NLClinicalTrialsIMP object

Applicable national regulations

General Act(s) on Medical/Clinical Research in Humans
Transposition of (CT) Directive 2001/20/EC
Other

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

Lov om legemidler m.v. (legemiddelloven) /
Norwegian Regulation relating to clinical trials on medicinal products for human use, of 30 Oct 2009 („Regulation 2009 for clinical trials (en)“- unofficial english translation):
National implementation of the European requirements of Directive 2001/20/EC;
Non-interventional trials are not covered!

General legislation on Medical/ Clinical Research in Humans

Lov om medisinsk og helsefaglig forskning (helseforskningsloven - hfl) /
Act relating to medical and health research, no.44 June 2008 („The Health Research Act“- unofficial english translation)
It applies to medical and health research on Norwegian territory or when the research takes place under the auspices of a Research Manager (Institution Responsible for Research) who is established in Norway.

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

Lov om behandling av etikk og rederlighet i forskning (Forskningsetikkloven-fel) /
Act on ethics and integrity in research (en)

Additional Information

Guideline on transitory period for the application of Regulation (EU) No 536/2014

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
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