Decision C-3188/2019 dated 19 December 2022
20 January 2023 – The appellant is the authorisation holder of the medicinal product B., which contains the substance C. In the context of the amendment of the Therapeutic Products Act (TPA), distribution category C, to which B. belonged, was abolished. The appellant objected to the new classification of its products by Swissmedic into distribution category B (Art.42 of the Ordinance on Medicinal Products [Arzneimittelverordnung, VAM]) and claimed that its two medicinal products belonged to distribution category D (Art. 43 VAM). Distribution category B includes prescription-only medicines, while the distribution of category D products requires specialist advice.
Originally, B. was classified in distribution category A. To ensure rapid availability, the requirement for a doctor's prescription was waived and B. was reassigned to dispensing category C, under the condition that it be distributed by a health professional after a personal consultation. The focus was not on professional advice as such, but on clarifying the suitability of the preparation. A further condition for classification in distribution category C was that the pharmacists be informed and trained accordingly. B. could only be marketed after this training had been completed. The aim of the training was, in particular, to clarify any risks and the suitability of a medicinal product with the same area of application as B. Therefore, the Federal Administrative Court (the Court) concluded that B. is subject to Art. 42 lit. f VAM.
For the reclassification into distribution category B, another criterion according to Art. 42 VAM must be fulfilled. According to the Court, there were contraindications for B. that support this classification. The active ingredient C. had a safety profile that is not compatible with distribution category D. Facilitated distribution was likely to be accompanied by an increased potential for abuse. In addition, various other medicines with the active substance C. contained long lists of contraindications for the active substance C. as well as warnings and precautionary measures in their expert information. Therefore, the requirements for Art. 42 lit. b and c VAM were fulfilled. This led to a reclassification of B. to distribution category B.
According to the Court, even after the assignment to distribution category B, B. could still be dispensed without a prescription through personal contact with a pharmacist, which means that, contrary to the appellant's view, rapid availability was still guaranteed. A significantly stricter regulation, as the appellant claims, was not evident. The appeal was dismissed.
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