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Laws and Regulations

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Act on Medicinal Products

Medicinal Products Act, No. 100/2020 Act on Medicinal Products

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Act on Medical Devices

Act on Medical Devices No. 132 2020 Act on Medical Devices

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Act on Product Safety and Official Market Control No. 134/1995 Act on Medical Devices

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Acts on Healthcare

Act on Health Security and Communicable Diseases, No. 19/1997 Acts on Healthcare

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Act on Health Insurance, No. 112/2008 Acts on Healthcare

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Act on Scientific Research in the Health Sector, No. 44/2014 Acts on Healthcare

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Health Service Act, No. 40/2007 Acts on Healthcare

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Act on Narcotics

Narcotics Act, No. 65/ Act on Narcotics

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Acts on Social Security

Act on Patient Insurance No. 111/2000 Acts on Social Security

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Social Security Act, No. 100/2007 Vefeyðublað Acts on Social Security

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Acts on Administrative Predures and Information

Administrative Procedures Act, No. 37/1993 Acts on Administrative Procedures and Information

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The Information Act, No. 140/2012 Acts on Administrative Procedures and Information

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Regulations on Medicinal Products

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

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Regulation concerning the Manufacture of Medicinal Products, No. 893/2004 Regulations on Medicinal Products

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Regulation on the Importation by Individuals of Medicinal Products for their own Use, No. 1277/2022 Regulations on Medicinal Products

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Regulation on Marketing Authorisations for Propietary Medicinal Products, their Labelling and Package Leaflets, No. 545/2018 (in icelandic only) Regulations on Medicinal Products

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Regulations on Clinical Trials

Regulation on Clinical Trials of Medicinal Products in Humans Regulations on Clinical Trials

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Regulation on Narcotics

Regulation on Habit-forming and Narcotic Substances and Other Controlled Substances, No. 233/2001 Regulation on Narcotics

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Regulations on Medical Devices

Regulation on instructions for use for medical devices, No. 630/2022 (in icelandic only) Regulations on Medical Devices

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Regulation on reprocessing of single use devices, No. 1154/2021 (in icelandic only) Regulations on Medical Devices

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Regulation on In Vitro Medical Devices, No. 936 (in icelandic only) Regulations on Medical Devices

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EU regulation on in vitro diagnostic medical devices, No. 2017/746 (in icelandic only) Regulations on Medical Devices

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EU regulation on medical devices, No 2017/745 (in icelandic only) Regulations on Medical Devices

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Last updated: December 5, 2023
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