Federal Administrative Court, Decision C-5010/2019 of 24 September 2021
8 octobre 2021 – The court had to decide whether the reclassification of several of the appellant’s medicinal products into category B was lawful. The appellant argued that the conditions of the Medicinal Product Regulation were not met for a categorisation into category B, as no frequent, non-intended use of the concerned medicinal products was given. As a result of the revision of the TPA, preparations in dispensing category C that cannot be reclassified to dispensing category D for safety reasons are to be reclassified to dispensing category B. The competence for reallocation lies with Swissmedic. For the reclassification the court held that Art. 42 letter f VAM was not sufficient in itself to justify the reclassification of a medicinal product into dispensing category B. In addition, (at least) one further criterion must be fulfilled in accordance with Art. 42 VAM for all prescription-only medicinal products of category B. In this context, the court had to assess whether letter c was fulfilled, which requires (i) a use for purposes other than those for which it is intended, (ii) which occurs frequently and (iii) may directly or indirectly endanger health. In the present case, the Court held that letter c was fulfilled on the basis of well-known facts. The court based this on the fact that there were numerous and extensive scientific publications, information sites and articles by specialised bodies and individuals that pointed to the misuse potential of the substance in question. Moreover, the desired effect by abusers could easily be achieved due to the substance concentration of the medicinal product in question. As a consequence, the court dismissed the appeal.
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