Por la emergencia sanitaria, debido a la COVID-19, se ha generado una mayor demanda de antisépticos y desinfectantes a nivel nacional.
Los geles y alcoholes antisépticos con un porcentaje mayor al 70% de alcohol son considerados medicamentos, de conformidad con la normatividad sanitaria.
Por esta razón, el Instituto Nacional de Vigilancia de Medicamentos y Alimentos -Invima-, autorizó la fabricación nacional de antisépticos y desinfectantes de uso externo, como medicamentos vitales no disponibles, de acuerdo con los requisitos establecidos por la Resolución 520 de 2020, expedida por el Ministerio de Salud y Protección Social.
Sin embargo, la referente de Control de Medicamentos, de la Secretaría de Salud de Boyacá, Liliana Marcela Dorado, advierte que, pese a que la comercialización de alcohol fue declarada por el Invima como vital NO disponible, la fabricación de este producto debe cumplir con el permiso respectivo.
“Algunas personas malinterpretan y comercializan sin permiso y sin las medidas sanitarias requeridas; es por ello, que se están encontrando productos fraudulentos en algunos supermercados, plazas de mercado y otros lugares, en los cuales al producto no se le puede determinar su procedencia y no cumplen con lo establecido legalmente”, aseguró Dorado.
Agregó, que es importante fijarse en el porcentaje de alcohol que contiene, ya que los desinfectantes con una concentración de alcohol entre 60 y 95% son más efectivos para matar gérmenes, que aquellos con una menor concentración o desinfectantes para manos sin alcohol.
Para la fabricación de antisépticos y desinfectantes de uso tópico externo, con un porcentaje de alcohol igual o mayor al 70%, se deberán cumplir los siguientes requisitos para obtener la respectiva autorización:
• Formato de solicitud diligenciado.
• Autorización vigente otorgada por el Invima para la fabricación de bebidas alcohólicas, productos fitoterapéuticos o cosméticos en la línea de fabricación de líquidos o semisólidos, según corresponda.
• Fórmula cualicuantitativa del producto a fabricar.
• Presentar boceto de las etiquetas del envase y empaque (si aplica), con la siguiente información: ingrediente activo, concentración, forma farmacéutica y vía de administración.
Para la fabricación de productos de higiene para la prevención del COVID-19, tales como: toallitas húmedas antibacteriales, geles y soluciones antibacteriales de uso tópico, cuya concentración de alcohol se encuentre entre el 60% y 69%, requieren de notificación sanitaria obligatoria.
De la misma manera, los productos de higiene doméstica para la desinfección, tales como: limpiadores de pisos y superficies, así como los lavavajillas, entre otros. Estas son de tipo automático y, por lo tanto, el mismo día se podrá obtener el código de la Notificación Sanitaria Obligatoria -NSO-.
Los productos de higiene desinfectante dirigidos al mercado industrial, hospitalario o para uso exclusivo en centros comerciales y colegios, NO requieren notificación sanitaria obligatoria por parte del Instituto. Así que, quienes dispongan de estos productos, los cuales son de uso industrial, para su comercialización, no deberán realizar trámites ante el Invima, para su comercialización.
“Debemos evitar aquellos geles hidroalcohólicos que no estén avalados por el Invima y no muestren etiqueta, productos sin estas características pueden también traer algunas desventajas para la salud y la piel”, indicó la referente de salud.
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