Decision C-3189/2019, C-3190/2019 dated 19 December 2022

20. Januar 2023 – The appellant is the authorisation holder of the medicinal products B. (tablet) and B. (coated tablet), which contain the substance C. In the context of the amendment of Therapeutic Products Act (TPA), distribution category C, to which the two products 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 category D products requires specialist advice.

Originally, B. (tablet) was classified in distribution category A. To ensure rapid availability, the requirement for a doctor's prescription was waived and B. (tablet) was reassigned to dispensing category C, under the condition that it be distributed by a health professional after a personal consultation. B. (coated tablet) was only placed on the market later and was directly assigned to distribution category C with the indication that B. (coated tablet) had to be distributed exclusively by a doctor or a pharmacist, and that a consultation had to be held prior to the distribution to determine whether the preparation was suitable. Therefore, the Federal Administrative Court (the Court) concluded that the two drugs were subject to Art. 42 lit. f VAM.

For the reclassification into distribution category B, another criterion according to Art. 42 VAM must be fulfilled. In terms of distribution category, B. was to be treated in the same way as preparations containing the active ingredient D., which had already been reclassified to distribution category C years earlier to ensure rapid availability, if they were dispensed by a medical professional after a personal consultation. At that time, neither the appellant nor the lower court assumed that the safety-relevant requirements for classification in distribution category D had been met. Now that the reclassification under discussion was made for legal reasons and not because of a changed safety profile, a classification in distribution category B was deemed appropriate. The active ingredient C. had a safety profile that is not compatible with the classification in distribution category D. Facilitated distribution was likely to be accompanied by an increased potential for abuse. The impact of the effect of C. on the body underpinned a risk profile that met the requirements of Art. 42 lit. b and c VAM. 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 meant 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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