21 August 2025
Decision C-802/2021 of 5 August 2025
In its decision C-802/2021 of 5 August 2025 the Federal Administrative Court rejected the appeal filed by A. AG, which operated pharmacies. A. AG had argued that ethanol 70%, which was used as disinfectant, was to be considered a medicinal product in the sense of the Therapeutic Products Act (Heilmittelgesetz, HMG) and, therefore, its production in a pharmacy holding a production permit would not require authorization according to the Ordinance on Biocidal Products (Biozidverordnung, VBP).
The court held that a biocidal product was only subject to the HMG if, from an objective point of view, it was primarily intended for medical use. This would have to be assessed based on its composition, the associated product properties as well as the normal purpose according to the common understanding of customers.
The court argued that the average consumer would know that hand and surface disinfectants are primarily used for decontamination. Additionally, Switzerland has signed a Mutual Recognition Agreement (MRA) with the European Union (EU) regarding biocidal products. The MRA states that Switzerland should apply the VBP based on the harmonized interpretation within the EU. The EU itself categorizes hand and surface disinfectants as biocidal products.
Regarding the requirement of authorization to produce and sell the disinfectant, the court held that the active ingredient ethanol was not authorized within the EU. According to art. 13 VBP, a transitional authorization could be issued if the applicant proved that, according to the latest scientific and technical knowledge and when used as intended, the product and its residues are not expected to have any unacceptable effects on humans, animals, or the environment and that the biocidal product is sufficiently effective. Therefore, the sale of disinfectants with the active ingredient ethanol was subject to authorization under the VBP. A. AG did not have such authorization and was, therefore, prohibited from selling disinfectant with ethanol 70%.
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