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Servicios asistenciales de salud", "hasEnquiries": true, "value": {"amount": 51499123156, "currency": "PYG"}, "datePublished": "2022-08-08T13:34:28-04:00", "tenderPeriod": {"startDate": "2022-08-31T08:00:00-04:00", "endDate": "2022-09-01T08:00:00-04:00", "durationInDays": 1}, "awardPeriod": {"startDate": "2022-09-02T10:15:00-04:00"}, "contractPeriod": {"maxExtentDate": "2024-12-31T00:00:00-04:00"}, "enquiryPeriod": {"endDate": "2022-08-17T08:00:00-04:00", "startDate": "2022-08-08T13:34:28-04:00", "durationInDays": 8}, "mainProcurementCategory": "goods", "additionalProcurementCategories": ["services"], "procurementMethod": "open", "procurementMethodDetails": "Licitaci\u00f3n P\u00fablica Nacional", "procuringEntity": {"id": "DNCP-SICP-CODE-306", "name": "Ministerio de Salud P\u00fablica y Bienestar Social (MSPBS)"}, "criteria": [{"id": "1", "title": "Garant\u00eda de Mantenimiento de Ofertas", "description": "Los oferentes, proveedores o contratistas deber\u00e1n garantizar la seriedad de sus ofertas, mediante la garant\u00eda de mantenimiento de la oferta", "source": "tenderer", "requirementGroups": [{"id": "1-1", "description": "La garant\u00eda debe ser de un cierto porcentaje, periodo y tipo", "requirements": [{"id": "1-1-1", "title": "Porcentaje de la garantia", "expectedValue": "3"}, {"id": "1-1-2", "title": "Validez de la garantia en d\u00edas", "expectedValue": "150"}]}]}], "enquiries": [{"id": "7", "date": "2022-08-16T17:56:12-04:00", "title": "EXPERIENCIA REQUERIDA", "description": "En el Pliego de Bases y Condiciones, en el apartado de Experiencia Requerida menciona lo siguiente: Demostrar la experiencia en PROVISION DE MEDICAMENTOS, con facturaciones de venta y/o contratos ejecutados por un monto equivalente al 25 % como m\u00ednimo del monto m\u00e1ximo ofertado en la presente licitaci\u00f3n, en cualquiera de los siguientes a\u00f1os: 2019 2020-2021\u0085(Sic) Solicitamos a la convocante analice la posibilidad de aceptar la sumatoria de montos de dos a\u00f1os para llegar as\u00ed al 25% de lo solicitado y ampliar la experiencia  a 5 a\u00f1os.", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Ajustarse a la primera versi\u00f3n del PByC.-", "dateAnswered": "2022-08-25T10:07:14-04:00"}, {"id": "17", "date": "2022-08-17T07:33:12-04:00", "title": "SISTEMA DE ADJUDICACION ABASTECIMIENTO SIMULT\u00c1NEO", "description": "Considerando las convocatorias anteriores publicadas por el MSPYBS, donde se solicitaban grandes cantidades de medicamentos, esta convocante hab\u00eda establecido que la adjudicaci\u00f3n seria en  ABASTECIMIENTO SIMULTANEO hasta 3 oferentes, por lo tanto atendiendo al gran volumen y naturaleza del producto, se solicita que la presente convocatoria sea nuevamente en abastecimiento simult\u00e1neo y  se modifique de la siguiente manera:\na)\tEn caso de que exista 1 (una) sola oferta, y esta cumpla con todos los requisitos establecidos en el pliego de bases y condiciones del presente llamado, oferente por la cantidad m\u00e1xima de todos los \u00edtems y la capacidad para ejecutar el contrato, la convocante podr\u00e1 adjudicar a dicha oferta la totalidad de lo ofertado.\nb)\tEn caso de que exista 2 (dos) ofertas. La adjudicaci\u00f3n se distribuir\u00e1 de la siguiente forma: 60% para la oferta mejor calificada, 40% para la siguiente mejor calificada que acepte adecuar su precio al de la ofertar evaluada como la m\u00e1s baja.\nc)\tEn caso de que exista 3 (tres) ofertas. La adjudicaci\u00f3n se distribuir\u00e1 de la siguiente forma: 50% para la oferta mejor calificada, 30% para la siguiente mejor calificada y 20% para la siguiente mejor calificada, que las dos siguientes ofertas acepten adecuar su precio al de la oferta evaluada como la m\u00e1s baja.\n", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "Ajustarse a la \u00faltima versi\u00f3n del PByC.-", "dateAnswered": "2022-08-25T09:58:55-04:00"}, {"id": "16", "date": "2022-08-17T07:32:43-04:00", "title": "SISTEMA DE ADJUDICACION ABASTECIMIENTO SIMULT\u00c1NEO", "description": "Considerando las convocatorias anteriores publicadas por el MSPYBS, donde se solicitaban grandes cantidades de medicamentos, esta convocante hab\u00eda establecido que la adjudicaci\u00f3n seria en  ABASTECIMIENTO SIMULTANEO hasta 3 oferentes, por lo tanto atendiendo al gran volumen y naturaleza del producto, se solicita que la presente convocatoria sea nuevamente en abastecimiento simult\u00e1neo y  se modifique de la siguiente manera:\na)\tEn caso de que exista 1 (una) sola oferta, y esta cumpla con todos los requisitos establecidos en el pliego de bases y condiciones del presente llamado, oferente por la cantidad m\u00e1xima de todos los \u00edtems y la capacidad para ejecutar el contrato, la convocante podr\u00e1 adjudicar a dicha oferta la totalidad de lo ofertado.\nb)\tEn caso de que exista 2 (dos) ofertas. La adjudicaci\u00f3n se distribuir\u00e1 de la siguiente forma: 60% para la oferta mejor calificada, 40% para la siguiente mejor calificada que acepte adecuar su precio al de la ofertar evaluada como la m\u00e1s baja.\nc)\tEn caso de que exista 3 (tres) ofertas. La adjudicaci\u00f3n se distribuir\u00e1 de la siguiente forma: 50% para la oferta mejor calificada, 30% para la siguiente mejor calificada y 20% para la siguiente mejor calificada, que las dos siguientes ofertas acepten adecuar su precio al de la oferta evaluada como la m\u00e1s baja.", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "Ajustarse a la \u00faltima versi\u00f3n del PByC.-", "dateAnswered": "2022-08-25T09:58:45-04:00"}, {"id": "14", "date": "2022-08-17T07:31:26-04:00", "title": "ESPECIFICACIONES TECNICAS ITEM N\u00ba 1 ERITROPOYETINA 4.000 UI", "description": "Solicitamos a la Convocante ampliar la presentaci\u00f3n de entrega del \u00cdtem ERITROPOYETINA 4000 UI a VIAL. Esto a modo de potenciar la participaci\u00f3n de un mayor n\u00famero de oferentes, y a su vez  no limitar la participaci\u00f3n de los mismos. De esta manera la Convocante podr\u00e1 asegurar su permanente abastecimiento, as\u00ed como precios competitivos.", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "Se solicita ajustarse a la primera versi\u00f3n del Pliego de Bases y Condiciones. Jeringa Precargada con dispositivo de bioseguridad incorporado, se solicita dicha presentaci\u00f3n en concordancia con la Ley N\u00b04659/12, Que Implementa procedimientos de seguridad y mecanismos de prevenci\u00f3n de riesgos para los profesionales de la salud y pacientes. De esta manera se evita infecciones protegiendo al paciente y al personal de salud. Kit conteniendo vial con polvo liofilizado + solvente+ jeringa +2 agujas. o La Eritropoyetina requerida es la LIOFILIZADA cuya presentaci\u00f3n es en polvo liofilizado m\u00e1s solvente. o Se solicita esta forma farmac\u00e9utica porque no requiere cadena de fr\u00edo esto se traduce en los siguientes beneficios: Facilita el almacenamiento como el transporte a los dem\u00e1s servicios, especialmente a aquellos que se encuentran m\u00e1s lejano. Se evita los inconvenientes relacionados a los medicamentos que requieren cadena de fr\u00edo. Se garantiza de que el medicamento que llegue a los diferentes servicios sea eficaz y seguro. o Se solicita que el Kit contenga dos agujas, ya que una es utilizada para la preparaci\u00f3n del medicamento y la otra se utiliza para aplicar el medicamento al paciente. En caso de que el medicamento no trajera las agujas solicitadas se plantean las siguientes situaciones: Se necesitar\u00e1 la provisi\u00f3n de jeringas y agujas, esto se traduce en un nuevo llamado de adquisici\u00f3n que conlleva tiempo y dinero. En caso de contar con dicho insumo el mismo se debe de buscar de diferentes parques sanitarios lo que repercute en el factor tiempo. Gasto de bolsillo para el paciente renal, ya que si no se cuenta en stock de los parques sanitarios con las agujas y jeringas necesarias para la aplicaci\u00f3n del medicamento el paciente o sus familiares deben de conseguir el mismo traduci\u00e9ndose en un gasto de bolsillo para la familia. o Solicitando la eritropoyetina de forma farmac\u00e9utica Polvo Liofilizado en kit, se busca garantizar la eficacia y seguridad del medicamento a la hora del almacenamiento y del transporte como as\u00ed tambi\u00e9n se logra ahorro econ\u00f3mico y de tiempo ya que se obtiene el kit completo, sin necesidad de estar dependiendo de otros llamados de adquisici\u00f3n. Asi mismo se solicita dicha presentaci\u00f3n en concordancia con la Ley N\u00b04659/12, Que Implementa procedimientos de seguridad y mecanismos de prevenci\u00f3n de riesgos para los profesionales de la salud y pacientes. De esta manera se evita infecciones protegiendo al paciente y al personal de salud.", "dateAnswered": "2022-08-25T10:18:22-04:00"}, {"id": "4", "date": "2022-08-16T10:52:44-04:00", "title": "Sistema de Adjudicacion", "description": "Requerimos que la Convocante analice y disponga la aplicaci\u00f3n del proceso de Abastecimiento simultaneo, por razones de estrategia y seguridad en la provisi\u00f3n del bien, a favor del Estado, conforme lo dispuesto en la legislaci\u00f3n vigente. Art\u00edculo 35. Sistema de abastecimiento simult\u00e1neo. ( Decreto N\u00ba 5174/05). ", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Ajustarse a la \u00faltima versi\u00f3n del PByC.-", "dateAnswered": "2022-08-25T09:58:28-04:00"}, {"id": "13", "date": "2022-08-16T18:51:05-04:00", "title": "REQUISITOS DE CALIDAD ", "description": "El Pliego de Bases y Condiciones en el apartado, Requisito documental para evaluar la capacidad t\u00e9cnica, en cual en el punto 9 indica: \u0085Los productos biosimilares deber\u00e1n incluir sus estudios cl\u00ednicos y de inmunogenecidad, propio y concluidos, para demostrar la comparabilidad con el producto innovador de referencia, calidad, eficacia y seguridad seg\u00fan el ejercicio de biocomparabilidad que establece la OMS o certificado emitido por la DNVS, en el cual indique que dichos estudios fueron presentados ante el mencionado ente rector (sic). En relaci\u00f3n a este requerimiento y a que los estudios cl\u00ednicos tienen como objeto garantizar la seguridad y eficacia de f\u00e1rmacos y tratamientos, solicitamos a la Convocante se sirva en excluir la presentaci\u00f3n del certificado emitido por la DNVS, manteniendo unicamente la presentaci\u00f3n de los estudios clinicos, de modo a garantizar la eficacia y seguridad de los productos licitados. ", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Las documentaciones solicitadas fueron elaboradas de acuerdo a la necesidad del Instituto Nacional de Nefrolog\u00eda, por lo que se solicita ajustarse a la primera versi\u00f3n del Pliego de Bases y Condiciones. ", "dateAnswered": "2022-08-25T10:16:46-04:00"}, {"id": "10", "date": "2022-08-16T18:00:23-04:00", "title": "CAPACIDAD TECNICA", "description": "En el PBC, en el apartado de Requisito documental para evaluar la capacidad t\u00e9cnica en el punto N\u00b0 10 menciona: Presentar Folletos, Cat\u00e1logos, prospectos impresos descriptivos de los bienes propuestos en castellano\u0085 (Sic). Con relaci\u00f3n a este punto se solicita a la convocante que analice la posibilidad de aceptar un idioma diferente con la traducci\u00f3n oficial.", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Este requisito en el PBC, se basa en la Resoluci\u00f3n MERCOSUR/GMC/RES N\u00ba 93/25 donde se indica que el prospecto, rotulo, estuche deber\u00e1n ser escritos en el idioma del Estado Parte Receptor, es decir que si el medicamento se encuentra registrado en Paraguay debe de contar con el prospecto en el idioma espa\u00f1ol, por lo que se solicita ajustarse a la primera versi\u00f3n del pliego de bases y condiciones. ", "dateAnswered": "2022-08-25T10:11:19-04:00"}, {"id": "6", "date": "2022-08-16T16:32:47-04:00", "title": "Especificaciones t\u00e9cnicas", "description": "Item 1 e Item 3. La presentaci\u00f3n Kit conteniendo: vial con polvo liofilizado +solvente + jeringa + 2 agujas est\u00e1 limitando innecesariamente la participaci\u00f3n a oferentes que cuentan con el producto de presentaci\u00f3n: FRASCO AMPOLLA con SOLUCI\u00d3N INYECTABLE, garantizando calidad y precio sin alterar la acci\u00f3n terap\u00e9utica ni el modo de aplicaci\u00f3n en comparaci\u00f3n con lo solicitado. Solicitamos respetuosamente a la convocante modificar las especificaciones t\u00e9cnicas en los siguientes puntos; PRESENTACI\u00d3N: VIAL y en PRESENTACI\u00d3N DE ENTREGA: FRASCO AMPOLLA. Lo solicitado es a fin de precautelar lo establecido en el Art. 4 de la ley 2051 b) Igualdad y Libre Competencia.", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "Se solicita ajustarse a la primera versi\u00f3n del Pliego de Bases y Condiciones.\n\n\tJeringa Precargada con dispositivo de bioseguridad incorporado, se solicita dicha presentaci\u00f3n en concordancia con la Ley N\u00b04659/12, Que Implementa procedimientos de seguridad y mecanismos de prevenci\u00f3n de riesgos para los profesionales de la salud y pacientes. De esta manera se evita infecciones protegiendo al paciente y al personal de salud. \n \n\tKit conteniendo vial con polvo liofilizado + solvente+ jeringa +2 agujas. \no\tLa Eritropoyetina requerida es la LIOFILIZADA cuya presentaci\u00f3n es en polvo liofilizado m\u00e1s solvente.\no\tSe solicita esta forma farmac\u00e9utica porque no requiere cadena de fr\u00edo esto se traduce en los siguientes beneficios:\n\tFacilita el almacenamiento como el transporte a los dem\u00e1s servicios, especialmente a aquellos que se encuentran m\u00e1s lejano.  \n\tSe evita los inconvenientes relacionados a los medicamentos que requieren cadena de fr\u00edo.\n\tSe garantiza de que el medicamento que llegue a los diferentes servicios sea eficaz y seguro.   \no\tSe solicita que el Kit contenga  dos agujas, ya que una es utilizada para la preparaci\u00f3n del medicamento y la otra se utiliza para aplicar el medicamento al paciente. En caso de que el medicamento no trajera las agujas solicitadas se plantean las siguientes situaciones:\n\tSe necesitar\u00e1 la provisi\u00f3n de jeringas y agujas, esto se traduce en un nuevo llamado de adquisici\u00f3n que conlleva tiempo y dinero.  En caso de contar con dicho insumo el mismo se debe de buscar de diferentes parques sanitarios lo que repercute  en el factor tiempo.\n\tGasto de bolsillo para el paciente renal, ya que si no se cuenta en stock de los parques sanitarios  con las agujas y jeringas necesarias para la aplicaci\u00f3n del medicamento el paciente o sus familiares deben de conseguir el mismo traduci\u00e9ndose en un gasto de bolsillo para la familia. \no\tSolicitando la eritropoyetina de forma farmac\u00e9utica Polvo Liofilizado en kit,  se busca garantizar la eficacia y seguridad del medicamento a la hora del almacenamiento y del transporte como as\u00ed tambi\u00e9n se logra ahorro econ\u00f3mico y de tiempo ya que  se obtiene el kit completo, sin necesidad de estar dependiendo de otros llamados de adquisici\u00f3n. \nAsi mismo se solicita dicha presentaci\u00f3n en concordancia con la Ley N\u00b04659/12, Que Implementa procedimientos de seguridad y mecanismos de prevenci\u00f3n de riesgos para los profesionales de la salud y pacientes. De esta manera se evita infecciones protegiendo al paciente y al personal de salud.\n", "dateAnswered": "2022-08-25T10:06:40-04:00"}, {"id": "1", "date": "2022-08-11T15:28:19-04:00", "title": "Especificaciones T\u00e9cnicas ", "description": "El \u00edtem 1: cuya presentaci\u00f3n de entrega es: \u00bf Kit conteniendo vial con polvo liofilizado + solvente + jeringa +2 agujas?\nEl \u00edtem 2: Cuya presentaci\u00f3n es: \u00bfJeringa precargada con dispositivo de Bioseguridad incorporado?\nSolicitamos a la convocante abrir a la participaci\u00f3n a m\u00e1s oferentes. Las presentaciones solicitadas, pareciera est\u00e1 dirigida a solo 2 (dos) oferentes (que son los que cumplen con estos requisitos), atendiendo a que son 12 (doce) la empresa que actualmente cuenta con este producto (medicamento). \nLa  forma de presentaci\u00f3n no puede ni debe condicionarse a Una sola presentaci\u00f3n que es como se constata en el PBC. \nEl pedido de estas presentaciones atenta contra la libre competencia seg\u00fan el Art. 4 de la ley 2051\tb) Igualdad y Libre Competencia: Permitir\u00e1n que todo potencial proveedor o contratista que tenga la solvencia t\u00e9cnica, econ\u00f3mica y legal necesaria y que cumpla con los requisitos establecidos en esta ley, en su reglamento, en las bases o pliegos de requisitos y en las dem\u00e1s disposiciones administrativas, est\u00e9 en posibilidad de participar sin restricci\u00f3n y en igualdad de oportunidades en los procedimientos de contrataci\u00f3n p\u00fablica.\nAs\u00ed tambi\u00e9n atenta con el Art. 4: a) Econom\u00eda y Eficiencia: Garantizar\u00e1n que los organismos, entidades y municipalidades se obliguen a planificar y programar sus requerimientos de contrataci\u00f3n, de modo que las necesidades p\u00fablicas se satisfagan con la oportunidad, la calidad y el costo que aseguren al Estado Paraguayo las mejores condiciones, sujet\u00e1ndose a disposiciones de racionalidad, austeridad y disciplina presupuestaria.\nLo m\u00e1s importante que se debe tener en cuenta al solicitar medicamentos v\u00eda licitaci\u00f3n son: Calidad y precios convenientes, tanto a la convocante que es del estado y a los pacientes. \nCuando se trata de compras p\u00fablicas, deber\u00eda ser abierta a todos los potenciales participantes. \n", "author": {"name": "Bioethic Pharma S.A.", "id": "PY-RUC-80058902-5"}, "answer": "\tJeringa Precargada con dispositivo de bioseguridad incorporado, se solicita dicha presentaci\u00f3n en concordancia con la Ley N\u00b0 4659/12, Que Implementa procedimientos de seguridad y mecanismos de prevenci\u00f3n de riesgos para los profesionales de la salud y pacientes. De esta manera se evita infecciones protegiendo al paciente y al personal de salud. \n \n\tKit conteniendo vial con polvo liofilizado + solvente+ jeringa +2 agujas. \no\tLa Eritropoyetina requerida es la LIOFILIZADA cuya presentaci\u00f3n es en polvo liofilizado m\u00e1s solvente.\no\tSe solicita esta forma farmac\u00e9utica porque no requiere cadena de fr\u00edo esto se traduce en los siguientes beneficios:\n\tFacilita el almacenamiento como el transporte a los dem\u00e1s servicios, especialmente a aquellos que se encuentran m\u00e1s lejano.  \n\tSe evita los inconvenientes relacionados a los medicamentos que requieren cadena de fr\u00edo.\n\tSe garantiza de que el medicamento que llegue a los diferentes servicios sea eficaz y seguro.   \no\tSe solicita que el Kit contenga  dos agujas, ya que una es utilizada para la preparaci\u00f3n del medicamento y la otra se utiliza para aplicar el medicamento al paciente. En caso de que el medicamento no trajera las agujas solicitadas se plantean las siguientes situaciones:\n\tSe necesitar\u00e1 la provisi\u00f3n de jeringas y agujas, esto se traduce en un nuevo llamado de adquisici\u00f3n que conlleva tiempo y dinero.  En caso de contar con dicho insumo el mismo se debe de buscar de diferentes parques sanitarios lo que repercute  en el factor tiempo.\n\tGasto de bolsillo para el paciente renal, ya que si no se cuenta en stock de los parques sanitarios  con las agujas y jeringas necesarias para la aplicaci\u00f3n del medicamento el paciente o sus familiares deben de conseguir el mismo traduci\u00e9ndose en un gasto de bolsillo para la familia. \no\tSolicitando la eritropoyetina de forma farmac\u00e9utica Polvo Liofilizado en kit,  se busca garantizar la eficacia y seguridad del medicamento a la hora del almacenamiento y del transporte como as\u00ed tambi\u00e9n se logra ahorro econ\u00f3mico y de tiempo ya que  se obtiene el kit completo, sin necesidad de estar dependiendo de otros llamados de adquisici\u00f3n.\nAjustarse a la primera versi\u00f3n del PBC.-\n", "dateAnswered": "2022-08-25T09:55:13-04:00"}, {"id": "5", "date": "2022-08-16T10:54:04-04:00", "title": "PLAN DE ENTREGA", "description": "El Pliego de Bases y Condiciones en su apartado Plan de Entregas menciona cuanto sigue: \u0085Cronograma de Entrega: Las \u00f3rdenes de compra ser\u00e1n emitidas por la Direcci\u00f3n General de Gesti\u00f3n de Insumos Estrat\u00e9gico en Salud, seg\u00fan necesidad y stock del Instituto Nacional de Nefrolog\u00eda. Los plazos ser\u00e1n computados en d\u00edas corridos. El proveedor deber\u00e1 tener la capacidad para realizar entregas fraccionadas, la recepci\u00f3n en cuanto a cantidades y plazos se realizar\u00e1 de la siguiente manera: Cantidades: La primera Orden de Compra, ser\u00e1 emitida dentro de los 15 (quince) d\u00edas corridos posteriores a la firma del contrato. 1) Hasta 20% de la cantidad m\u00ednima adjudicada : El proveedor tendr\u00e1 hasta los 10 (diez) d\u00edas corridos para la entrega, contados a partir de la recepci\u00f3n de la Orden de Compra, emitida por la Direcci\u00f3n General de Gesti\u00f3n de Insumos Estrat\u00e9gicos en Salud, seg\u00fan necesidad y stock del Instituto Nacional de Nefrolog\u00eda. 2 ) Hasta el 30%de la cantidad m\u00ednima adjudicada : El proveedor tendr\u00e1 hasta los 15 (Quince) d\u00edas corridos para la entrega, contados a partir de la recepci\u00f3n de la Orden de Compra, emitida por la Direcci\u00f3n General de Gesti\u00f3n de Insumo  Estrat\u00e9gicos en Salud, seg\u00fan necesidad y stock del Instituto Nacional de Nefrolog\u00eda. 3) Saldo de la cantidad m\u00ednima El proveedor tendr\u00e1 hasta los 20 (Veinte) d\u00edas corridos para la entrega contados a partir de la recepci\u00f3n de la Orden de Compra emitida por la Direcci\u00f3n General de Gesti\u00f3n de Insumos Estrat\u00e9gicos en Salud, seg\u00fan necesidad y stock del Instituto Nacional de Nefrolog\u00eda. La emisi\u00f3n de la Orden de Compra de la totalidad de la cantidad m\u00ednima ser\u00e1 emitida dentro de los 12 (doce) meses posteriores a la firma del contrato Cantidades M\u00e1ximas. A ser fraccionadas seg\u00fan necesidad y stock del Instituto Nacional de Nefrolog\u00eda, las \u00d3rdenes de Compra ser\u00e1n emitidas una vez emitida la totalidad de las cantidades m\u00ednimas, con plazos de entrega de hasta 30 (treinta) d\u00edas corridos, contados a partir de la recepci\u00f3n de las \u00d3rdenes de Compra emitida por la Direcci\u00f3n General de Gesti\u00f3n de Insumos Estrat\u00e9gicos en Salud, seg\u00fan necesidad y stock del Instituto Nacional de Nefrolog\u00eda. La emisi\u00f3n de la Orden de Compra de la totalidad de la cantidad m\u00e1xima, ser\u00e1 emitida hasta el 31/12/2024(sic) . Considerando que: estos productos deben ser importados y que por la naturaleza de los mismos su vencimiento te\u00f3rico no superan los 30 meses y que a su vez, pasan por rigurosos procesos de aseguramiento de calidad para asegurar la eficacia y la estabilidad del producto que pueden extenderse hasta 4 meses, sumado al tiempo de tr\u00e1nsito y desaduanaje por la coyuntura actual por la que se atraviesa a nivel global, por la disminuci\u00f3n de los itinerarios a\u00e9reos y las escasa disponibilidad de espacio en las aeronaves, los cuales generan dilaciones significativas en las importaciones. En este sentido, solicitamos a la Convocante analice la posibilidad de establecer el siguiente plan de entregas: CANTIDAD MINIMA: - Primera Entrega Hasta el 20 % de la Cantidad M\u00ednima Adjudicada. Hasta los 15 (quince) d\u00edas corridos contados desde la recepci\u00f3n de la Orden de compra por parte del proveedor. Con entregas que podr\u00e1n ser fraccionadas siempre dentro del mencionado plazo. \u0096 Segunda Entrega: Hasta el 30 % de la Cantidad M\u00ednima adjudicada: Hasta los 20 (veinte) d\u00edas corridos, contados desde la recepci\u00f3n de la Orden de compra por parte del proveedor. Con entregas que podr\u00e1n ser fraccionadas siempre dentro del mencionado plazo. Saldo de la cantidad m\u00ednima: hasta los 25 (Veinte y cinco ) d\u00edas corridos para la entrega contados a partir de la recepci\u00f3n de la Orden de Compra emitida por la Direcci\u00f3n General de Gesti\u00f3n de Insumos Estrat\u00e9gicos en Salud, seg\u00fan necesidad y stock del Instituto Nacional de Nefrolog\u00eda. Cantidades m\u00e1ximas Las cantidades m\u00e1ximas podr\u00e1n ser fraccionadas seg\u00fan necesidad y stock de los servicios tendr\u00e1 hasta 30 (treinta) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de compras emitida por la DGGIES seg\u00fan necesidad y del Instituto Nacional de Nefrolog\u00eda.", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "El plan de entrega fue elaborado de acuerdo a las necesidades del Instituto Nacional de Nefrolog\u00eda por lo que se solicita ajustarse la primera versi\u00f3n del PByC.-", "dateAnswered": "2022-08-25T10:04:49-04:00"}, {"id": "9", "date": "2022-08-16T17:59:31-04:00", "title": "CAPACIDAD TECNICA", "description": "En el PBC, en el apartado de Requisito documental para evaluar la capacidad t\u00e9cnica en el punto N\u00b0 5 y 6 menciona lo siguiente: 5. Para productos importados Biol\u00f3gicos, copia Legalizada y/o apostillada o declaraci\u00f3n jurada del fabricante (debidamente legalizada y/o apostillada) con el link web oficial del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n vigente, otorgado por alguna de las Agencias regulatorias previstas en el art\u00edculo 11 de la Ley N\u00b0 3283/07, Agencias\nreguladoras de la EMA (European Medicines Agency), FDA, Agencias Reguladoras de Referencia (Nivel 4) reconocidas por la OPS. 6. Para productos importados Biol\u00f3gicos, copia Legalizada y/o apostillada o declaraci\u00f3n jurada del fabricante 22/45 (debidamente legalizada y/o apostillada) con el link web oficial del Registro Sanitario o CPP vigente, otorgado por alguna de las Agencias regulatorias previstas en el art\u00edculo 11 de la Ley N\u00b0 3283/07, Agencias reguladoras de la EMA (European Medicines Agency), FDA, Agencias Reguladoras de Referencia (Nivel 4) reconocidas por la OPS\u0085(Sic).  En relaci\u00f3n con  este punto se solicita a la Convocante, se sirva en aclarar si podr\u00eda remitirse el Certificado de Buenas Pr\u00e1cticas del Fabricante  legalizado /apostillado,  sin necesidad de remitirse el link web oficial. \n\n", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Tal como lo indica el enunciado se puede entregar copia del certificado de buenas pr\u00e1cticas de fabricaci\u00f3n vigente (legalizado y/o apostillado), otorgado por alguna de las Agencias regulatorias previstas en art\u00edculo 11 de la Ley N\u00b0 3283/07, Agencias reguladoras de la EMA (European Medicines Agency), FDA, Agencias Reguladoras de Referencia (Nivel 4) reconocidas por la OPS. La presentaci\u00f3n de la declaraci\u00f3n jurada del fabricante con el link web oficial (legalizado y/o apostillado) es para aquellos que poseen el mismo. ", "dateAnswered": "2022-08-25T10:10:25-04:00"}, {"id": "18", "date": "2022-08-17T07:34:11-04:00", "title": "REQUISITO DOCUMENTAL PARA EVALUAR LA CAPACIDAD T\u00c9CNICA", "description": "En los puntos N\u00ba 5 y 6 de los requisitos documentales se solicitan los siguientes documentos:\n5. Para productos importados Biol\u00f3gicos, copia Legalizada y/o apostillada o declaraci\u00f3n jurada del fabricante (debidamente legalizada y/o apostillada) con el link web oficial del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n vigente, otorgado por alguna de las Agencias regulatorias previstas en el art\u00edculo 11 de la Ley N\u00b0 3283/07, Agencias reguladoras de la EMA (European Medicines Agency), FDA, Agencias Reguladoras de Referencia (Nivel 4) reconocidas por la OPS.\n6. Para productos importados Biol\u00f3gicos, copia Legalizada y/o apostillada o declaraci\u00f3n jurada del fabricante 22/45 (debidamente legalizada y/o apostillada) con el link web oficial del Registro Sanitario o CPP vigente, otorgado por alguna de las Agencias regulatorias previstas en el art\u00edculo 11 de la Ley N\u00b0 3283/07, Agencias reguladoras de la EMA (European Medicines Agency), FDA, Agencias Reguladoras de Referencia (Nivel 4) reconocidas por la OPS.\nSOLICITAMOS AMABLEMENTE A LA CONVOCANTE QUE UNIFIQUE DICHO REQUISITO, A MODO DE PRESENTAR INDISTINTAMENTE UNO U OTRO DOCUMENTO, NO AMBOS, ESTO DE NINGUN MODO ALTERARIA NI COMPROMETERIA LA CALIDAD, SEGURIDAD NI EFICACIA DE LOS PRODUCTOS OFERTADOS.", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "Al tratarse de un medicamento biol\u00f3gico, ambas documentaciones son presentadas a la hora de solicitar el registro sanitario por lo que el oferente debe de poseer el mismo. Se solicita ajustarse a la primera versi\u00f3n del Pliego de Bases y Condiciones. ", "dateAnswered": "2022-08-25T10:20:16-04:00"}, {"id": "11", "date": "2022-08-16T18:01:51-04:00", "title": "EMBALAJES Y DOCUMENTOS", "description": "En el Pliego de Bases y Condiciones en el apartado de EMBALAJES Y DOCUMENTOS menciona lo siguiente: Los embalajes de los productos suministrados deber\u00e1n ser adecuados, de tal forma a que impida su deterioro y permita su conservaci\u00f3n y protecci\u00f3n de la humedad y cualquier otro agente del medio ambiente nocivo para el mismo. Los embalajes o envases deber\u00e1n estar etiquetados con la misma informaci\u00f3n descripta para los productos, indicando cantidad m\u00e1xima de apilamiento y la leyenda Fr\u00e1gil, en el caso de que as\u00ed lo sean. 1. El Proveedor embalar\u00e1 los bienes en la forma necesaria para impedir que se da\u00f1en o deterioren durante el transporte al lugar de destino final indicado en el contrato. El embalaje deber\u00e1 ser adecuado para resistir, sin limitaciones, su manipulaci\u00f3n brusca y descuidada, su exposici\u00f3n a temperaturas extremas, la sal y las precipitaciones, y su almacenamiento en espacios abiertos. En el tama\u00f1o y peso de los embalajes se tendr\u00e1 en cuenta, cuando corresponda, la lejan\u00eda 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.\n2. El embalaje, las identificaciones y los documentos que se coloquen dentro y fuera de los bultos deber\u00e1n cumplir estrictamente con los requisitos especiales que se hayan estipulad expresamente en el contrato y cualquier otro requisito si lo hubiere, especificado en las condiciones contractuales\u0085(Sic). Con relaci\u00f3n al punto, y considerando que los productos ofertados son de cadena de frio, se solicita a la Convocante, estudie la posibilidad de agregar lo siguiente: Para mantener la cadena de frio de los productos que lo requieran podr\u00e1n mantener el requisito de etiquetado del producto en el envase secundario, incorporando mecanismos de inviolabilidad adicionales (precintos, sellos), evitando manipular el embalaje primario.\n", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "El Pliego fue elaborado de acuerdo a las necesidades del Instituto Nacional de Nefrolog\u00eda por lo que se solicita ajustarse a la primera versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2022-08-25T10:15:26-04:00"}, {"id": "2", "date": "2022-08-16T08:09:43-04:00", "title": "ESPECIFICACIONES TECNICAS ITEM N\u00b0 2-4", "description": "Solicitamos a la Convocante ampliar la presentaci\u00f3n requerida para el producto del ITEM N\u00b0 2-4 - ERITROPOYETINA 4000 - 10000 UI JERINGA PRECARGADA Jeringa precargada con dispositivo de Bioseguridad incorporado y/o ERITROPOYETINA 4000 - 10000 UI JERINGA PRECARGADA (como m\u00ednimo), hay historial de compras del INN donde ya se han adquirido la presentaci\u00f3n de Jeringa Precargada, con la presentaci\u00f3n con dispositivo de bioseguridad est\u00e1n limitando la participaci\u00f3n de potenciales oferentes. Esto a fin de dar mayor oportunidad de apertura y contar con m\u00e1s ofertas susceptibles de ser adjudicados, garantizando el principio de igualdad y libre competencia previsto en la Ley 2051/03 \"De Contrataciones P\u00fablicas", "author": {"name": "MEGALABS PARAGUAY SOCIEDAD AN\u00d3NIMA", "id": "PY-RUC-80003391-4"}, "answer": "Se solicita dicha presentaci\u00f3n en concordancia con la Ley N\u00b04659/12, Que Implementa procedimientos de seguridad y mecanismos de prevenci\u00f3n de riesgos para los profesionales de la salud y pacientes. De esta manera se evita infecciones protegiendo al paciente y al personal de salud. Ajustarse a la primera versi\u00f3n del PByC.-", "dateAnswered": "2022-08-25T09:56:09-04:00"}, {"id": "3", "date": "2022-08-16T10:46:17-04:00", "title": "VENCIMIENTO", "description": "El pliego de Bases y Condiciones en su apartado Vencimiento indica: El vencimiento m\u00ednimo del producto no deber\u00e1 ser inferior a 18 (diez y ocho) meses al momento de la entrega en los\nparques sanitarios del MSPyBS, si por la naturaleza del mismo o por necesidad de la Instituci\u00f3n no se puede cumplir con este requisito, la recepci\u00f3n del art\u00edculo deber\u00e1 ser autorizada por Direcci\u00f3n de Log\u00edstica de la DGGIES y el Instituto Nacional de Nefrolog\u00eda. Para productos con vencimiento menor a 18 (Diez y ocho) meses o menos la recepci\u00f3n del producto deber\u00e1 ser autorizada por la Direcci\u00f3n de Log\u00edstica de la DGGIES y el Instituto Nacional de Nefrolog\u00eda (Nota de Autorizaci\u00f3n) y Carta de Compromiso de Canje y P\u00f3liza de Seguro por el 100% del monto del producto con identificaci\u00f3n del n\u00famero de Lote; que ser\u00e1n entregados en la Oficina de Contrato y Garant\u00edas de la DGGIES y el duplicado en el Parque Sanitario que corresponda. La validez de dicha p\u00f3liza deber\u00e1 ser por 3 meses posteriores a la fecha del vencimiento del producto a entregar. Adem\u00e1s, deber\u00e1n presentar Declaraci\u00f3n Jurada por la cual el oferente se compromete en caso de ser adjudicados a canjear el producto 3 a 6 meses antes de su vencimiento, previo informe Direcci\u00f3n de Log\u00edstica de la DGGIES y el Instituto Nacional de Nefrolog\u00eda.  Considerando que: Los \u00edtems objeto de este llamado se tratan de productos biol\u00f3gicos que se obtienen mediante el empleo de organismos o c\u00e9lulas vivas, cuyo vencimiento te\u00f3rico no supera los 24 meses debido a esta condici\u00f3n, y que a su vez, pasa por rigurosos procesos de aseguramiento de calidad para asegurar la eficacia y la estabilidad del producto que pueden extenderse hasta 4 meses, sumado al tiempo de tr\u00e1nsito y desaduanaje que en promedio se extiende tambi\u00e9n por otros 4 meses para poder entregar los productos a la Convocante en tiempo y forma.  Para poder cumplir con el plan de entregas establecido por el pliego de bases y condiciones requiere contar con un stock de seguridad para dar respuesta inmediata a las necesidades de la Convocante.  El requerimiento de una p\u00f3liza de seguro para medicamentos con vencimiento mayor a 18 meses podr\u00eda incidir de forma negativa en la estructura de costos del proceso. Solicitamos que: La Convocante analice la posibilidad de modificar su segundo p\u00e1rrafo, solicitando Carta Compromiso de Canje y P\u00f3liza de Seguro por el 100% del monto del producto a ser entregado, para productos con vencimiento inferior a 12 meses.\n", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Dicho requisito fue elaborado de acuerdo a la necesidad del Instituto Nacional de Nefrolog\u00eda. Ajustarse a la primera versi\u00f3n del PByC.-", "dateAnswered": "2022-08-25T09:57:24-04:00"}, {"id": "19", "date": "2022-08-17T07:44:24-04:00", "title": "SISTEMA DE ADJUDICACION - ABASTECIMIENTO SIMULTANEO", "description": "SOLICITAMOS AMABLEMENTE A LA CONVOCANTE QUE EL SISTEMA DE ADJUDICACION SEA MODIFICADO Y QUE APLIQUE EL ABASTECIMIENTO SIMULTANEO. ESTO A MODO DE QUE LA CONVOCANTE ASEGURE SU ABASTECIMIENTO Y SE PUEDA DAR MAYOR PARTICIPACION A LOS OFERENTES.", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "Ajustarse a la \u00faltima versi\u00f3n del PByC.-", "dateAnswered": "2022-08-25T09:59:07-04:00"}, {"id": "8", "date": "2022-08-16T17:57:40-04:00", "title": "CAPACIDAD TECNICA", "description": "En el PBC, en el apartado de Requisito documental para evaluar la capacidad t\u00e9cnica en el punto N\u00b0 11 solicita lo siguiente: Copia del certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n y/o almacenamiento, seg\u00fan corresponda, del oferente, fabricante y/o distribuidor, emitida por la Direcci\u00f3n Nacional de Vigilancia Sanitaria del MSPyBS, vigente durante toda la duraci\u00f3n del contrato\u0085(Sic). En relaci\u00f3n con este punto, y en los casos de que el mismo se encuentre vencido, solicitamos a la Convocante analice la posibilidad de agregar al citado requerimiento,  la posibilidad de presentar la constancia expedida por la autoridad regulatoria (DNVS),  donde consta que el mismo se encuentra en tr\u00e1mite de renovaci\u00f3n  ", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Las Buenas Pr\u00e1cticas de Fabricaci\u00f3n y/o almacenamiento se debe de encontrar vigente, por lo que se solicita ajustarse a la primera versi\u00f3n del Pliego de Bases y Condiciones. ", "dateAnswered": "2022-08-25T10:08:30-04:00"}, {"id": "12", "date": "2022-08-16T18:03:06-04:00", "title": "REAJUSTE", "description": "El Pliego de Bases y Condiciones en el apartado reajuste estipula lo siguiente: Para Bienes Importados: La f\u00f3rmula y el procedimiento de precios ser\u00e1n los siguientes: el reajuste de precio deber\u00e1 ser solicitado por el Contratista y aprobado por el Contratante por medio de notas oficiales. Los precios reajustados, solo tendr\u00e1n incidencia sobre los bienes a\u00fan no prove\u00eddos; y, no tendr\u00e1n ning\u00fan efecto retroactivo respecto a los ya fueron prove\u00eddos antes de la verificaci\u00f3n del reajuste. El Precio Reajustado del Contrato, estar\u00e1 determinado por la siguiente f\u00f3rmula: V1=P* {(Cmc/Co) 1}. En este sentido, solicitamos a la Convocante se sirva en aclarar que signo es el que antecede en la formula al numeral 1 ya que solo expresa lo siguiente: V1=P* {(Cmc/Co) 1}.", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "La convocante aclara que para esta formula teniendo en cuenta lo que antecede al numeral 1 corresponde al signo menos.-", "dateAnswered": "2022-08-25T10:14:42-04:00"}, {"id": "15", "date": "2022-08-17T07:31:59-04:00", "title": "ESPECIFICACIONES TECNICAS ITEM N\u00ba 3 ERITROPOYETINA 10.000 UI", "description": "Solicitamos a la Convocante ampliar la presentaci\u00f3n de entrega del \u00cdtem ERITROPOYETINA 10.000 UI a VIAL. Esto a modo de potenciar la participaci\u00f3n de un mayor n\u00famero de oferentes, y a su vez  no limitar la participaci\u00f3n de los mismos. De esta manera la Convocante podr\u00e1 asegurar su permanente abastecimiento, as\u00ed como precios competitivos.", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "Se solicita ajustarse a la primera versi\u00f3n del Pliego de Bases y Condiciones. Jeringa Precargada con dispositivo de bioseguridad incorporado, se solicita dicha presentaci\u00f3n en concordancia con la Ley N\u00b04659/12, Que Implementa procedimientos de seguridad y mecanismos de prevenci\u00f3n de riesgos para los profesionales de la salud y pacientes. De esta manera se evita infecciones protegiendo al paciente y al personal de salud. Kit conteniendo vial con polvo liofilizado + solvente+ jeringa +2 agujas. o La Eritropoyetina requerida es la LIOFILIZADA cuya presentaci\u00f3n es en polvo liofilizado m\u00e1s solvente. o Se solicita esta forma farmac\u00e9utica porque no requiere cadena de fr\u00edo esto se traduce en los siguientes beneficios: Facilita el almacenamiento como el transporte a los dem\u00e1s servicios, especialmente a aquellos que se encuentran m\u00e1s lejano. Se evita los inconvenientes relacionados a los medicamentos que requieren cadena de fr\u00edo. Se garantiza de que el medicamento que llegue a los diferentes servicios sea eficaz y seguro. o Se solicita que el Kit contenga dos agujas, ya que una es utilizada para la preparaci\u00f3n del medicamento y la otra se utiliza para aplicar el medicamento al paciente. En caso de que el medicamento no trajera las agujas solicitadas se plantean las siguientes situaciones: Se necesitar\u00e1 la provisi\u00f3n de jeringas y agujas, esto se traduce en un nuevo llamado de adquisici\u00f3n que conlleva tiempo y dinero. En caso de contar con dicho insumo el mismo se debe de buscar de diferentes parques sanitarios lo que repercute en el factor tiempo. Gasto de bolsillo para el paciente renal, ya que si no se cuenta en stock de los parques sanitarios con las agujas y jeringas necesarias para la aplicaci\u00f3n del medicamento el paciente o sus familiares deben de conseguir el mismo traduci\u00e9ndose en un gasto de bolsillo para la familia. o Solicitando la eritropoyetina de forma farmac\u00e9utica Polvo Liofilizado en kit, se busca garantizar la eficacia y seguridad del medicamento a la hora del almacenamiento y del transporte como as\u00ed tambi\u00e9n se logra ahorro econ\u00f3mico y de tiempo ya que se obtiene el kit completo, sin necesidad de estar dependiendo de otros llamados de adquisici\u00f3n. Asi mismo se solicita dicha presentaci\u00f3n en concordancia con la Ley N\u00b04659/12, Que Implementa procedimientos de seguridad y mecanismos de prevenci\u00f3n de riesgos para los profesionales de la salud y pacientes. 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