[Issues regarding the legal regulation of drugs in Argentina].
This work describes the main functions and attributions of the National Administration of Medicines, Food and Medical Technology (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) of Argentina in the control and supervision of pharmaceutical products. The four properties that a medicine must full-fill (efficacy, safety, quality and accessibility) are described, and the role of ANMAT with regard to each one is specified. Criteria employed in the classification of pharmaceutical products marketed in Argentina with the regulatory agency permission are specified, and a reference to pharmaceutical products not registered before the Agency is also included.
Bignone
Inés M
IM
Facultad de Medicina, Universidad de Buenos Aires, Argentina.
D001118:Argentina; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D016903:Drug Monitoring / Q000592:standards*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D006801:Humans