NLClinicalTrialsIMP object

Applicable national regulations

General Act(s) on Medical/Clinical Research in Humans
National Act on Medicinal Products
Other

Transposition of (CT) Directive 2001/20/EC (or comparable national legal framework)

Heilmittelgesetz (HMG), Bundesgesetz über Arzneimittel und Medizinprodukte, SR 812.21 (2000)/ Therapeutic Products Act (TPA), Federal Act on Medicinal Products and Medical Devices (en, non-official translation)

Applicable to ATMP/ GMO trials

Yes

General legislation on Medical/ Clinical Research in Humans

Humanforschungsgesetz (HFG), Bundesgesetz über die Forschung am Menschen, SR 810.30 (2011)/
Human Research Act (HRA), Federal Act on Research involving Human Beings (en, non-official translation)

Other applicable regulations/ implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)

The Federal Council has approved three ordinances on the law on research involving humans, effective as from 01.01.2014:
Verordnung über klinische Versuche (KlinV), Verordnung über klinische Versuche in der Humanforschung, SR 810.305 (2013)/ Clinical Trials Ordinance; ClinO (NB: en, non-official translation)
NB: KlinV/ClinO is also applicable to Gene Therapy trials; however, it does not consider clinical trials on vital organs, tissues or ells of human or animal origin including ex-vivo gene therapy!
Organisationsverordnung HFG (OV- HFG); Organisationsverordnung zum Humanforschungsgesetz; SR 810.308 (2013)/ HRA Organisation Ordinance (OrgO-HRA) (en, non-official translation)
Humanforschungsverordnung (HFV); SR 810.301 (2013)/Human Research Ordinance (HRO) (NB: en, non-official translation)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395