Article type: Research Article
Authors: Olivera, María
Eugenia; | Uema, Sonia Andrea
Naeko; | Romañuk, Carolina
Beatriz; | Caffaratti, Mariana | Mastroianni, Patricia
Carvalho | Varallo, Fabiana Rossi | Vazquez, Marta | Fagiolino, Pietro | Maldonado, Cecilia | Vega, Elena María | Galvan, Zully Vera | Maidanag, Mabel | Acostag, Patricia | Rivero, Roxana | Barros, Carolina | Fontana, Daniela
Affiliations: Departamento de Farmacia, Facultad de Ciencias
Químicas, Universidad Nacional de Córdoba, Argentina | Unidad de Investigación y Desarrollo en
Tecnología Farmacéutica, CONICET and Departamento de Farmacia,
Facultad de Ciencias Químicas, Universidad Nacional de Córdoba,
Argentina | Centro de Información de Medicamentos, Facultad de
Ciencias Químicas, Universidad Nacional de Córdoba, Argentina | Departamento de Fármacos e Medicamentos, Faculdade
de Ciências Farmacêuticas, Universidade Estadual Paulista Júlio de
Mesquita Filho (FcFAR/UNESP), São Paulo, Brazil | Departamento de Ciencias Farmacéuticas, Facultad
de Química, Universidad de la República, Montevideo, Uruguay | Departamento de Ciencias y Tecnología
Farmacéuticas. Facultad de Ciencias Químicas y Farmacéuticas,
Universidad de Chile, Santiago, Chile | CIM, Facultad de Ciencias Químicas, Universidad
Nacional de Asunción, Asunción, Paraguay | Dpto de Farmacoepidemiología e Información
Científica. Dirección de Marketing y Comercialización. Laboratorio
de Hemoderivados. Universidad Nacional de Córdoba, Argentina
Note: [] Corresponding author: María Eugenia Olivera, Departamento
de Farmacia, Facultad de Ciencias Quimicas, UNC-UNITEFA-CONICET, Haya de la
Torre y Medina Allende, Edificio Ciencias II. Ciudad Universitaria (5000),
Córdoba, Argentina. Tel./Fax: +54 351 5353865 ext 53360; E-mail: meoliver@fcq.unc.edu.ar
Abstract: Pharmacovigilance is responsible for monitoring the safety of
medicines in normal clinical use and during clinical trials. Legal requirements
for pharmacovigilance in some Latin American countries (Argentina, Brazil,
Chile, Paraguay and Uruguay) were reviewed. Disparities in the legal framework
among the countries are observed being those for marketing authorization
holders one of the most evident. The active rol of the universities and drug
information centers for/of pharmacovilance seems to be a positive common point.
Legal requirements regarding pharmacovigilance of biosimilar medicines, is
still a point to be developed.
Keywords: Drug information services, product surveillance, postmarketing, pharmaceutical industry, public health
DOI: 10.3233/PPL-140390
Journal: Pharmaceuticals, Policy and Law, vol. 16, no. 3-4, pp. 289-312, 2014
Received 10 October 2014
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Accepted 10 October 2014
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Published: 2014
