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Servicios asistenciales de salud", "hasEnquiries": true, "value": {"amount": 138930940948, "currency": "PYG"}, "datePublished": "2022-10-21T14:35:01-04:00", "tenderPeriod": {"startDate": "2023-01-04T08:00:00-04:00", "endDate": "2023-01-05T08:00:00-04:00", "durationInDays": 1}, "awardPeriod": {"startDate": "2023-01-09T10:00:00-04:00"}, "enquiryPeriod": {"endDate": "2022-10-27T10:00:00-04:00", "startDate": "2022-10-21T14:35:01-04:00", "durationInDays": 5}, "mainProcurementCategory": "goods", "additionalProcurementCategories": ["services"], "procurementMethod": "open", "procurementMethodDetails": "Licitaci\u00f3n P\u00fablica Nacional", "procuringEntity": {"id": "DNCP-SICP-CODE-157", "name": "Instituto de Previsi\u00f3n Social (IPS)"}, "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": "180"}]}]}], "enquiries": [{"id": "8", "date": "2022-10-26T19:18:26-04:00", "title": "Experiencia requerida", "description": "En el punto de referencia, en su parte pertinente se menciona cuanto sigue: Para el caso de que el oferente no sea el fabricante y/o el titular del registro sanitario de los medicamentos, dicha experiencia deber\u00e1 estar igualmente acreditada por el oferente, por el titular del registro sanitario y el fabricante del producto que se oferta. \n\nAl respecto, de dicho texto entendemos que la Convocante pretende lo siguiente: 1. Para productos nacionales: En caso de que el oferente no sea el fabricante y/o el titular del registro sanitario de los medicamentos, dicha experiencia deber\u00e1 estar igualmente acreditada por el oferente, por el titular del registro sanitario y el fabricante del producto que se oferta. 2. Para productos importados: En caso de que el oferente no sea el titular del registro sanitario; dicha experiencia deber\u00e1 estar igualmente acreditada tanto por el oferente y el titular del registro sanitario. \n\nFavor, recomendamos replantear lo requerido, estableciendo claramente esta interpretaci\u00f3n, a fin de evitar confusiones en los potenciales oferentes. \n", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones", "dateAnswered": "2022-11-17T14:01:40-04:00"}, {"id": "24", "date": "2022-10-26T22:02:30-04:00", "title": "Capacidad Tecnica", "description": "En el punto 1.3, inciso c., la Convocante establece el siguiente requisito: c.) Los productos multifuente cuyos principios activos se encuentren incluidos en el Listado de Medicamentos Esenciales de la OMS y que sean considerados de ventana terap\u00e9utica estrecha y/o atiendan enfermedades cr\u00edticas deber\u00e1n anexar reportes locales de Farmacovigilancia propios, siguiendo los indicadores de Farmacovigilancia de la OMS.  La Farmacovigilancia implica el desarrollo de un Plan de Gesti\u00f3n de Riesgos (PGR) basados en la planificaci\u00f3n de la misma con criterio proactivo. Esta planificaci\u00f3n deber\u00e1 contar con: - La notificaci\u00f3n: El reporte, que es el medio por el cual un reportante notifica sobre la presencia de una reacci\u00f3n adversa a un medicamento (RAM) o un problema relacionado a un medicamento en calidad y eficacia del medicamento (PRM) a un sistema de Farmacovigilancia. - Estrategias complementarias: descripci\u00f3n de las acciones realizadas para resolver o mitigar el evento adverso.\nAl respecto, es necesario aclarar que la farmacovigilancia abarca desde la comercializaci\u00f3n del producto y no se limita al desarrollo de un plan de gesti\u00f3n de riesgos, siendo estos eventos completamente distintos y que pueden realizarse sin ser dependientes, por tanto, solicitamos verificar lo detallado. \nAsimismo, cabe mencionar que al realizar un plan de gesti\u00f3n de riesgo como bien lo indica la Convocante con criterios proactivos, los cuales implican espec\u00edficamente la minimizaci\u00f3n de los posibles riesgos, la actividad propuesta en el plan de gesti\u00f3n de riesgo no necesariamente deber\u00e1 contar con una notificaci\u00f3n como lo pretende la Convocante. En vista de que al no ocurrir eventos adversos en consecuencia a los criterios proactivos llevados a cabo durante el desarrollo del plan de gesti\u00f3n de riesgo, no se contar\u00edan con fichas de notificaci\u00f3n propiamente, considerando que estos son elaborados espec\u00edficamente cuando se cuenta con una notificaci\u00f3n de evento adverso. \nAdem\u00e1s, es importante recordar que estas notificaciones son documentos confidenciales y no pueden ser divulgados a instancias distintas a la autoridad reguladora. \nFinalmente, recordamos que los problemas relacionados con la calidad y eficacia del producto no se tratan en el plan de gesti\u00f3n de riesgo, si dichos medicamentos no entraron en contacto con el paciente, por lo que no corresponde incluir problemas relacionados a medicamentos en el plan de gesti\u00f3n de riesgo conforme a lo solicitado en el PBC. \nPor tanto, en base a todo lo detallado, solicitamos a la Convocante replantear lo requerido, en base a lo que implica un trabajo de farmacovigilancia y considerando cual es la finalidad de la misma al requerir estos documentos.  \n", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:06:22-04:00"}, {"id": "26", "date": "2022-10-26T22:13:33-04:00", "title": "Capacidad T\u00e9cnica", "description": "En el punto 1.3, inciso d., la Convocante establece el siguiente requisito: d) Los productos innovadores (Originales) solo deben presentar copia autenticada de Certificado de Libre Venta/CPP, emitido por una entidad regulatoria de referencia, FDA o EMA. \nAl respecto, consultamos a la Convocante el motivo por el cual la misma no solicita para los productos innovadores lo establecido en el inciso c. de este mismo criterio conforme es requerido para los dem\u00e1s oferentes. Esto considerando que corresponde al mismo principio activo y estos son los que se encuentran incluidos dentro del listado, no pudiendo disociarse el riesgo por ser un innovador o biosimilar / gen\u00e9rico como pretende la Convocante. Por tanto, en base a esto, se solicita requerir igualmente lo detallado en el inciso c. para los productos innovadores, considerando adem\u00e1s la variabilidad poblacional que existe entre el lugar donde se desarrollaron los estudios para productos innovadores y donde se utilizaran finalmente los mismos. \n", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones. ", "dateAnswered": "2022-11-17T14:06:42-04:00"}, {"id": "21", "date": "2022-10-26T21:41:47-04:00", "title": "Porcentaje de Multas", "description": "La Convocante establece como porcentaje de multa el 0.1%. Al respecto, solicitamos a la misma la modificaci\u00f3n de dicho porcentaje a por lo menos el 0.01%. Esto considerando que los productos a ser adquiridos por la misma son de un muy alto costo y la mayor\u00eda de ellos corresponden a productos importados que son dif\u00edciles de mantener un stock y dependen de muchos agentes externos. Por lo que en caso de existir atrasos los costos serian demasiado elevados para ser solventados por el proveedor, considerando el atraso constante de la Convocante en los pagos a proveedores que deben solventar la compra de estos productos sin el pago de la Convocante por ellos en un largo plazo.   ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:05:47-04:00"}, {"id": "28", "date": "2022-10-27T09:04:44-04:00", "title": "Item 7 -Inmunoglobulina anti D", "description": "Se solicita actualizar precio referencial del producto. El precio establecido est\u00e1 por debajo del precio de mercado actual.", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "El oferente deber\u00e1 adecuarse a los Datos Cargados en SICP.", "dateAnswered": "2022-11-17T14:06:59-04:00"}, {"id": "25", "date": "2022-10-26T22:13:21-04:00", "title": "Capacidad Tecnica", "description": "10.\tEn el punto 1.3, inciso d., la Convocante establece el siguiente requisito: d) Los productos innovadores (Originales) solo deben presentar copia autenticada de Certificado de Libre Venta/CPP, emitido por una entidad regulatoria de referencia, FDA o EMA. \nAl respecto, consultamos a la Convocante el motivo por el cual la misma no solicita para los productos innovadores lo establecido en el inciso c. de este mismo criterio conforme es requerido para los dem\u00e1s oferentes. Esto considerando que corresponde al mismo principio activo y estos son los que se encuentran incluidos dentro del listado, no pudiendo disociarse el riesgo por ser un innovador o biosimilar / gen\u00e9rico como pretende la Convocante. Por tanto, en base a esto, se solicita requerir igualmente lo detallado en el inciso c. para los productos innovadores, considerando adem\u00e1s la variabilidad poblacional que existe entre el lugar donde se desarrollaron los estudios para productos innovadores y donde se utilizaran finalmente los mismos. \n", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:06:32-04:00"}, {"id": "30", "date": "2022-10-27T09:15:32-04:00", "title": "Experiencia requerida", "description": "Demostrar la experiencia en Provisi\u00f3n 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 promedio en los 3 (tres) (2019 - 2020 - 2021) a\u00f1os.                                                                    Se solicita aclarar la forma de evaluaci\u00f3n de lo requerido, al expresar en promedio de los 3 a\u00f1os se entiende que: se tomara la sumatoria de los documentos presentados y dividirlos por 3. ", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "Se aclara al oferente que el an\u00e1lisis efectuado es el correcto, en consecuencia corresponde adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:07:19-04:00"}, {"id": "10", "date": "2022-10-26T19:42:30-04:00", "title": "REQUISITO DOCUMENTAL PARA EVALUAR LA CAPACIDAD T\u00c9CNICA ", "description": "En el apartado Requisitos para evaluar la CAPACIDAD T\u00c9CNICA, se menciona cuanto sigue:\nCertificado de Buenas Pr\u00e1cticas (TRADUCIDO EN IDIOMA ESPA\u00d1OL)\nb. En el caso de que el Oferente no sea el fabricante del Producto ofertado, deber\u00e1 presentar: Copia autenticada del Certificado de Buenas Pr\u00e1cticas de Almacenamiento, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), adem\u00e1s del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n del Fabricante del producto ofertado, los cuales deber\u00e1n mantener su vigencia durante toda la duraci\u00f3n del contrato.\nCon respecto al apartado donde dice: adem\u00e1s del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n del Fabricante del producto ofertado. Conviene aclarar a la convocante que en la actualidad existen pa\u00edses que ya no emiten Certificados de Buenas Pr\u00e1cticas de Fabricaci\u00f3n, tal es el caso de la Rep\u00fablica Popular China el cual desde el a\u00f1o 2019, ha reglamentado no emitir tales certificados, sino m\u00e1s bien emitir como \u00fanico documento la Licencia/Certificado de Fabricaci\u00f3n en el cual se refleja por un lado la habilitaci\u00f3n de la planta elaboradora y por otro el cumplimiento de las buenas pr\u00e1cticas de fabricaci\u00f3n. Es importante mencionarles que el ente regulador (DINAVISA) ya se ha expedido al respecto y la misma admite dichas licencias como documento suficiente para acreditar el cumplimiento de las buenas pr\u00e1cticas de fabricaci\u00f3n. En caso de duda solicitamos amablemente realizar la consulta al ente regulador.\nPor todo esto, solicitamos a la convocante la ampliaci\u00f3n de dicho requisito de la siguiente manera:\nCertificado de Buenas Pr\u00e1cticas (TRADUCIDO EN IDIOMA ESPA\u00d1OL)\nb. En el caso de que el Oferente no sea el fabricante del Producto ofertado, deber\u00e1 presentar: Copia autenticada del Certificado de Buenas Pr\u00e1cticas de Almacenamiento, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), adem\u00e1s del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n del Fabricante o Licencia/Certificado de Fabricaci\u00f3n del producto ofertado, los cuales deber\u00e1n mantener su vigencia durante toda la duraci\u00f3n del contrato.", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:01:57-04:00"}, {"id": "12", "date": "2022-10-26T19:52:36-04:00", "title": "Capacidad Tecnica", "description": "4.\tEn el punto 1.4 Para f\u00e1rmacos como Octeotrida Acetato, Abiraterona (terapia hormonal), solicitan lo siguiente: Registro y/o Certificado del producto ofertado, emitido por una Autoridad Sanitaria Reguladora de Alta Vigilancia como: \na. FDA o EMA. \nb. O los indicados de alta vigilancia en el Art 11 de la Ley 3283/2007. \nc. O Pa\u00edses certificados por OPS como autoridades reguladoras de referencia regional del continente americano (Nivel IV), ANMAT (Argentina), ANVISA (Brasil), INVIMA (Colombia), CEDMED (Cuba), COFEPRIS (M\u00e9xico), HEALTH CANADA y FDA (USA).\nAl respecto, se solicita a la convocante incluir y aclarar los requisitos para productos de fabricaci\u00f3n NACIONAL. Cabe resaltar que queda fuera de lugar establecer requisitos que el ente regulador (DNVS) no requiera para la autorizaci\u00f3n de comercializaci\u00f3n dentro del territorio nacional.\n", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:03:42-04:00"}, {"id": "9", "date": "2022-10-26T19:35:48-04:00", "title": "Capacidad T\u00e9cnica", "description": "2.\tEn los criterios de capacidad t\u00e9cnica la Convocante establece cuanto sigue: El precio ofertado no deber\u00e1 superar el 65% del precio fijado en el Acta de Fijaci\u00f3n, atendiendo al principio de econom\u00eda y eficiencia Al respecto, solicitamos a la Convocante aclarar si en este proceso, en ning\u00fan caso se podr\u00e1 superar el 65% del acta de precios. En caso afirmativo, solicitamos a la Convocante replantear el criterio y establecer el mismo conforme lo hace normalmente la misma en los dem\u00e1s procesos de contrataci\u00f3n, que dice: El precio ofertado no deber\u00e1 superar el 65% del precio fijado en el Acta de Fijaci\u00f3n de precios expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) actualizado y vigente, salvo parecer de la Convocante atendiendo al principio de econom\u00eda y eficiencia. Esta solicitud se realiza considerando el alto costo de los productos a adquirir por la misma, de modo a evitar una suba general en los productos. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Se aclara al oferente que, el precio ofertado no deber\u00e1 superar el 65% del precio fijado en el Acta de Fijaci\u00f3n de Precios, por lo tanto, el oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones", "dateAnswered": "2022-11-17T14:01:50-04:00"}, {"id": "2", "date": "2022-10-25T08:17:30-04:00", "title": "ITEM 7 - INMUNOGLOBULINA ANTI D ", "description": "Solicitamos a la convocante actualizar el precio referencial del ITEM 7 - INMUNOGLOBULINA ANTI D a Gs. 650.000 teniendo en cuenta el ultimo proceso adjudicado por esta instituci\u00f3n en el llamado con ID N\u00b0 392.633 el precio referencial actual se encuentra desfasado.", "author": {"name": "MATHER COMPANY SRL", "id": "PY-RUC-80006850-5"}, "answer": "El oferente deber\u00e1 adecuarse a los Datos Cargados en SICP.", "dateAnswered": "2022-11-17T14:00:48-04:00"}, {"id": "17", "date": "2022-10-26T19:59:25-04:00", "title": "PORCENTAJE DE MULTA", "description": "En la Secci\u00f3n de Porcentaje de Multas, la Convocante declara que el valor de la misma ser\u00e1: 0,1% por cada d\u00eda de atraso. Solicitamos a la convocante reducir las penalidades por atraso en entregas en un 0,01% por cada d\u00eda de atraso en el bien en demora. Ya que la tasa expuesta de 0,1% supera la tasa usuraria indicada por el BCP, que a la fecha se encuentra a 33,18% como porcentaje tope.", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:04:44-04:00"}, {"id": "31", "date": "2022-10-27T09:19:38-04:00", "title": "Experiencia requerida", "description": "Solicitamos a la convocante considerar la siguiente redacci\u00f3n a fin de no limitar la participaci\u00f3n de potenciales oferentes:                                                          \nDemostrar la experiencia en Provisi\u00f3n de Medicamentos con Contratos y/o Facturas a instituciones p\u00fablicas o privadas por un monto equivalente al 50 % como m\u00ednimo del monto total ofertado en la\npresente licitaci\u00f3n, dentro de los \u00faltimos: 5 (cinco) (2017 2018 2019 2020 2021) a\u00f1os. En caso de lograr el porcentaje requerido , en uno o en m\u00e1s a\u00f1os, que correspondan a los a\u00f1os establecidos\nen el presente punto, el mismo ser\u00e1 considerado como valedero para la participaci\u00f3n.\n\nPara el caso de que el oferente no sea el fabricante y/o el titular del registro sanitario de los medicamentos, dicha experiencia deber\u00e1 estar igualmente acreditada por el oferente, por el titular del registro sanitario y el fabricante del producto que se oferta.", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:07:28-04:00"}, {"id": "19", "date": "2022-10-26T20:02:39-04:00", "title": "Porcentaje de Multas", "description": "La Convocante establece como porcentaje de multa el 0.1%. Al respecto, solicitamos a la misma la modificaci\u00f3n de dicho porcentaje a por lo menos el 0.01%. Esto considerando que los productos a ser adquiridos por la misma son de un muy alto costo y la mayor\u00eda de ellos corresponden a productos importados que son dif\u00edciles de mantener un stock y dependen de muchos agentes externos. Por lo que en caso de existir atrasos los costos serian demasiado elevados para ser solventados por el proveedor, considerando el atraso constante de la Convocante en los pagos a proveedores que deben solventar la compra de estos productos sin el pago de la Convocante por ellos en un largo plazo.   ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:05:17-04:00"}, {"id": "27", "date": "2022-10-26T22:17:11-04:00", "title": "ITEM 7. INMUNOGLOBULINA ANTI D INYECTABLE ", "description": "En relaci\u00f3n al \u00edtem, solicitamos a la Convocante tenga a bien ampliar la presentaci\u00f3n requerida, aceptando adem\u00e1s de la presentaci\u00f3n \"frasco ampolla\", la presentaci\u00f3n de \"jeringa prellenada\", esto teniendo en cuenta las presentaciones disponibles en el mercado, evitando limitar la participaci\u00f3n de potenciales oferentes. Garantizando igualmente que esta ampliaci\u00f3n no implica la modificaci\u00f3n del principio activo, concentraci\u00f3n, indicaci\u00f3n medica, calidad y seguridad del producto a adquirir. Adem\u00e1s, se debe considerar que en caso de adquirir jeringa prellenada, la Convocante podr\u00e1 utilizar el producto de forma inmediata, evitando realizar gastos adicionales para la utilizaci\u00f3n del producto como es el caso de frasco ampolla. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:06:51-04:00"}, {"id": "4", "date": "2022-10-25T11:58:13-04:00", "title": "Especificaciones T\u00e9cnicas - Item 6", "description": "Para el item 6 Somatropina Inyectable - Hormona de Crecimiento, Solicitamos por favor ajustar la PRESENTACI\u00d3N DE ENTREGA a lo establecido en el Vademecum Institucional a los efectos de garantizar la seguridad y eficacia del medicamento al momento de su administraci\u00f3n, considerando que se utiliza principalmente en pacientes menores (ni\u00f1os y adolescentes) Presentaci\u00f3n (Vademecum Institucional): KIT (AMPOLLA/FRASCO AMPOLLA + SOLVENTE + JERINGA + AGUJA INTRAMUSCULAR + AGUJA USO SUBCUTANEO)", "author": {"name": "VICENTE SCAVONE & CIA. S.A.E", "id": "PY-RUC-80001446-4"}, "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:01:04-04:00"}, {"id": "29", "date": "2022-10-27T09:06:21-04:00", "title": "Item 8 - Leflunomida", "description": "Se solicita actualizar el precio de referencia. El precio establecido se encuentra muy por debajo al precio de mercado actual.", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "El oferente deber\u00e1 adecuarse a los Datos Cargados en SICP.", "dateAnswered": "2022-11-17T14:07:08-04:00"}, {"id": "3", "date": "2022-10-25T11:37:00-04:00", "title": "Especificaciones T\u00e9cnicas Item 6", "description": "Para el item 6 Somatropina Inyectable - Hormona de Crecimiento, Solicitamos por favor ajustar la PRESENTACI\u00d3N DE ENTREGA a lo establecido en el Vademecum Institucional a los efectos de garantizar la seguridad y eficacia del medicamento al momento de su administraci\u00f3n, considerando que se utiliza principalmente en pacientes menores (ni\u00f1os y adolescentes)\nPresentaci\u00f3n (Vademecum Institucional): KIT (AMPOLLA/FRASCO AMPOLLA + SOLVENTE + JERINGA + AGUJA INTRAMUSCULAR + AGUJA USO SUBCUTANEO) ", "author": {"name": "VICENTE SCAVONE & CIA. S.A.E", "id": "PY-RUC-80001446-4"}, "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:00:56-04:00"}, {"id": "15", "date": "2022-10-26T19:57:53-04:00", "title": "Capacidad Tecnica", "description": "5.\tEn el punto 1.4 Para f\u00e1rmacos como Octeotrida Acetato, Abiraterona (terapia hormonal), solicitan lo siguiente: Registro y/o Certificado del producto ofertado, emitido por una Autoridad Sanitaria Reguladora de Alta Vigilancia como: \na. FDA o EMA. \nb. O los indicados de alta vigilancia en el Art 11 de la Ley 3283/2007. \nc. O Pa\u00edses certificados por OPS como autoridades reguladoras de referencia regional del continente americano (Nivel IV), ANMAT (Argentina), ANVISA (Brasil), INVIMA (Colombia), CEDMED (Cuba), COFEPRIS (M\u00e9xico), HEALTH CANADA y FDA (USA).\nConsiderando que existen productos de fabricaci\u00f3n nacional, para los cuales no resulta un requisito por parte de la autoridad sanitaria contar con la documentaci\u00f3n detallada para la obtenci\u00f3n del registro sanitario respectivo. Se solicita eliminar dicha solicitud para productos de origen nacional y establecer claramente que estos requisitos solo aplican a productos importados y no as\u00ed a productos nacionales, considerando que este requerimiento a productos nacionales solo limita de forma innecesaria la participaci\u00f3n de potenciales oferentes.\n", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:04:23-04:00"}, {"id": "13", "date": "2022-10-26T19:54:19-04:00", "title": "CAPACIDAD T\u00c9CNICA Certificado de Buenas Pr\u00e1cticas", "description": "d. Para los medicamentos Importados, deber\u00e1n presentar Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n y Almacenamiento vigente del Fabricante emitido por la Agencia Reguladora del pa\u00eds de Origen.\nCon respecto al apartado donde dice: Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n emitido por la Agencia reguladora del Pa\u00eds de Origen, a nombre del fabricante del Producto.Conviene aclarar a la convocante que en la actualidad existen pa\u00edses que ya no emiten Certificados de Buenas Pr\u00e1cticas de Fabricaci\u00f3n, tal es el caso de la Rep\u00fablica Popular China el cual desde el a\u00f1o 2019, ha reglamentado no emitir tales certificados, sino m\u00e1s bien emitir como \u00fanico documento la Licencia/Certificado de Fabricaci\u00f3n en el cual se refleja por un lado la habilitaci\u00f3n de la planta elaboradora y por otro el cumplimiento de las buenas pr\u00e1cticas de fabricaci\u00f3n. Es importante mencionarles que el ente regulador (DINAVISA) ya se ha expedido al respecto y la misma admite dichas licencias como documento suficiente para acreditar el cumplimiento de las buenas pr\u00e1cticas de fabricaci\u00f3n. En caso de duda solicitamos amablemente realizar la consulta al ente regulador.\nPor todo esto, solicitamos a la convocante la ampliaci\u00f3n de dicho requisito de la siguiente manera:\nCertificado de Buenas Practicas \nd. En el caso de que el Oferente no sea el fabricante del Producto ofertado, deber\u00e1 presentar: \nCertificado de Buenas Pr\u00e1cticas de Almacenamiento emitido a nombre del OFERENTE expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) adem\u00e1s deber\u00e1 presentar Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n o Licencia/Certificado de Fabricaci\u00f3n del producto ofertado, emitido por la Agencia reguladora del Pa\u00eds de Origen, a nombre del fabricante del Producto.\n", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:03:55-04:00"}, {"id": "23", "date": "2022-10-26T21:42:11-04:00", "title": "Capacidad Tecnica", "description": "8.\tEn el punto 1.5 Para f\u00e1rmacos hemoderivados como inmunoglobulinas, solicitan lo siguiente: Registro y/o Certificado del producto ofertado, emitido por una Autoridad Sanitaria Reguladora de Alta Vigilancia como: \na. FDA o EMA. \nb. O los indicados de alta vigilancia en el Art 11 de la Ley 3283/2007. \nc. O Pa\u00edses certificados por OPS como autoridades reguladoras de referencia regional del continente americano (Nivel IV), ANMAT (Argentina), ANVISA (Brasil), INVIMA (Colombia), CEDMED (Cuba), COFEPRIS (M\u00e9xico), HEALTH CANADA y FDA (USA).\nAl respecto, se solicita considerar que los productos detallados corresponden a medicamentos biol\u00f3gicos por lo que la referencia a la Ley 3283/2007 no corresponde. Solicitamos modificar e incluir en la misma el Decreto 6611/2016 aplicable para medicamentos biol\u00f3gicos. Adem\u00e1s, se solicita incluir a la ISP de Chile como pa\u00eds certificado por OPS como autoridades reguladoras de referencia regional del continente americano (Nivel IV).\n", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:06:11-04:00"}, {"id": "22", "date": "2022-10-26T21:41:59-04:00", "title": "Capacidad Tecnica", "description": "7.\tEn relaci\u00f3n al requerimiento del Certificado de Buenas Pr\u00e1cticas de origen para medicamentos importados. Recomendamos a la Convocante replantear el criterio estableciendo claramente que dichos certificados deben haber sido emitidos por uno de los pa\u00edses detallados en la Ley 3283/2007 para especialidades farmac\u00e9uticas y el Decreto 6611/16 para medicamentos biol\u00f3gicos. Esto a fin de dar fiel cumplimiento a lo dispuesto en la normativa vigente. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:05:58-04:00"}, {"id": "6", "date": "2022-10-26T17:46:27-04:00", "title": "\u00cdTEM 13 ", "description": "En la p\u00e1gina de la D.N.C.P. al ingresar en \u00cdtems Solicitados, donde aparecen los precios de referencia y otros detalles del llamado, en el \u00edtem 13 Palbociclib Capsula, en Unidad de Medida dice: Costo por Mil, cuando en todos los dem\u00e1s \u00edtems dice: Unidad.\nFavor explicar a que se refiere esa descripci\u00f3n.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "El oferente deber\u00e1 remitirse a los Datos Cargados en el SICP.", "dateAnswered": "2022-11-17T14:01:24-04:00"}, {"id": "18", "date": "2022-10-26T20:02:22-04:00", "title": "CAPACIDAD T\u00c9CNICA", "description": "1. 2. Para productos Oncol\u00f3gicos Orales e Inyectables: Mercaptoctan Sulfonato S\u00f3dico, Melfalan, Gemcitabina, Leflunomida, Pemetrexed, Anfotericina B. se solicita:\na. Registro y/o Certificado del producto ofertado, emitido por una Autoridad Sanitaria Reguladora de Alta Vigilancia.\nEn ese sentido, la especialidad medicinal ofertada debe encontrarse registrada en:\n- FDA o EMA\n- O Los indicados de alta vigilancia en el Art 11 de la Ley 3283/2007.\n- O Pa\u00edses certificados por OPS como autoridades reguladoras de referencia regional del continente americano (Nivel IV), ANMAT (Argentina), ANVISA (Brasil), INVIMA (Colombia),\nCEDMED (Cuba), COFEPRIS (M\u00e9xico), HEALTH CANADA y FDA (USA).\nCon relaci\u00f3n a los productos solicitados, creemos conveniente recordar al IPS que los mismos corresponden a productos clasificados como sint\u00e9ticos\nRespecto a los medicamentos sint\u00e9ticos, la DINAVISA (seg\u00fan Ley N\u00b0 1119/97 De productos para la salud y otros y dem\u00e1s reglamentaciones) establece como requisito para su registro local, que en caso de que el elaborador de los medicamentos no sea de un pa\u00eds de alta o adecuada vigilancia, conforme lo mencionado en el Art. 11 de la Ley No. 3283/2007, se presente indefectiblemente: GMP/Aprobaci\u00f3n de planta emitido por cualquiera de los pa\u00edses mencionados en el Art. 11 de Ley 3283/2007 o por pa\u00edses certificados por la OPS como autoridades reguladoras de referencia regional del continente americano (NIVEL IV)  o Registro Sanitario emitido por cualquiera de los pa\u00edses mencionados en el Art. 11 de Ley 3283/2007 o por pa\u00edses certificados por la OPS como autoridades reguladoras de referencia regional del continente americano (NIVEL IV)  \u0096 Consularizado y Legalizado o Apostillado. \nSeguidamente, al realizar un comparativo del requerimiento establecido en el punto 1.2 del PBC y los requerimientos establecidos por la autoridad competente (DNVS), nos percatamos de que existen incongruencias entre lo solicitado por la Convocante y lo efectivamente requerido por la DNVS para el otorgamiento de los registros sanitarios de medicamentos sint\u00e9ticos en el pa\u00eds. \nEntonces, en base a lo manifestado, solicitamos a la convocante la reformulaci\u00f3n de dicho requisito, adecu\u00e1ndose a los requerimientos de la DNVS, quedando de la siguiente manera:\n1. 2. Para productos Oncol\u00f3gicos Orales e Inyectables: Mercaptoctan Sulfonato S\u00f3dico, Melfalan, Gemcitabina, Leflunomida, Pemetrexed, Anfotericina B.\na. Registro Sanitario o Certificado de Buenas pr\u00e1cticas de fabricaci\u00f3n del fabricante, emitido por una Autoridad Sanitaria Reguladora de referencia, tales como:\na. FDA o EMA.\nb. O los pa\u00edses indicados en el Art 11 de la Ley 3283/2007.\nc. O Pa\u00edses certificados por la OPS como autoridades reguladoras de referencia regional del continente americano (NIVEL IV), ANMAT (Argentina), ANVISA (Brasil), INVIMA (Colombia) CECMED (Cuba), COFEPRIS (M\u00e9xico), Health Canad\u00e1 y FDA (USA), ISP (Chile).", "author": {"name": "EUROQUIMICA S.A.", "id": "PY-RUC-80061211-6"}, "answer": "Se aclara al oferente que los requisitos t\u00e9cnicos que conforman el PBC para adquirir medicamentos contra el c\u00e1ncer han sido siempre acordes al rigor t\u00e9cnico del tipo de medicamento, con el objetivo de preservar garant\u00edas de calidad, seguridad y eficacia para los pacientes. Estos requisitos tienen antecedentes similares en todas las licitaciones del IPS, por lo tanto, el oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:05:03-04:00"}, {"id": "16", "date": "2022-10-26T19:58:46-04:00", "title": "EXPERIENCIA REQUERIDA", "description": "En el apartado Requisitos para validar la Experiencia, se menciona cuanto sigue:\nDemostrar la experiencia en PROVISI\u00d3N 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 promedio en los a\u00f1os: 2019 2020-2021. Para el caso de que el oferente no sea el fabricante y/o el titular del registro sanitario de los medicamentos, dicha experiencia deber\u00e1 estar igualmente acreditada por el oferente, por el titular del registro sanitario y el fabricante del producto que se oferta.\nSolicitamos a la Convocante que el requisito quede establecido de la siguiente manera: Demostrar la experiencia en PROVISI\u00d3N 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 promedio en los a\u00f1os: 2019 2020-2021. Ya que deber\u00eda ser suficiente con que el oferente demuestre tener experiencia por s\u00ed mismo y de manera individual en la provisi\u00f3n de medicamentos en los a\u00f1os establecidos, de tal manera que dicho requisito no atente contra el principio de igualdad y libre Competencia.", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:04:35-04:00"}, {"id": "5", "date": "2022-10-26T17:24:08-04:00", "title": "PLAZO DE ENTREGA", "description": "El Pliego de Bases y Condiciones indica en el apartado Plan de Entrega de los bienes, cuanto sigue: \u0085CANTIDAD MINIMA- 20%: Hasta los 8 (ocho) d\u00edas calendarios. Con entregas que podr\u00e1n ser fraccionadas siempre dentro del mencionado plazo. - 80%: Hasta los 20 (veinte) d\u00edas calendarios. Con entregas que podr\u00e1n ser fraccionadas siempre dentro del mencionado plazo. CANTIDAD M\u00c1XIMA: Con Orden de Entrega de la Direcci\u00f3n de Log\u00edstica de Suministros de Salud, una vez emitida la totalidad de las cantidades m\u00ednimas, el plazo de entrega ser\u00e1 de hasta 20 (veinte) d\u00edas calendarios. Las \u00d3rdenes de Entrega podr\u00e1n ser fraccionadas de acuerdo a la necesidad del IPS, stock y espacio disponible en el DASM. (sic) \nTeniendo en cuenta que estos productos deben ser importados y que por la naturaleza de los mismos su vencimiento te\u00f3rico no superan los 24  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,  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 dentro de 10 d\u00edas corridos, con entregas que podr\u00e1n ser fraccionadas siempre dentro del mencionado plazo. \u0096 80%, hasta los 25 (treinta) d\u00edas calendarios. Con entregas que podr\u00e1n ser fraccionadas siempre dentro del mencionado plazo. CANTIDAD M\u00c1XIMA: Con Orden de Entrega de la Direcci\u00f3n de Log\u00edstica de Suministros de Salud, una vez emitida la totalidad de las cantidades m\u00ednimas, el plazo de entrega ser\u00e1 de hasta 30 (treinta) d\u00edas calendarios. Las \u00d3rdenes de Entrega podr\u00e1n ser fraccionadas de acuerdo a la necesidad del IPS, stock y espacio disponible en el DASM. \n\n \n", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:01:14-04:00"}, {"id": "14", "date": "2022-10-26T19:55:09-04:00", "title": "ESPECIFICACIONES T\u00c9CNICAS \u00cdTEM 7: INMUNOGLOBULINA ANTI D", "description": "Si bien es cierto que la convocante elabora el PBC en base a su vadem\u00e9cum institucional se solicita amablemente a la convocante CONSIDERAR AL MOMENTO DE LA EVALUACI\u00d3N la CONCENTRACI\u00d3N DE 250 MCG A 300 MCG. Esto de manera a no limitar innecesariamente la participaci\u00f3n de m\u00e1s oferentes que cuentan con diferentes concentraciones en el mercado nacional.", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:04:05-04:00"}, {"id": "20", "date": "2022-10-26T20:03:57-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica:", "description": "En el apartado Requisitos para validar la Experiencia, se menciona cuanto sigue:\nDemostrar la experiencia en PROVISI\u00d3N 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 promedio en los 3 a\u00f1os: 2019 2020-2021. Para el caso de que el oferente no sea el fabricante y/o el titular del registro sanitario de los medicamentos, dicha experiencia deber\u00e1 estar igualmente acreditada por el oferente, por el titular del registro sanitario y el fabricante del producto que se oferta.\nCon respecto al apartado donde dice: Para el caso de que el oferente no sea el fabricante y/o el titular del registro sanitario de los medicamentos, dicha experiencia deber\u00e1 estar igualmente acreditada por el oferente, por el titular del registro sanitario y el fabricante del producto que se oferta.  Conviene aclarar a la convocante que la forma en la que se encuentra redactada da lugar a varias interpretaciones que pueden ocasionar cierta confusi\u00f3n a los oferentes al momento de elaborar sus ofertas, por lo cual, en base a nuestra interpretaci\u00f3n que creemos es la correcta, recomendamos que quede redactado de la siguiente manera:\nDemostrar la experiencia en PROVISI\u00d3N 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 promedio en los a\u00f1os: 2019 2020-2021.\nI.\tPara productos nacionales: En caso de que el oferente no sea el fabricante y/o el titular del registro sanitario de los medicamentos, dicha experiencia deber\u00e1 estar igualmente acreditada por el oferente, por el titular del registro sanitario y el fabricante del producto que se oferta.\nII.\tPara productos importados: En caso de que el oferente no sea el titular del registro sanitario; dicha experiencia deber\u00e1 estar igualmente acreditada tanto por el oferente y el titular del registro sanitario.", "author": {"name": "EUROQUIMICA S.A.", "id": "PY-RUC-80061211-6"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:05:29-04:00"}, {"id": "7", "date": "2022-10-26T17:47:44-04:00", "title": "Experiencia requerida.", "description": "Demostrar la experiencia en Provisi\u00f3n de Medicamentos, con facturaciones de venta y/o contratos ejecutados por un monto equivalente al 25% al 25 % como m\u00ednimo del monto m\u00e1ximo ofertado en la presente licitaci\u00f3n, en promedio en los 3 (tres) (2019 - 2020 - 2021) a\u00f1os. Para el caso de que el oferente no sea el fabricante y/o el titular del registro sanitario de los medicamentos, dicha experiencia deber\u00e1 estar igualmente acreditada por el oferente, por el titular del registro sanitario y el fabricante del producto que se oferta. \n\nFavor aclarar qu\u00e9 documentos deber\u00e1n presentarse para demostrar la experiencia del titular del registro sanitario y el fabricante del producto que se oferta si el producto ofertado es IMPORTADO.\n", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "Se aclara al oferente que los documentos a presentar son las facturaciones de venta y/o contratos ejecutados en el extranjero.", "dateAnswered": "2022-11-17T14:01:32-04:00"}, {"id": "1", "date": "2022-10-21T15:46:31-04:00", "title": "Especificaciones T\u00e9cnicas", "description": "Respecto a las Especificaciones T\u00e9cnicas del \u00cftem N\u00b0 4 Heparina de bajo peso molecular Inyectable-ENOXAPARINA SODICA (HBPM) Solicitamos incluir en la presentaci\u00f3n de entrega JERINGA PRE LLENADA NO RETRACTIL CON DISPOSITIVO DE SEGURIDAD INCORPORADO de modo a cumplir con lo establecido en la Ley N\u00b0 4659/12 de Prevenci\u00f3n de Riesgos al Personal de Salud", "author": {"name": "VICENTE SCAVONE & CIA. S.A.E", "id": "PY-RUC-80001446-4"}, "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2022-11-17T14:00:42-04:00"}, {"id": "11", "date": "2022-10-26T19:48:26-04:00", "title": "Capacidad T\u00e9cnica", "description": "3.\tEn el punto 1.4 Para farmacos como Octeotrida Acetato, Abiraterona (terapia hormonal), solicitan lo siguiente: Registro y/o Certificado del producto ofertado, emitido por una Autoridad Sanitaria Reguladora de Alta Vigilancia como: \na. FDA o EMA. \nb. O los indicados de alta vigilancia en el Art 11 de la Ley 3283/2007. \nc. O Pa\u00edses certificados por OPS como autoridades reguladoras de referencia regional del continente americano (Nivel IV), ANMAT (Argentina), ANVISA (Brasil), INVIMA (Colombia), CEDMED (Cuba), COFEPRIS (M\u00e9xico), HEALTH CANADA y FDA (USA).\nConsiderando que existen productos de fabricaci\u00f3n nacional, para los cuales no resulta un requisito necesario para contar con el registro sanitario emitido por la autoridad nacional. Se solicita eliminar dicha solicitud para productos de origen nacional y establecer claramente que estos requisitos solo aplican a productos importados y no as\u00ed a productos nacionales, considerando que este requerimiento a productos nacionales solo limita de forma innecesaria la participaci\u00f3n de potenciales oferentes. Adem\u00e1s, esto unificara el criterio establecido en el PBC en relaci\u00f3n a productos de origen nacional, considerando que en los dem\u00e1s puntos, la Convocante si ha realizado las previsiones necesarias para la cotizaci\u00f3n de productos nacionales. \n", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 adecuarse a lo establecido en el Pliego de Bases y Condiciones", "dateAnswered": "2022-11-17T14:03:24-04:00"}], "lots": [{"id": "cs7hjA6rcJU=", "title": "11 - Nintedanib Capsula-NINTEDANIB", "status": "active", "statusDetails": "Activo", "value": {"amount": 27255760000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "11", "id": "1"}]}, {"id": "NGiUlMxvxzg=", "title": "10 - Mercaptoctan sulfonato sodico-MERCAPTOCTAN SULFONATO SODICO", "status": "active", "statusDetails": "Activo", "value": {"amount": 317800000, "currency": "PYG"}, "openContractType": " 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