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Se solicita a la convocante establecer que una vez culminada la subasta TODOS LOS PARTICIPANTES presentes sus ofertas f\u00edsicas", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "AJUSTARSE  LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-02T10:07:15-04:00"}, {"id": "12", "date": "2023-05-31T07:31:17-04:00", "title": "Embalajes y documentos", "description": "En el PBC se se\u00f1ala que:\nEl Proveedor embalará los bienes en la forma necesaria para impedir que se dañen o deterioren durante el transporte al lugar de destino final indicado en el contrato. El embalaje deberá ser adecuado para resistir, sin limitaciones, su manipulación brusca y descuidada, su exposición a temperaturas extremas, la sal y las precipitaciones, y su almacenamiento en espacios abiertos. En el tamaño y peso de los embalajes se tendrá en cuenta, cuando corresponda, la lejanía del lugar de destino final de los bienes y la carencia de equipo pesado de carga y descarga en todos los puntos en que los bienes deban transbordarse.\nAl respecto de esto, debemos se\u00f1alar que los requerimientos en cuesti\u00f3n son extremadamente subjetivos, puesto que no existe manera de determinar de manera objetiva como ser\u00eda una manipulaci\u00f3n brusca y descuidada, as\u00ed tambi\u00e9n, un requerimiento tal como resistencia a temperaturas extremas sin estar determinado expresamente cuales ser\u00edan dichas temperaturas, podr\u00eda llevar a un absurdo de pretender que el material del embalaje deba ser ign\u00edfugo y, en caso de no entregarlo con dicha caracteristica, podr\u00eda ser rechazado. Solicitamos a la convocante reformular estos requerimientos de modo tal a que los parametros de determinaci\u00f3n del cumplimiento o no de las EE.TT. sean objetivos. De igual modo, debemos se\u00f1alar que, dada la naturaleza de estos bienes (medicamentos), de hecho no deber\u00edan ser sometidos a las condiciones previamente descritas.", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "AJUSTARSE  LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-02T10:07:26-04:00"}, {"id": "2", "date": "2023-05-31T07:16:32-04:00", "title": "Capacidad t\u00e9cnica", "description": "En relaci\u00f3n a los Requisitos documentales para evaluar la capacidad t\u00e9cnica establecido en el Pliego de bases y condiciones se sugiere a la convocante se incluya la presentaci\u00f3n del * Certificado de Buenas Pr\u00e1cticas del Oferente, para fabricar, importar y/o distribuir seg\u00fan corresponda, emitido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria. ", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "AJUSTARSE  LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-02T10:05:59-04:00"}, {"id": "7", "date": "2023-05-31T07:26:32-04:00", "title": "Reajuste", "description": "En el apartado en cuesti\u00f3n, aparentemente la convocante se habr\u00eda olvidado de incluir uno de los elementos de la formula, ya que de la misma (Pr=PxIPC1) no forma parte el IPC0 y, el resultado de la multiplicaci\u00f3n del P x el IPC1 no arroja un resultado razonable.", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "AJUSTARSE  LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-02T10:06:37-04:00"}, {"id": "5", "date": "2023-05-31T07:18:48-04:00", "title": "Embalajes y documentos", "description": "La entidad solicita: Los medicamentos entregados en la Farmacia del Instituto Nacional del C\u00e1ncer deber\u00e1n ir acompa\u00f1ado del control de calidad del pa\u00eds de origen.. Consulta: \u00bfSe aceptar\u00e1 certificado de control de calidad en otro idioma con su respectiva traducci\u00f3n?, en el caso de aceptar, se solicita sustanciar en una adenda a fin de no tener inconvenientes al momento de entregar el producto adjudicado.", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "AJUSTARSE  LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-02T10:06:23-04:00"}, {"id": "4", "date": "2023-05-31T07:18:05-04:00", "title": "Capacidad t\u00e9cnica", "description": "Recomendamos a la convocante incluir como requisito la presentaci\u00f3n del ACTA DE PRECIO del producto ofertado.", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "AJUSTARSE  LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-02T10:06:15-04:00"}, {"id": "14", "date": "2023-05-31T07:42:18-04:00", "title": "Plazo para presentar las ofertas", "description": "La convocante establece que culminada la etapa competitiva solo presentar\u00e1 su oferta f\u00edsica el que queda en primer lugar. Se solicita a la convocante establecer que una vez culminada la subasta TODOS LOS PARTICIPANTES presentes sus ofertas f\u00edsicas", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "AJUSTARSE  LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-02T10:07:48-04:00"}, {"id": "10", "date": "2023-05-31T07:30:20-04:00", "title": "Periodo de validez de la Garant\u00eda de los bienes", "description": "La convocante expresa: El vencimiento de los medicamentos debe ser de (12 doce) meses, contados a partir de la fecha de entrega en el Lugar\nIndicado en la Orden de Compra.\u0085\u0085. Dicha redacci\u00f3n NO da lugar a la entrega de productos con vencimiento mayor a 12 meses, anteriormente esta redacci\u00f3n ya ha generado inconvenientes a la hora de gestionar su cobranza correspondiente teniendo que recurrir a eventuales adendas posteriores a la firma del contrato. Solicitamos amablemente a la convocante modificar la redacci\u00f3n a la siguiente expresi\u00f3n: El vencimiento de los medicamentos no debe ser menor a (12 doce) meses contados a partir de la fecha de entrega en el Lugar Indicado en la Orden de Compra. Si por la naturaleza de los mismos o por necesidad de la Instituci\u00f3n no se puede cumplir con este requisito, la recepci\u00f3n del producto con vencimiento de 11(once) y 10(diez) meses deber\u00e1 ser autorizada por la Direcci\u00f3n General del Instituto Nacional del C\u00e1ncer mediante una Nota de Autorizaci\u00f3n y Carta de compromiso de canje.\u0085..", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "AJUSTARSE  LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-02T10:06:58-04:00"}, {"id": "13", "date": "2023-05-31T07:32:06-04:00", "title": "Detalle de los productos con las respectivas especificaciones técnicas ", "description": "En el apartado en cuesti\u00f3n, se tanto en la Formula Farmaceutica como en la Presentaci\u00f3n se ha consignado Capsula. Entendemos que debe ser un error ya que la presentaci\u00f3n de estos productos es en blister, frasco, etc.", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "AJUSTARSE  LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-02T10:07:37-04:00"}, {"id": "1", "date": "2023-05-31T07:15:52-04:00", "title": "Experiencia requerida y Requisitos documentales", "description": "Se solicita a la convocante unificar criterios en los apartados de \"EXPERIENCIA REQUERIDA\" y los \"REQUISITOS DOCUMENTALES PARA LA EVALUACION DE LA EXPERIENCIA\", espec\u00edficamente en lo relacionado al porcentaje de experiencia requerido y al tipo de producto (Medicamento en general o Medicamentos Oncol\u00f3gicos).\nAdemas de ello, se solicita aclarar si es que el porcentaje en cuesti\u00f3n deber\u00e1 ser en promedio o la sumatoria; esto considerando que en el primer apartado se se\u00f1ala promedio y en el segundo sumatoria.\n", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "AJUSTARSE  LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-02T10:05:51-04:00"}, {"id": "15", "date": "2023-06-05T19:46:52-04:00", "title": "CAPACIDAD T\u00c9CNICA", "description": "En el apartado de Capacidad T\u00e9cnica de la nueva versi\u00f3n del PBC se ha inclu\u00eddo el siguiente requerimiento: \u0085a) Para Palbociclib (inhibidor de CDK4/6) (\u0085) 1. Los productos farmac\u00e9uticos multifuente (seg\u00fan definici\u00f3n OMS) deber\u00e1n presentar sus estudios de demostraci\u00f3n de equivalencia terap\u00e9utica con el producto de referencia original. \nAl respecto solicitamos que este requerimiento sea eliminado atendiendo a que el mismo resulta arbitrario al no encontrar asidero en normativa alguna. Esto es as\u00ed debido a que en la Resoluci\u00f3n SG N\u00ba 092/20 del MSPYBS, puntualmente en el Anexo 5, se se\u00f1ala taxativamente cual es el listado de principios activos que requieren demostraci\u00f3n de bioequivalencia y, entre ellos, no se encuentra citado el palbociclib. Contrario sensu, el mismo no requiere.\nCabe recordar que, conforme el Art\u00edculo 20 de la Ley 2051/03, Para la participación, contratación o adjudicación en adquisiciones, locaciones, servicios u obras públicas, no se podrán exigir a los participantes requisitos distintos a los señalados por esta ley, ni se podrán establecer elementos que no resulten técnicamente indispensables, si con ello se limitan las posibilidades de concurrencia a eventuales proveedores o contratistas.. De mas est\u00e1 decir que si la propia autoridad de aplicaci\u00f3n de la normativa sanitaria considera que para este producto NO resulta t\u00e9cnicamente indispensable requerir estudios de bioequivalencia para la obtenci\u00f3n del Certificado de Registro Sanitario y, por ende, tampoco para su comercializaci\u00f3n, resultar\u00eda un sin sentido y una limitante injustificada que para este llamado en particular lo est\u00e9n requiriendo.\n", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "AJUSTARSE LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-08T08:36:17-04:00"}, {"id": "16", "date": "2023-06-06T08:16:55-04:00", "title": "CAPACIDAD T\u00c9CNICA", "description": "En el apartado de Capacidad T\u00e9cnica de la nueva versi\u00f3n del PBC se ha inclu\u00eddo el siguiente requerimiento: \u0085a) Para Palbociclib (inhibidor de CDK4/6) (\u0085) 1. Los productos farmac\u00e9uticos multifuente (seg\u00fan definici\u00f3n OMS) deber\u00e1n presentar sus estudios de demostraci\u00f3n de equivalencia terap\u00e9utica con el producto de referencia original. \nAl respecto solicitamos que este requerimiento sea eliminado atendiendo a que el mismo resulta arbitrario al no encontrar asidero en normativa alguna. Esto es as\u00ed debido a que en la Resoluci\u00f3n SG N\u00ba 092/20 del MSPYBS, puntualmente en el Anexo 5, se se\u00f1ala taxativamente cual es el listado de principios activos que requieren demostraci\u00f3n de bioequivalencia y, entre ellos, no se encuentra citado el palbociclib. Contrario sensu, el mismo no requiere.\nCabe recordar que, conforme el Art\u00edculo 20 de la Ley 2051/03, Para la participación, contratación o adjudicación en adquisiciones, locaciones, servicios u obras públicas, no se podrán exigir a los participantes requisitos distintos a los señalados por esta ley, ni se podrán establecer elementos que no resulten técnicamente indispensables, si con ello se limitan las posibilidades de concurrencia a eventuales proveedores o contratistas.. De mas est\u00e1 decir que si la propia autoridad de aplicaci\u00f3n de la normativa sanitaria considera que para este producto NO resulta t\u00e9cnicamente indispensable requerir estudios de bioequivalencia para la obtenci\u00f3n del Certificado de Registro Sanitario y, por ende, tampoco para su comercializaci\u00f3n, resultar\u00eda un sin sentido y una limitante injustificada que para este llamado en particular lo est\u00e9n requiriendo.\n", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "AJUSTARSE A LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-08T08:36:42-04:00"}, {"id": "17", "date": "2023-06-06T08:59:25-04:00", "title": "Sistema de Adjudicaci\u00f3n", "description": "Se solicita a la convocante modificar el sistema de adjudicaci\u00f3n a ABASTECIMIENTO SIMULTANEO a fin de asegurar la provisi\u00f3n del producto solicitado.", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "AJUSTARSE A LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-08T08:37:04-04:00"}, {"id": "8", "date": "2023-05-31T07:28:45-04:00", "title": "Abastecimiento Simultaneo ", "description": "Teniendo en cuenta el volumen del producto requerido, se solicita a la convocante establecer sistema de adjudicaci\u00f3n por ABASTECIMIENTO SIMULTANEO a fin de garantizar la provisi\u00f3n de los productos solicitados.", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "AJUSTARSE  LA NUEVA VERSION DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2023-06-02T10:06:44-04:00"}, {"id": "9", "date": "2023-05-31T07:29:47-04:00", "title": "Identificaci\u00f3n de la unidad solicitante y justificaciones", "description": "Se solicita a la convocante excluir el requisito: El precio ofertado no deber\u00e1 superar el 65 % del precio de venta al p\u00fablico fijado por la Direcci\u00f3n Nacional de Vigilancia Sanitaria conforme al acta de Fijaci\u00f3n de Precios, expedida por la Direcci\u00f3n Nacional de Vigilancia Sanitaria. -- Se recuerda a la convocante que establecer requisitos que no sean estrictamente t\u00e9cnicos solo vulnera el principio de IGUALDAD Y LIBRE COMPETENCIA. Ademas, debemos se\u00f1alar que el porcentaje se\u00f1alado no responde a ni un estudio econ\u00f3mico, o cuanto menos, ello no se extrae del PBC, raz\u00f3n por la cual podr\u00eda ser considerado como arbitrario. 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