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Servicios asistenciales de salud", "id": 17}]}}], "tender": {"id": "1f09a02b-8e1e-6212-bf5a-bdfcac4a0a66", "coveredBy": ["oferta_electronica"], "title": "SBEN N\u00b0 36/2025 \"ADQUISICION DE PEMBROLIZUMAB 100 MG PARA PACIENTES DEL INCAN Y OTROS CENTROS DEPENDIENTES DEL MINISTERIO DE SALUD PUBLICA Y BIENESTAR SOCIAL - PLURIANUAL - CONTRATO ABIERTO\"", "status": "complete", "awardCriteria": "priceOnly", "awardCriteriaDetails": "Por Item", "submissionMethod": ["electronicAuction"], "techniques": {"hasElectronicAuction": true}, "bidOpening": {"date": "2025-11-19T10:00:00-04:00", "address": {"streetAddress": "A trav\u00e9s del portal, Apertura electr\u00f3nica"}}, "submissionMethodDetails": "Lugar entrega ofertas: A trav\u00e9s del portal, Oferta electr\u00f3nica", "statusDetails": "Adjudicada", "clarificationMeetings": [{"address": {"streetAddress": "NO"}, "id": "1"}], "mainProcurementCategoryDetails": "Bienes - Medicamentos y Productos Farmaceuticos", "hasEnquiries": false, "value": {"amount": 438780200000, "currency": "PYG"}, "datePublished": "2025-10-10T16:23:19-04:00", "tenderPeriod": {"startDate": "2025-10-10T16:23:19-04:00", "endDate": "2025-11-19T10:00:00-04:00", "durationInDays": 39}, "awardPeriod": {"startDate": "2025-11-19T10:00:00-04:00"}, "contractPeriod": {"maxExtentDate": "2027-12-31T00:00:00-04:00"}, "enquiryPeriod": {"endDate": "2025-11-13T12:00:00-04:00", "startDate": "2025-10-10T16:23:19-04:00", "durationInDays": 33}, "mainProcurementCategory": "services", "additionalProcurementCategories": ["services"], "procurementMethod": "open", "procurementMethodDetails": "Subasta a la baja electr\u00f3nica nacional", "procuringEntity": {"id": "DNCP-SICP-CODE-1431", "name": "Instituto Nacional del Cancer / Ministerio de Salud P\u00fablica y Bienestar Social"}, "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": "120"}]}]}], "enquiries": [{"id": "d26362e1b070977e9ceee1322a195530-1", "date": "2025-10-28T11:59:16-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "En relaci\u00f3n con el punto f) para productos de origen nacional y los requisitos detallados en los puntos b), c) y d) del PBC, se solicita a la convocante confirmar si la presentaci\u00f3n de los estudios de caracterizaci\u00f3n fisicoqu\u00edmica, farmacocin\u00e9tica/farmacodinamia y estudios cl\u00ednicos no aplica para los productos de origen nacional.", "answer": "Remitirse al Pliego de Bases y Condiciones.", "dateAnswered": "2025-11-14T11:25:00-04:00"}, {"id": "98a4f5b676e06008992f328c1f4084f5-1", "date": "2025-10-21T10:14:56-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica - Punto d)", "description": "En relaci\u00f3n con el requisito del PBC que solicita: \"d) Los productos biol\u00f3gicos deber\u00e1n incluir sus estudios cl\u00ednicos, propios y concluidos con una poblaci\u00f3n estad\u00edsticamente significativa\", solicitamos a la convocante eliminarlo por ser un requisito improcedente y contrario al marco legal vigente. Dicha exigencia contraviene expresamente lo establecido en la Ley N.\u00ba 3283/2007 \"De Protecci\u00f3n de Informaci\u00f3n No Divulgada y Datos de Prueba\", la cual proh\u00edbe requerir o divulgar la informaci\u00f3n confidencial (datos de prueba, estudios cl\u00ednicos) presentada ante la autoridad sanitaria para la obtenci\u00f3n del Registro Sanitario. Estos datos confidenciales ya forman parte del expediente t\u00e9cnico evaluado y aprobado por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) para la emisi\u00f3n del Registro Sanitario (Resoluci\u00f3n N.\u00ba 233/2024). Por lo tanto, su solicitud en el proceso licitatorio resulta improcedente y ajena al \u00e1mbito de evaluaci\u00f3n del ente convocante, limit\u00e1ndose la evaluaci\u00f3n al cumplimiento de la normativa de la DINAVISA y no a la re-evaluaci\u00f3n de datos t\u00e9cnicos protegidos.\nDe mantenerse este requisito, se estar\u00eda limitando la participaci\u00f3n de potenciales oferentes en clara contravenci\u00f3n a los principios de Igualdad y Libre Competencia (Ley N\u00b0 7021/2022 Art 4. Inciso D).", "answer": "Remitirse al Pliego de Bases y Condiciones.", "dateAnswered": "2025-11-14T11:06:24-04:00"}, {"id": "c16df2d0423806fa5c0e7ba05bbf091a-1", "date": "2025-10-21T10:36:31-04:00", "title": "Especificaciones t\u00e9cnicas", "description": "Favor aclarar la forma farmac\u00e9utica solicitada, dado que solo expresa la presentaci\u00f3n del producto.", "answer": "Remitirse al Pliego de Bases y Condiciones.", "dateAnswered": "2025-11-14T11:10:57-04:00"}, {"id": "ceae10c46881902d7a369ca39ff3e09e-1", "date": "2025-10-21T10:47:28-04:00", "title": "Documentos t\u00e9cnicos", "description": "A la entidad compradora: Solicitamos confirmar si ser\u00e1n aceptados documentos de origen INDIA y CHINA.", "answer": "Los documentos deben ser traducidos al espa\u00f1ol por traductor matriculado. El Comit\u00e9 de Evaluaci\u00f3n deber\u00e1 concluir ci\u00f1\u00e9ndose al Pliego de Bases y Condiciones.", "dateAnswered": "2025-11-14T11:15:26-04:00"}, {"id": "842fbf13ef4f0d8f2eb3655d6054ce2f-1", "date": "2025-11-11T14:08:04-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "5) Los productos biosimilares no deben tener rechazo de Autorizaci\u00f3n de Comercializaci\u00f3n en ninguna de las Autoridades Sanitarias\nmencionadas en el punto e). Consulta: Ser\u00e1 aceptada una DDJJ que exprese no tener rechazo en las autoridades Sanitarias?", "answer": "Es un documento que puede ser considerado. La Convocante podr\u00e1 recurrir a instancias para certificar la Declaraci\u00f3n Jurada.", "dateAnswered": "2025-11-14T11:27:03-04:00"}, {"id": "594e13915bf25e851ffcc7d319dae26b-1", "date": "2025-10-21T11:22:46-04:00", "title": "CAPACIDAD TECNICA", "description": "CONSULTA 1\nEn la VERSION 1 del Pliego, titulo Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica, la convocante estableci\u00f3:\nPara productos importados:\n1. El producto biosimilar presentara copia autenticada del Certificado de Registro Sanitario o Certificado de Libre Venta / CPP vigente otorgado por otorgado por al menos 1 (una) de las siguientes Autoridades de Alta Vigilancia Sanitaria EMA, FDA, HEALTH CANADA, ANVISA o ANMAT.\n2. El producto biosimilar deber\u00e1n incluir sus estudios pre-clinicos, cl\u00ednico y de inmunogenecidad, propios y concluidos, para demostrar comparabilidad con el producto innovador de referencia. en calidad, eficacia y seguridad seg\u00fan el ejercicio de biocomparabilidad que establece la OMS o ICH. Estos estudios deber\u00e1n ser multicentricos, aleatorizados, en una poblaci\u00f3n estad\u00edsticamente significativa cuyo dise\u00f1o reslute de las recomendaciones de OMS o ICH, conforme a la REsoluci\u00f3n DINAVISA N\u00b0 233/2024. Los documentos podr\u00e1n presentarse en copia simple, no obstante para la firma del contrato los mismos deber\u00e1n estar debidamente legalizados por el Ministerio de Relaciones Exteriores del Paraguay o apostillados\n3. Los productos farmac\u00e9uticos multifuentes (seg\u00fan definici\u00f3n OMS) deber\u00e1n presentar estudios de demostraci\u00f3n de Bioequivalencia comparable con el producto de referencia original y/o pruebas de disoluci\u00f3n comparativas que respaldan la bioexenci\u00f3n de las concentraciones menores. Los documentos podr\u00e1n presentarse en copia simple, no obstante para la firma del contrato los mismos deber\u00e1n estar debidamente legalizados por el Ministerio de Relaciones Exteriores del Paraguay o apostillados\n4. Los productos biol\u00f3gicos innovadores (Originales) solo deben presentar copia autenticada de Certificado de Libre Venta/CPP, emitido por una entidad regulatoria de referencia, FDA o EMA, debidamente legalizado y/o apostillado.\n \nLuego la convocante publica una VERSION 2, modificando los requisitos anteriores y estableciendo:\nPara Anticuerpos Monoclonales\na. Los productos biol\u00f3gicos, sean innovadores o biosimilares, deber\u00e1n contar con Registro Sanitario vigente con la inscripci\u00f3n MB, en cumplimiento del Decreto 6611/16, expedido por la Direcci\u00f3n de Vigilancia Sanitaria (DNVS) del Ministerio de Salud P\u00fablica y Bienestar Social, con antelaci\u00f3n de por lo menos 2 (dos) a\u00f1os.\nb) Los productos biol\u00f3gicos deber\u00e1n presentar la caracterizaci\u00f3n fisicoqu\u00edmica similar al producto biol\u00f3gico innovador de referencia.\nc) Los productos biol\u00f3gicos deber\u00e1n presentar estudios de farmacocin\u00e9tica y farmacodinamia comparables al biol\u00f3gico innovador.\nd) Los productos biol\u00f3gicos deber\u00e1n incluir sus estudios cl\u00ednicos, propios y concluidos con una poblaci\u00f3n estad\u00edsticamente significativa.\ne) El producto biosimilar importado presentar\u00e1 certificados de Registro Sanitario y Autorizaci\u00f3n de Comercializaci\u00f3n vigentes, otorgados por lo menos por 1 de las Autoridades de Alta Vigilancia Sanitaria: EMA, FDA, Health Canad\u00e1, ANVISA, o ANMAT, con antelaci\u00f3n de 18 (dieciocho) meses.\nf) En caso de ofertar un producto de origen nacional, se presentar\u00e1 \u00fanicamente Certificado de Registro Sanitario y Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n y Control, ambas emitidas por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA).\ng) El oferente deber\u00e1 presentar Certificado de Buenas Pr\u00e1cticas de Farmacovigilancia (BPFV), emitida por la Direcci\u00f3n Nacional de Vigilancia Sanitaria, el cual deber\u00e1 mantenerse valido durante la vigencia del contrato.\nh) Los productos biosimilares no deben tener rechazo de Autorizaci\u00f3n de Comercializaci\u00f3n en ninguna de las Autoridades Sanitarias mencionadas en el punto e)\ni) Los productos biol\u00f3gicos innovadores presentar\u00e1n copia autenticada de Certificado de Libre Venta, emitido por una entidad regulatoria de referencia, FDA o EMA (No requieren presentar estudios mencionados) ni la experiencia a 18 (dieciocho) meses.\nj) Copia autenticada del acta de fijaci\u00f3n de precios del producto ofertado, expedida por la Direcci\u00f3n de Vigilancia Sanitaria (DNVS) del Ministerio de Salud P\u00fablica y Bienestar Social, en forma legible y emitida con anterioridad a la fecha de apertura o inicio de la etapa competitiva.\nk) 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). En el caso que el oferente no cuente con Deposito propio, deber\u00e1 presentar copia autenticada del Contrato de Alquiler con la Empresa Depositaria, m\u00e1s el Certificado de Buenas Practicas de Almacenamiento Vigente de la Empresa Titular del Dep\u00f3sito, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA).\nl) Declaraci\u00f3n jurada donde el oferente declara de qu\u00e9 cuentan con equipos de refrigeraci\u00f3n acorde para almacenar a temperatura constante medicamentos que requieran de temperaturas de 2\u00b0a 8\u00aa (refrigerados) y con generadores propios para suministrar energ\u00eda el\u00e9ctrica en caso de cortes energ\u00e9ticas.\nm) Declaraci\u00f3n jurada del proveedor que posee capacidad de mantener en sus dep\u00f3sitos stock suficiente para la entrega programada seg\u00fan necesidad del INCAN, conforme a espacio y disponibilidad.\nn) Declaraci\u00f3n Jurada del oferente donde manifiesta que asignar\u00e1 c\u00f3digos de barras/QR a los productos que le fueran adjudicados para su entrega en el INCAN al momento de ser implementado y requerido por el MSPBS.\nEn caso de que las documentaciones emitidas por la Direcci\u00f3n Nacional de Vigilancia Sanitaria se encuentren vencidas, deber\u00e1 acompa\u00f1ar la Copia Autenticada de la Constancia emitida por la (DINAVISA) de que los mismos se encuentran en tr\u00e1mite de Renovaci\u00f3n, y que el producto puede seguir siendo comercializados y/o importados mientras dure el tr\u00e1mite\nLos documentos podr\u00e1n presentar en copia simple, no obstante para la firma del contrato deber\u00e1n estar debidamente legalizados por el Ministerio de Relaciones Exteriores del Paraguay o apostillados.\nEn caso de necesidad o duda la convocante a trav\u00e9s del Comit\u00e9 Evaluador podr\u00e1 solicitar al oferente o a La Direcci\u00f3n Nacional de Vigilancia Sanitaria del Ministerio de Salud P\u00fablica y Bienestar Social toda la documentaci\u00f3n presentada por el oferente a la mencionada Direcci\u00f3n de conformidad al Decreto 6611/16 POR EL CUAL SE REGLAMENTA EL ARTICULO 24 DE LA LEY 111997 DE PRODUCTOS PARA LA SALUD Y OTROS\", Y SE ESTABLECEN LOS REQUISITOS PARA EL REGISTRO DE MEDICAMENTOS BIOLOGICOS\" Art. N\u00b0 12. La presentaci\u00f3n de la oferta en el marco del presente llamado implica la autorizaci\u00f3n del oferente para acceder a dicha documentaci\u00f3n.\n \n  \nCONSULTA: La convocante debe evitar que al momento de la evaluaci\u00f3n de ofertas, los requisitos generen MULTIPLES interpretaciones en los miembros del comit\u00e9 que conlleven dificultades para su aplicaci\u00f3n e imprevistos a la hora de la adjudicaci\u00f3n, ocasionando que luego puedan generar impugnaciones cuyo efecto solo ser\u00eda la dilaci\u00f3n de la ejecuci\u00f3n del contrato, en detrimento de la atenci\u00f3n al p\u00fablico. Dejando constancia de que los requisitos y condiciones, por mandato legal, deben ser claros y precisos,  buscando tambi\u00e9n asegurar la calidad del producto.\n \nEn atenci\u00f3n a ello, notamos que en la Versi\u00f3n 2, la Convocante adem\u00e1s de modificar los t\u00edtulos de \u201cpara productos importados\u201d a \u201cPara Anticuerpos Monoclonales\u201d ha consignado en los incisos b) c) y d) \u201clos productos biol\u00f3gicos\u201d desplegando una serie de estudios, debiendo corresponder, como se establec\u00eda en la primera versi\u00f3n y decir para los inc. b), c) y d) \u201clos productos biosimilares\u201d.\n \nAs\u00ed mismo, en el inciso f), la Convocante ha establecido que, en caso de ofertarse un producto de origen nacional, se presentar\u00e1 \u00fanicamente certificado de Registro Sanitario y Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n y control. Entendemos que en este caso no existe producto nacional y si existiere el mismo debe garantizar su calidad por ser BIOSIMILAR con los estudios de  biosimilaridad seg\u00fan reglamentaciones vigentes y otros respectivamente.\nAs\u00ed tambi\u00e9n, la versi\u00f3n 2 ha eliminado el requisito constante en esta clase de procesos: Los productos biol\u00f3gicos innovadores (Originales) solo deben presentar copia autenticada de Certificado de Libre Venta/CPP, emitido por una entidad regulatoria de referencia, FDA o EMA, debidamente legalizado y/o apostillado.\nLo establecido en la versi\u00f3n 2 contiene en s\u00ed mismo contradicciones entre sus requerimientos. Tampoco, tal como est\u00e1n requeridos, se garantiza la  calidad, seguridad y eficacia del producto, equiparando al producto innovador los biosimilares y/o nacionales, sin los estudios de biosimilaridad y otros.\nAtento a lo expuesto, solicitamos a la Convocante excluir la redacci\u00f3n de la versi\u00f3n 2 del PBC respecto a los requisitos se\u00f1alados, estableci\u00e9ndolos conforme a la Versi\u00f3n 1, por ser estos los que se encuentran redactados en forma clara y precisa, siguiendo la forma en que en el Ministerio de Salud y otras instituciones rutinariamente lo realizan, todo ello a fin de garantizar la calidad, seguridad y eficacia del producto y evitar m\u00faltiples e indebidas interpretaciones al momento de la evaluaci\u00f3n.", "answer": "Se realizaron las adecuaciones pertinente. Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-11-14T11:20:05-04:00"}, {"id": "befb02b85ba47ca3e1242b34058503fc-1", "date": "2025-10-21T11:09:26-04:00", "title": "Plan de Entrega de los bienes", "description": "en PBC expresa: CANTIDAD MAXIMA A ser fraccionadas seg\u00fan necesidad y stock del Departamento de Farmacia - Banco de Drogas. Las \u00f3rdenes de compras ser\u00e1n emitidas una vez emitida la totalidad de las cantidades m\u00ednimas, donde se deber\u00e1 emitir hasta 30 d\u00edas antes de la fecha de tope de vigencia del contrato, con un plazo de entrega de hasta 15(quince) d\u00edas corridos contados a partir de la recepci\u00f3n de las ordenes de compra. Vemos como innecesaria esta instrucci\u00f3n dado que solo limita al INCAN y sus facultades de ejecutar sus contratos de acuerdo a sus necesidades. Recomendamos a la entidad excluir dicho punto a fin de proteger sus propios intereses.", "answer": "La fecha tope de emisi\u00f3n de Ordenes de Compra se establece a fin de otorgar al proveedor un plazo para la log\u00edstica de provisi\u00f3n enmarcado en el contrato vigente.", "dateAnswered": "2025-11-14T11:18:11-04:00"}, {"id": "3d5526ac042ea5b345d4f06cff2f1193-1", "date": "2025-10-21T09:41:15-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "La convocante solicita para el punto a) \u201cLos productos biol\u00f3gicos, sean innovadores o biosimilares, deber\u00e1n contar con Registro Sanitario vigente con la inscripci\u00f3n MB, en cumplimiento del Decreto 6611/16, expedido por la Direcci\u00f3n de Vigilancia Sanitaria (DNVS) del Ministerio de Salud P\u00fablica y Bienestar Social, CON ANTELACI\u00d3N DE POR LO MENOS 2 (DOS) A\u00d1OS.\u201d\n A fin de entrar en ambig\u00fcedades o contradicciones con el punto e) en la que solicitan \u201ccon antelaci\u00f3n de 18 (dieciocho) meses\u201d, se solicita a la convocante excluir la antig\u00fcedad solicitada en el PUNTO a). Se sugiere la siguiente redacci\u00f3n:\n\u201ca) Los productos biol\u00f3gicos, sean innovadores o biosimilares, deber\u00e1n contar con Registro Sanitario vigente con la inscripci\u00f3n MB, expedido por la Direcci\u00f3n de Vigilancia Sanitaria (DNVS) del Ministerio de Salud P\u00fablica y Bienestar Social\u201d", "answer": "Remitirse al Pliego de Bases y Condiciones.", "dateAnswered": "2025-11-14T11:05:33-04:00"}, {"id": "b1f751b2fcc9e6161c5ee4f5eb39651b-1", "date": "2025-10-21T11:49:57-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "Se solicita incorporar como requisito documental la presentaci\u00f3n de una Constancia o Certificaci\u00f3n de Buenas Pr\u00e1cticas de Farmacovigilancia vigente, emitida por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), aplicable a todo oferente, sea nacional o importado.\nConforme a la Ley N\u00b0 1119/97, la Ley N\u00b0 3283/07 y su modificaci\u00f3n por la Ley N\u00b0 7256/24, as\u00ed como la Resoluci\u00f3n DINAVISA N\u00b0 51/2022, la responsabilidad sobre la farmacovigilancia y el seguimiento post-comercializaci\u00f3n recae en el titular del registro sanitario o su representante local. Por tanto, corresponde exigir la constancia de cumplimiento de Buenas Pr\u00e1cticas de Farmacovigilancia como condici\u00f3n t\u00e9cnica para garantizar la seguridad y trazabilidad de los productos ofertados.", "answer": "Se realizaron las adecuaciones pertinentes. Remitirse al Pliego de Bases y Condiciones.", "dateAnswered": "2025-11-14T11:24:34-04:00"}, {"id": "27730fcc004fbc60852efa575e30e204-1", "date": "2025-10-21T10:36:36-04:00", "title": "Requisitos documentales para la evaluaci\u00f3n de la experiencia", "description": "No queda claro si la entidad solicita FACTURAS+REMISI\u00d3N, o si solo ser\u00e1 necesaria la presentaci\u00f3n de la factura. La redacci\u00f3n genera confusi\u00f3n. Favor delimitar correctamente los documentos solicitados a fin de no generar un proceso de evaluaci\u00f3n que podr\u00eda desembocar en resultados arbitrarios.", "answer": "La Convocante requiere facturas con su respectiva nota de remisi\u00f3n y/o acta de recepcion. 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