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National Authority for Medicines and Health Products – Autoridade national do Medicamento e Productos de Saùde (INFARMED)

Under the aegis of the Ministry of Health the National Authority for Medicines and Health Products (INFARMED) is the national regulatory authority that evaluates, authorizes, regulates and controls human medicines as well as health products namely medical devices, homeopathic products and cosmetics.

The Authority's main goal is to ensure the quality, safety and efficacy of medicines and the quality, safety and performance of health products in order to avoid the risks of their use while ensuring adequate standards of public health and consumer's protection.

Amongst INFARMED top activities, the regulation and supervision of medicinal and health products, from research up to their use by healthcare professionals and patients, is of particular importance.

Principal areas of activity

  • research, evaluation and authorisation of medicines
  • quality, safety and efficacy control of medicines and health products
  • Good Clinical Practices (GCP's) in clinical trials
  • research, assessment, registration, monitoring and supervision of health products
  • clinical research evaluation, assessment and registration of CE marked medical devices, notification of health care products and market supervision activities
  • licensing and inspection of pharmaceutical activity
  • collecting medicines and health products samples along the whole circuit and their analytical control at Infarmed's laboratory
  • monitoring, collection and evaluation of Adverse Drug Reactions or any other incidents that may occur with medical devices and any other information related with the usage of medicines and health products
  • supervision of the evolution of the market and promotion of the rational use of medicines, including generics
  • evaluation of pharmaco-therapeutic and pharmaco-economic studies and of medicines for reimbursement purposes
  • release of information to healthcare professionals and citizens
  • development of preventive and corrective actions on the Medicines Policy is under implementation

Infarmed carries out Portugal's tasks within the framework of the European System of Medicines namely by ensuring the representation and participation in the various evaluation and supervision bodies and activities of the European Medicines Agency (EMA), of the European Commission and of the European Network of Medicines and Health Products Authorities.

Infarmed is part of the Network of Official Control Laboratories and represents Portugal at the European Pharmacopoeia and at the United Nations International Narcotics Control Board in regard to the control of narcotic and psychotropic substances for medical and scientific use.

The Institute also participates at the World Health Organisation (WHO) medicines monitoring system through the Uppsala Monitoring Centre.

Infarmed is actively engaged in regular cooperation activities particularly with Portuguese speaking countries like Brazil, Cape Verde, Mozambique and Angola and maintains a collaboration protocol with Macao. It also promotes different bilateral cooperation actions with other European Union (EU) members and with Latin American and Maghreb countries.

 

Site: www.infarmed.pt