23. Can an exemption be granted on marketing grounds?

Marketing grounds as such are not listed in the Act on Pharmaceuticals as a reason for granting an exemption. Again, it must be stated that SUKL will always evaluate the matter ad hoc, e.g. in view of specific circumstances of every particular administrative procedure. If SUKL comes to the conclusion that there are grounds set out in the Act on Pharmaceuticals, it shall decide that the sunset clause shall not apply, i.e. the marketing authorisation shall not cease to be valid.