Federal Administrative Court, Decision C-3805/2018 of 12 November 2020
10 December 2020 – In a recent decision, the Federal Administrative Court held that the frequency of application must be determined in other appropriate and comprehensible ways if it is not precisely described in the professional information. However, it could not be assumed without detailed clarification and justification that exactly the same single dose was to be applied to the preparations used for the comparison. The mere fact that the comparison preparations are comparable galenic forms does not justify the lump sum calculation. The Federal Administrative Court remitted the dispute to the lower court for supplementary clarifications and completion of the information.
For the full decision, see here.