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Clinical trial
legislation in Portugal has been revised (national legislation Lei
No. 46/2004 of 19 August 2004) to implement the EU Directive 2001/20/EC.
The procedures for performing clinical trials have thus been standardised.
A central Ethics Committee (CEIC) will now give a single opinion,
and improved timelines come into effect.
The National Institute of Pharmacy and Medicines (INFARMED), which
is accountable to the Ministry of Health, is responsible for issues
related to medicines and health products. It is the regulatory authority
in charge of authorising clinical trials, and may carry out inspections
to ensure compliance with the principles of Good Clinical Practice.
Clinical trials have to be notified to the INFARMED through the National
Centre for Pharmacovigilance, which is also in charge of monitoring
adverse effects of medicines and assessing benefits and risks.
 Health
Care System
In urban areas, modern medical facilities are available and there
is a good doctor-patient ratio. In addition to large urban hospitals
and regional hospitals, there are numerous community health centres
all over the country which provide primary care. The majority of the
population are registered with general practitioners / family doctors
within the National Health Service (NHS).
Portugal's NHS, a decentralised structure financed by the state budget,
was established in 1979 to provide universal, comprehensive care.
The great majority of doctors work within the NHS, although many of
these also work in private practice.
A new general healthcare law was approved in 1990 establishing basic
healthcare principles, and in 1999 several organisational reforms
were introduced concerning the public health services, in particular
regarding the creation and operation of health centres and the rules
governing regional health systems. These local health systems are
each made up of the health centres, hospitals, etc. (both public and
private) within a specified geographical area with a maximum population
of 500 000 inhabitants.
Authorities
Ministry of Health
(Ministério da Saúde)
National
Institute of Pharmacy and Medicines, INFARMED (Instituto Nacional
de Farmácia e do Medicamento)
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PORTUGAL
