INFARMED - National Authority of Medicines and Health Products, IP. is a Government agency accountable to the Health Ministry.
Mission
The mission of INFARMED, IP. shall be to regulate and supervise the medicines, medical devices and cosmetics and personal hygiene products sectors, in keeping with the highest standards of public health protection, and to ensure health professionals and the general public have access to quality, effective and safe medicines, medical devices and cosmetics and personal hygiene products,
Functions
a) Contribute to the formulating of health policy, namely the defining and executing of policies covering medicines, medical devices and cosmetics and personal hygiene products;
b) Regulate, evaluate, authorise, discipline, inspect, verify analytically as the reference laboratory, and provide vigilance and control over medicines, medical devices and cosmetics and personal hygiene products research, production, distribution, sale and use;
c) Guarantee medicines, medical devices and cosmetics and personal hygiene products research, production, distribution, sale and use are regulated and supervised;
d) Ensure compliance with the rules applying to the authorising of clinical trials for medicines and ensure they follow good clinical practices;
e) Guarantee the quality, safety, efficacy and cost-effectiveness of medicines for human use, medical devices and cosmetics and personal hygiene products;
f) Monitor medicines consumption and use;
g) Promote health professionals' and the general public's access to the information required to use medicines for human use, medical devices and cosmetics and personal hygiene products rationally;
h) Promote and support, in conjunction with national and foreign universities and other research and development institutions, the studies and research in the fields of pharmaceutical science and technology, biotechnology, pharmacology, pharmaco-economics, and pharmaco-epidemiology;
i) Ensure suitable integration and participation in the European Union system relating to the evaluation and supervision of medicines for human use, including cooperation with the European Medicines Agency, the European Commission and other European institutions;
j) Ensure suitable integration and participation in the European Union's network of medicines, medical devices and cosmetics and personal hygiene products authorities and the European network of official medicines quality assurance laboratories;
l) Fulfil the State's other international duties within the context of its functions, namely in the context of the European Union, as well as in regard to the Council of Europe and, in particular, the European Pharmacopeia Commission and the United Nations in terms of the control of stupefacients and psychotropical drugs;
m) Pursue acts of national and international, bilateral and multilateral, cooperation within the context of its functions.
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