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Repuestos, herramientas, c\u00e1maras y cubiertas.", "id": 18}, {"name": "Construcci\u00f3n, Restauraci\u00f3n, Reconstrucci\u00f3n o Remodelaci\u00f3n y Reparaci\u00f3n de Inmuebles", "id": 21}]}}, {"name": "GRUPO INGENIO SOCIEDAD ANONIMA", "id": "PY-RUC-80088101-0", "identifier": {"id": "80088101-0", "legalName": "GRUPO INGENIO SOCIEDAD ANONIMA", "scheme": "PY-RUC"}, "roles": ["enquirer"], "contactPoint": {"name": "JORGE DAMIAN BENITEZ FRANCO", "email": "sac@grisa.com.py", "url": "http://www.grisa.com.py"}, "address": {"countryName": "Paraguay", "locality": "ASUNCION", "region": "Asunci\u00f3n", "streetAddress": "25 DE MAYO N\u00b0 1050 ESQUINA PASAJE MOLAS"}, "details": {"scale": "sme", "legalEntityTypeDetail": "S.A.", "activityTypes": ["goods", "services"], "categories": [{"name": "Equipos, Productos e instrumentales M\u00e9dicos y de Laboratorio. Servicios asistenciales de salud", "id": 17}, {"name": "Consultor\u00edas, Asesor\u00edas e Investigaciones. Estudios y Proyectos de inversi\u00f3n", "id": 5}, {"name": "Servicios T\u00e9cnicos", "id": 7}, {"name": "Capacitaciones y Adiestramientos", "id": 4}, {"name": "Utiles de oficina, Productos de papel y cart\u00f3n e impresos", "id": 11}, {"name": "Productos quimicos", "id": 16}, {"name": "Servicios de Limpiezas, Mantenimientos y reparaciones menores y mayores de Instalaciones, Maquinarias y Veh\u00edculos", "id": 2}]}}], "tender": {"id": "1effb489-d832-6138-a1df-2b2be50ad0bc", "title": "Mantenimiento Preventivo y Correctivo con Asistencia T\u00e9cnica y    provisi\u00f3n de repuestos de la Planta de Generaci\u00f3n de Oxigeno", "status": "complete", "awardCriteria": "priceOnly", "awardCriteriaDetails": "Por Total", "submissionMethod": ["inPerson"], "bidOpening": {"date": "2025-04-04T10:00:00-04:00", "address": {"streetAddress": "UOC N\u00b0 4 HOSPITAL NACIONAL"}}, "submissionMethodDetails": "Lugar entrega ofertas: UOC N\u00b0 4 HOSPITAL NACIONAL", "statusDetails": "Adjudicada", "enquiriesAddress": {"streetAddress": "Consultas Virtuales a trav\u00e9s del portal"}, "clarificationMeetings": [{"date": "2025-03-28T11:00:00-04:00", "address": {"streetAddress": "CENTRO MEDICO NACIONAL-HOSPITAL NACIONAL"}, "id": "1"}], "mainProcurementCategoryDetails": "Servicios - Servicios de Produccion, Fabricacion Industrial y Mantenimientos de maquinarias", "hasEnquiries": false, "value": {"amount": 2500000000, "currency": "PYG"}, "datePublished": "2025-03-19T16:28:13-04:00", "tenderPeriod": {"startDate": "2025-03-19T16:28:13-04:00", "endDate": "2025-04-04T09:45:00-04:00", "durationInDays": 15}, "awardPeriod": {"startDate": "2025-04-04T10:00:00-04:00"}, "contractPeriod": {"maxExtentDate": "2027-12-31T00:00:00-04:00"}, "enquiryPeriod": {"endDate": "2025-03-31T12:00:00-04:00", "startDate": "2025-03-19T16:28:13-04:00", "durationInDays": 11}, "mainProcurementCategory": "goods", "procurementMethod": "open", "procurementMethodDetails": "Licitaci\u00f3n P\u00fablica Nacional", "procuringEntity": {"id": "DNCP-SICP-CODE-1684", "name": "Hospital Nacional  / 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"}]}]}], "additionalProcurementCategories": ["consultingServices"], "enquiries": [{"id": "295b7f3f68f112fa8cb709413f7c3a4e-1", "date": "2025-03-29T16:25:24-04:00", "title": "CAPACIDAD TECNICA", "description": "Se solicita a la convocante que ELIMINE o MODIFIQUE el requerimiento indicado en el apartado CAPACIDAD TECNICA del PBC espec\u00edficamente donde dice \u201cEl oferente deber\u00e1 contar con stock de repuestos para reparaci\u00f3n de Planta Generadora de Oxigeno PSA y todos sus componentes, tarjeta RFI para resetear alarma de compresor, Presentar Declaraci\u00f3n Jurada con autorizaci\u00f3n a la Convocante, para la Realizar una visita t\u00e9cnica, durante la etapa de evaluaci\u00f3n, al local del oferente para asegurar el cumplimiento de dicho requerimiento\u201d. Debido a que este requerimiento no resulta t\u00e9cnicamente indispensable para la presentaci\u00f3n y evaluaci\u00f3n de la oferta y la capacidad t\u00e9cnica, en vista de que los servicios ser\u00e1n ejecutados posterior a la Adjudicaci\u00f3n, y los repuestos adecuados para el equipo se pueden adquirir sin necesidad de contar en Stock. Por razonabilidad no se pueden adquirir antes los repuestos y dejarlo almacenado en local sin antes saber si, finalmente tu empresa ser\u00e1 adjudicada, a no ser que de antemano ya sepas que tu empresa ser\u00e1 la adjudicada y por ello ya tienes todos los repuestos almacenados en stock y solo faltar\u00eda realizar una inspecci\u00f3n ocular para evaluar este criterio cumplido.\nAl eliminar o modificar este requerimiento del PBC se dar\u00e1 cumplimiento al principio de igualdad de condiciones de participaci\u00f3n y libre competencia establecido en la Ley 7021 de Contrataciones Publicas y concordantes.\nEN LA FORMA QUE SE ENCUENTRA REDACTADO ACTUALEMENTE EL PLIEGO DE BASES Y CONDICIONES, SE DENOTA UN CLARO DIRECCIONAMIENTO DE ESTE LLAMADO HACIA UNA EMPRESA YA PRE-ADJUDICADA antes del inicio del proceso de adjudicaci\u00f3n. \nQueda completamente evidenciado la transgresi\u00f3n de los preceptos de la Ley 7021 en su Art\u00edculo 4\u00b0, en sus inc. d, e, f, h, i, j, k, n, o y p, por parte del comit\u00e9 evaluador y finalmente refrendado en la resoluci\u00f3n de adjudicaci\u00f3n.", "answer": "Ajustarse al PBC, el oferente deber\u00e1 estar en el rubro y tener stock de repuestos debido a que se trata de un equipo de primera necesidad, que requiere de atenci\u00f3n inmediata, evitando de esa manera que el equipo este parado por tiempo prolongado a la espera de importaciones de repuestos, contar con la tarjeta RFI de reseteo de alarma y garantizar la realizaci\u00f3n del servicio seg\u00fan recomendaciones del fabricante.- ", "dateAnswered": "2025-04-01T12:55:41-04:00"}, {"id": "317a60962a47d499b75fa44b4334b0fb-1", "date": "2025-03-30T18:38:22-04:00", "title": "CAPACIDAD TECNICA", "description": "Se solicita a la convocante que ELIMINE o MODIFIQUE el requerimiento indicado en el apartado CAPACIDAD TECNICA del PBC espec\u00edficamente donde dice: T\u00e9cnico con certificado de capacitaci\u00f3n emitido por alg\u00fan fabricante de PSA, adjuntar Curriculum del Profesional y certificado del encargado del servicio solicitado, la cual tendr\u00e1 relaci\u00f3n laboral directa con el oferente de m\u00ednimo 6 (seis) meses demostrable con planilla de pago del seguro social, donde deber\u00e1 estar inscripto dicho profesional.- Debido a que este requerimiento no resulta t\u00e9cnicamente indispensable para la presentaci\u00f3n y evaluaci\u00f3n de la oferta y la capacidad t\u00e9cnica, a raz\u00f3n de que la Empresa Adjudica ser\u00e1 libre de organizar sus recursos humanos disponibles de acuerdo a la demanda, no puede de antemano designar a un ENCARGADO para el Servicio sin antes haber firmado un contrato con la Convocante.\n\nLo que genera tambi\u00e9n suspicacias en la inclusi\u00f3n de este requisito, \u00bfCu\u00e1l es la raz\u00f3n de que el oferente deba presentar las documentaciones del Encargado designado para el servicio de este llamado, sin tener la certeza de que finalmente su empresa ser\u00e1 adjudicada?\n\nSe deber\u00eda considerar m\u00e1s que suficiente presentar certificado o certificados de capacitaci\u00f3n emitido por alg\u00fan fabricante de Planta Generadora de OX\u00cdGENO PSA, de los t\u00e9cnicos que forman parte del equipo de expertos de la empresa oferente.", "answer": "Ajustarse al PBC, el oferente deber\u00e1 dedicarse al rubro de Mantenimiento de Planta Generadora de Oxigeno Medicinal PSA, y por consiguiente deber\u00e1 contar con profesionales capacitados y certificados con experiencia, con relaci\u00f3n de dependencia directa con el oferente, adem\u00e1s como se especifica en la secci\u00f3n de Subcontrataci\u00f3n del PBC, la misma no aplica para el presente llamado, pagina 51 del PBC.- ", "dateAnswered": "2025-04-01T12:56:02-04:00"}, {"id": "cb452ef2a5a16b5612f99f778a54e8d6-1", "date": "2025-03-28T15:11:17-04:00", "title": "ID 463315 consulta sobre items solicitados", "description": "Buenas, en la lista de repuestos no se observa un importante componente del sistema PSA que es la Zeolita (el absorbente de nitr\u00f3geno, tamiz molecular) favor aclarar si se agregar\u00e1 \u00e9ste item, ya que en la visita t\u00e9cnica se pudo observar la posibilidad de requerir este elemento para la reparaci\u00f3n del equipo en cuesti\u00f3n. Gracias", "answer": "La vida \u00fatil promedio de las zeolitas es de aproximadamente 10 (diez) a\u00f1os, teniendo en cuenta que dicho elemento se encuentra dentro del ciclo de vida \u00fatil, atendiendo la duraci\u00f3n del presente contrato, no se requerir\u00e1 el cambio de dicho componente, motivo por el cual no ha sido agregado dentro de las especificaciones t\u00e9cnicas,  ajustarse al PBC.- ", "dateAnswered": "2025-04-01T12:55:29-04:00"}, {"id": "74c7d49a55e996f35f8c39065cb794ec-1", "date": "2025-03-30T17:37:58-04:00", "title": "CAPACIDAD TECNICA", "description": "Se solicita a la convocante que ELIMINE el requerimiento indicado en el apartado CAPACIDAD TECNICA del PBC espec\u00edficamente donde dice: Constancia de Habilitaci\u00f3n de especialidades farmac\u00e9uticas (Gases Medicinales = Oxigeno) Servicio T\u00e9cnico de Mantenimiento de Dispositivos M\u00e9dicos, emitido por la DINAVISA. La cual debe estar vigente al momento de la presentaci\u00f3n de oferta.\n\nDebido a que este requerimiento NO APLICA para evaluar la capacidad t\u00e9cnica del oferente. La resoluci\u00f3n DINAVISA N\u00b0 338/2022 de fecha 6 de octubre de 2022, POR LA CUAL SE ESTABLECEN LOS REQUISITOS Y LAS CONDICIONES PARA LA OBTENCION DE REGISTRO SANITARIO CONDICIONAL DE ESPECILIDADES FARMACEUTICAS. Y su concordante LEY 1119/17 DE PRODUCTOS PARA LA SALUD, establece en su Art\u00edculo 1\u00ba.- 1. La presente ley y sus correspondientes reglamentos regulan la fabricaci\u00f3n, elaboraci\u00f3n, fraccionamiento, control de calidad, distribuci\u00f3n, prescripci\u00f3n, dispensaci\u00f3n, comercializaci\u00f3n, representaci\u00f3n, importaci\u00f3n, exportaci\u00f3n, almacenamiento, uso racional, r\u00e9gimen de precios, informaci\u00f3n, publicidad, y la evaluaci\u00f3n, autorizaci\u00f3n y registro de los medicamentos de uso humano, drogas, productos qu\u00edmicos, reactivos y todo otro producto de uso y aplicaci\u00f3n en medicina humana, y los productos considerados como cosm\u00e9ticos y domisanitarios.\n\n2. Tambi\u00e9n regula los principios, normas, criterios y exigencias b\u00e1sicas sobre la eficacia, seguridad y calidad de los productos objeto de esta ley, y la actuaci\u00f3n de las personas f\u00edsicas o jur\u00eddicas que intervienen en las actividades mencionadas en el p\u00e1rrafo anterior.\n\nPor tanto corresponde ACLARAR a la Convocante que UNA PLANTA DE OXIGENO ES UN SISTEMA INDUSTRIAL QUE GENERA OX\u00cdGENO y NO UN ESTABLECIMIENTO DE FABRICACION, ELABORACION\u2026DE MEDICAMENTOS Y PRODUCTOS CONSIDERADOS COMO COSMETICOS Y DOMISANITARIOS, por lo cual este requisito NO CORRESPONDE EXIGIR, nuevamente  se observa evidente que ha sido incluido con intenci\u00f3n de direccionar el resultado de la adjudicaci\u00f3n para una empresa que posea las Constancias mencionados, demostrando a su vez el desconocimiento de la legislaci\u00f3n reguladora de este requisito, limitando de esta manera la intenci\u00f3n de participaci\u00f3n de oferentes, y clara transgresi\u00f3n de los preceptos de la Ley 7021 en su Art\u00edculo 4\u00b0, en sus inc. d, e, f, h, i, j, k, n, o y p y concordante vigentes.", "answer": "Ajustarse al PBC, seg\u00fan Resoluci\u00f3n SG N\u00b0 208/09 del MSP y BS \"POR LA CUAL SE DETERMINA LOS GASES MEDICINALES CONSTITUYEN MEDICAMENTOS DE USO HUMANO -- ESTABLECIMIENTO DE DISPOSICIONES REFERENTES A LA HABILITACI\u00d3N DE ESTABLECIMIENTOS PRODUCTORES Y DE COMERCIALIZACI\u00d3N DE GASES MEDICINALES, GARANT\u00cdAS DE CALIDAD Y EL USO DE BUENAS PR\u00c1CTICAS DE FABRICACI\u00d3N DE MEDICAMENTOS\". Art\u00edculo 1\u00b0.- Determinar de la presente resoluci\u00f3n, los productos definidos como gases medicinales ser\u00e1n considerados como medicamentos de uso humano y por lo tanto, sometidos a las disposiciones legales que rigen la materia.\nPor lo tanto se debe cumplir con este requisito ya que se trata de un equipo de fabricaci\u00f3n de medicamentos de consumo humano, no de una planta industrial.- ", "dateAnswered": "2025-04-01T12:55:57-04:00"}, {"id": "76b0fcf0c4017e207ece6935dfafbeb0-1", "date": "2025-03-30T01:50:59-04:00", "title": "CAPACIDAD TECNICA", "description": "Se solicita a la convocante que ELIMINE el requerimiento indicado en el apartado CAPACIDAD TECNICA del PBC espec\u00edficamente donde dice: \u201cEl Oferente deber\u00e1 contar con el Certificado de cumplimiento de Buenas Pr\u00e1cticas de Fabricaci\u00f3n y control (BPAyD) emitido por DINAVISA. La cual debe estar vigente al momento de la presentaci\u00f3n de oferta\u201d, Debido a que este requerimiento NO APLICA para evaluar la capacidad t\u00e9cnica del oferente, los certificados mencionados solo son aplicables al ESTABLECIMIENTO DEL OFERENTE que tenga declaradas como actividades: Laboratorios de producci\u00f3n, fraccionadoras y envasadoras, importadoras, exportadoras, distribuidoras de equipos m\u00e9dicos, materiales cortopunzantes y equipos de protecci\u00f3n individual de clase  I,II,III y V,\n\nCabe destacar que la Resoluci\u00f3n DINAVISA N\u00b0 202/2023 de fecha 7 de febrero de 2023 \u201cPOR LA CUAL SE REGLAMENTA EL PROCEDIMIENTO DE INSPECCION DE VERIFICACION DE BUENAS PRACTICAS DE FABRICACION Y CONTROL (BPFyC) Y DE BUENAS PRACTICAS DE ALMACENAMIENTO Y DISTRIBUCION  (BPAyD) PARA LABORATORIOS DE PRODUCION, FRACIONADORAS Y ENVASADORAS, IMPORTADORAS, EXPORTADORAS, DISTRIBUIDORAS DE DISPOSITIVOS MEDICOS, MATERIALES CORTOPIUNZANTES Y EQUIPO PROTECCION INDIVIDUAL CLASE I,II,III y V\u201d,  establece claramente en los siguientes;\n\n Art\u00edculo 1\u00b0 Establecer procedimiento de inspecci\u00f3n de verificaci\u00f3n de Buenas Practicas de Fabricaci\u00f3n y Control (BPFyC), y de Buenas Pr\u00e1cticas de Almacenamiento y Distribuci\u00f3n (BPAyD) para Laboratorios de producci\u00f3n, fraccionadoras y envasadoras, importadoras, exportadoras, distribuidoras de equipos m\u00e9dicos, materiales cortopunzantes y equipos de protecci\u00f3n individual de clase I,II,III y V,  \n\nArt\u00edculo 2\u00b0 Disponer que para el funcionamiento de los laboratorios de producci\u00f3n, fraccionadoras y envasadoras, importadoras, exportadoras, Distribuidoras de dispositivos m\u00e9dicos, Materiales corto punzantes y Equipos de protecci\u00f3n individual, es obligatorio que el establecimiento cuente con el certificado de cumplimiento de BPFyC y/o BPAyD vigente..\n\nEn este punto es importante ACLARAR a continuaci\u00f3n que UNA PLANTA DE OXIGENO ES UN SISTEMA INDUSTRIAL QUE GENERA OX\u00cdGENO y NO UN LABORATORIOS DE PRODUCION, FRACIONADORAS Y ENVASADORAS, IMPORTADORAS, EXPORTADORAS, DISTRIBUIDORAS DE DISPOSITIVOS MEDICOS, MATERIALES CORTOPIUNZANTES Y EQUIPO PROTECCION INDIVIDUAL CLASE I,II,III y V\u201d,\n\nDefinici\u00f3n de una Planta de ox\u00edgeno medicinal: \n\u2022 Es un Sistema industrial que genera ox\u00edgeno para uso m\u00e9dico.\n\u2022 Se utiliza en centros m\u00e9dicos que tienen una necesidad constante o experimentan picos de demanda.\n\u2022 Utiliza tecnolog\u00edas como la adsorci\u00f3n por oscilaci\u00f3n de presi\u00f3n (PSA), t\u00e9cnicas de separaci\u00f3n por membrana o t\u00e9cnicas criog\u00e9nicas.\n\u2022 Debe garantizar una alta pureza, generalmente m\u00e1s estricta que la del ox\u00edgeno industrial.\n\u2022 Est\u00e1 sujeta a requisitos espec\u00edficos de diversos organismos reguladores.\n\nPor tanto, NO APLICA el requisito \u201ccontar con el Certificado de cumplimiento de Buenas Pr\u00e1cticas de Fabricaci\u00f3n y control (BPAyD) emitido por DINAVISA\u201d. \n\nSe observa evidente, que este requisito ha sido incluido con \u00e1nimo de direccionar el resultado de la adjudicaci\u00f3n para una empresa que posea los certificados mencionados, demostrando a su vez el desconocimiento de la legislaci\u00f3n reguladora de este requisito, limitando de esta manera la intenci\u00f3n de participaci\u00f3n de oferentes, y clara transgresi\u00f3n de los preceptos de la Ley 7021 en su Art\u00edculo 4\u00b0, en sus inc. d, e, f, h, i, j, k, n, o y p", "answer": "Ajustarse al PBC, seg\u00fan Resoluci\u00f3n S.G. N\u00b0 208/09 del M.S.P. y B.S.  \"POR LA CUAL SE DETERMINA LOS GASES MEDICINALES CONSTITUYEN MEDICAMENTOS DE USO HUMANO -- ESTABLECIMIENTO DE DISPOSICIONES REFERENTES A LA HABILITACI\u00d3N DE ESTABLECIMIENTOS PRODUCTORES Y DE COMERCIALIZACI\u00d3N DE GASES MEDICINALES, GARANT\u00cdAS DE CALIDAD Y EL USO DE BUENAS PR\u00c1CTICAS DE MANUFACTURA DE MEDICAMENTOS\". Articulo 4\u00b0.- Los gases medicinales se fabricar\u00e1n y controlar\u00e1n bajo un sistema de garant\u00eda de calidad. A tal efecto, se establecer\u00e1 un Programa de Garant\u00eda de Calidad en el proceso de fabricaci\u00f3n y control de los gases medicinales. Se observar\u00e1 que se cumpla en sus procesos productivos las buenas Pr\u00e1cticas de Manufactura de Medicamentos, con la particularidades que correspondan las instalaciones y equipos, personal, envasado, rotulado, almacenamiento, distribuci\u00f3n y control de calidad de todas las etapas, tanto para los gases medicinales obtenidos por el m\u00e9todo criog\u00e9nico como por tamiz molecular (PSA). La garant\u00eda comprende, no s\u00f3lo al que, sin desarrollar el proceso completo, participan en el control, la elaboraci\u00f3n de alguna etapa del proceso, el fraccionamiento, acondicionamiento, representaci\u00f3n, importaci\u00f3n y/o comercializaci\u00f3n del gas medicinal. Los gases medicinales, obtenidos tanto por m\u00e9todo\ncriog\u00e9nico como por el m\u00e9todo PSA, dejar\u00e1n cumplir con la normativa vidente para productos farmac\u00e9uticos y con las especificaciones de calidad de farmacopeas aceptadas internacionalmente (U.S.P., Europea, Codex Franc\u00e9s).\nPor lo tanto se debe cumplir con este requisito, ya que all\u00ed se envasa el medicamento fabricado.- ", "dateAnswered": "2025-04-01T12:55:51-04:00"}], "lots": [{"id": "1effb4ef-3e12-6d44-9fa7-9b49c9c80c2a", "title": "1 - 1 - Mantenimiento Preventivo de la Planta de Oxigeno del Hospital Nacional", "status": "active", "statusDetails": "activo", "value": {"amount": 750000000, "currency": "PYG"}, "openContractType": "monto", "minValue": {"amount": 375000000, "currency": "PYG"}, "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "1", "id": "1"}]}, {"id": "1effb4f2-e13a-65fa-b0b3-17b525e6d390", "title": "1 - 2 - Mantenimiento Correctivo de la Planta de Oxigeno del Hospital 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