Nuevas prohibiciones de la ANMAT, un alcohol etílico, dos aceites de girasol y un antígeno

anmat

La Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) prohibió a través de su publicación en el Boletín Oficial, la comercialización de un alcohol etílico, dos aceites de girasol, un antígeno rápido contra el COVID-19 y otra serie de productos médicos.

Para comenzar, en la Disposición 3596/2021 se establece la prohibición del uso, comercialización y distribución en todo el territorio nacional de los productos y lotes de

  • “ETHICON ENDO-SURGERY, LLC, 1 PROXIMATE® PPH procedure for prolapse and Hemorrhoids Set, REF PPH03, 33 mm, LOT N93P4M, 30/11/2021” y prohíbe “a la firma INSUMED ARGENTINA de Javier BECERRA (CUIT N° 20-23223089-5) la distribución de cualquier producto médico fuera de su jurisdicción, hasta tanto se habilite en los términos de la Disposición ANMAT N° 6052/13”.

En el considerando se explica que la firma Johnson & Johnson Medical S.A., tomó conocimiento de que terceros habían distribuido productos ilegítimos de titularidad de la firma, como “SUTURA MECÁNICA HEMORROIDAL 33 MM, lote N93P4M- Vto. 30/11/2021”, que no habían sido importados por la empresa.

A su vez, destaca que el producto fue distribuido “por la firma HERMES MEDICAL S.A”. y frente a la inspección en relación a la procedencia del producto se exhibió factura y su correspondiente Remito con membrete de la firma INSUMED ARGENTINA de Becerra Javier, “que no se encuentra habilitado, ni su titular el Sr. Javier BECERRA figura en sus registros como profesional farmacéutico”.

Asimismo remarca que los lotes no fueron importados por su titular de registro en el país (Johnson & Johnson Medical S.A.), y no puede asegurarse que se trate de unidades que cumplan con las especificaciones correspondientes”.

Por su parte, la Disposición 3597/2021 fija la prohibición de venta de las “unidades sin datos de nacionalización identificados como:

  • SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), Beijing Lepu Medical Technology Co., Ltd., LOT 21CG2701X”. Todo se originó, según describe el texto, a partir de que el responsable técnico de la firma DOC 10 de ALZATE MARTÍNEZ Oriana reportó el robo de setenta mil (70.000) unidades del producto que llegaba de la fábrica china Beijing Lepu Medical Technology pero, precisa la denuncia policial, nunca arribó al depósito.

Aclara que se encuentra diseñado para la detección de antígeno contra el coronavirus en muestras clínicas a través del hisopado nasal y que su venta y uso “solo se encuentra autorizado en laboratorios de análisis clínicos o instituciones sanitarias habilitadas para esos fines”. Al desconocer el estado y condición del material robado, el ente avanzó con la medida en cuestión.

Por otra parte, la Disposición 3604/2021 dispone la prohibición del uso, comercialización y distribución en todo el territorio nacional del producto rotulado como:

  • “ALCOHOL ETILICO 96°, ANTIBACTERIAL ELIMINA EL 99,9% DE BACTERIAS Y VIRUS, R.N.E. N° 04003223 R.N.P.A. N° 04069014, ELABORADO Y FRACCIONADO POR NOVACOL, por tratarse de un producto que posee un etiquetado engañoso y fraudulento, respecto del cual se desconoce el efectivo origen, condiciones de elaboración y contenido”.

En la misma línea, la Disposición 3605/2021 determina la prohibición de la elaboración, fraccionamiento y comercialización de dos aceites:

  • “Aceite 100% girasol, producto para gastronomía, marca Girasoles, cont. neto 4.5 litros”.
  • “Aceite 100% girasol, producto para gastronomía, marca Girasoles, sin indicar contenido neto”, ambos con RNPA 04-0003576 y elaborados por RNE 04-000329, por carecer de registros de establecimiento y de producto, y por estar “falsamente” rotulados al exhibir en el rótulo un número de RNE y RNPA inexistentes, “resultando ser en consecuencia productos ilegales”. Prohíbe “la comercialización en todo el territorio nacional de todos aquellos productos que exhiban en sus rótulos el RNE 04-000329 y el RNPA 04-0003576, por ser productos falsamente rotulados que utilizan un RNE y un RNPA inexistentes, resultando ser en consecuencia ilegales”.

Finalmente, la Disposición 3606/2021 suspende la venta de todos los lotes y presentaciones, hasta tanto se encuentren inscriptos en el Registro de Especialidades Medicinales, de los productos rotulados como:

  • “Crema curativa con aceite de cannabis. Dolores musculares – Reuma – Dolores de Cuello – Calambres – Ciática – Lumbalgia – Artrosis – Artritis. Industria Argentina. LABORATORIO ANDES PHARMA S.A. Colón 1256, Maipú, Mendoza, Elab. Leg. N 2932 – Res 155-98.” y “Pomada en gel cannabis 100% natural, alivia los dolores – anlagésico –antinflamatorio”. También prohibió cualquier producto elaborado por LABORATORIO ANDES PHARMA S.A. hasta que obtenga las autorizaciones necesarias para elaborar y distribuir sus productos en la República Argentina.

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