State Institute for Drug Control

Marketing reasons are not specifically listed in the Act on Pharmaceuticals as a reason for granting the exemption. It should be repeated that SÚKL shall always consider the cases ad hoc (case by case), i.e. taking into account the specific circumstances of each administrative procedure. Should SÚKL conclude that the reasons stipulated by the Act on Pharmaceuticals do exist, it shall decide for non-application of the sunset clause, i.e. that the marketing authorisation will not cease to be valid.