The INFARMED - National Authority for Medicines and Health Products, IP, shortly designated by Infarmed, is a public institute integrated in the indirect administration of the State, endowed with administrative, financial and autonomous autonomy.
Infarmed pursues the attributions of the Ministry of Health, under the oversight and tutelage of the respective minister.
Infarmed is a central body with jurisdiction over the entire national territory, without prejudice to the collaboration of the autonomous regions' own bodies, in accordance with their responsibilities.
Infarmed is headquartered in Lisbon.
Mission and attributions
Infarmed's mission is to regulate and supervise the medical, medical and cosmetic products sectors, according to the highest standards of public health protection, and ensure access by health professionals and citizens to medicines, medical devices, cosmetic products, quality, effective and safe.
They are Infarmed's assignments:
(a) contribute to the formulation of health policy, in particular in the definition and implementation of policies for medicinal products for human use, medical devices and cosmetic products;
(b) regulate, evaluate, authorize, discipline, monitor, analyze analytically as a reference laboratory, and ensure the surveillance and control of research, production, distribution, marketing and use of medicinal products, medical devices and cosmetic products in accordance with their respective legal systems;
c) To regulate and supervise the activities of research, production, distribution, commercialization and use of medicinal products for human use, medical devices and cosmetic products;
(d) ensuring compliance with the rules applicable to the authorization of clinical trials with medicinal products and monitoring compliance with good clinical practice in medicinal products;
(e) ensure the quality, safety, efficacy and cost-effectiveness of medicinal products for human use, medical devices and cosmetic products;
f) Monitor the consumption and use of medicines;
(g) to promote the access of health professionals and consumers to the information necessary for the rational use of medicinal products for human use, medical devices and cosmetic products;
(h) promote and support research and development in the fields of pharmaceutical science and technology, biotechnology, pharmacology, pharmacoeconomics and pharmacoepidemiology, in liaison with universities and other national and foreign research and development institutions;
(i) ensure appropriate integration and participation in the European Union system for the evaluation and supervision of medicinal products for human use, including liaison with the European Medicines Agency and the European Commission and other European institutions;
(j) ensure the appropriate integration and participation in the network of European Union drug authorities, medical devices and cosmetic products and the network of official drug quality testing laboratories in Europe;
l) Ensure the other international obligations of the State within the scope of its attributions, in particular within the European Union, as well as in the framework of the Council of Europe, and in particular the European Pharmacopoeia Commission and the United Nations, in the area of control of narcotic drugs and psychotropic substances;
m) To develop national and international cooperation activities, bilateral or multilateral, within the scope of its attributions.
Infarmed provides and receives collaboration from the services and bodies of the direct and indirect or autonomous administration of the State, within the scope of its attributions.