NLClinicalTrialsIMP object

Applicable national regulations

General Act(s) on Medical/Clinical Research in Humans
National Act on Medicinal Products
Transposition of (CT) Directive 2001/20/EC
Transposition of Directive 2001/83/EC

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

Regulation on clinical trials of medicinal products in humans, No. 443/2004 (as amended by Regulations No. 907/2004 and No. 1099/2010) („Regulation no 443/2004“):
This regulation implements Directive 2001/20/EC as well as Directive 2001/83/EC on medicinal products for humans)
It covers bioavailability and bioequivalence studies, applies to radioactive medicines, natural medicines, homeopathic medicines, medicines for gene-therapy or for remedy with body cells and medicines, which contain genetically modified organisms
NB! Not applicable to non-interventional investigation!

Applicable to ATMP/ GMO trials


General legislation on Medical/ Clinical Research in Humans

Act on Scientific Research in the Health Sector No. 44/2014 („Scientific Research Act 2014“).
It applies to scientific studies carried out, in whole or in part, in Iceland.

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

(1) Medicinal Products Act, No. 93/1994, as amended.
(2) Insurance: Act on Patient Insurance, No. 111/2000, as amended:
Patients who suffer physical or mental damage in connection with examination or medical treatment in a hospital, health-care centre or other health institution are covered by this act.