- PUBLICADO:
Facilitan la importación de gel antibacterial y dispositivos de protección médica
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A raíz del Estado de Emergencia Nacional provocado por el COVID-19, el Instituto Nacional de Vigilancia de Medicamentos y Alimentos -INVIMA-, declaró el gel antibacterial, la solución tópica desinfectante y los dispositivos médicos destinados para la protección de los profesionales de la salud, como Medicamentos Vitales No Disponibles, con el fin de facilitar su importación.
Esta medida significa que estos productos ya no necesitarán un registro sanitario vigente para ingresar al país, cabe resaltar, que la decisión fue tomada por un eventual riesgo de desabastecimiento de estos productos.
Gel antibacterial
Así mismo, el INIVIMA informó que actualmente en el país hay 8 titulares, para 12 registros sanitarios de geles antibacteriales y soluciones tópicas desinfectantes de fabricación nacional.
Sin embargo, hasta la fecha, solo 3 titulares reportan la disponibilidad inmediata de 396.202 unidades de estos productos y un cuarto titular aseguró que la disponibilidad de estos, está condicionada a los pedidos que hagan los usuarios.
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Requisitos para comercializar un Medicamento Vital No disponible:
- Copia del recibo de consignación
- Solicitud expresa de importación
- Certificado de venta libre o certificado ajustado a los requisitos previstos por la Organización Mundial de la Salud (OMS), para productos objeto de comercio internacional apostillado o consularizado y legalizado
- Número IUM y/o número de solicitud
- Certificado de existencia y representación legal del solicitante
- Certificado de análisis
- Justificación de la cantidad solicitada
Es preciso decir, que esta medida solo estará vigente durante el periodo de emergencia que se presenta en el país, ya que la entidad busca estar alineada con los objetivos de prevención y cuidado de la salud establecidos por el Gobierno Nacional.
Finalmente, la entidad exhortó a los fabricantes para que en la importación y fabricación de los insumos de protección médica , sigan las recomendaciones brindadas y así garantizar la calidad, seguridad y eficacia en los productos dispuestos para el uso todos los ciudadanos y especialmente a los destinados para el personal de salud.
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