on the Mutual Recognition of Conformity Assessment between Switzerland and the European Union does not provide a basis for recognizing any inspections by German authorities or those of the European Union in the area of Good Distribution Practice for the purposes of the Swiss import and wholesale license.
However, the court has also established that an inspection of the warehouse abroad is possible…