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N\u00ba 669/16 \u00a8Por el cual se reglamenta el Art. 4 inciso B de la Ley N\u00ba4659/12..... estableciendo normas para la Obtencion de Registro Sanitario ante la Direccion Nacional de Vigilancia Sanitaria de productos considerados Dispositivos Medicos...\u00a8 mas aun que el producto hoy solicitado por el instituto de Prevision Social es categorizado bajo rubro de DISPOSITIVO MEDICO.\n", "author": {"name": "S.R. PRODUCTOS PARA LA SALUD S.A.", "id": "PY-RUC-80053294-5"}, "answer": "El oferente deber\u00e1 remitirse a la Adenda N\u00b06", "dateAnswered": "2020-12-02T14:26:16-04:00"}, {"id": "1", "date": "2020-10-21T05:15:01-04:00", "title": "PRECIO REFERENCIAL ITEM 1", "description": "Solicitamos a la convocante actualizar el precio referencial, atendiendo que el precio utilizado se encuentra muy por debajo del precio comercializado actualmente en el mercado nacional, pudiendo corroborar la convocante lo antes dicho verificando el Historial de Precios Adjudicados publicados en la p\u00e1gina de la DNCP. Espec\u00edficamente de la \u00faltima adjudicaci\u00f3n realizada en el corriente a\u00f1o,  la cual ser\u00eda la LPN 50/2019 ID 348.463 del MSPYBS.- \nEl precio sugerido para el \u00edtem es de Gs. 8.000 por unidad, con esta modificaci\u00f3n la convocante  evitar\u00eda adem\u00e1s tener que cancelar la adquisici\u00f3n del producto solicitado porque todas las ofertas sobrepasen el 15% del referencial.- \n", "author": {"name": "EUROQUIMICA S.A.", "id": "PY-RUC-80061211-6"}, "answer": "Se aclara al oferente que en el Dictamen de la U.O.C. N\u00b0 91/20, se detalla el mecanismo utilizado para la obtenci\u00f3n del precio de referencia, el mismo se encuentra acorde a lo establecido en la Resoluci\u00f3n DNCP N\u00b0 1890/20 POR LA CUAL SE REGULA LA ESTIMACION DE PRECIOS Y SU PUBLICIDAD EN LOS PROCEDIMIENTOS DE CONTRATACIONES PUBLICAS EN EL MARCO EN LA LEY 2051/03.  ", "dateAnswered": "2020-12-02T14:25:17-04:00"}, {"id": "4", "date": "2020-10-21T05:22:59-04:00", "title": "PERIODO DE VALIDEZ DE LA GARANTIA DE BIENES ", "description": "En el PBC punto 24. Se establece que el periodo de validez de la garant\u00eda de los bienes ser\u00e1 de 1 a\u00f1o, que regir\u00e1 una vez emitida el acta de recepci\u00f3n definitiva, con respecto a ello solicitamos a la convocante aclarar a que se refiere, en atenci\u00f3n que en el presente llamado NO se solicitan Equipos M\u00e9dicos.- ", "author": {"name": "EUROQUIMICA S.A.", "id": "PY-RUC-80061211-6"}, "answer": "El oferente deber\u00e1 remitirse a la Adenda N\u00b0 6", "dateAnswered": "2020-12-02T14:25:40-04:00"}, {"id": "3", "date": "2020-10-21T05:22:04-04:00", "title": "SISTEMA DE ADJUDICACION POR ABASTECIMIENTO SIMULT\u00c1NEO", "description": "Solicitamos que la convocante considere aplicar el sistema de adjudicaci\u00f3n por abastecimiento simultaneo hasta 3 oferentes para el producto solicitado, de esta manera el Instituto de Previsi\u00f3n Social evitar\u00e1 quedar desabastecido, m\u00e1s aun en atenci\u00f3n a que el mercado global se encuentra afectado por la pandemia (COVID-19), generando de esta forma incertidumbre a los proveedores en cuanto a la provisi\u00f3n oportuna de los medicamentos (para importadores) y materia prima (para fabricantes nacionales).", "author": {"name": "EUROQUIMICA S.A.", "id": "PY-RUC-80061211-6"}, "answer": "Se aclara al oferente que se establece en el PBC en el punto 12 Precio y Formulario de la oferta, que el sistema de adjudicaci\u00f3n es por Abastecimiento Simultaneo. El oferente deber\u00e1 adecuarse a lo establecido en el PBC.", "dateAnswered": "2020-12-02T14:25:33-04:00"}, {"id": "8", "date": "2020-10-21T09:49:36-04:00", "title": "DOCUMENTOS EMITIDOS POR LA D.N.V.S. DEL MSP Y BS", "description": "Solicitamos a la convocante incluir entre los documentos legales para evaluar la capacidad t\u00e9cnica del producto solicitado lo siguiente:\n1. COPIA DEL CERTIFICADO DE REGISTRO SANITARIO VIGENTE DEL PRODUCTO OFERTADO, emitido por la D.N.V.S.\nDicho pedido no hace m\u00e1s que dar cumplimiento a lo mencionado en la Resoluci\u00f3n S.G. 669/16 que reglamenta el Art. N\u00b0 4 de la Ley 4659/12. Que dice:\nArt. N\u00b0 4) Se considerar\u00e1n que los dispositivos m\u00e9dicos, materiales cortopunzantes y los equipos de protecci\u00f3n individual definidos en esta ley, son de uso seguro en la Rep\u00fablica del Paraguay cuando re\u00fanan las siguientes condiciones\u0085 b) Obtener el Registro Sanitario Obligatorio, otorgado por al Direcci\u00f3n Nacional de Vigilancia Sanitaria\u0085", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 remitirse a la Adenda N\u00b0 6", "dateAnswered": "2020-12-02T14:26:09-04:00"}, {"id": "7", "date": "2020-10-21T07:53:00-04:00", "title": "ABASTECIMIENTO SIMULT\u00c1NEO", "description": "Solicitamos a la convocante que el sistema de adjudicaci\u00f3n sea por abastecimiento simult\u00e1neo considerando los antecedentes de licitaciones (LPN SBE N\u00b0123/2019 Y CVE SBE N\u00b067/2020) donde la convocante estableci\u00f3 la posibilidad de adjudicaci\u00f3n a 3 oferentes. Esta solicitud nace con la finalidad de preservar el abastecimiento de la instituci\u00f3n, ya que teniendo en cuenta las estrictas disposiciones sanitarias en varios pa\u00edses para evitar la propagaci\u00f3n del COVID-19,  el tiempo de tr\u00e1nsito y la liberaci\u00f3n por parte de Aduana son motivos suficientes que generan retrasos significativos en las importaciones y tambi\u00e9n permitir\u00e1 mayor participaci\u00f3n de oferentes.-", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "Se aclara al oferente que se establece en el PBC en el punto 12 Precio y Formulario de la oferta, que el sistema de adjudicaci\u00f3n es por Abastecimiento Simultaneo. El oferente deber\u00e1 adecuarse a lo establecido en el PBC.", "dateAnswered": "2020-12-02T14:26:03-04:00"}, {"id": "6", "date": "2020-10-21T07:52:24-04:00", "title": "REQUISITO DOCUMENTAL PARA EVALUAR LA CAPACIDAD TECNICA", "description": "Solicitamos a la convocante incluir entre los requisitos exigidos para evaluar la capacidad t\u00e9cnica lo siguiente: COPIA DEL REGISTRO SANITARIO VIGENTE DEL DISPOSITIVO MEDICO OFERTADO EXPEDIDO POR LA DNVS DEL MSPYBS ,en atenci\u00f3n a que el producto solicitado ante el ente regulador (DNVS) es categorizado bajo el rubro de DISPOSITIVO MEDICO. \nAdem\u00e1s es importante mencionar que seg\u00fan RESOLUCION N\u00b0 669 Por la cual se reglamenta el Art. 4 inciso B de la Ley n\u00b0 4659/12\u0085. estableciendo normas para la Obtenci\u00f3n del Registro Sanitario ante la Direcci\u00f3n Nacional de Vigilancia Sanitaria de productos considerados Dispositivos M\u00e9dicos \u0085. En el cual se deja m\u00e1s que claro que la concesi\u00f3n del REGISTRO SANITARIO otorgado por parte de la DNVS autoriza la distribuci\u00f3n y comercializaci\u00f3n de dicho dispositivo medico.-  \nCon la inclusi\u00f3n del requisito solicitado, la convocante tendr\u00eda la seguridad de que el producto a ser adquirido cuenta con autorizaci\u00f3n para su comercializaci\u00f3n y se asegurar\u00eda de la calidad del mismo.- \n", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "El oferente deber\u00e1 remitirse a la Adenda N\u00b0 6", "dateAnswered": "2020-12-02T14:25:57-04:00"}, {"id": "5", "date": "2020-10-21T07:51:31-04:00", "title": "PRECIO REFERENCIAL ", "description": "En atenci\u00f3n a la situaci\u00f3n por el cual est\u00e1 atravesando el mercado mundial, manifestamos que el costo de adquisici\u00f3n de la materia prima para la elaboraci\u00f3n del producto solicitado  ha sufrido un considerable aumento en comparaci\u00f3n a a\u00f1os anteriores, es por ello que sugerimos a la convocante que el precio referencial sea de Gs. 9.000 por unidad. \nYa que el precio referencial marcado, no refleja el costo de adquisici\u00f3n del mismo en la actualidad.- \n", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "Se aclara al oferente que en el Dictamen de la U.O.C. 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