Disposición 6404/2014, B.O. 15/09/14
VISTO el Expediente Nº 1-47-1110-539-14-1 del Registro de la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, y CONSIDERANDO: Que se inician las actuaciones referidas en el VISTO con el informe del Instituto Nacional de Medicamentos (INAME) de fojas 1/3 en el cual el citado Instituto hace saber que con fecha 23 de junio del corriente el Sistema Nacional de Farmacovigilancia elaboró un reporte sobre la especialidad medicinal GLUCONATO DE CALCIO LARJAN 100 mg/ml (gluconato de calcio + dextrosacarato de calcio), inyectable I.V., ampolla x 10 mI., Lote 12419, Vencimiento 02/2016, elaborada por Laboratorio VEINFAR I.C.S.A. Que en el mencionado reporte (obrante a fojas 5), el Sistema Nacional de Farmacovigilancia informó que “se detecta una ampolla contaminada íntegra por un hongo que flota en la superficie del líquido”, mientras que las restantes 16 no presentaban contaminación detectable a simple vista. Que posteriormente, mediante O.I. Nº 438/14 se realizó una inspección al laboratorio VEINFAR I.C.S.A. de la cual surgió que la Directora Técnica, farmacéutica M. Cristina Zuso, reconoció las 17 (diecisiete) unidades como originales de la firma, informando también que el producto no presentaba “no conformidades” en los registros de reclamos o devoluciones. Que asimismo, revisando la documentación de Lote, el INAME observó “que no se realizó el ensayo de hermeticidad en el 100% de las unidades (ítem 18.111), el monitoreo microbiológico de las áreas productivas se realizó con placas de exposición con 50 mI de medio cultivo durante 17 hs. Método no validado (ítem 4.11, 15.13 y 18.9), rendimiento de 50% menor a especificación de rendimiento 85%, desvío incorrectamente investigado (ítem 1.2.j y 16.3) y no se realizaron estudios de bioduren de la solución antes de la filtración y dosificado (ítem 18.4)” todas referidas a la Disposición ANMAT Nº 2819/04. Que por último, la Directora Técnica manifestó que iniciaría el retiro del mercado del producto GLUCONATO DE CALCIO 100 mg/ml, ampollas x 10 ml (gluconato de calcio + dextrosacarato de calcio) lote 12419, vencimiento 2/2016. Que al respecto, la ley Nacional de Medicamentos Nº 16.463 establece: “Quedan sometidos a la presente ley y a los reglamentos que en su consecuencia se dicten, la importación, exportación, producción, elaboración, fraccionamiento, comercialización o depósito en jurisdicción nacional o con destino al comercio interprovincial, de las drogas, productos químicos, reactivos, formas farmacéuticas, medicamentos, elementos de diagnóstico y todo otro producto de uso y aplicación en la medicina humana y las personas de existencia visible o ideal que intervengan en dichas actividades”. Que a su vez, el artículo 2° de la citada norma jurídica reza: “Las actividades mencionadas en el artículo 1º sólo podrán realizarse, previa autorización y bajo el contralor del Ministerio de Asistencia Social y Salud Pública, en establecimientos habilitados por el mismo y bajo la dirección técnica del profesional universitario correspondiente, inscrito en dicho ministerio. Todo ello en las condiciones y dentro de las normas que establezca la reglamentación, atendiendo a las características particulares de cada actividad y a razonables garantías técnicas en salvaguardia de la salud pública y de la economía del consumidor”. Que asimismo, el artículo 3° establece: “Los productos comprendidos en la presente ley deberán reunir las condiciones establecidas en la farmacopea argentina y, en caso de no figurar en ella, las que surgen de los patrones internacionales y de los textos de reconocido valor científico. El titular de la autorización y el director técnico del establecimiento, serán personal y solidariamente responsables de la pureza y legitimidad de los productos”. Que la Disposición ANMAT Nº 1402/08 ordena que los procedimientos para el Retiro de Productos Farmacéuticos y Productos de Higiene Personal, Cosméticos y Perfumes serán aplicables a todos los establecimientos habilitados y a todos los titulares de los referidos productos inscriptos ante esta Administración Nacional y en la Farmacopea Argentina 7ma. Ed. Vol. 1, Capítulo 650 se determina: “(…) Las soluciones inyectables, incluyendo las obtenidas por disolución de sólidos estériles, deben estar libres de partículas que puedan detectarse por inspección visual…”. Que en virtud de lo expuesto, el INAME sugiere prohibir el uso y la comercialización en todo el territorio nacional del producto GLUCONATO DE CALCIO LARJAN 100 mg/ml (gluconato de calcio + dextrosacarato de calcio), inyectable I.V., ampolla x 10 mI., Lote 12419, Vencimiento 02/2016; ordenar el retiro del mercado del lote e instruir el sumario correspondiente. Que desde el punto de vista procedimental, lo actuado por el INAME se enmarca dentro de las atribuciones conferidas a la ANMAT por el artículo 10º inciso q) del Decreto Nº 1490/92. Que en relación a las medidas aconsejadas, resulta competente esta Administración Nacional en virtud de las atribuciones conferidas por los incisos n) y ñ) del artículo 8° del Decreto Nº 1490/92. Que la Dirección General de Asuntos Jurídicos y el Instituto Nacional de Medicamentos han tomado la intervención de su competencia. Que se actúa en virtud de las facultades conferidas por el Decreto Nº 1490/92 y por el Decreto Nº 1271/13. Por ello,
EL ADMINISTRADOR NACIONAL DE LA ADMINISTRACION NACIONAL DE MEDICAMENTOS, ALIMENTOS Y TECNOLOGIA MEDICA DISPONE:
Artículo 1° — Prohíbese el uso y comercialización en todo el territorio nacional de la especialidad medicinal GLUCONATO DE CALCIO LARJAN 100 mg/ml (gluconato de calcio + dextrosacarato de calcio), inyectable I.V., ampolla x 10 mI., Lote 12419, Vencimiento 02/2016, por las razones expuestas en el Considerando de la presente Disposición.
Art. 2° — Ordénase a la firma VEINFAR I.C.S.A., el retiro del mercado del producto GLUCONATO DE CALCIO LARJAN 100 mg/ml (gluconato de calcio + dextrosacarato de calcio), inyectable I.V., ampolla x 10 ml., Lote 12419, Vencimiento 02/2016 en los términos de la Disposición ANMAT Nº 1402/08, debiendo presentar la documentación respaldatoria de dicha diligencia.
Art. 3° — Instrúyase sumario sanitario a la firma VEINFAR I.C.S.A. con domicilio en la calle José E. Rodó 5679/85, Ciudad de Buenos Aires, y a quien resulte ser su Director Técnico, por los presuntos incumplimientos a los artículos 2º y 3º de la Ley Nacional de Medicamentos Nº 16.463 y a los ítems 18.111; 4.11; 15.13; 18.9; 1.2.j; 16.3 y 18.4 de la Disposición ANMAT Nº 2819/04.
Art. 4° — Regístrese. Dése a la Dirección Nacional del Registro Oficial para su publicación. Comuníquese a las autoridades sanitarias provinciales y a la del Gobierno de la Ciudad de Buenos Aires y a las Cámaras y entidades profesionales correspondientes. Comuníquese a la Dirección de Relaciones Institucionales y Regulación Publicitaria. Dése a la Dirección de Faltas Sanitarias de la Dirección General de Asuntos Jurídicos. — Carlos Chiale.
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