O ato administrativo de concessão de registro de medicamentos na Agência Nacional de Vigilância Sanitária
Drugs as a special product have to be efficient, safe and present good quality, with the purpose of minimizing the possible risks to the population health which could be verified through a rigorous technical analysis of the register requirements. The aim of this study is to expose medicine registrat...
| Autores: | , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2010 |
| País: | Brasil |
| Institución: | Universidade de São Paulo (USP) |
| Repositorio: | Revista de Direito Sanitário (Online) |
| Idioma: | portugués |
| OAI Identifier: | oai:revistas.usp.br:article/13175 |
| Acceso en línea: | https://www.revistas.usp.br/rdisan/article/view/13175 |
| Access Level: | acceso abierto |
| Palabra clave: | Administrative Act Drugs Registration Health Surveillance Technical Discretionary Ato administrativo Discricionariedade Técnica Registro de Medicamentos Vigilância Sanitária |
| Sumario: | Drugs as a special product have to be efficient, safe and present good quality, with the purpose of minimizing the possible risks to the population health which could be verified through a rigorous technical analysis of the register requirements. The aim of this study is to expose medicine registration grant as an administrative act which allows manufacturing rights and the launch of products into the market. Despite being considered an entailed act, some technicians decisions about medicine registration are based on technical discretionary, requiring a well-based technical foundation of the part of the public administration to ensure correct decisions, considering that the procedures are not totally detailed by legislation. |
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