Role

The Institute'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.

Infarmed performs at national and European levels its competences and responsibilities of National Competent Authority on medicines and health products and of Reference Laboratory on the Quality Control of Medicines within the scope of the Network of Official Medicines Control Laboratories (OMCL).

 

Activities

The Institute pursues its activity in several domains at national and at European levels:

  • Research, evaluation and authorisation of medicines
  • Quality, safety and efficacy control of medicines
  • 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
  • Licensing, auditing and inspection of manufacturers, wholesalers and pharmacies ensuring the respect for the rules applicable to each operator namely Good Manufacturing Practices (GMP's), Good Distribution Practices (GDP's) and Good Pharmacy Practices (GPP's)
  • Medicines and health products quality control
  • Collecting medicines and health products samples along the whole circuit and their analytical control at Infarmed's laboratory
  • Adverse Drug Reactions monitoring through pharmacovigilance, vigilance and monitoring of the use of health products
  • Collecting and evaluating 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 medicines for reimbursement purposes
  • Evaluation of pharmaco-therapeutic and pharmaco-economic studies
  • Monitoring of the access and use of medicines and health products
  • Release of information to healthcare professionals and citizens with a view to promote the safe and rational use of medicines and other health products
  • Release of information for various users through the web site of Infarmed and also through specific publications (such as the Therapeutic Handbook, the National Formulary of Medicines, the Guide of Generic Medicines, the Pharmacovigilance Bulletin, Infarmed Notícias Journal  distributed to all partners)
  • The Medicines Information Blue line (800 222 444)
  • The Information Centre on Medicines and Health Products and the Technical and Scientific Documentation Centre
  • Development of preventive and corrective actions on the Medicines Policy under implementation

 

Co-ordination on community and international affairs

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.

At the European Union (EU) level Infarmed articulates its activities through a Telematics Network in which operate the systems of alert and rapid exchange of information on quality and safety as well as the database systems on pharmacovigilance (Eudravigilance) and on the management of mutual recognition procedures for medicines authorisation (CTS), among others recently created, e.g. EudrACT for clinical trials, or under development, e.g. the EuroPHARM database for medicinal products authorised in the EU.

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 EU members and with Latin American and Maghreb countries.


Human resources

To fulfil its responsibilities in the various fields the Institute counts with 330 staff members of which more than 50 per cent has educational background on pharmaceutical and medical sciences amongst other scientific areas.

Infarmed relies likewise on a significant support of highly qualified experts from universities, hospitals and research centres. These professionals carry out their tasks in the Institute's several specialised technical committees as well as in external technical and scientific working groups, all totalling app. 150 experts.

 

Executive board

Rui Santos Ivo (President)
António Faria Vaz (Vice-president)
Cláudia Belo Ferreira (Member)