- PUBLICADO:
Confirmado Reglamento técnico de medicamentos y dispositivos médicos
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El Ministerio de Salud y Protección Social mediante resolución que permanece para observaciones, busca determinar la permanencia del reglamento técnico de medicamentos expedido a través del Decreto 549 de 2001 modificados por los Decretos 162 de 2004 y 900 de 2018 relacionado con la obtención del Certificado de Cumplimiento de la Buenas Prácticas de Manufactura por parte de los laboratorios fabricantes de medicamentos que se importen o produzcan en el país.
¿Porque se debe determinar la permanencia del reglamento técnico de medicamentos?
El Decreto 1595 de 2015 modificó el Capítulo 7 del Título 1 Parte 2 del Libro 2 del Decreto 1074 de 2015 Único del Sector Comercio, Industria y Turismo, que en su artículo 2.2.1.7.6.7 establece, entre otros que, los reglamentos técnicos expedidos serán sometidos a revisión por parte de la entidad reguladora, con el fin de determinar su permanencia, modificación o derogatoria, por lo menos, una vez cada cinco (5) años, o antes, si cambian las causas que le dieron origen.
Reglamento técnico medicamentos y dispositivos médicos
Además, establece la permanencia del reglamento técnico de medicamentos biológicos expedido a través del Decreto 1782 de 2014, por el cual se instauran los requisitos y procedimiento para las Evaluaciones Farmacológica y Farmacéutica de los medicamentos biológicos en el trámite del registro sanitario.
Así mismo, determina la permanencia del reglamento técnico de dispositivos médicos sobre medida para la salud visual y ocular y los establecimientos en los que se elaboren y comercialicen dichos insumos, expedido mediante el Decreto 1030 de 2007.
Descargue la resolución en borrador, que determina la permanencia del reglamento técnico medicamentos y dispositivos médicos.
Ministerio de salud y protección social
Este artículo tiene documentos adjuntos que podrá descargar para ampliar su información:
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