Laws and Regulations
Acts of Parliament
Medicinal Products
Medicinal Products Act, No. 100/2020
Healthcare
Act on Health Security and Communicable Diseases nr. 19/1997
Act on Medical Devices, No. 16/2001
Healthcare Practitioners Act No. 34/2012
Act on Health Insurance, No. 112/2008
Act on Scientific Research in the Health Sector No. 44/2014
Health Service Act, No. 40/2007
Social Security
Act on Patient Insurance nr. 111/2000
Social Security Act nr. 100/2007
Narcotics
Narcotics Act, No. 65/1974
Protection of Privacy
Act on Data Protection and the Processing of Personal Data no. 90/2018 (only in Icelandic)
Administrative Procedures and Information
Administrative Procedures Act No. 37/1993
The Information Act No. 140/2012
Regulations
Regulation concerning the manufacture of medicinal products No. 893/2004
Regulation on clinical trials of medicinal products in humans, No. 443/2004
Regulation on habit-forming and narcotic substances and other controlled substances, No. 233/2001
Regulation on Marketing Authorisations for Proprietary Medicinal Products, their Labelling and Package Leaflets No. 545/2018 (in Icelandic only)
Regulation on Medical Devices No. 934/2010
Regulation on active implanted medical devices No. 320/2011 (in Icelandic only)
Regulation on in vitro medical devices No. 936/2011 and amendment No. 879/2010 (in Icelandic only)
Regulation for transposition of EU regulation on medical devices nr. 627/2013 (in Icelandic only)
Regulation for transposition of EU regulation on medical devices (II) nr. 1296/2013 (in Icelandic only)
Tariffs for evaluation on application for clinical trials of medical devices No. 1295/2013 (in Icelandic only)