[English-Español] TEST DE REACTIVOS PARA COVID-19

Test reagents COVID-19
Information concerning the measures on the use of reagents in vitro use.
Tuesday 17 March 2020
Regarding the distribution by Productos Roche SA Q and I, Division Diagnóstica units reagents vitro in use for detecting COVID-19 to various health institutions, regardless of the recommendations issued by the Ministry of Health of the Nation without the intervention of the National Administration it is reminded professionals currently the National Administration of Laboratories and Health Institutes ANLIS "Dr. Carlos G. Malbrán "is the only laboratory in the country authorized for use thereof. This measure, recommended by the Ministry, seeks to maintain the correct measurement of cases and achieve unity of purpose to ensure the collection of reliable data and the same time, optimize health resources.
Additional reports that the procedure for entering the reagents mentioned diagnostic must fall under the authorization application products for diagnosis in use vitro unregistered low marketing, whose import is required for use in research and / or developing or have exceptional characteristics warrant their use; as provided in ANMAT No. 2675/99.
Test de reactivos para COVID-19
Información relativa a las medidas sobre la utilización de reactivos de uso in vitro.
martes 17 de marzo de 2020
En relación a la distribución por parte de Productos Roche S. A. Q e I, División Diagnóstica de unidades de reactivos de uso in vitro para detección de COVID-19 a diversas Instituciones Sanitarias, sin considerar las recomendaciones emitidas por el Ministerio de Salud de la Nación y sin la intervención de esta Administración Nacional, se recuerda a los profesionales que actualmente la Administración Nacional de Laboratorios e Institutos de Salud ANLIS "Dr. Carlos G. Malbrán" es el único laboratorio autorizado del país para la utilización de los mismos. Esta medida, recomendada por el Ministerio, busca mantener la correcta medición de casos y lograr la unidad de criterio para garantizar la recolección de datos confiables y al mismo tiempo, optimizar los recursos sanitarios.
Asimismo, se informa que el procedimiento para ingresar los mencionados reactivos de diagnóstico deben encuadrarse bajo la solicitud de autorización de productos para diagnóstico de uso in vitro no registrados, de baja comercialización, cuya importación es requerida para ser utilizados en tareas de investigación y/ o desarrollo o cuyas características de excepcionalidad ameriten su uso; según lo previsto en la Disposición ANMAT N° 2675/ 99.

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