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Esta normativa no establece que el rubro relacionado a \u201cDispositivos M\u00e9dicos\u201d debe contar con acta de fijaci\u00f3n de precios. \n\nEn esta licitaci\u00f3n, en la Secci\u00f3n \u201cRequisitos de participaci\u00f3n y criterios de evaluaci\u00f3n\u201d se requiere para la \u201cCapacidad t\u00e9cnica\u201d la presentaci\u00f3n del \u201cacta de fijaci\u00f3n de precio\u201d del producto ofertado. En el \u00edtem 6 el IPS se solicita la cotizaci\u00f3n del producto \u201cAcido Hialuronico inyectable\u201d, el cual, es catalogado por la DINAVISA como \u201cDispositivo m\u00e9dico Clase de Riesgo IV\u201d. Como se ha mencionado, por aplicaci\u00f3n de la normativa emitida por la DINAVISA en agosto de 2024, no es exigible el acta de fijaci\u00f3n de precio para esta categor\u00eda. Ante tal escenario, consultamos: \u00bfPodr\u00eda incluirse en el PBC que la presentaci\u00f3n del acta de fijaci\u00f3n de precios resulta aplicable \u00fanicamente para aquellos productos que, seg\u00fan la normativa vigente, dicho documento es exigible? \nPor lo tanto, proponemos a la convocante el siguiente escrito para la nueva versi\u00f3n del PBC:\nAnte las consultas formuladas, proponemos a la Convocante la siguiente modificaci\u00f3n al PBC, que favorecer\u00e1 la concurrencia a la licitaci\u00f3n de conformidad a lo establecido en el art. 45 de la Ley N\u00b0 7021/22 que dispone: \u201c\u2026En los procedimientos de contrataci\u00f3n ser\u00e1 obligaci\u00f3n de las convocantes 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 Oferente\u2026\u201d. \n\n\u201cCapacidad T\u00e9cnica\u201d de la secci\u00f3n \u201cRequisitos de Participaci\u00f3n y Criterios de Evaluaci\u00f3n\u201d del PBC \u2013 Acta de fijaci\u00f3n de precio. \u201cEspecificaciones T\u00e9cnicas \u2013 Suministros requeridos\u201d:\n\n\u201cActa de Fijaci\u00f3n de Precios: IDENTIFICAR CADA ITEM OFERTADO SEG\u00daN PBC Copia autenticada del Acta de Fijaci\u00f3n de Precios del producto ofertado, expedida por la Direcci\u00f3n de Vigilancia Sanitaria (DINAVISA), en forma legible y emitida como m\u00e1ximo hasta la fecha de Apertura de Oferta. Observaci\u00f3n: 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, atendiendo al principio de econom\u00eda y eficiencia. \"Los oferentes que presentan productos que, por disposiciones de la DINAVISA no deben contar con acta de fijaci\u00f3n de precios, quedan exentos de la presentaci\u00f3n de esta exigencia y del l\u00edmite dispuesto en este PBC relacionado al porcentaje establecido con relaci\u00f3n al precio ofertado\u201d.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-03T14:18:48-04:00"}, {"id": "4790b04fb09de1fbcda332bfd072a54d-1", "date": "2025-02-04T08:55:31-04:00", "title": "Experiencia requerida", "description": "1.\tSeg\u00fan lo establecido en la Secci\u00f3n \u201cRequisitos de Calificaci\u00f3n y Criterios de Evaluaci\u00f3n\u201d del PBC de la licitaci\u00f3n de referencia, el IPS requiere la acreditaci\u00f3n de 5 a\u00f1os de experiencia en la provisi\u00f3n de dispositivos m\u00e9dicos, en los t\u00e9rminos siguientes: \u201cDemostrar la experiencia en PROVISI\u00d3N DE DISPOSITIVOS M\u00c9DICOS 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 presente licitaci\u00f3n, dentro de los \u00faltimos: 5 (cinco) (2019 2020 2021 2022 2023) a\u00f1os\u201d.\n\n2.\tPor su parte, para la acreditaci\u00f3n de la experiencia en provisi\u00f3n de medicamentos, el IPS ha establecido: \u201cDemostrar 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, sumatoria de los a\u00f1os: 2021 -2022 \u2013 2023\u201d.\n\n3.\tEn relaci\u00f3n con el m\u00e9todo establecido por la convocante para la acreditaci\u00f3n de la experiencia, consultamos: \u00bfPor qu\u00e9 el IPS solicita la acreditaci\u00f3n de experiencia espec\u00edfica en provisi\u00f3n de dispositivos m\u00e9dicos? \u00bfCu\u00e1l es el fundamento t\u00e9cnico de solicitar la acreditaci\u00f3n espec\u00edfica en la provisi\u00f3n de dispositivos m\u00e9dicos? Entendemos que el objeto de la licitaci\u00f3n (medicamentos varios) no requiere de la acreditaci\u00f3n espec\u00edfica y diferenciada entre la experiencia adquirida por una empresa en la provisi\u00f3n de medicamentos y la experiencia adquirida en la provisi\u00f3n de dispositivos m\u00e9dicos. Por tal motivo, solicitamos a la Convocante que la acreditaci\u00f3n de la experiencia sea unificada conforme a lo siguiente: (i) se elimine la experiencia espec\u00edfica en provisi\u00f3n de dispositivos m\u00e9dicos; y que (ii) sea requerida como criterio de calificaci\u00f3n la experiencia en provisi\u00f3n de medicamentos. \n\nPROPUESTA DE MODIFICACI\u00d3N DEL PBC:\n1.\tSe solicita que se elimine del PBC las siguientes secciones relacionadas a la acreditaci\u00f3n de experiencia espec\u00edfica en la provisi\u00f3n de dispositivos m\u00e9dicos considerando que las empresas con experiencia en la provisi\u00f3n de medicamentos en general cuentan con el conocimiento, la capacidad log\u00edstica y el \u201cknow how\u201d que se requiere para la distribuci\u00f3n de cualquier tipo de insumo m\u00e9dico. La provisi\u00f3n de dispositivos m\u00e9dicos no presenta diferencias sustanciales con la provisi\u00f3n de medicamentos ya que ambas actividades comparten aspectos claves sobre los mecanismos de entrega, distribuci\u00f3n y log\u00edstica, por lo que no existir\u00edan fundamentos t\u00e9cnicos para solicitar una experiencia espec\u00edfica en ese sentido y limitar la concurrencia a la licitaci\u00f3n en contravenci\u00f3n a lo establecido en el art. 45  de la Ley N\u00b0 7021/22 \u201cDe Suministro y Contrataci\u00f3n P\u00fablica\u201d: \n\n-\tExperiencia requerida: PARA DISPOSITIVOS M\u00c9DICOS \u00cdTEM 5. Demostrar la experiencia en PROVISI\u00d3N DE DISPOSITIVOS M\u00c9DICOS 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 presente licitaci\u00f3n, dentro de los \u00faltimos: 5 (cinco) (2019 2020 2021 2022 2023) a\u00f1os.  En caso de lograr el porcentaje requerido, en uno o en m\u00e1s a\u00f1os, que correspondan a los a\u00f1os establecidos en el presente punto, el mismo ser\u00e1 considerado como valedero para la participaci\u00f3n. *ELIMINAR*.", "answer": "Se aclara que se solicita de experiencia espec\u00edfica en la provisi\u00f3n de dispositivos m\u00e9dicos, debido a que los proveedores deben garantizar que tengan el conocimiento, de las normativas, la log\u00edstica y el soporte t\u00e9cnico que pueden ser necesarios, adem\u00e1s de la  capacidad adecuada, en la provisi\u00f3n. \nLos dispositivos m\u00e9dicos pueden ser complejos y requieren un manejo especializado, tanto en su entrega como en su uso, por lo que el Oferente deber\u00e1  ajustarse a lo establecido en el Pliego de Bases y Condiciones\n", "dateAnswered": "2025-04-28T08:23:37-04:00"}, {"id": "9e30b29e5f76bd3101fb798d65497461-1", "date": "2024-10-10T23:50:42-04:00", "title": "Especificaciones t\u00e9cnicas", "description": "Para el Item 6 - Enalaprilato inyectable la entidad solicita presentaci\u00f3n AMPOLLA, se solicita a la entidad aceptar AMPOLLA/FRASCO AMPOLLA a fin de dar oportunidad a la mayor cantidad de oferentes posibles", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-03T14:20:56-04:00"}, {"id": "2b7d50d41c42d27e5bb509475b79dbad-1", "date": "2024-10-10T16:55:00-04:00", "title": "Criterios de desempate de ofertas", "description": "Solicitamos a la Convocante aclarar los impuestos que se deben considerar para realizar el cuadro de composici\u00f3n de precios, en caso de que alguna oferta sobre pase el 15% del precio referencial o el 25% por debajo del mismo.", "answer": "Se aclara que el Oferente deber\u00e1 tener en cuenta lo establecido en el Art. 2, de la Resoluci\u00f3n DNCP N\u00b0 454/2024.", "dateAnswered": "2025-02-03T14:19:30-04:00"}, {"id": "c39ddced0448934b3aff6f79df229718-1", "date": "2024-10-11T08:56:14-04:00", "title": "ITEM 4 - ENALAPRIL INYECTABLE", "description": "Solicitamos aceptar presentaci\u00f3n FRASCO AMPOLLA, siendo que esta presentaci\u00f3n es la que circula en el mercado nacional.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-03T14:21:50-04:00"}, {"id": "e3c4a3ba33248bfdfb4146a94fe8c50e-1", "date": "2025-02-03T22:37:02-04:00", "title": "Capacidad T\u00e9cnica y Requisitos documentales para evaluar la capacidad t\u00e9cnica \u2013 \u00cdTEM 5", "description": "Solicitamos considerar que para el \u00edtem 5. HIALURONATO DE SODIO/ACIDO HIALURONICO, la DNVS ha otorgado registros sanitarios de forma indistinta como dispositivos m\u00e9dicos o especialidades farmac\u00e9uticas, por lo que solicitamos a la Convocante separar las documentaciones para dicho \u00edtem conforme a la clasificaci\u00f3n del registro sanitario otorgado por DNVS y no limitar los requisitos a un solo tipo de clasificaci\u00f3n: \u201cdispositivos m\u00e9dicos\u201d. Esta separaci\u00f3n y aclaraci\u00f3n sobre que tipos de documentaciones aplica de acuerdo con la clasificaci\u00f3n del registro sanitario emitido por la DNVS ya ha sido incluida en llamados anteriores tales como la LPN N\u00ba 99/19 (ID N\u00ba 367517), LPN N\u00b0 96-22 (ID N\u00ba 416711).", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-04-28T08:23:17-04:00"}, {"id": "877f75af376d41fbbc5d0cc80f67e88f-1", "date": "2024-10-10T17:03:39-04:00", "title": "Plan de entrega", "description": "Solicitamos aumentar los plazos de entrega de las cantidades m\u00ednimas y m\u00e1ximas teniendo en cuenta la crisis hidrol\u00f3gica que provoca la bajante del rio que dificulta el ingreso de las materias primas y productos terminados.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-03T14:19:54-04:00"}, {"id": "40459eaf5c084372bbdc6f30e0190c1d-1", "date": "2024-10-08T18:25:49-04:00", "title": "\u00cdTEM 5. FLUCONAZOL SOLUCI\u00d3N INYECTABLE", "description": "Solicitamos a la Convocante incluir en la presentaci\u00f3n de entrega del producto, la presentaci\u00f3n conforme se encuentra establecido y aprobado en el propio vadem\u00e9cum institucional: \"frasco ampolla / sachet\". Esto considerando que lo requerido no afecta a la indicaci\u00f3n, uso ni administraci\u00f3n del producto, y lo que se solicita a la Convocante es regirse por su propia reglamentaci\u00f3n. \nA continuaci\u00f3n, se detalla link de descarga donde se puede observar que lo solicitado en la consulta corresponde a lo establecido en su propio vadem\u00e9cum institucional. \nhttps://portal.ips.gov.py/sistemas/ipsportal/archivos/archivos/1726498574.pdf", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-03T14:18:01-04:00"}, {"id": "f57d476b3a480a2ef3ed340864755c68-1", "date": "2025-02-03T22:11:58-04:00", "title": "Experiencia requerida", "description": "Solicitamos a la Convocante considerar la experiencia adquirida en el ejercicio fiscal 2024, considerando que este ya se encuentra cerrado.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-04-28T08:22:41-04:00"}, {"id": "2a7dea488e60c984be3d65134bcbed1b-1", "date": "2025-02-04T08:59:41-04:00", "title": "CONSULTA AL PBC", "description": "Por su parte, para la acreditaci\u00f3n de la experiencia en provisi\u00f3n de medicamentos, el IPS ha establecido: \u201cDemostrar 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, sumatoria de los a\u00f1os: 2021 -2022 \u2013 2023\u201d.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-04-28T08:23:59-04:00"}, {"id": "469065a3502875ec0c95f35c6f764262-1", "date": "2024-10-04T18:07:11-04:00", "title": "\u00cdtem 5", "description": "Solicitamos respetuosamente a la convocante, que para el \u00edtem 5 Fluconazol inyectable, la presentaci\u00f3n de entrega corresponda a \"Envase x 100mL\", puesto que permitir\u00eda mayor presentaci\u00f3n de oferentes\"", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-03T14:17:27-04:00"}, {"id": "9e947b59f23f8b035c8be71f1dd466f6-1", "date": "2024-10-08T17:45:54-04:00", "title": "\u00cdTEM 4. ENALAPRILATO (ENALAPRIL INYECTABLE)", "description": "Solicitamos a la Convocante incluir en la presentaci\u00f3n de entrega del producto, la presentaci\u00f3n conforme se encuentra establecido y aprobado en el propio vadem\u00e9cum institucional: \"ampolla / frasco ampolla\". Esto considerando que lo requerido no afecta a la indicaci\u00f3n, uso ni administraci\u00f3n del producto, y lo que se solicita a la Convocante es regirse por su propia reglamentaci\u00f3n. \nA continuaci\u00f3n, se detalla link de descarga donde se puede observar que lo solicitado en la consulta corresponde a lo establecido en su propio vadem\u00e9cum institucional. \nhttps://portal.ips.gov.py/sistemas/ipsportal/archivos/archivos/1726498574.pdf", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-03T14:17:37-04:00"}, {"id": "07a88ef3a7ce9787231282842eb48fcd-1", "date": "2025-04-29T10:06:34-04:00", "title": "MUESTRAS PARA CONTROL DE CALIDAD", "description": "En relaci\u00f3n a las muestras requeridas para Control de Calidad de IPS, solicitamos tengas a bien la posibilidad de disminuir las cantidades requeridas para el \u00edtem 5. Hialuronato de Sodio/Acido Hialuronico, considerando el costo del producto y que el mismo corresponde a una jeringa prellenada, para las cuales normalmente se requiere solo la presentaci\u00f3n de la DDJJ respectiva junto con el COA del producto.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-05-12T13:19:00-04:00"}, {"id": "8881d1a12443d7d7bcd8e572968d53fc-1", "date": "2025-02-03T22:35:52-04:00", "title": "Experiencia requerida \u2013 \u00edtem 5", "description": "Solicitamos considerar que para el \u00edtem 5. HIALURONATO DE SODIO/ACIDO HIALURONICO, la DNVS ha otorgado registros sanitarios de forma indistinta como dispositivos m\u00e9dicos o especialidades farmac\u00e9uticas, por lo que solicitamos considerar que para la experiencia se acepte de forma indistinta la experiencia en medicamentos y/o dispositivos m\u00e9dicos conforme haya sido otorgado el registro sanitario respectivo.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-04-28T08:23:09-04:00"}, {"id": "fe608a64f4562d5e63166aed3689af8c-1", "date": "2025-02-04T08:58:40-04:00", "title": "Requisitos de Calificaci\u00f3n y Criterios de Evaluaci\u00f3n", "description": "Seg\u00fan lo establecido en la Secci\u00f3n \u201cRequisitos de Calificaci\u00f3n y Criterios de Evaluaci\u00f3n\u201d del PBC de la licitaci\u00f3n de referencia, el IPS requiere la acreditaci\u00f3n de 5 a\u00f1os de experiencia en la provisi\u00f3n de dispositivos m\u00e9dicos, en los t\u00e9rminos siguientes: \u201cDemostrar la experiencia en PROVISI\u00d3N DE DISPOSITIVOS M\u00c9DICOS 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 presente licitaci\u00f3n, dentro de los \u00faltimos: 5 (cinco) (2019 2020 2021 2022 2023) a\u00f1os\u201d.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-04-28T08:23:42-04:00"}, {"id": "f25576d0cd15914b2e22a6050ecec6d8-1", "date": "2024-10-10T19:25:29-04:00", "title": "CONSULTA REQUISITOS DOCUMENTALES PARA DISPOSITIVOS MEDICOS", "description": "Corresponde aclarar a la convocante que en el presente llamado en el \u00cdtem N\u00ba 6 se solicita un producto clasificado por la DINAVISA como dispositivo m\u00e9dico, por lo cual solicitamos que la convocante separe en el apartado \u201cREQUISITOS DOCUMENTAL PARA EVALUAR CAPACIDAD T\u00c9CNICA\u201d los documentos que deber\u00e1n ser presentados por los oferentes en caso de cotizar especialidades farmac\u00e9uticas y/o dispositivos m\u00e9dicos seg\u00fan lo registrado ante la DINAVISA", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-03T14:20:40-04:00"}, {"id": "c94d5686aa5936fe00f80539a54cc9ef-1", "date": "2024-10-11T08:55:57-04:00", "title": "Requisitos documentales para la evaluaci\u00f3n de la experiencia", "description": "Solicitamos aceptar Copia de Contratos, Facturaciones y/o recepciones finales para avalar la experiencia requerida.", "answer": "El Oferente deber\u00e1 ajustarse al Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-03T14:21:15-04:00"}, {"id": "51b1610080a62de2fe11f47c7132b5f6-1", "date": "2025-02-04T08:59:47-04:00", "title": "EXPERIENCIA REQUERIDA", "description": "3.\tEn relaci\u00f3n con el m\u00e9todo establecido por la convocante para la acreditaci\u00f3n de la experiencia, consultamos: \u00bfPor qu\u00e9 el IPS solicita la acreditaci\u00f3n de experiencia espec\u00edfica en provisi\u00f3n de dispositivos m\u00e9dicos? \u00bfCu\u00e1l es el fundamento t\u00e9cnico de solicitar la acreditaci\u00f3n espec\u00edfica en la provisi\u00f3n de dispositivos m\u00e9dicos? Entendemos que el objeto de la licitaci\u00f3n (medicamentos varios) no requiere de la acreditaci\u00f3n espec\u00edfica y diferenciada entre la experiencia adquirida por una empresa en la provisi\u00f3n de medicamentos y la experiencia adquirida en la provisi\u00f3n de dispositivos m\u00e9dicos. Por tal motivo, solicitamos a la Convocante que la acreditaci\u00f3n de la experiencia sea unificada conforme a lo siguiente: (i) se elimine la experiencia espec\u00edfica en provisi\u00f3n de dispositivos m\u00e9dicos; y que (ii) sea requerida como criterio de calificaci\u00f3n la experiencia en provisi\u00f3n de medicamentos.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-04-28T08:24:09-04:00"}, {"id": "c147f5cc0d01909406f146525c8cffbc-1", "date": "2024-10-10T19:25:25-04:00", "title": "CAPACIDAD TECNICA: Item N\u00b0 6 ACIDO HIALURONICO", "description": "Solicitamos aclaraci\u00f3n a la convocante referente a los documentos solicitados en la capacidad t\u00e9cnica para el item N\u00b0 6 ACIDO HIALURONICO, debido a que lo solicitado en el PBC corresponde a especialidades farmac\u00e9uticas. Con relaci\u00f3n al producto solicitado, creemos conveniente recordar al IPS que el mismo corresponde a un producto clasificado como \u201cdispositivo m\u00e9dico\u201d.\nRespecto a los dispositivos m\u00e9dicos, la DINAVISA (seg\u00fan Res. 669/16 \u201cPor el cual se reglamenta el Art\u00edculo 4\u00b0 inciso B) de la Ley N\u00b0 4659/12 \u201cQue implementa Procedimientos de seguridad y Mecanismos de Prevenci\u00f3n de Riesgos para los Profesionales de la Salud y Pacientes\u201d, Estableciendo Normas Para la Obtenci\u00f3n del Registro Sanitario de Productos Considerados Dispositivos M\u00e9dicos, Material Cortopunzantes y Equipos de Protecci\u00f3n Individual\u201d) en su art. 4) Inc. D) establece que para el registro local de dispositivos m\u00e9dicos se debe presentar: \u201cDocumentaci\u00f3n acreditando fehacientemente el cumplimento de las normas de calidad en los procesos de producci\u00f3n BPF/GMP otorgada por la Autoridad Sanitaria, competente en origen o certificado ISO/CE/UL/FDA/ TUVF- otorgado por la entidad certificadora de origen\u201d\n\nSeguidamente, al realizar un comparativo del requerimiento establecido en el 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 dispositivos m\u00e9dicos 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:\nPara el producto ITEM N\u00b0 6: ACIDO HIALUR\u00d3NICO 25/20MG. INYECTABLE. JERINGA PRELLENADA\nSe solicita la siguiente documentaci\u00f3n:\n\u201cDocumentaci\u00f3n acreditando fehacientemente el cumplimento de las normas de calidad en los procesos de producci\u00f3n BPF/GMP otorgada por la Autoridad Sanitaria, competente en origen o certificado ISO/CE/UL/FDA/ TUVF- otorgado por la entidad certificadora de origen\u201d\nEsta separaci\u00f3n y modificaci\u00f3n ya ha sido incluida en llamados anteriores tales como la LPN N\u00ba 99/19 (ID N\u00ba 367517), LPN N\u00b0 96-22, en donde la misma convocante accedi\u00f3 a modificar su PBC para con el mismo producto.", "answer": "Se aclara que por un lado se solicita copia de contratos y/o facturas para demostrar la experiencia en monto equivalente al 50% como m\u00ednimo del monto total ofertado y por otro lado demostrar que dichos productos son utilizados en Instituciones P\u00fablicas, que se demuestra con Acta de Recepci\u00f3n final o un Certificado emitido por una Instituci\u00f3n Privada en la que se avale la conformidad en la utilizaci\u00f3n de dichos insumos , por lo que el oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-10T14:28:32-04:00"}, {"id": "ec1ea25376eb494d0a2e84ec739b8eaf-1", "date": "2024-10-10T15:38:36-04:00", "title": "\u00cdTEM 6 - ACIDO HIALURONICO INYECTABLE", "description": "Favor tener en cuenta que algunos registros de Acido hialuronico la Direcci\u00f3n Nacional de Vigilancia Sanitaria autoriza que sea registrado como dispositivo medico, raz\u00f3n por la cual no cuentan con Acta de Fijaci\u00f3n de Precio.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-03T14:19:24-04:00"}, {"id": "6d64f5fad76a58a366a4ab8de9fca241-1", "date": "2024-10-10T19:25:11-04:00", "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": "2025-02-03T14:20:09-04:00"}, {"id": "c33de770f28f597fa12785b45df4a86c-1", "date": "2025-02-03T22:26:27-04:00", "title": "Capacidad T\u00e9cnica y Requisitos documentales para evaluar la capacidad t\u00e9cnica \u2013 \u00cdTEM 5", "description": "Con relaci\u00f3n a las documentaciones requeridas para el \u00edtem 5. HIALURONATO DE SODIO/ACIDO HIALURONICO, solicitamos a la Convocante considerar que la DNVS ha otorgado registros sanitarios de forma indistinta como especialidades farmac\u00e9uticas / dispositivos m\u00e9dicos de acuerdo con las documentaciones presentadas por cada proveedor al momento de registrar el producto. Por lo que solicitamos a la Convocante la reformulaci\u00f3n de dicho requisito, estableciendo que para dicho \u00edtem deben aplicar las documentaciones conforme a la clasificaci\u00f3n del registro sanitario respectivo y no limitar los requisitos a un solo tipo de clasificaci\u00f3n: \u201cdispositivos m\u00e9dicos\u201d. Esta separaci\u00f3n y aclaraci\u00f3n sobre que tipos de documentaciones aplica de acuerdo con la clasificaci\u00f3n del registro sanitario emitido por la DNVS ya ha sido incluida en llamados anteriores tales como la LPN N\u00ba 99/19 (ID N\u00ba 367517), LPN N\u00b0 96-22 (ID N\u00ba 416711).", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-04-28T08:23:01-04:00"}, {"id": "217dbc19fee512bc23228e7816ff7e91-1", "date": "2025-02-04T08:58:43-04:00", "title": "CONSULTA AL PBC", "description": "Por su parte, para la acreditaci\u00f3n de la experiencia en provisi\u00f3n de medicamentos, el IPS ha establecido: \u201cDemostrar 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, sumatoria de los a\u00f1os: 2021 -2022 \u2013 2023\u201d.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-04-28T08:23:50-04:00"}, {"id": "ce05ca05975d198b98d51a4ebceb764f-1", "date": "2024-10-11T00:36:38-04:00", "title": "Especificaciones t\u00e9cnicas", "description": "Para el Item 6 - Enalaprilato inyectable la entidad solicita presentaci\u00f3n AMPOLLA, se solicita a la entidad aceptar AMPOLLA/FRASCO AMPOLLA a fin de dar oportunidad a la mayor cantidad de oferentes posibles", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-03T14:21:05-04:00"}, {"id": "106ef5f8fb17dc78d48c2d3536c228d9-1", "date": "2025-04-25T12:39:40-04:00", "title": "Capacidad t\u00e9cnica para el item 5- Punto 4", "description": "\u201cEl PBC cita cuanto sigue: 4-Certificado de Buenas Pr\u00e1cticas: Para los productos Importados: Certificado 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 Practicas de Fabricaci\u00f3n emitido por la Agencia reguladora del Pa\u00eds de Origen, a nombre del fabricante del Producto\u201d\nSolicitamos a la convocante excluir el punto expuesto m\u00e1s arriba puesto que para acreditar las  normas de calidad para el ITEM 5 es indistinto la presentaci\u00f3n de GMP o en su defecto certificado como ISO/CE/UL/FDA/TUVF, cuyo requisito ya es solicitado en el punto 5 del PBC.\nEsto teniendo en cuenta la disposici\u00f3n de la Res. DNVS N\u00ba 226/2024 Art. 6 para productos importados Inc. A", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.\n\n", "dateAnswered": "2025-05-12T13:18:57-04:00"}, {"id": "9c591fef4550a0d251e9d47b14fd1d23-1", "date": "2024-10-10T16:59:28-04:00", "title": "Item 4", "description": "Solicitamos a la Convocante modificar la presentaci\u00f3n de entrega del \u00edtem 4 a \"frasco ampolla\" tal como se solicito en la LPN 96/22 ID 416711 para dar oportunidad a mas oferentes y no dirigir la compra a una marca en particular.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-02-03T14:19:54-04:00"}], "lots": [{"id": "1ef71e89-b8eb-6d9a-9d5d-03d90f4640e4", "title": "7 - 7 - POLIMIXINA+BACITRACINA+NEOMICINA UNGUENTO", "status": "active", "statusDetails": "activo", "value": {"amount": 219204000, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "7", "id": "7"}]}, {"id": 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