Laws and Regulations

Acts of Parliament

 
Medicinal Products

 

Healthcare

Act on Health Security and Communicable Diseases nr. 19/1997

Act on Medical Devices, No. 16/2001

Patients' Rights Act nr. 74/1997

 

Social Security

Act on Patient Insurance nr. 111/2000

 

Narcotics

 

Protection of Privacy

Act on the Protection of Privacy as regards the Processing of Personal Data No. 77/2000

 

Administrative Procedures and Information

 

 

Regulations

 

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 a Health Sector Database No. 32/2000

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 importation by individuals of medicinal products for personal use No. 212/1998

Regulation on Marketing Authorisations for Proprietary Medicinal Products, their Labelling and Package Leaflets No. 141/2011

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

Regulations on Scientific Research in the Biomedical Field No. 286/2008

 

Links

Acts and regulations translated by the ministry of welfare
Acts and regulations translated by the ministry of the interior