Federal Administrative Court, Decision C-4697/2019 of 9 August 2021

8 octobre 2021 – In its decision, the court had to assess, whether the lower instance – Swissmedic – had correctly reclassified four of the appellants drugs from distribution category C to distribution category B. The appellant requested the reclassification of its medicinal products to category D (dispensing without prescription, after professional consultation). Swissmedic was of the opinion that the legislation on narcotics precludes the classification of the medicinal products in dispute in dispensing category D. The court followed the decision C-4125/2019 of March 10, 2021, where the appeal of an authorisation holder of similar products as in dispute here, which had been reclassified to distribution category B, was dismissed. In said decision, the Federal Administrative Court recognized, in accordance with the opinion of Swissmedic, that the legislation on narcotics precludes the classification of the medicinal products in dispute in dispensing category D. It has essentially considered that only the partially controlled medicinal products - as previously in category C - could be dispensed by pharmacists (according to Art. 24 para. 1 lit. a num. 1 TPA and Art. 45 lit. c TPO) without a doctor's prescription. Concerning the appellant’s request for reclassification, the court stated here that a reclassification of medicinal products also covered by the narcotics legislation did not conflict with the basic idea of the TPA-revision and was entirely in line with the legislative intent. The court thus dismissed the appeal.

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