NLCombinationStudies object
Applicable national regulations
One legal act for both study types available
Legal act applicable to both study types
Heilmittelgesetz (HMG), Bundesgesetz über Arzneimittel und Medizinprodukte, SR 812.21 (2000)/
Therapeutic Products Act (TPA), Federal Act on Medicinal Products and Medical Devices (NB: en, non-official translation)
NB: HMG/TPA is also applicable to Gene Therapy trials
Other applicable regulations / implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)
Humanforschungsgesetz (HFG), Bundesgesetz über die Forschung am Menschen, SR 810.30 (2011)
Human Research Act (HRA), Federal Act on Research involving Human Beings (NB: en, non-official translation)
