[The Portuguese Pharmacovigilance System].
In Portugal, the National Pharmacovigilance System (NPS) was created in 1992,  completing during this year 20 years of existence. Having been established in  a centralized manner, it soon became aware that its geographic decentralization  would bring advantages in terms of proximity of the System to health professionals  as well as the involvement of the universities. The NPS currently has four regional  pharmacovigilance centres, which cover the entire mainland, which became centers  of scientific vocation, carrying out pharmacoepidemiological studies in the area  of drug safety. Also, they are the guarantee of proper collection, processing  and evaluation of spontaneous reports of adverse drug reactions (ADRs), as well  as the continuing disclosure of the System among health professionals and promotion  of spontaneous reporting. Over these 20 years, the NPS has been adapting to the  EU requirements in the area of pharmacovigilance, and is currently a mature and  well implemented system, with the objectives of the evaluation of the safety profile  of marketed drugs and triggering of actions to reduce the risk of these drugs.  From the second half of 2012, new adaptation will be run with the implementation  of recent European legislation on Pharmacovigilance, published in December 2010.  Among other changes, there is the possibility for consumers to report their suspicious  of ADR directly to the NPS (exclusive, so far, to health professionals). This  work aims to be a reflection about the evolution of the National Pharmacovigilance  System and its growing importance in the protection of public health.
Unidade de Farmacovigilância do Norte, Faculdade de Medicina da Universidade do Porto, Porto.
Maria Teresa
MT
Herdeiro
Mónica
M
Ferreira
Inês
I
Ribeiro-Vaz
Jorge
J
Junqueira Polónia
Altamiro
A
Costa-Pereira
D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards; D010568:Peru; D060735:Pharmacovigilance; D011996:Records