Medicinal Products Act (No. 100 of 2020).

The objectives of this Act are to ensure the residents of the country have an adequate supply of necessary medicinal products, prioritizing patient safety, and to achieve the most efficient distribution of medicines based on fair competition and in accordance with the regulations applicable in the European Economic Area or under the founding agreement of the European Free Trade Association. Additionally, this Act aims to ensure, as far as possible, the quality and safety of medicinal products and pharmaceutical services, to increase education on the use of medicinal products, to curb excessive use, and to keep pharmaceutical costs to a minimum. The Act applies to medicinal products for humans unless otherwise specifically stated. Rules are included on authorization for veterinarians to sell medicines intended for use in animals.
The Act contains 112 Articles organized in the following chapters: I. Objectives, Scope, and Definitions; II. Governance, Role of the Icelandic Medicines Agency, and Responsibilities; III. Medicinal Product Registries; IV. Marketing Authorization of Medicinal Products; V. Clinical Trials of Medicinal Products in Humans; VI. Manufacturing of Medicinal Products; VII. Wholesale Distribution of Medicinal Products; VIII. [repealed]; IX. Pharmacies, Drugstores, etc.; X. Management of Medicinal Products in Healthcare Institutions; XI. Safety Features on the Packaging of Medicinal Products; XII. Prescription of Medicinal Products and Dispensing in Pharmacies; XIII. Advertising of Medicinal Products, Forecasting, and Health Technology Assessment; XIV. Pharmacovigilance; XV. Drug Pricing and Co-payment; XVI. Pharmaceutical Statistics and Medicinal Product Database; XVII. Supervision; XVIII. Fees; XIX. Enforcement Measures; XX. Final provisions.