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PARA R F HOFFMANN LA ROCHE LTD", "name": "Fabricante", "id": "3"}, {"value": "HEMLIBRA 30 MG/ 1ML", "name": "Marca", "id": "4"}, {"name": "Orden", "value": "1", "id": "7"}]}, {"id": "1ef43a3f-d1f6-6d16-a8b8-0bb0795f1f05", "description": "Emicizumab Inyectable", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51111713-9990", "description": "Emicizumab Inyectable", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51111713-9990"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51111713", "description": "Anticuerpo Monoclonal Humanizado", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51111713"}], "quantity": 2191, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 29785000, "currency": "PYG"}}, "relatedLot": "1ef43a3f-d1ee-6ca6-9733-0bb0795f1f05", "attributes": [{"value": "JAPON/SUIZA", "name": "Procedencia", "id": "1"}, {"value": "CHUGAI PHARMA MANUFACTURING CO., LTD PARA R F HOFFMANN LA ROCHE LTD", "name": "Fabricante", "id": "3"}, {"value": "HEMLIBRA 60 MG/0,4 ML", "name": "Marca", "id": "4"}, {"name": "Orden", "value": "2", "id": "7"}]}, {"id": "1ef43a45-5825-6f4a-8eef-3bebaa5fb451", "description": "Factor 7 recombinante Inyectable", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51131907-9998", "description": "Factor 7 recombinante Inyectable", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51131907-9998"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51131907", "description": "Factor proteinico de plasma humano", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51131907"}], "quantity": 274, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 25850000, "currency": "PYG"}}, "relatedLot": "1ef43a45-5823-683a-9854-3bebaa5fb451", "attributes": [{"value": "DINAMARCA", "name": "Procedencia", "id": "1"}, {"value": "NOVO NORDIKS A/S", "name": "Fabricante", "id": "3"}, {"value": "NOVOSEVEN RT", "name": "Marca", "id": "4"}, {"name": "Orden", "value": "5", "id": "7"}]}]}], "tender": {"id": "1ef34035-3aef-68d2-b403-a190759a4e6a", "title": "LPN N\u00b0 112/2024 \"ADQUISICI\u00d3N DE MEDICAMENTOS PARA PROGRAMAN NACIONAL DE SANGRE\".", "status": "complete", "awardCriteria": "priceOnly", "awardCriteriaDetails": "Por Item", "submissionMethod": ["inPerson"], "bidOpening": {"date": "2024-11-06T09:30:00-04:00", "address": {"streetAddress": "Dpto. de Licitaciones- Direcci\u00f3n Operativa de Contrataciones"}}, "submissionMethodDetails": "Lugar entrega ofertas: Dpto. de Licitaciones- Direcci\u00f3n Operativa de Contrataciones", "statusDetails": "Adjudicada", "enquiriesAddress": {"streetAddress": "SICP de la DNCP"}, "mainProcurementCategoryDetails": "Bienes - Medicamentos y Productos Farmaceuticos", "hasEnquiries": false, "value": {"amount": 94460222500, "currency": "PYG"}, "datePublished": "2024-08-20T12:11:30-04:00", "tenderPeriod": {"startDate": "2024-08-20T12:11:30-04:00", "endDate": "2024-11-06T09:00:00-04:00", "durationInDays": 77}, "awardPeriod": {"startDate": "2024-11-06T09:30:00-04:00"}, "contractPeriod": {"maxExtentDate": "2026-12-31T00:00:00-04:00"}, "enquiryPeriod": {"endDate": "2024-10-30T08:00:00-04:00", "startDate": "2024-08-20T12:11:30-04:00", "durationInDays": 70}, "mainProcurementCategory": "services", "additionalProcurementCategories": ["services"], "procurementMethod": "open", "procurementMethodDetails": "Licitaci\u00f3n P\u00fablica Nacional", "procuringEntity": {"id": "DNCP-SICP-CODE-306", "name": "Ministerio de Salud P\u00fablica y Bienestar Social (MSPBS)"}, "criteria": [{"id": "1", "title": "Garant\u00eda de Mantenimiento de Ofertas", "description": "Los oferentes, proveedores o contratistas deber\u00e1n garantizar la seriedad de sus ofertas, mediante la garant\u00eda de mantenimiento de la oferta", "source": "tenderer", "requirementGroups": [{"id": "1-1", "description": "La garant\u00eda debe ser de un cierto porcentaje, periodo y tipo", "requirements": [{"id": "1-1-1", "title": "Porcentaje de la garantia", "expectedValue": "5"}, {"id": "1-1-2", "title": "Validez de la garantia en d\u00edas", "expectedValue": "180"}]}]}], "enquiries": [{"id": "3363260456411e15c30089fdb8e040d7-1", "date": "2024-08-29T18:44:29-04:00", "title": "\u00cdTEM 7. FACTOR VIII PLASMATICO LIOFILIZADO", "description": "En las especificaciones t\u00e9cnicas se establece lo siguiente: \"Se requiere documentos de trazabilidad de todas las unidades entregadas hasta la materia prima mediante certificado de materia prima y certificado de calidad del producto del lote a ser entregado\" Al respecto, entendemos que este criterio es para la entrega de los productos y no corresponde a las especificaciones t\u00e9cnicas. Favor confirmar este entendimiento.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-10-24T16:36:35-04:00"}, {"id": "15580eb5212d2fbece1e64f5ec33507d-1", "date": "2024-08-29T16:08:45-04:00", "title": "ITEM 7- Factor VIII Plasm\u00e1tico liofilizado", "description": "En cuanto al requisito: Se requiere documentos de trazabilidad de todas las unidades entregadas hasta la materia prima mediante certificado de materia prima y certificado de calidad del producto del lote a ser entregado\u201d, al respecto se consulta a la convocante. Solicitamos a la convocante que la misma sea excluida de apartado de EETT e incluidas en el apartado de plan de entrega y los documentos que se deben acompa\u00f1ar a cada partida entregada a los parques sanitarios.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-10-24T16:34:53-04:00"}, {"id": "07588e4a813042dbd386e73a14d12d9e-1", "date": "2024-08-29T16:08:02-04:00", "title": "ITEM 3- Factor de coagulaci\u00f3n VIII recombinante", "description": "El PBC cita cuanto sigue: Frascos conteniendo Factor de coagulaci\u00f3n VIII de 500 UI de origen recombinante de cuarta generaci\u00f3n, como polvo est\u00e9ril y apir\u00f3geno para infusi\u00f3n intravenosa, conteniendo soluci\u00f3n de reconstituci\u00f3n para el tratamiento de la Hemofilia A. Con baja inmunogenicidad incidencia de inhibidores totales no superior al 30 % con documentaci\u00f3n respaldatoria\nCon lo que respecta a este \u00faltimo \u201cCon baja inmunogenicidad incidencia de inhibidores totales no superior al 30 % con documentaci\u00f3n respaldatoria\u201d. Solicitamos a la convocante modificarlo y acuerdo a lo ya requerido en un proceso anterior (LPN N\u00ba 25-23 ID 421679) quedando de la siguiente manera: \u201cFrascos conteniendo Factor de coagulaci\u00f3n VIII de 500 UI de origen recombinante de cuarta generaci\u00f3n, como polvo est\u00e9ril y apir\u00f3geno para infusi\u00f3n intravenosa, conteniendo soluci\u00f3n de reconstituci\u00f3n para el tratamiento de la Hemofilia A. Con baja inmunogenicidad exigida, se requiere una incidencia de inhibidores totales no superior al 30 % con estudios cl\u00ednicos publicados en revistas cient\u00edficas indexadas.\u201d\nLa importancia de avalar la baja incidencia de inhibidores a trav\u00e9s de estudios cl\u00ednicos publicados radica en que, son estos documentos los que avalan que el producto ofertado cuenta con las garant\u00edas de seguridad y eficacia en el tratamiento de la hemofilia A, recordemos que los inhibidores son anticuerpos que neutralizan los concentrados de factor de coagulaci\u00f3n y representan la complicaci\u00f3n mas grave de la enfermedad.\nReiteramos que de nada sirve solicitar la acreditaci\u00f3n de la baja inmunogenicidad del producto ofertado si estos no se encuentran sustentados en estudio cient\u00edfico sino solo en documentaciones que no pueden ser certificadas por la comunidad cient\u00edfica.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-10-24T16:33:36-04:00"}, {"id": "56fd3982a3f53d4890679e05d0dbce2c-1", "date": "2024-09-02T11:43:11-04:00", "title": "LISTA DE PRECIO - ESPECIFICACIONES DEL PLIEGO", "description": "Existe una diferencia sustancial entre los bienes requeridos en el Pliego y los determinados en la lista de precios. Los Items 3, 4, 5, 6 y 8 son designdaos con un numero de factor y en la lista de precios estan con otro numero de factor. Favor modificar.  Verificar tambien la especificaci\u00f3n de los Items", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-10-24T16:36:54-04:00"}, {"id": "c4cc828589012ef5b8a565a0b5005544-1", "date": "2024-08-29T16:08:51-04:00", "title": "ITEM 7- Factor VIII Plasm\u00e1tico liofilizado", "description": "Para el Factor VIII plasm\u00e1tico se requiere la presentaci\u00f3n de documentos de trazabilidad de todas las unidades entregadas hasta la materia prima mediante certificado de materia prima y certificado de calidad del producto del lote a ser entregado\u201d, al respecto se consulta a la convocante. \u00bfCu\u00e1l es el fin que persigue al solicitar dicha documentaci\u00f3n? Cuando que ya es exigencia la presentaci\u00f3n de estudios que demuestran que los productos ofertados cuentan con doble proceso de inactivaci\u00f3n/remoci\u00f3n viral.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-10-24T16:35:03-04:00"}, {"id": "64f8631264194347430e52b293a18b9f-1", "date": "2024-08-29T18:35:30-04:00", "title": "EETT ITEMS 3 Y 4", "description": "Cuando requieren que el producto cuente con baja inmunogenicidad incidencia de inhibidores totales no superior al 30 % con documentaci\u00f3n respaldatoria. Se consulta si esto se refiere a la poblaci\u00f3n tratada en general o a la poblaci\u00f3n ya tratada previamente con el factor VIII.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-10-24T16:36:26-04:00"}, {"id": "9663bcd117abdf08e8627fed42a11b48-1", "date": "2024-08-29T18:34:41-04:00", "title": "EETT - ITEMS 3 Y 4", "description": "En el PBC se requiere lo siguiente: \u201cCon baja inmunogenicidad incidencia de inhibidores totales no superior al 30 % con documentaci\u00f3n respaldatoria.\u201d Solicitamos aclarar en base a que criterios se establece que la incidencia de inhibidores totales no debe ser superior al 30%. Considerando que existen estudios cl\u00ednicos que arrojan una aceptaci\u00f3n de hasta el 50% de incidencia. Solicitamos tengan a bien considerar estos estudios y aumentar la incidencia a al menos 45%. Esto en base a los diferentes estudios publicados y de manera a establecer criterios que eviten favorecer indebidamente a un oferente en particular.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-10-24T16:36:10-04:00"}, {"id": "9e685d2b81b77880dffc851c18854dd2-1", "date": "2024-09-02T16:49:05-04:00", "title": "SUMINISTROS REQUERIDOS Y EETT", "description": "Solicitamos a la Convocante verificar el listado de Suministros requeridos en el PBC y los requeridos en el Portal de Contrataciones P\u00fablicas, ya que existe una discrepancia entre las numeraciones asignadas a los \u00edtems, por lo cual tampoco los precios corresponden. Se solicita que dicha discrepancia sea subsanada a modo de evitar confusiones en los potenciales oferentes.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-10-24T16:37:06-04:00"}, {"id": "7509b56ba3251465992e93e2634643fd-1", "date": "2024-08-29T18:22:44-04:00", "title": "Especifiaciones Tecnicas - \u00cdTEMS 3 y 4 - Factor de coagulaci\u00f3n VIII recombinante", "description": "En las especificaciones t\u00e9cnicas se requiere lo siguiente: \u201cCon baja inmunogenicidad incidencia de inhibidores totales no superior al 30 % con documentaci\u00f3n respaldatoria.\u201d\nAl respecto, solicitamos a la Convocante establecer claramente a que poblaci\u00f3n se refiere al requerir este porcentaje de incidencia de inhibidores totales. \u00bfEsta incidencia es requerida para pacientes previamente tratados o para pacientes sin tratamiento previo? Esta consulta la realizamos considerando que no existe evidencia cient\u00edfica, que establezca un riesgo similar entre ambas poblaciones. \nEs necesario considerar que los pacientes sin tratamiento previo son quienes presentan desde el punto de vista inmunog\u00e9nico, una mayor predisposici\u00f3n al desarrollo de inhibidores. Por esta raz\u00f3n se debe realizar la aclaraci\u00f3n sobre qu\u00e9 grupo de pacientes desea la Convocante el estudio, ya que existe un n\u00famero considerablemente mayor de pacientes previamente tratados, que no representan el mismo riesgo inmunog\u00e9nico que los pacientes sin tratamiento previo, y por tanto, a la poblaci\u00f3n mayor se le analizar\u00eda bajo un criterio que corresponder\u00eda solamente a pacientes sin tratamiento previo.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-10-24T16:35:52-04:00"}, {"id": "505776047765ea646cf671a7f5883826-1", "date": "2024-08-29T16:08:11-04:00", "title": "ITEM 7- Factor VIII Plasm\u00e1tico liofilizado", "description": "Frascos de 1000 UI, conteniendo Factor de coagulaci\u00f3n VIII de origen plasm\u00e1tico humano liofilizado con inactivaci\u00f3n viral, conteniendo soluci\u00f3n de reconstituci\u00f3n para tratamiento de la Hemofilia. Se requiere documentos de trazabilidad de todas las unidades entregadas hasta la materia prima mediante certificado de materia prima y certificado de calidad del producto del lote a ser entregado. La oferta debe contener estudios de baja inmunogenicidad e inactivaci\u00f3n viral con la documentaci\u00f3n respaldatoria.\nCon lo que respecta al siguiente punto: \u201cSe requiere documentos de trazabilidad de todas las unidades entregadas hasta la materia prima mediante certificado de materia prima y certificado de calidad del producto del lote a ser entregado\u201d. Solicitamos a la convocante la exclusi\u00f3n de dicho requisito de las EETT puesto que: 1) Esa informaci\u00f3n es obtenida a partir de los Certificados de An\u00e1lisis de Calidad de Origen (COA) que se acompa\u00f1a a cada lote elaborado y 2) Estos productos son fabricados en el extranjero por lo tanto resulta irrazonable exigir la presentaci\u00f3n de estos documentos cuando que la adjudicaci\u00f3n y la obligaci\u00f3n en la entrega de los productos no se ha dado.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-10-24T16:33:59-04:00"}, {"id": "2e9c0fb709ea461f20f226263f5627de-1", "date": "2024-08-26T15:22:53-04:00", "title": "ITEMS - PBC", "description": "Los items cargados en el SICP no coinciden con lo establecido en el PBC. Desde el ITEM 3 al ITEM 8. Solicitamos a la convocante corregir dicha situaci\u00f3n.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-10-24T16:32:48-04:00"}, {"id": "5e81b3f6bcad0d4e84002f9854d12b6a-1", "date": "2024-08-29T16:09:15-04:00", "title": "ITEMS SOLICITADOS", "description": "Solicitamos a la convocante verificar los datos subidos en el SICP, puesto que no coinciden con lo solicitado en el PBC y esto podr\u00eda generar confusiones al momento de la presentaci\u00f3n de la oferta.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-10-24T16:35:36-04:00"}, {"id": "667c26216b575fc69dd2a0b2ee29bcb9-1", "date": "2024-08-29T18:05:02-04:00", "title": "PRECIO REFERENCIAL ITEM 6- Factor IX plasmatico", "description": "Solicitamos a la convocante modificar el precio referencial del \u00edtem 6 a 7.767.669 gs, esto en atenci\u00f3n que se encuentra por debajo del precio del mercado y teniendo en cuenta la \u00faltima adjudicaci\u00f3n de vuestra instituci\u00f3n en la LPN 25-23 ID 421679", "answer": "Ajustarse al Dictamen de Precios DOC 103/2024.-", "dateAnswered": "2024-10-24T16:39:32-04:00"}, {"id": "4c2bc6ae8b84c6d046ae5f437fd9f74a-1", "date": "2024-08-29T18:04:48-04:00", "title": "PRECIO REFERENCIAL ITEM 3- Factor de coagulacion VIII recombinante", "description": "Solicitamos a la convocante modificar el precio referencial del \u00edtem 3 a 4.800.000 gs, esto en atenci\u00f3n que se encuentra por debajo del precio del mercado y teniendo en cuenta la \u00faltima adjudicaci\u00f3n de vuestra instituci\u00f3n en la LPN 25-23 ID 421679", "answer": "Ajustarse al Dictamen de Precios DOC 103/2024.-", "dateAnswered": "2024-10-24T16:39:23-04:00"}, {"id": "8b2db5398a7d3073e87a1e86eccb9fe5-1", "date": "2024-08-29T16:08:07-04:00", "title": "ITEM 4- Factor de coagulaci\u00f3n VIII recombinante", "description": "El PBC cita cuanto sigue: Frascos conteniendo Factor de coagulaci\u00f3n VIII de 1000 UI de origen recombinante de cuarta generaci\u00f3n, como polvo est\u00e9ril y apir\u00f3geno para infusi\u00f3n intravenosa, conteniendo soluci\u00f3n de reconstituci\u00f3n para el tratamiento de la Hemofilia A. Con baja inmunogenicidad incidencia de inhibidores totales no superior al 30 % con documentaci\u00f3n respaldatoria.\nCon lo que respecta a este \u00faltimo \u201cCon baja inmunogenicidad incidencia de inhibidores totales no superior al 30 % con documentaci\u00f3n respaldatoria\u201d. Solicitamos a la convocante modificarlo y acuerdo a lo ya requerido en un proceso anterior (LPN N\u00ba 25-23 ID 421679) quedando de la siguiente manera: \u201cFrascos conteniendo Factor de coagulaci\u00f3n VIII de 1000 UI de origen recombinante de cuarta generaci\u00f3n, como polvo est\u00e9ril y apir\u00f3geno para infusi\u00f3n intravenosa, conteniendo soluci\u00f3n de reconstituci\u00f3n para el tratamiento de la Hemofilia A. Con baja inmunogenicidad exigida, se requiere una incidencia de inhibidores totales no superior al 30 % con estudios cl\u00ednicos publicados en revistas cient\u00edficas indexadas.\u201d\nLa importancia de avalar la baja incidencia de inhibidores a trav\u00e9s de estudios cl\u00ednicos publicados radica en que, son estos documentos los que avalan que el producto ofertado cuenta con las garant\u00edas de seguridad y eficacia en el tratamiento de la hemofilia A, recordemos que los inhibidores son anticuerpos que neutralizan los concentrados de factor de coagulaci\u00f3n y representan la complicaci\u00f3n mas grave de la enfermedad.\nReiteramos que de nada sirve solicitar la acreditaci\u00f3n de la baja inmunogenicidad del producto ofertado si estos no se encuentran sustentados en estudios cient\u00edficos sino solo en documentaciones que no pueden ser certificadas por la comunidad cient\u00edfica.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": 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