Federal Administrative Court, Decision C-2652/2019 from 22 December 2021

27 janvier 2022 – The subject of the present dispute was Swissmedic's decision, by which it had, on the one hand, ordered the destruction of 90 tablets of appellant’s medicinal product which had been withheld by the Zurich Airport Customs Inspectorate and, on the other hand, charged the appellant the fees relating to its decision. The qualification of the seized products as medicinal products in the sense of art. 4 lit. a of the Therapeutic Products Act (TPA) was not disputed. Such medicinal products that are ready for use require an authorisation pursuant to art. 9 al. 1 TPA. The Court held that no authorisation existed for the medicinal product in question since it was not on the list of medicines authorised in Switzerland. It further stated that even though certain active ingredients of the medicinal product in question were on said list of authorised substances, the appellant could not derive an authorisation from that fact for itself as the quantity of these ingredients in appellant’s products allowed for 90 days of treatment which exceeded the maximum authorised by Swissmedic of a treatment of one month with these ingredients. Moreover, this did not constitute a small quantity for personal consumption in the sense of the established practice allowing for the import of such small quantities. Consequently, the medicinal products in question lacked an authorisation. Pursuant to art. 66 TPA, Swissmedic can take all measures necessary to execute the law. In the present case, the Court held that the medicinal products presented a health hazard by exceeding the permitted quantity of certain ingredients. Moreover, the Court pointed out that the products in question were manufactured in India and therefore were not under a state supervision comparable to the supervision in Switzerland. In view of these circumstances and the public health objective pursued by Swissmedic, in particular the protection of public health by ensuring that unauthorised medicinal products are not placed on the market in excessive quantities, the ordered destruction of the seized medicinal products did not unreasonably prejudice the interests of the appellant and could be described as an appropriate measure pursuant to the Court.

Therefore, the Court dismissed the appeal.

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