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Diez años de la regulación de los productos de uso y consumo humano en el Instituto Nacional de Higiene "Rafael Rangel" (2008-2018) / Ten years of the sanitary regulation of the products of use and human consumption in the National Institute of Hygiene "Rafael Rangel" (2008-2018)
Hernández C, Alexandra; Rodríguez S, Suraima; Monsalve B, Zenia; Agatón, Ana.
Affiliation
  • Hernández C, Alexandra; Instituto Nacional de Higiene Rafael Rangel. Gerencia Sectorial de Registro y Control. Caracas. VE
  • Rodríguez S, Suraima; Instituto Nacional de Higiene Rafael Rangel. Gerencia Sectorial de Registro y Control. Caracas. VE
  • Monsalve B, Zenia; Instituto Nacional de Higiene Rafael Rangel. Gerencia Sectorial de Registro y Control. Caracas. VE
  • Agatón, Ana; Instituto Nacional de Higiene Rafael Rangel. Gerencia Sectorial de Registro y Control. Caracas. VE
Rev. Inst. Nac. Hig ; 49(1): 77-103, 2018. ilus, graf
Article in Spanish | LILACS, LIVECS | ID: biblio-1096219
Responsible library: VE9.1
RESUMEN
La Gerencia Sectorial de Registro y Control se crea en el año 1993 con el objetivo de proteger la salud y la vida de la población Venezolana, estando conformada por la División de Control de Medicamentos y Cosméticos, la División de Control de Alimentos y la División de Control Nacional de Productos Biológicos. Esta Gerencia viene a llenar un vacío legal existente en materia de salud y entre sus funciones se encuentran •Otorgar el Registro Sanitario, Renovación y Cambios Post- Registro a los Medicamentos (Especialidades Farmacéuticas y Productos Biológicos) comercializados en el país, previa evaluación de su calidad, seguridad y eficacia. •Realizar el Control Sanitario de los medicamentos. •Evaluar con fines de registro y control sanitario los alimentos, productos naturales, cosméticos, productos médicos y otros productos de uso y consumo humano. •Evaluar los Protocolos de Investigación Clínica de Medicamentos. •Efectuar la Farmacovigilancia de los medicamentos distribuidos a nivel nacional. •Evaluar el desempeño en Serología de los Bancos de Sangre del país. •Coordinar la Red Venezolana de Laboratorios de Análisis de Alimentos. •Participar en las Redes Internacionales de Armonización y Cooperación en el área de competencia.
ABSTRACT
The Sectorial Management of Registration and Control was created in 1993 with the objective of protecting the health and life of the Venezuelan population, being formed by the Division of Control of Medicines and Cosmetics, the Division of Food Control and the Division of National Control of Biological Products. This Management comes to fill an existent legal void in matter of health and between its functions they are •Grant the Sanitary Registration, Renewal and Post-Registration Changes to Drugs (Pharmaceutical Specialties and Biological Products) marketed in the country, after evaluating their quality, safety and efficacy. •Carry out the Sanitary Control of medicines. •Evaluate for sanitary registration and control purposes food, natural products, cosmetics, medical products and other products for human use and consumption. •Evaluate the Clinical Drug Resechar Protocols. •Carry out pharmacovigilance of medicines distributed nationwide. •Evaluate the performance in Serology of the Blood Banks of the country. •Coordinate the Venezuelan Network of Food Analysis Laboratories. •Participate in the International Networks of Harmonization and Cooperation in the eaar of competence
Subject(s)

Full text: Available Collection: International databases Health context: SDG3 - Health and Well-Being Health problem: Target 3.9: Reduce the amount of deaths produced by dangerous chemicals and the pollution of the air, water and soil Database: LILACS / LIVECS Main subject: Health Surveillance / Drug Evaluation / Products Registration / Health Facilities / History of Medicine Type of study: Practice guideline / Screening study Limits: Female / Humans / Male Language: Spanish Journal: Rev. Inst. Nac. Hig Journal subject: Public Health Year: 2018 Document type: Article Affiliation country: Venezuela Institution/Affiliation country: Instituto Nacional de Higiene Rafael Rangel/VE
Full text: Available Collection: International databases Health context: SDG3 - Health and Well-Being Health problem: Target 3.9: Reduce the amount of deaths produced by dangerous chemicals and the pollution of the air, water and soil Database: LILACS / LIVECS Main subject: Health Surveillance / Drug Evaluation / Products Registration / Health Facilities / History of Medicine Type of study: Practice guideline / Screening study Limits: Female / Humans / Male Language: Spanish Journal: Rev. Inst. Nac. Hig Journal subject: Public Health Year: 2018 Document type: Article Affiliation country: Venezuela Institution/Affiliation country: Instituto Nacional de Higiene Rafael Rangel/VE
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