Federal Administrative Court, Decision C-4772/2019 of 6 September 2021
24. September 2021 – The object of objection and thus the limitation of the subject matter of the present appeal proceedings before the Federal Administrative Court was the ruling by which the Federal Office of Public Health (FOPH) granted the appellant an exceptional authorisation for the manufacture and marketing of soft gelatine capsules for medicinal use abroad, limited until 31 December 2022. The object of objection was explicitly not the FOPH's change of practice as such, but the ruling issued on the basis of it. Specifically at issue and to be examined by the Federal Administrative Court was the question of whether the appellant fulfilled the requirements for the granting of an exemption permit within the meaning of art. 8 para. 5 of the Federal Act on Narcotics and Psychotropic Substances (NarcA).
After a differentiated examination of the term "restricted medical use", the Federal Administrative Court came to the conclusion that the facts underlying the appellant's application did not fall within the scope of art. 8 para. 5 NarcA. Due to the lack of a legal basis for the intended commercial export of medicinal cannabis to the USA, the FOPH had no discretionary power to grant an exemption. It was therefore not objectionable that the FOPH had come to the conclusion that the legal requirements for the granting of an ordinary exceptional authorisation were not met.
Consequently, the appeal was dismissed by the Federal Administrative Court.
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