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"mainProcurementCategory": "services", "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": "5"}, {"id": "1-1-2", "title": "Validez de la garantia en d\u00edas", "expectedValue": "180"}]}]}], "enquiries": [{"id": "2188e844228ac696085e78551200f1c5-1", "date": "2024-10-11T08:07:03-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "1.4.Para f\u00e1rmacos Inmunosupresores-> Se solicita a la convocante especificar los productos que contempla dicho requisito.", "answer": "Se aclara al oferente que en los requisitos est\u00e1n establecidos los criterios para f\u00e1rmacos inmunosupresores por lo que se entiende y se debe considerar que el oferente debe conocer y saber el producto que ofertara,  para  competir y demostrar que sus productos cumplen con los criterios establecidos, por lo que el Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-12-19T08:55:07-04:00"}, {"id": "8580b9b86b916ffb60a8dcb5d8899de5-1", "date": "2024-10-10T19:32:44-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Se solicita a la convocante aplicar el Sistema de Abastecimiento Simultaneo, para evitar desabastecimiento de los productos.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones", "dateAnswered": "2024-12-19T08:50:10-04:00"}, {"id": "c0a57e7aa3153b8824055c27125504aa-1", "date": "2025-01-13T08:22:37-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "Dice: Los documentos de los productos importados ofertados, deber\u00e1n estar debidamente legalizados por el Ministerio de Relaciones Exteriores del Paraguay o apostillados.\nSe solicita a la convocante poder presentar en copias autenticadas por escriban\u00eda y poder presentar su correspondiente legalizaci\u00f3n/apostillado al momento de firmar el contrato en caso de ser adjudicado.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-26T15:02:03-04:00"}, {"id": "58efea6541c7d7348a7985cc02367082-1", "date": "2025-02-27T11:35:00-04:00", "title": "Muestras", "description": "\u00bfLas muestras presentadas para evaluaci\u00f3n podr\u00edan ser consideradas como parte de la entrega en el caso de recaer la adjudicaci\u00f3n en el oferente? de no ser as\u00ed, \u00bfSe podr\u00edan presentar muestras vencidas ya que la muestra es solo con el fin de comprobar Presentaci\u00f3n, Forma Farmac\u00e9utica y todo lo relacionado a lo visual?", "answer": "Se aclara al oferente en caso de ser adjudicado se considerara la muestra como parte de la primera entrega. Pero se debe considerar el aparto de muestras donde dice: \u00b4\u00b4En el caso de que se presentaran procesos de impugnaci\u00f3n (protesta y/o denuncia) ante la Direcci\u00f3n Nacional de Contrataciones P\u00fablicas, las muestras de los \u00edtems, objeto de protesta, deber\u00e1n permanecer en las instalaciones de la unidad solicitante hasta tanto se resuelva los referidos procesos de impugnaci\u00f3n.", "dateAnswered": "2025-03-18T14:24:15-04:00"}, {"id": "ce34751a45001505cab06a3514c54f72-1", "date": "2025-01-12T22:15:26-04:00", "title": "Experiencia requerida", "description": "Solicitamos a la Convocante considerar la experiencia adquirida en el periodo 2024 e incluir el a\u00f1o 2024 como posibilidad de avalar la experiencia.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-26T15:01:02-04:00"}, {"id": "c8e9e790fb521d31c5f429857ee0edcf-1", "date": "2025-02-26T17:05:20-04:00", "title": "EE.TT ITEM N\u00b012", "description": "Solicitamos a la Convocante ampliar la presentaci\u00f3n requerida para el producto del ITEM N\u00b0 12 ENOXAPARINA SODICA INYECTABLE 80 MG/0,8ML JERINGA PRELLENADA NO RETRAIBLE CON DISPOSITIVO DE BIOSEGURIDAD , Hay posibilidad de incluir  que la presentaci\u00f3n requerida sea tambi\u00e9n  ENOXAPARINA SODICA INYECTABLE 80 MG/0,8ML JERINGA PRELLENADA  SIN DISPOSITIVO DE BIOSEGURIDAD , teniendo en cuenta que la presentaci\u00f3n requerida en PBC  limita la cantidad 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\u201d", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T14:23:36-04:00"}, {"id": "1c1336afa1a38c8b9c2fed12091078d3-1", "date": "2025-01-12T21:02:56-04:00", "title": "Capacidad Tecnica", "description": "En cuanto al listado de documentos espec\u00edficos requeridos para cada tipo de producto (biol\u00f3gicos, oncol\u00f3gicas, inmunosupresores, etc.), solicitamos a la Convocante aclarar a que \u00edtems aplica cada clasificaci\u00f3n expuesta en PBC: Productos Biol\u00f3gicos/Productos oncol\u00f3gicos/Inhibidores, etc., dado que existen \u00edtems que pertenecen a m\u00e1s de una clasificaci\u00f3n generando inconvenientes a los proveedores al momento de preparar los documentos de la oferta, debido a que no resultan ser criterios claros, objetivos y espec\u00edficos, pues no podemos determinar bajo que clasificaci\u00f3n considerara el equipo evaluador al momento de su an\u00e1lisis, siendo pasibles de descalificaci\u00f3n por una falta de claridad en los requerimientos de los productos.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-26T15:00:16-04:00"}, {"id": "e669ad1562c38ca9ba17d8e2c94c6892-1", "date": "2024-10-11T08:22:53-04:00", "title": "Sistema de adjudicaci\u00f3n", "description": "Se solicita a la entidad aplicar el SISTEMA DE ABASTECIMIENTO SIMULTANEO para todos los \u00edtems a fin de asegurar la provisi\u00f3n con la adjudicaci\u00f3n a m\u00e1s de un proveedor. Recordamos a la entidad que son productos de naturaleza compleja y un inconveniente en un \u00fanico proveedor podr\u00eda generar desabastecimientos innecesarios en perjuicio de los asegurado y la intercambiabilidad entre marcas no es un inconveniente para este caso.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-19T08:55:17-04:00"}, {"id": "4d135c99024d49c271a7ac0a308e99e1-1", "date": "2025-01-13T07:49:55-04:00", "title": "Capacidad T\u00e9cnica - Punto 7- 1.2. Para productos oncol\u00f3gicos orales e inyectables", "description": "De acuerdo a la interpretaci\u00f3n, respecto al Certificado de Buenas Pr\u00e1cticas del Elaborador, es v\u00e1lido el emitido por cualquiera de los pa\u00edses que integran el Mercosur, es correcto?", "answer": "Se consideran los pa\u00edses establecido en las normativas vigentes en la Republica de Paraguay, por lo que el Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-26T15:01:22-04:00"}, {"id": "5cabc73073b87a8016eb0973df1bae39-1", "date": "2025-03-21T11:22:53-04:00", "title": "Experiencia requerida", "description": "Favor unificar lo requerido en \"Experiencia requerida y en Requisitos documentales para la evaluaci\u00f3n\", en uno dice Facturaciones de venta y/o contratos, y en el otro dice Copia de facturaciones y/o recepciones finales. Esto genera confusi\u00f3n a la hora de preparar la oferta.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-04-04T09:44:47-04:00"}, {"id": "b69cf31c03adf88cef3c0c19f3e21016-1", "date": "2024-10-11T00:39:07-04:00", "title": "Capacidad T\u00e9cnica y en Requisitos documentales para evaluar la capacidad t\u00e9cnica, punto 1.4 \u201cPara f\u00e1rmacos inmunosupresores\u201d", "description": "En Capacidad T\u00e9cnica y en Requisitos documentales para evaluar la capacidad t\u00e9cnica, punto 1.4 \u201cPara f\u00e1rmacos inmunosupresores\u201d se requiere:\n\u201cY adem\u00e1s, deber\u00e1 presentar estudios de bioequivalencia contra el producto de referencia.\u201d \nAl respecto, solicitamos amablemente eliminar esta solicitud, considerando que, conforme a la normativa emitida por la autoridad reguladora nacional, esta no establece como exigencia el estudio de bioequivalencia requerido por la Convocante en el llamado para los productos requeridos.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-12-19T08:51:24-04:00"}, {"id": "4407cd08de55c055eddb3333e342d037-1", "date": "2025-04-02T10:50:44-04:00", "title": "Plan de entrega de los bienes", "description": "Solicitamos a la convocante considerar una adecuaci\u00f3n del plazo m\u00e1ximo de entrega de los bienes en funci\u00f3n a la naturaleza de los mismos, ya que requieren an\u00e1lisis espec\u00edficos como el de estabilidad que supera ampliamente los 20 d\u00edas calendarios que indica el PBC. Sugerimos al menos 60 d\u00edas ya que bajar los plazos en la Ordenes de Entrega no hace que desaparezcan los procesos farmac\u00e9uticos necesarios para la elaboraci\u00f3n de los medicamentos. Muchas gracias desde ya.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-04-15T10:04:42-04:00"}, {"id": "091d0008149df73bd6c52df4f218aa25-1", "date": "2025-01-22T14:06:28-04:00", "title": "ABASTECIMIENTO SIMULT\u00c1NEO", "description": "Se solicita a la convocante considerar Abastecimiento Simult\u00e1neo para evitar el desabastecimiento de los productos requeridos.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-26T15:02:41-04:00"}, {"id": "c2d3c9cf7b6a1e8e6c41088a1c4eb748-1", "date": "2025-03-21T11:25:33-04:00", "title": "Muestras", "description": "Teniendo en cuenta el elevado costo de los productos solicitados en el presente llamado y que los mismos son con temperatura controlada, consultamos a la Convocante si pueden ser presentadas muestras vencidas en el proceso de evaluaci\u00f3n, esto a modo de evitar desv\u00edos de temperatura en productos que posteriormente ser\u00e1n entregados. Los mismos ser\u00e1n entregados al solo efecto de su verificaci\u00f3n como \"muestras\" a fin de corroborar que el producto corresponde a lo obrante en el Registro Sanitario aprobado por DNVS as\u00ed como lo declarado en la planilla de datos garantizados.", "answer": "Se aclara que se debe considerar lo establecido en la Secci\u00f3n Datos de la Convocatoria, en el apartado de Muestras, por lo que el Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-04-04T09:44:52-04:00"}, {"id": "439f1e773067ea4bcc3bbbda43a809e3-1", "date": "2024-10-07T12:07:57-04:00", "title": "1.4.Para f\u00e1rmacos Inmunosupresores", "description": "Solicitamos a la convocante, admitir Estudios de Equivalencia Farmac\u00e9utica, como documento de  comparaci\u00f3n con el producto original.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-12-19T08:48:58-04:00"}, {"id": "1ba44da9107426be14037c7af4ad7e4e-1", "date": "2025-02-24T09:10:33-04:00", "title": "COPIA DE LA OFERTA", "description": "\"En la secci\u00f3n \u00b4\u00b4Datos de la Convocatoria\u00b4\u00b4, espec\u00edficamente en el apartado \u00b4\u00b4Copia de la Oferta\u00b4\u00b4 (p\u00e1gina 6 del Pliego de Bases y Condiciones), la Convocante estableci\u00f3 que no solicitar\u00e1 copia de la oferta. Quisiera confirmar si esta disposici\u00f3n es correcta?", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-03-18T14:23:12-04:00"}, {"id": "9c343f9e17178c3890f56f9a6396fa9d-1", "date": "2025-02-27T11:29:13-04:00", "title": "Capacidad t\u00e9cnica", "description": "Solicitamos respetuosamente a la entidad aclarar cuales son los productos seg\u00fan clasificaci\u00f3n.\n\n1.1 Medicamentos biol\u00f3gicos (cuales son) 1.2 Para productoss oncologicos orales (cuales son), etc.. como siempre ven\u00edan realizando a lo largo de los a\u00f1os. alg\u00fan producto a ofertar podr\u00eda caer en m\u00e1s de una clasificaci\u00f3n y generar inconvenientes tanto a la hora de ofertar como de evaluar. Es necesario recordar que a fin de evitar subjetividades los requisitos deben ser claros y precisos.", "answer": "Se aclara que el Oferente debe conocer el producto que va ofertar, y los requisitos se encuentran bien establecidos para cada grupo.", "dateAnswered": "2025-03-18T14:24:08-04:00"}, {"id": "78f0521529704b166cab2dde70571f5c-1", "date": "2024-10-10T13:33:02-04:00", "title": "multas", "description": "se solicita amablemente a la convocante  modifica el % de multar, de 0.1% a 0.01%, esto debido a que la multa por la no entrega es superior a los inter\u00e9s que debe pagar por la falta de pago.  favor igual ambos porcentaje, ya que el no cobro genera un perjuicio muy altos a las empresas.", "answer": "Cuando se ingresa 0,1 %  el sistema de la DNCP agrega un cero adicional, este tipo de formato es com\u00fan en sistemas que manejan montos y porcentajes, aunque \"0,1\" y \"0,10\" representan el mismo valor. Por lo que se aclara que el valor del porcentaje de multas que ser\u00e1 aplicado por el atraso en la prestaci\u00f3n de servicios ser\u00e1 de: 0,1 %.", "dateAnswered": "2024-12-19T08:49:30-04:00"}, {"id": "6c8e02ccbbcb9125def500c37b33c1a7-1", "date": "2024-10-11T08:01:32-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "1.3 Para f\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos moleculares  -> Solicitamos a la convocante especificar los productos que contempla el requisito a fin de evitar confusiones o contratiempos tanto para la entidad como para el potencial oferente", "answer": "Se aclara al oferente que en los requisitos est\u00e1n establecidos los criterios para f\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos moleculares, por lo que se entiende y se debe considerar que el oferente debe conocer y saber el producto que ofertara,  para  competir y demostrar que sus productos cumplen con los criterios establecidos, por lo que el Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-19T08:54:53-04:00"}, {"id": "ab8a769c8364ee8b64b9e7899d6bbccd-1", "date": "2025-02-24T15:01:16-04:00", "title": "MUESTRAS", "description": "En la p\u00e1gina 09 del PBC, apartado Muestras menciona lo siguiente:\n\"Con las muestras se verificar\u00e1n si el producto ofertado corresponde al producto licitado en cuanto a especificaciones t\u00e9cnicas indicadas en la Secci\u00f3n III. Asimismo, ser\u00e1n verificados la presentaci\u00f3n, marca, origen, procedencia y fabricante, los cuales deber\u00e1n estar impresos en el embalaje primario, que deber\u00e1 estar de acuerdo a los documentos obrantes DINAVISA y en el Formulario de la Lista de Precios. En caso de detectarse discrepancia entre la Planilla de Precios, Planilla de Muestras presentadas y Planilla de Datos Garantizados, prevalecer\u00e1 la Planilla de Precios.\"\n\nProponemos que se acepte, adem\u00e1s, muestras que se encuentren impresas y/o etiquetadas, ya que esta medida no limitar\u00eda la participaci\u00f3n de potenciales oferentes y evitar\u00eda el direccionamiento hacia determinadas marcas.\n\nAsimismo, recordamos que, seg\u00fan el principio de libre competencia consagrado en el art\u00edculo 4 de la Ley N\u00ba 7021, se debe garantizar la igualdad de oportunidades para todos los participantes. Cabe destacar, por otro lado, que DINAVISA ya acepta productos que se encuentren impresos o etiquetados, lo que confirma el cumplimiento de los requisitos de seguridad, trazabilidad y normativa vigente.\n\nAgradecemos la reconsideraci\u00f3n de este requisito para promover una competencia m\u00e1s equitativa y eficiente.", "answer": "Se aclara que las muestras ser\u00e1n aceptadas tal cual como se encuentran aprobadas para su comercializaci\u00f3n en el pa\u00eds por el ente regulador de la Republica de Paraguay.  Por lo que no vemos en qu\u00e9 punto puede haber alguna transgresi\u00f3n de la Ley N\u00b0 7021.  Se recuerda que existen normativas en cuanto a los requisitos m\u00ednimos para envases primarios y secundarios de medicamentos los cuales son aprobados por la DINAVISA. Seg\u00fan MERCOSUR/GMC/RES N\u00ba 23/95 una de las normativas por la cual se rige el ente regulador para aprobar un producto para ser comercializado en el pa\u00eds.  Adem\u00e1s, se aclara que ning\u00fan requisito del apartado de muestra se requiere m\u00e1s de lo que establecen las normativas, por lo que el Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T14:23:23-04:00"}, {"id": "3f885e016b6a48a5eb579c5608c253ff-1", "date": "2025-01-13T07:57:50-04:00", "title": "Capacidad T\u00e9cnica - Punto 7- 1.4. Para f\u00e1rmacos Inmunosupresores", "description": "Respecto a los estudios de bioequivalencia y de acuerdo a la interpretaci\u00f3n, es v\u00e1lido el emitido por cualquiera de los pa\u00edses que integran el Mercosur, es correcto?", "answer": "Se aclara que en el PBC no se establece el pa\u00eds que debe emitir dicho estudio, por lo que el Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-26T15:01:36-04:00"}, {"id": "e9a532ed7712ca7c290360ef9e88f056-1", "date": "2024-10-07T11:45:46-04:00", "title": "1.4.Para f\u00e1rmacos Inmunosupresores", "description": "En donde dice: Y adem\u00e1s, deber\u00e1 presentar estudios de bioequivalencia contra el producto de referencia. Solicitamos a la convocante, tener en cuenta los siguientes documentos: Certificado de Producto (CLV) o(CPP) y GMP de origen del fabricante, como as\u00ed tambi\u00e9n el Certificado de an\u00e1lisis,  siendo estos de Direcciones denominadas de \"Alta Vigilancia\" y excluir el estudio de Bioequivalencia. As\u00ed permitir\u00e1 una mayor participaci\u00f3n de Oferentes.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-12-19T08:48:47-04:00"}, {"id": "daa9979f789ab9bf6e007d26b04a3f51-1", "date": "2025-01-13T08:41:13-04:00", "title": "Precio referencial - Item 8", "description": "Se solicita a la convocante subir el precio referencial del producto solicitado en el item 8 - tacrolimus. El precio establecido se encuentra considerablemente por debajo del precio del mercado actual, estoy podr\u00eda desembocar en un impedimento a la hora de ejecutar el contrato de provisi\u00f3n afectando a la misma entidad.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en los Datos Cargados en el SICP.", "dateAnswered": "2025-02-26T15:02:09-04:00"}, {"id": "3dc892eb933e6b01388f94161ff5c441-1", "date": "2024-10-11T08:01:27-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "La convocante incluye en sus exigencias: \"Deber\u00e1 presentar el certificado vigente de Buenas Pr\u00e1cticas de Fabricaci\u00f3n ofertado emitido por la Agencia reguladora de medicamentos del pa\u00eds seg\u00fan la Ley N\u00b0 7256/24 Y RES. DNVS N\u00ba 148/24 o forma parte del MERCOSUR y el registro o Certificado de producto ofertado, emitido por una de las Agencias de Referencia\". Se solicita cordialmente a la convocante incluir en este punto el certificado de exportaci\u00f3n emitido por la agencia de reguladora de or\u00edgen dado que en ocasiones un producto solo es elaborado con fines de exportaci\u00f3n. Sugerencia de redacci\u00f3n: \"..parte del MERCOSUR y el registro o Certificado de producto ofertado o Certificado de exportaci\u00f3n\"", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-12-19T08:54:43-04:00"}, {"id": "e3db8463bf1450900a8c0e2f8b020b25-1", "date": "2025-01-12T20:03:04-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Considerando convocatorias anteriores de la Convocante y llamados en curso, se solicita utilizar la modalidad de ABASTECIMIENTO SIMULTANEO, a fin de garantizar a la Convocante el abastecimiento de los productos por m\u00e1s de un proveedor, logrando de esta manera una atenci\u00f3n oportuna a los pacientes y otorgando una mayor oportunidad de competencia a todo potencial oferente que cumpla con las condiciones establecidas en el Pliego de Bases y Condiciones para la provisi\u00f3n de los productos requeridos.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-26T14:59:54-04:00"}, {"id": "729bf519065fe6a41f891e8e0ca8e89c-1", "date": "2025-02-27T11:29:08-04:00", "title": "Capacidad t\u00e9cnica", "description": "1.3. Para f\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos. Inc. 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\nestrecha y/o atiendan enfermedades cr\u00edticas deber\u00e1n anexar reportes de Farmacovigilancia, presentar PGR (Plan de Gesti\u00f3n de Riesgos). Se solicita a la convocante aclarar si el requisito es presentar Reporte de Farmacovigilancia y PGR o se podr\u00e1 presentar solamente uno de los dos", "answer": "Se aclara que deber\u00e1n presentar los reportes de Farmacovigilancia y el PGR  (Plan de Gesti\u00f3n de Riesgos), por lo que el oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-03-18T14:23:59-04:00"}, {"id": "bde5716e5b9e063f4d36f85130472a7b-1", "date": "2025-01-12T21:24:08-04:00", "title": "SISTEMA DE ABASTECIMIENTO SIMULT\u00c1NEO", "description": "Considerando convocatorias anteriores de la Convocante y llamados en curso, se solicita utilizar la modalidad de ABASTECIMIENTO SIMULTANEO, a fin de garantizar a la Convocante el abastecimiento de los productos por m\u00e1s de un proveedor, logrando de esta manera una atenci\u00f3n oportuna a los pacientes y otorgando una mayor oportunidad de competencia a todo potencial oferente que cumpla con las condiciones establecidas en el Pliego de Bases y Condiciones para la provisi\u00f3n de los productos requeridos.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-26T15:00:34-04:00"}, {"id": "694107686965578136ce5c91dbebf4ec-1", "date": "2025-01-12T21:24:22-04:00", "title": "item 10 enzalutamida", "description": "se solicita amablemente a la convocante modificar el precio de referencia del item 10 enzalutamida, considerando las ultimas adjudicaciones realizada en el IPS,  ID 430314 PRECIO adjudicado 188.000 gs, ID 429959 PRECIO adjudicado 189.102 gs.", "answer": "El Oferente deber\u00e1 remitirse a los Datos Cargados en el SICP.", "dateAnswered": "2025-02-26T15:00:48-04:00"}, {"id": "16f9138b2e663497a39a46ee910bfdd7-1", "date": "2024-10-10T09:42:40-04:00", "title": "Cronograma de entrega", "description": "Solicitamos ampliar como m\u00ednimo a 30 d\u00edas el plazo de entrega para el 80% restante de las cantidades m\u00ednimas.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases  y Condiciones.", "dateAnswered": "2024-12-19T08:49:06-04:00"}, {"id": "8095a8b40cefd7f545d508f0bfe887ab-1", "date": "2024-10-11T08:06:57-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "a. Las empresas que ofertan Medicamentos de Origen Nacional, deber\u00e1n presentar copia autenticada del Certificado de Registro Sanitario emitido por la Direcci\u00f3n Nacional de\nVigilancia Sanitaria y el Certificado de Buenas Practicas de Fabricaci\u00f3n y Control expedida por la Direcci\u00f3n Nacional de Vigilancia Sanitari Y adem\u00e1s Los productos farmac\u00e9uticos\nmultifuente (seg\u00fan definici\u00f3n OMS) deber\u00e1n presentar sus estudios de demostraci\u00f3n de equivalencia terap\u00e9utica con el producto de referencia original. ---> Se solicita aceptar en reemplazo del estudio de demostraci\u00f3n de equivalencia terap\u00e9utica el Certificado de Bioequivalencia emitido por la DINAVISA", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-12-19T08:54:58-04:00"}, {"id": "0a3dfbd2a4578e0aa027d57d7379a51a-1", "date": "2025-01-10T11:49:02-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Solicitamos a la Convocante establecer la utilizaci\u00f3n de abastecimiento simultaneo, considerando que el mismo garantiza a la Convocante el abastecimiento de los productos por m\u00e1s de un proveedor, logrando de esta manera una atenci\u00f3n oportuna a los pacientes y otorgando una mayor oportunidad de competencia a todo potencial oferente que cumpla con las condiciones establecidas en el Pliego de Bases y Condiciones para la provisi\u00f3n de los productos requeridos.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-26T14:59:46-04:00"}, {"id": "5ed8efc7f4efc4d2ed92d937424b75a5-1", "date": "2024-10-10T19:29:28-04:00", "title": "Certificado de Buenas Pr\u00e1cticas (En idioma Espa\u00f1ol)", "description": "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, adem\u00e1s, como referencia citamos procesos licitatorios del IPS en donde se ha procedido a modificar este requisito (LPN N\u00ba 32/22, LPN N\u00ba 104/22, LPN N\u00ba 96/22 y LPN N\u00ba 99/22)\nPor todo esto, SOLICITAMOS A LA CONVOCANTE LA AMPLIACI\u00d3N DE DICHO REQUISITO DE LA SIGUIENTE MANERA: Certificado de Buenas Pr\u00e1cticas (TRADUCIDO EN IDIOMA ESPA\u00d1OL) b. Para productos importados: Copia autenticada del Certificado de Buenas Pr\u00e1cticas de Almacenamiento, emitido a nombre del OFERENTE 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 fabricante del producto ofertado.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-12-19T08:50:02-04:00"}, {"id": "8bbbd3082a8368a9920d4c43e4770987-1", "date": "2025-01-13T07:43:00-04:00", "title": "Requisitos de Participaci\u00f3n y Criterios de Evaluaci\u00f3n - Punto 4 Certificado de Buenas Pr\u00e1cticas", "description": "De acuerdo a la interpretaci\u00f3n, es v\u00e1lido el Certificado de Buenas Pr\u00e1cticas de cualquier pa\u00eds que forma parte del Mercosur, es correcto?", "answer": ": Se consideran los pa\u00edses establecido en las normativas vigentes en la Republica de Paraguay, por lo que el Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-26T15:01:11-04:00"}, {"id": "d39862da137b98d01e1fb541b8eebb6e-1", "date": "2025-01-12T21:02:08-04:00", "title": "Capacidad Tecnica", "description": "En Capacidad T\u00e9cnica, punto 4., segundo p\u00e1rrafo, establecen cuanto sigue: \nCuando el pa\u00eds de origen del elaborador no es clasificado conforme al Art. 1 de la LEY N\u00b0 7256/24 \u00b4\u00b4QUE MODIFICA EL ARTICULO 11\u00b0 Y AMPLIA LA LEY N\u00b0 3283/2007 y RES. DINAVISA N\u00b0148/24 \u00b4\u00b4POR LA CUAL SE EMITE EL LISTADO ANUAL OFICIAL DE LOS PAISES EN CUMPLIMIENTO AL ART.3 DE LA LEY N\u00b0 7256/24\u00b4\u00b4 o no forme parte del MERCOSUR, deber\u00e1 presentar Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n vigente emitido por la Agencia Reguladora de medicamentos del pa\u00eds de origen o Licencia/Certificado de Fabricaci\u00f3n vigente del producto ofertado. Adem\u00e1s, deber\u00e1 presentar el certificado de Buenas Pr\u00e1cticas de fabricaci\u00f3n del fabricante vigente o Licencia/Certificado de Fabricaci\u00f3n vigente emitido por cualquiera de las agencias declaradas en la LEY N\u00b0 7256/24 y RES. DINAVISA N\u00b0 148/24 o el Registro Sanitario del producto ofertado emitido por cualquiera de las agencias declaradas en la Ley N\u00b07256/24. \nAl respecto, solicitamos eliminar el requerimiento del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n vigente emitido por la Agencia Reguladora de medicamentos del pa\u00eds de origen o Licencia/Certificado, considerando que al presentar el certificado de Buenas Pr\u00e1cticas de fabricaci\u00f3n del fabricante vigente o Licencia/Certificado de Fabricaci\u00f3n vigente emitido por cualquiera de las agencias declaradas en la LEY N\u00b0 7256/24 y RES. DINAVISA N\u00b0 148/24, considerando que la normativa no exige contar con el GMP de origen para la evaluaci\u00f3n y obtenci\u00f3n del registro. Siendo validado exclusivamente el GMP emitido por una autoridad reguladora estricta para la obtenci\u00f3n del correspondiente registro sanitario.", "answer": "Se aclara que uno de los requisitos para registrar un medicamento en el pa\u00eds es la de presentar el certificado de buenas pr\u00e1cticas del pa\u00eds de origen, seg\u00fan el \u00b4\u00b4Listado de requisitos de registro sanitario DINAVIA INF-DGRS-001 versi\u00f3n 02 vigente desde 21/11/2024. El mismo se encuentra disponible para todo p\u00fablico en la p\u00e1gina oficial del ente regulador, por lo que el Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-26T15:00:07-04:00"}, {"id": "b6caecbfea93b7642370efb94bbe32d7-1", "date": "2025-01-23T12:24:55-04:00", "title": "Abastecimiento simultaneo", "description": "Considerando las Convocatorias anteriores de la misma convocante se solicita modificar el Sistema de adjudicaci\u00f3n a ABASTECIMIENTO SIMULTANEO. Dicha modificaci\u00f3n solicitada se debe a que la convocante contar\u00e1 con m\u00e1s proveedores adjudicados lo que garantizara el stock permanente para satisfacer eficientemente la necesidad del producto.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-26T15:02:51-04:00"}, {"id": "462a273739a0140fa10a49e5d8c9376b-1", "date": "2024-10-11T00:35:48-04:00", "title": "Capacidad T\u00e9cnica", "description": "Los requisitos de capacidad t\u00e9cnica y Requisitos documentales para evaluar la capacidad t\u00e9cnica realizan una diferenciaci\u00f3n al momento de requerir documentaciones. Al respecto, solicitamos a la Convocante listar en cada una de estas diferenciaciones, los productos a los cuales corresponden estos criterios. Esto a fin de evitar confusiones en cuanto a que criterios son aplicables a cada producto. Recordamos que las Convocantes deben elaborar las bases y condiciones del llamado con la mayor amplitud de acuerdo con la naturaleza espec\u00edfica del contrato con el objeto de que concurra el mayor n\u00famero de Oferentes y deber\u00e1n ser suficientemente claras, objetivas e imparciales para evitar favorecer a alg\u00fan participante conforme lo dispone el Art. 45 de la Ley 7021/22.", "answer": "Se aclara al oferente que en los requisitos est\u00e1n establecidos los criterios para medicamentos de origen biol\u00f3gicos y de origen sint\u00e9tico los cuales se clasifican en productos oncol\u00f3gicos orales o inyectables,  f\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos moleculares, f\u00e1rmacos inmunosupresores, por lo que se entiende y se debe considerar que el oferente debe conocer y saber el producto que ofertara,  para  competir y demostrar que sus productos cumplen con los criterios establecidos, por lo que el Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-19T08:50:43-04:00"}, {"id": "32c148742571f0c471b071ed247aded5-1", "date": "2025-01-22T14:05:17-04:00", "title": "CRONOGRAMA DE ENTREGA", "description": "Se solicita a la convocante que para la entrega del 80% del producto adjudicado se tenga en cuenta el plazo de 30 (treinta) d\u00edas.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones", "dateAnswered": "2025-02-26T15:02:32-04:00"}, {"id": "e9ea9f338b02ffa435a2509214d3ad08-1", "date": "2024-10-10T19:29:18-04:00", "title": "REQUISITOS DOCUMENTALES PARA LA EVALUACI\u00d3N DE LA EXPERIENCIA", "description": "Solicitamos a la convocante reformular los requisitos documentales para la experiencia requerida de la siguiente forma en el punto 1. Copia de facturaciones y/o contratos y/o actas de recepciones finales que avalen la experiencia requerida.\nEsto a modo de unificar los criterios solicitados en la Experiencia requerida.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases  y Condiciones.", "dateAnswered": "2024-12-19T08:49:52-04:00"}, {"id": "155ddc473cf3e60a879b75ea186d2775-1", "date": "2024-10-11T00:34:27-04:00", "title": "CAPACIDAD TECNICA", "description": "Los requisitos de capacidad t\u00e9cnica y Requisitos documentales para evaluar la capacidad t\u00e9cnica realizan una diferenciaci\u00f3n al momento de requerir documentaciones. Al respecto, solicitamos a la Convocante listar en cada una de estas diferenciaciones, los productos a los cuales corresponden estos criterios. Esto a fin de evitar confusiones en cuanto a que criterios son aplicables a cada producto. Recordamos que las Convocantes deben elaborar las bases y condiciones del llamado con la mayor amplitud de acuerdo con la naturaleza espec\u00edfica del contrato con el objeto de que concurra el mayor n\u00famero de Oferentes y deber\u00e1n ser suficientemente claras, objetivas e imparciales para evitar favorecer a alg\u00fan participante conforme lo dispone el Art. 45 de la Ley 7021/22.", "answer": "Se aclara al oferente que en los requisitos est\u00e1n establecidos los criterios para medicamentos de origen biol\u00f3gicos y de origen sint\u00e9tico los cuales se clasifican en productos oncol\u00f3gicos orales o inyectables,  f\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos moleculares, f\u00e1rmacos inmunosupresores, por lo que se entiende y se debe considerar que el oferente debe conocer y saber el producto que ofertar\u00e1,  para  competir y demostrar que sus productos cumplen con los criterios establecidos, por lo que el Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-19T08:50:30-04:00"}, {"id": "a2af3154ca7895f7c357a2a98c7a527e-1", "date": "2024-10-10T09:42:57-04:00", "title": "Cronograma de Entregas", "description": "Solicitamos que el plazo de entrega para las cantidades m\u00e1ximas se ampl\u00ede como m\u00ednimo a 30 d\u00edas.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases  y Condiciones.", "dateAnswered": "2024-12-19T08:49:14-04:00"}, {"id": "16e85ec57043bb2c7036730996f1328e-1", "date": "2025-01-13T08:22:31-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "1.3.Para f\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos moleculares.\n\nPunto b-:...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\nreferencia original. \nSolicitamos a la convocante aceptar el CERTIFICADO DE BIOEQUIVALENCIA emitido por la DINAVISA en reemplazo del estudio de demostraci\u00f3n de equivalencia terap\u00e9utica.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-26T15:01:55-04:00"}, {"id": "5bdb0ba7605aa9c5dea23666fa15ae35-1", "date": "2024-10-11T08:01:23-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "\"1.2.Para productos oncol\u00f3gicos orales e inyectables.:\" Se solicita a la convocante especificar los productos que contemplan dichos requisitos a fin de evitar confuciones dado que ciertos productos podr\u00edan caer en m\u00e1s de una categor\u00eda.", "answer": "Se aclara al oferente que en los requisitos est\u00e1n establecidos los criterios productos oncol\u00f3gicos orales o inyectables, por lo que se entiende y se debe considerar que el oferente debe conocer y saber el producto que ofertara,  para  competir y demostrar que sus productos cumplen con los criterios establecidos, por lo que el Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-12-19T08:54:34-04:00"}, {"id": "cd3ece1ea2bb4d4931a4c0591490f9ac-1", "date": "2025-01-13T08:22:22-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Solicitamos considerare establecer el sistema de ABASTECIMIENTO SIMULT\u00c1NEO al menos en el \u00edtem 10 \"Enzalutamida\", con el reducir las posibilidades de desabastecimiento del producto recayendo la provisi\u00f3n en un solo proveedor. Es necesario recordar que este sistema ha ayudado a la entidad a mantener una provisi\u00f3n continua en ocasiones anteriores.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-26T15:01:43-04:00"}, {"id": "d08c23b5e7fe3d0e492de73be17123a6-1", "date": "2024-10-11T00:30:45-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "5.\tSolicitamos a la Convocante establecer la utilizaci\u00f3n del abastecimiento simultaneo para todos los \u00edtems del proceso. Considerando que el sistema de abastecimiento simultaneo garantiza a la Convocante el abastecimiento de los productos por m\u00e1s de un proveedor, logrando de esta manera una atenci\u00f3n oportuna a los pacientes y otorgando una mayor oportunidad de competencia a todo potencial oferente que cumpla con las condiciones establecidas en el Pliego de Bases y Condiciones para la provisi\u00f3n de todos los productos requeridos.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-19T08:50:17-04:00"}, {"id": "47bb4bd13ea7d8349ca72b8b5f06735c-1", "date": "2024-10-10T13:33:22-04:00", "title": "declaracion jurada,   de muestras", "description": "se solicita amablemente a la convocante, modificar la nota presentada  ante  la DIRECCI\u00d3N DE LOGISTICA DE SUMINSTROS DE SALUD donde dice Firma del Apoderado y Regente de la empresa, solo diga   Firma del Apoderado, debido a que es el apoderado quien es el representante ante la instituci\u00f3n  y no es necesario la firma de la regente, que es la que representa y responsable de todos los productos  de la empresa donde presta servicio ante el MSP Y BS . lo que hace innecesaria una firma conjunta para validar la DDJJ, siendo mas que suficiente la firma del apoderado.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases  y Condiciones.", "dateAnswered": "2024-12-19T08:49:42-04:00"}, {"id": "805d9c22ce0d85336916ce3054836458-1", "date": "2024-10-11T00:41:27-04:00", "title": "1.4 Para f\u00e1rmacos inmunosupresores", "description": "En Capacidad T\u00e9cnica, 1.4 \u201cPara f\u00e1rmacos inmunosupresores\u201d se establece: \n\u201cY adem\u00e1s, deber\u00e1 presentar estudios de bioequivalencia contra el producto de referencia.\u201d \nAl respecto, solicitamos amablemente eliminar esta solicitud para productos nacionales, teniendo en cuenta que actualmente se encuentra en proceso de implementaci\u00f3n la realizaci\u00f3n de los 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