Laws and Regulations

Acts of Parliament

Medicinal Products

Medicinal Products Act, No. 100/2020



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 Act, No. 65/1974


Protection of Privacy

Act on Data Protection and the Processing of Personal Data no. 90/2018  (only in Icelandic)

Biobanks Act No. 110/2000


Administrative Procedures and Information

Administrative Procedures Act No. 37/1993  

The Information Act No. 140/2012




Regulation concerning Marketing Authorisations for Natural Medicinal Products and Registration of Traditional Herbal Medicinal Products No. 142/2011

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)

Regulation on reporting of communicable diseases and agents posing a threat to public health No. 221/2012



Acts and regulations translated by the ministry of welfare