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Estudios y Proyectos de inversi\u00f3n", "id": 5}, {"name": "Equipos, Productos e instrumentales M\u00e9dicos y de Laboratorio. Servicios asistenciales de salud", "id": 17}, {"name": "Productos quimicos", "id": 16}]}}, {"name": "Bioethic Pharma S.A.", "id": "PY-RUC-80058902-5", "identifier": {"id": "80058902-5", "legalName": "Bioethic Pharma S.A.", "scheme": "PY-RUC"}, "roles": ["tenderer"], "contactPoint": {"name": "EDGAR VILLALBA - DIEGO VARELA- Zulma Alvarenga - Gerardo Fines", "email": "licitaciones@bioethicpharma.com.py", "telephone": "0972197328"}, "address": {"countryName": "Paraguay", "locality": "Asuncion", "region": "Asunci\u00f3n", "streetAddress": "Tacuari N\u00b0 221 esq. Dr. Eligio Ayala"}, "details": {"legalEntityTypeDetail": "S.A.", "activityTypes": ["services"], "categories": [{"name": "Combustibles y Lubricantes", "id": 15}, {"name": "Equipos, Productos e instrumentales M\u00e9dicos y de Laboratorio. Servicios asistenciales de salud", "id": 17}, {"name": "Productos Alimenticios", "id": 14}]}}, {"name": "EUROQUIMICA S.A.", "id": "PY-RUC-80061211-6", "identifier": {"id": "80061211-6", "legalName": "EUROQUIMICA S.A.", "scheme": "PY-RUC"}, "roles": ["tenderer"], "contactPoint": {"name": "MARCELO RIENZI ZUCOLILLO - PAOLA RIENZI ZUCOLILLO - Paola Roa Gonzalez", "email": "licitaciones@euroquimica.com.py", "faxNumber": "021600777", "telephone": "0972425942"}, "address": {"countryName": "Paraguay", "locality": "ASUNCION (DISTRITO)", "region": "Central", "streetAddress": "AVDA. AVIADORES DEL CHACO CASI LOPEZ MOREIRA (EDIFICIO THE TOP) PISO 10-OFICINA 02"}, "details": {"legalEntityTypeDetail": "S.A.", "activityTypes": ["goods", "services"], "categories": [{"name": "Equipos, Productos e instrumentales M\u00e9dicos y de Laboratorio. 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Servicios asistenciales de salud", "id": 17}]}}, {"name": "TASSOS SA", "id": "PY-RUC-80078413-8", "identifier": {"id": "80078413-8", "legalName": "TASSOS SA", "scheme": "PY-RUC"}, "roles": ["tenderer", "supplier", "payee"], "contactPoint": {"name": "Guillermo Martin Camperchioli - Jorge Camperchioli  Chamorro- Oscar Leon- Oscar Limprich", "email": "licitaciones@tassos.com.py", "telephone": "0985872093", "url": "https://www.tassos.com.py/"}, "address": {"countryName": "Paraguay", "locality": "Asuncion", "region": "Asunci\u00f3n", "streetAddress": "Avenida Sant\u00edsimo Sacramento N\u00b0 2194"}, "details": {"legalEntityTypeDetail": "S.A.", "activityTypes": ["goods", "services"], "categories": [{"name": "Muebles y Enseres", "id": 23}, {"name": "Equipos, Productos e instrumentales M\u00e9dicos y de Laboratorio. Servicios asistenciales de salud", "id": 17}, {"name": "Utiles de oficina, Productos de papel y cart\u00f3n e impresos", "id": 11}]}}, {"name": "PHARMANEST S.A.", "id": "PY-RUC-80088851-0", "identifier": {"id": "80088851-0", "legalName": "PHARMANEST S.A.", "scheme": "PY-RUC"}, "roles": ["enquirer"], "address": {"countryName": "Paraguay", "streetAddress": "JERUSALEN E/ SAN ANTONIO Y AVDA. PASTORA CESPEDES"}, "details": {"legalEntityTypeDetail": "S.A.", "activityTypes": ["goods", "services"]}, "contactPoint": {"email": "licitacion@vytfarma.com.py"}}], "tender": {"id": "1efb961b-c1dc-6aea-8759-c1371f7a1cf4", "title": "LPN N\u00b0 01/2025 \"ADQUISICION DE MEDICAMENTOS PARA PACIENTES ONCOLOGICOS DEL INCAN Y OTROS CENTROS DEPENDIENTES DEL MINISTERIO DE SALUD PUBLICA Y BIENESTAR SOCIAL - AD REFERENDUM AL PGN 2025 - PLURIANUAL - CONTRATO ABIERTO\"", "status": "complete", "awardCriteria": "priceOnly", "awardCriteriaDetails": "Por Item", "submissionMethod": ["inPerson"], "bidOpening": {"date": "2025-04-01T11:15:00-04:00", "address": {"streetAddress": "UOC N\u00b0 03 - INCAN - Capiata Km 23,5 Ruta 2 Ramal Aregua"}}, "submissionMethodDetails": "Lugar entrega ofertas: UOC N\u00b0 03 - INCAN - Capiata Km 23,5 Ruta 2 Ramal Aregua", "statusDetails": "Adjudicada", "enquiriesAddress": {"streetAddress": "Consultas Virtuales a trav\u00e9s del portal de la DNCP"}, "mainProcurementCategoryDetails": "Bienes - Medicamentos y Productos Farmaceuticos", "hasEnquiries": false, "value": {"amount": 265295181843, "currency": "PYG"}, "datePublished": "2025-01-31T13:33:11-04:00", "tenderPeriod": {"startDate": "2025-01-31T13:33:11-04:00", "endDate": "2025-04-01T11:00:00-04:00", "durationInDays": 59}, "awardPeriod": {"startDate": "2025-04-01T11:15:00-04:00"}, "contractPeriod": {"maxExtentDate": "2026-12-31T00:00:00-04:00"}, "enquiryPeriod": {"endDate": "2025-03-25T12:00:00-04:00", "startDate": "2025-01-31T13:33:11-04:00", "durationInDays": 52}, "mainProcurementCategory": "services", "additionalProcurementCategories": ["services"], "procurementMethod": "open", "procurementMethodDetails": "Licitaci\u00f3n P\u00fablica 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": "4d524612f835def398b7b3cc6a536f12-1", "date": "2025-02-20T11:38:56-04:00", "title": "Especificaciones t\u00e9cnicas", "description": "Dice: Para aquellos medicamentos cuyo vencimiento sea inferior a 18 meses, adem\u00e1s de la autorizaci\u00f3n de la Direcci\u00f3n General,\nse deber\u00e1 presentar P\u00f3liza de Seguro por el 100% del monto del producto con identificaci\u00f3n del numero de Lote, que\nser\u00e1n entregados un original en la Oficina de la Unidad Operativa de Contrataci\u00f3n N\u00b0 3 y el duplicado en el Departamento\nde Farmacia - Banco de Drogas del INCAN. La validez de dicha p\u00f3liza a deber\u00e1 ser por 3 meses posteriores a la fecha el\nvencimiento del articulo a entregar.\n\n--- Se solicita a la convocante que la p\u00f3liza de seguro por el 100% del monto a entregar sea para medicamentos con vencimiento menores a 12 meses. Lo solicitado a fin de evitar sobre costos que ser\u00edan trasladados a la convocante.", "answer": "Remitirse a la Adenda N\u00b0 01", "dateAnswered": "2025-02-21T13:07:46-04:00"}, {"id": "ed5596aebdbaefe080ec09fb5c6afc9e-1", "date": "2025-02-10T15:01:51-04:00", "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": "REMITIRSE A LA ADENDA N\u00b0 01", "dateAnswered": "2025-02-21T12:31:51-04:00"}, {"id": "a376e739348ed09a65d4aa7ebafd8db8-1", "date": "2025-03-17T11:13:29-04:00", "title": "CAPACIDAD T\u00c9CNICA PARA PRODUCTOS IMPORTADOS", "description": "Solicitamos encarecidamente a la Convocante Modificar en el pbc de la versi\u00f3n 2 en el punto 7 1.1 para f\u00e1rmaco Bortezomib tener solo en cuenta el registro sanitario y el acta de fijaci\u00f3n de precio. Ya que al tener registro de alta vigilancia de los productos ofertados importados ya cumplen con las garant\u00edas de calidad, seguridad y eficacia.", "answer": "En Capacidad T\u00e9cnica, se solicitan los documentos de manera a garantizar que el principio activo que ser\u00e1 suministrado al paciente cumpla con todos los requisitos de Seguridad, Calidad y Eficacia. Los productos son considerados de ventana terap\u00e9utica estrecha donde la mol\u00e9cula debe demostrar ser equivalente terap\u00e9utico al producto de referencia a fin de asegurar la calidad, seguridad y eficacia del medicamento. Los estudios solicitados se constituyen en los m\u00e9todos m\u00e1s id\u00f3neos para demostrar la equivalencia entre dos medicamentos", "dateAnswered": "2025-03-26T10:48:25-04:00"}, {"id": "315edcc8f908ea58d7bb2ef1d1d3bbfd-1", "date": "2025-03-17T11:57:38-04:00", "title": "CAPACIDAD T\u00c9CNICA PARA PRODUCTOS IMPORTADOS", "description": "Para solidos orales (Lenalidomida 10 mg c\u00e1psulas y Lenalidomida 25 mg c\u00e1psulas):  Eliminar del PBC el requisito de la presentaci\u00f3n de \u201cEstudios 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\u201d, debido a que los mencionados principios activos no se encuentran listados en el ANEXO II de la Resoluci\u00f3n 92/2020.", "answer": "En Capacidad T\u00e9cnica, se solicitan los documentos de manera a garantizar que el principio activo que ser\u00e1 suministrado al paciente cumpla con todos los requisitos de Seguridad, Calidad y Eficacia. Los productos son considerados de ventana terap\u00e9utica estrecha donde la mol\u00e9cula debe demostrar ser equivalente terap\u00e9utico al producto de referencia a fin de asegurar la calidad, seguridad y eficacia del medicamento. Los estudios solicitados se constituyen en los m\u00e9todos m\u00e1s id\u00f3neos para demostrar la equivalencia entre dos medicamentos.", "dateAnswered": "2025-03-26T10:48:47-04:00"}, {"id": "c38889e3a711c51dcdd687a725f0ec7b-1", "date": "2025-02-10T12:50:38-04:00", "title": "Plan de entrega", "description": "El PBC establece:\"CANTIDADES MINIMAS SOLICITADAS\n1- Hasta 20% de la cantidad m\u00ednima adjudicada: La primera orden de compra, ser\u00e1 dentro de los 20(veinte) d\u00edas corridos posteriores a la firma del contrato donde el proveedor tendr\u00e1 hasta 8(ocho) d\u00edas corridas para la entrega contados a partir de le recepci\u00f3n de la orden de compra, emitida por el Departamento de Adquisici\u00f3n y Suministro, seg\u00fan necesidad y stock del Instituto Nacional del C\u00e1ncer.\" \nSolicitamos modificar el plazo de entrega a 8 d\u00edas h\u00e1biles a partir de la recepci\u00f3n de la orden de compra debido a que la mayor\u00eda de los bienes solicitados son importados.", "answer": "REMITIRSE A LA ADENDA N\u00b0 01", "dateAnswered": "2025-02-21T12:31:37-04:00"}, {"id": "49b7863c76c2a502388777c5cf032a9d-1", "date": "2025-02-10T15:10:17-04:00", "title": "Porcentaje de Multa - Interes por Mora", "description": "Solicitamos a la Convocante unificar el porcentaje de multa conforme al inter\u00e9s por mora, esto con el objeto de lograr una igualdad entre las partes.", "answer": "El PBC se ajusta a la Ley 7021/2022 en el principio de libre igualdad y competencia. El porcentaje de multa se establece en proporci\u00f3n al da\u00f1o o perjuicio que la falta de provisi\u00f3n o su retraso pueda causar a la Instituci\u00f3n, en este caso a pacientes Oncol\u00f3gicos. El porcentaje de inter\u00e9s por mora por falta de pago de la contratante se ajusta a la policita institucional constatable en convocatoria del MSP y BS.", "dateAnswered": "2025-02-21T13:06:13-04:00"}, {"id": "62f5bf1c20a9422da7719ccd6cf08f88-1", "date": "2025-03-17T11:57:11-04:00", "title": "CAPACIDAD T\u00c9CNICA PARA PRODUCTOS IMPORTADOS", "description": "Para inyectables (Bortezomib 3,5 mg  Iny.): Eliminar del PBC el requisito de la presentaci\u00f3n de Farmacoequivalencia comparable con el producto de referencia original, en vista que no es requerido por la m\u00e1xima Autoridad Sanitaria Regulatoria DINAVISA, para el proceso de emisi\u00f3n de registro sanitario. Tampoco queda claro cual ser\u00eda el producto de referencia original, debido a que no se encuentra reglamentado por DINAVISA dicho requisito.", "answer": "En Capacidad T\u00e9cnica, se solicitan los documentos de manera a garantizar que el principio activo que ser\u00e1 suministrado al paciente cumpla con todos los requisitos de Seguridad, Calidad y Eficacia. Los productos son considerados de ventana terap\u00e9utica estrecha donde la mol\u00e9cula debe demostrar ser equivalente terap\u00e9utico al producto de referencia a fin de asegurar la calidad, seguridad y eficacia del medicamento. Los estudios solicitados se constituyen en los m\u00e9todos m\u00e1s id\u00f3neos para demostrar la equivalencia entre dos medicamentos. El producto de referencia original es al que debe corresponder el estudio.", "dateAnswered": "2025-03-26T10:48:38-04:00"}, {"id": "37515a5d5926d058763c258a47d21429-1", "date": "2025-02-10T12:51:06-04:00", "title": "Interes por mora", "description": "Solicitamos a la Convocante unificar el porcentaje de multa establecido para la presente licitaci\u00f3n (0,01%) con el porcentaje de tasa de inter\u00e9s por Mora por falta de pago de la contratante (0,001%). Solicitamos sean unificados a 0,001% a fin de lograr una igualdad de condiciones entre las partes.", "answer": "El PBC se ajusta a la Ley 7021/2022 en el principio de libre igualdad y competencia. El porcentaje de multa se establece en proporci\u00f3n al da\u00f1o o perjuicio que la falta  de provisi\u00f3n o su retraso pueda causar a la Instituci\u00f3n, en este caso a pacientes Oncol\u00f3gicos. El porcentaje de inter\u00e9s por mora por falta de pago de la contratante se ajusta a la policita institucional constatable en convocatoria del MSP y BS. ", "dateAnswered": "2025-02-21T13:03:36-04:00"}, {"id": "91eb423c2b0afab68d7e955741908e67-1", "date": "2025-02-10T12:53:14-04:00", "title": "Forma y condiciones de pago", "description": "El PBC menciona lo siguiente \"La Contratante efectuar\u00e1 los pagos, dentro del plazo establecido en este apartado, sin exceder sesenta (60) d\u00edas despu\u00e9s de la presentaci\u00f3n de una factura por el proveedor, y despu\u00e9s de que la contratante la haya aceptado. Dicha aceptaci\u00f3n o rechazo, deber\u00e1 darse a m\u00e1s tardar en quince (15) d\u00edas posteriores a su presentaci\u00f3n\". Solicitamos a la Convocante aclarar si la comunicaci\u00f3n en caso de rechazo se har\u00e1 por notificaci\u00f3n v\u00eda correo electr\u00f3nico?.", "answer": "La comunicaci\u00f3n en caso de rechazo se realiza conforme procedimientos de la Ventanilla \u00danica del Proveedor (VUP) del Ministerio de Salud Publica y  Bienestar Social. La frase del PBC corresponde a la secci\u00f3n del PBC est\u00e1ndar aprobado por DNCP el cual no permite modificaci\u00f3n.", "dateAnswered": "2025-02-21T12:55:20-04:00"}, {"id": "55bcdc9d45f61000dbb9a6431f3f66f0-1", "date": "2025-03-17T11:12:44-04:00", "title": "CAPACIDAD T\u00c9CNICA PARA PRODUCTOS IMPORTADOS", "description": "Solicitamos a la Convocante modificar en el pbc de la versi\u00f3n 2 en el punto 7 1.1 para f\u00e1rmaco Lenalidomida tener solo en cuenta el registro sanitario y el acta de precio. Ya que al tener registro de alta vigilancia de los productos ofertados importados ya cumplen con las garant\u00edas de calidad, seguridad y eficacia.", "answer": "En Capacidad T\u00e9cnica, se solicitan los documentos de manera a garantizar que el principio activo que ser\u00e1 suministrado al paciente cumpla con todos los requisitos de Seguridad, Calidad y Eficacia. Los productos son considerados de ventana terap\u00e9utica estrecha donde la mol\u00e9cula debe demostrar ser equivalente terap\u00e9utico al producto de referencia a fin de asegurar la calidad, seguridad y eficacia del medicamento. Los estudios solicitados se constituyen en los m\u00e9todos m\u00e1s id\u00f3neos para demostrar la equivalencia entre dos medicamentos.", "dateAnswered": "2025-03-26T10:48:20-04:00"}, {"id": "0fae10ba2560b89b83ada03b6a706aba-1", "date": "2025-03-17T11:18:56-04:00", "title": "Requisitos documentales para la evaluaci\u00f3n de la experiencia", "description": "Solicitamos ajustar la redacci\u00f3n de la siguiente forma:  \"Copia de Facturas y/o contratos y/o recepciones finales que avalen la experiencia requerida.\" esto evitar\u00e1 por completo inconvenientes de interpretaci\u00f3n al momento de elaborar la oferta y al momento de la evaluaci\u00f3n.", "answer": "Se aclara que podr\u00e1n presentarse indistintamente, facturaciones de ventas o contratos o recepciones finales a fin de acreditar la experiencia requerida.", "dateAnswered": "2025-03-26T10:48:34-04:00"}, {"id": "72be180127e458c95d0e337b40480864-1", "date": "2025-03-17T09:44:11-04:00", "title": "CAPACIDAD TECNICA- PUNTO 9", "description": "En cuanto al punto citado solicitamos que se modifique de la siguiente manera: \u201cLOS PRODUCTOS BIOSIMILARES IMPORTADOS Y NACIONALES no deben tener rechazo de autorizaci\u00f3n de comercializaci\u00f3n en ninguna de las autoridades sanitarias seg\u00fan Resoluci\u00f3n N\u00ba 148/24 \u201cpor el cual se emite el listado anual oficial de los pa\u00edses en cumplimiento al Art 3. De la Ley N\u00ba 7256/24\u201d. El oferente deber\u00e1 presentar una Declaraci\u00f3n Jurada emitida por el Fabricante de que cumple con este requisito. La Convocante podr\u00e1 validar dicha informaci\u00f3n a trav\u00e9s de las p\u00e1ginas oficiales de las agencias reguladoras de alta vigilancia donde se encuentren siendo comercializadas\u201d\nDicha modificaci\u00f3n se justifica en virtud a que fue promulgada la Ley 7256/24 \u201cQUE MODIFICA EL ARTICULO 11\u00ba Y AMPLIA LA LEY N\u00ba 3283/2007 \u201cDE PROTECCION DE LA INFORMACION DE LA INFORMACION NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMACEUTICOS\u201d, que modific\u00f3 el art\u00edculo 11\u00ba de la ley N\u00ba 3283/2007, el cual ya no identifica taxativamente a los pa\u00edses de alta vigilancia, sino que traslad\u00f3 a la DINAVISA (art. 3\u00ba de la ley 7256) la responsabilidad de identificar a los citados pa\u00edses en un listado anual oficial siguiendo los criterios y par\u00e1metros establecidos en el art\u00edculo 2\u00ba de la citada normativa.", "answer": "El requisito se remite a las autoridades regulatorias contempladas en la Resoluci\u00f3n DINAVISA N\u00b0 148/2024 que son referentes en farmacovigilancia, y a efectos de garantizar que el medicamento ofertado que ser\u00eda suministrado al paciente no cuente con alertas farmacol\u00f3gicas. ", "dateAnswered": "2025-03-26T10:48:15-04:00"}, {"id": "23ff81ef18a7b6e6f274c739441bd6e4-1", "date": "2025-03-17T11:57:29-04:00", "title": "CAPACIDAD T\u00c9CNICA PARA PRODUCTOS IMPORTADOS", "description": "Para solidos orales (Lenalidomida 10 mg c\u00e1psulas y Lenalidomida 25 mg c\u00e1psulas):  Eliminar del PBC el requisito de la presentaci\u00f3n de \u201cEstudios 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\u201d, en vista que no es requerido por la m\u00e1xima Autoridad Sanitaria Regulatoria DINAVISA, para el proceso de emisi\u00f3n de registro sanitario. Tampoco queda claro cual ser\u00eda el producto de referencia original, debido a que no se encuentra reglamentado por DINAVISA dicho requisito.", "answer": "En Capacidad T\u00e9cnica, se solicitan los documentos de manera a garantizar que el principio activo que ser\u00e1 suministrado al paciente cumpla con todos los requisitos de Seguridad, Calidad y Eficacia. Los productos son considerados de ventana terap\u00e9utica estrecha donde la mol\u00e9cula debe demostrar ser equivalente terap\u00e9utico al producto de referencia a fin de asegurar la calidad, seguridad y eficacia del medicamento. Los estudios solicitados se constituyen en los m\u00e9todos m\u00e1s id\u00f3neos para demostrar la equivalencia entre dos medicamentos.", "dateAnswered": "2025-03-26T10:48:42-04:00"}, {"id": "993f41bfec2222ef873edf626d6a498c-1", "date": "2025-02-10T12:39:27-04:00", "title": "Experiencia requerida", "description": "El PBC establece \"Demostrar la experiencia en MEDICAMENTOS ONCOLOGICOS con facturaciones de venta, contratos y/o recepciones finales, tanto en el sector p\u00fablico como en el sector privado, por un monto equivalente al [50] % como m\u00ednimo del monto total ofertado en la presente licitaci\u00f3n, de los: 3 (tres) \u00faltimos a\u00f1os, 2021 - 2022 - 2023. Las sumatorias de las facturaciones deben alcanzar el porcentaje indicado, no ser\u00e1 necesaria la presentaci\u00f3n del porcentaje establecido por cada a\u00f1o.\" \nSolicitamos a la Convocante incluir el a\u00f1o 2024.", "answer": "REMITIRSE A LA ADENDA N\u00b0 01", "dateAnswered": "2025-02-21T12:30:59-04:00"}, {"id": "78338daf4e48a5c44e5bccbda14f9da8-1", "date": "2025-02-10T12:29:10-04:00", "title": "Vencimiento productos", "description": "El PBC establece en la pagina 14 \"Los plazos equivalentes al vencimiento de los medicamentos conforme el Apartado Especificaciones T\u00e9cnicas : El vencimiento de los medicamentos debe ser por lo menos de (12 doce) meses, contados a partir de la fecha de entrega en el Lugar Indicado en la Orden de Compra. Si por la naturaleza de los mismos o por necesidad de la Instituci\u00f3n no se puede cumplir con este requisito, la recepci\u00f3n del producto con vencimiento de 11 (once) y 10 (diez) meses deber\u00e1 ser autorizada por la Direcci\u00f3n General del Instituto Nacional del C\u00e1ncer mediante una Nota de Autorizaci\u00f3n y Carta de compromiso de canje Para aquellos medicamentos cuyo vencimiento sea de 9 (nueve) meses o inferior, adem\u00e1s de la autorizaci\u00f3n de la Direcci\u00f3n General del INCAN, se deber\u00e1 presentar P\u00f3liza de Seguro por el 100% del monto del producto con identificaci\u00f3n del n\u00famero de Lote, que ser\u00e1 entregado en la UOC N\u00b0 3 del INCAN. La validez de dicha p\u00f3liza deber\u00e1 ser por 3 meses posteriores a la fecha del vencimiento del art\u00edculo a entregar. Adem\u00e1s, deber\u00e1n presentar Declaraci\u00f3n Jurada por la cual el oferente se compromete en caso de ser adjudicados a canjear el medicamento 60 d\u00edas antes de su vencimiento, previo\ninforme del Departamento de Banco de Drogas del Instituto Nacional del C\u00e1ncer.\" \nSin embargo, en la pagina 27 establece: \"El vencimiento m\u00ednimo de medicamentos no deber\u00e1 ser inferior a 18(diez y ocho) meses al momento de la entrega en el Departamento de Farmacia - Banco de Drogas del Instituto Nacional del C\u00e1ncer, si por la naturaleza del mismo o por necesidad de la Instituci\u00f3n no se puede cumplir con este requisito, la recepci\u00f3n del medicamento deber\u00e1 ser autorizada por la Direcci\u00f3n General del Instituto del C\u00e1ncer. Para aquellos medicamentos cuyo vencimiento sea inferior a 18 meses, adem\u00e1s de la autorizaci\u00f3n de la Direcci\u00f3n General, se deber\u00e1 presentar P\u00f3liza de Seguro por el 100% del monto del producto con identificaci\u00f3n del numero de Lote, que ser\u00e1n entregados un original en la Oficina de la Unidad Operativa de Contrataci\u00f3n N\u00b0 3 y el duplicado en el Departamento de Farmacia - Banco de Drogas del INCAN. La validez de dicha p\u00f3liza a deber\u00e1 ser por 3 meses posteriores a la fecha el\nvencimiento del articulo a entregar. Adem\u00e1s, deber\u00e1n presentar Declaraci\u00f3n Jurada por la cual el oferente se compromete en caso de ser adjudicados a canjear los medicamentos 3 a 6 meses antes de su vencimiento, previo informe de los responsables del Departamento de Farmacia - Banco de Drogas del INCAN.\nSolicitamos a la Convocante utilizar solo lo que establece el PBC en la pagina 16 y reemplazar lo que dicta en la pagina 27 ya que se tratan de medicamentos oncologicos cuya importaci\u00f3n lleva un tiempo considerable y son de alto consumo.", "answer": "REMITIRSE A LA ADENDA N\u00b0 01", "dateAnswered": "2025-02-21T12:30:49-04:00"}, {"id": "2cd352c56a9a5520abdb1184286cdaf4-1", "date": "2025-03-17T11:59:04-04:00", "title": "CAPACIDAD T\u00c9CNICA PARA PRODUCTOS IMPORTADOS", "description": "Para solidos orales (Lenalidomida 10 mg c\u00e1psulas y Lenalidomida 25 mg c\u00e1psulas):  Eliminar del PBC el requisito de la presentaci\u00f3n de \u201cEstudios 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\u201d, debido a que el mencionado principio activo no se encuentra listado en el ANEXO 5 Y ANEXO 6 de la Resoluci\u00f3n S.G. N\u00b0 92/2020.", "answer": "En Capacidad T\u00e9cnica, se solicitan los documentos de manera a garantizar que el principio activo que ser\u00e1 suministrado al paciente cumpla con todos los requisitos de Seguridad, Calidad y Eficacia. Los productos son considerados de ventana terap\u00e9utica estrecha donde la mol\u00e9cula debe demostrar ser equivalente terap\u00e9utico al producto de referencia a fin de asegurar la calidad, seguridad y eficacia del medicamento. Los estudios solicitados se constituyen en los m\u00e9todos m\u00e1s id\u00f3neos para demostrar la equivalencia entre dos medicamentos.", "dateAnswered": "2025-03-26T10:48:53-04:00"}, {"id": "929a4ed718886ea50b56f9197ccad104-1", "date": "2025-02-10T15:02:00-04:00", "title": "Experiencia requerida", "description": "En cuanto a la experiencia requerida, solicitamos a la Convocante considerar la experiencia adquirida en medicamentos en general o disminuir el porcentaje requerido en el criterio, considerando que los medicamentos oncol\u00f3gicos reciben el mismo tratamiento que los los medicamentos en general, siendo diferenciados solamente en el almacenamiento y transporte en los casos de aquellos refrigerados. Esto a fin de no limitar la participaci\u00f3n de potenciales oferentes que cuentan con suficiente experiencia en la provisi\u00f3n de medicamentos de diferentes tipos pero no especificamente oncol\u00f3gicos como requiere la Convocante. Realizando la modificaci\u00f3n requerida la Convocante podr\u00e1 obtener una mayor cantidad de ofertas que se traducen en ofertas mas competitivas, siempre garantizando el cumplimiento de todos los requisitos documentales requeridos en el PBC.", "answer": "Remitirse a la Adenda N\u00b0 01", "dateAnswered": "2025-02-21T12:55:54-04:00"}, {"id": "5bd6bc9d9259dbfeba36a1dbc084bfc6-1", "date": "2025-03-17T11:14:36-04:00", "title": "Experiencia requerida", "description": "Dice: Demostrar la experiencia en MEDICAMENTOS con facturaciones de venta, contratos y/o recepciones finales, tanto en el sector p\u00fablico como en el sector privado, por un monto equivalente al [25] % como m\u00ednimo del monto total ofertado en la presente licitaci\u00f3n, de los: 3 (tres) \u00faltimos a\u00f1os, 2022 2023-2024. Las sumatorias de las facturaciones deben alcanzar el porcentaje indicado, no ser\u00e1 necesaria la presentaci\u00f3n del porcentaje establecido por cada a\u00f1o. --- Se solicita aclarar si ser\u00e1  suficiente presentar experiencia en al menos uno de los a\u00f1os, ya qued\u00f3 claro que no es necesario que los porcentajes cumplan en cada a\u00f1o pero no queda claro si existe la obligaci\u00f3n presentar experiencia en todos los a\u00f1os declarados.", "answer": "Se aclara el porcentaje requerido es en la sumatoria de los a\u00f1os estipulados \u00f3 en al menos uno de ellos. Se considerar\u00e1 la suma de la experiencia dentro de los a\u00f1os solicitados.", "dateAnswered": "2025-03-26T10:48:30-04:00"}, {"id": "a019da7473c1eea9192ed820fdbcf0e7-1", "date": "2025-03-17T09:43:51-04:00", "title": "CAPACIDAD TECNICA", "description": "Solicitamos a la convocante como una observaci\u00f3n general incluir para que se pueda acreditar que el fabricante cuenta con Buenas Pr\u00e1cticas de Fabricaci\u00f3n vigente o Certificado de Registro sanitario vigente en alguno de los pa\u00edses indicados como de alta vigilancia la declaraci\u00f3n jurada de LINK WEB OFICIAL, ya que entendemos que la convocante busca asegurar que los productos ofertados importados cumplen con las garant\u00edas de calidad, seguridad y eficacia.", "answer": "La Convocante establece claramente las condiciones de la Declaraci\u00f3n Jurada requerida y el procedimiento de validaci\u00f3n. El Oferente puede incorporar en su Declaraci\u00f3n Jurada la informaci\u00f3n adicional del link y/o web oficial, lo cual no impide al Comit\u00e9 a aplicar el procedimiento estipulado en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-26T10:48:11-04:00"}, {"id": "0003ff516644317301d0213615939e8d-1", "date": "2025-02-25T15:03:06-04:00", "title": "ADENDA", "description": "Solicito encarecidamente a la Convocante emitir la Adenda durante el periodo de consulta para tener tiempo y posibilidad de esclarecer cualquier duda con respecto a la adenda, para lo que hubiere lugar.", "answer": "La adenda contara  con los plazos de difusi\u00f3n ce\u00f1ida a normativa vigente as\u00ed como el periodo de consultas y respuesta previstos en la misma.", "dateAnswered": "2025-02-25T15:20:54-04:00"}, {"id": "b0ee11bd9410b9fff991dedfc4bec83a-1", "date": "2025-02-10T12:40:20-04:00", "title": "Otros criterios que la convocante requiera", "description": "El PBC reza \"La solicitud de documentaciones formales requeridos en el Pliego de Bases y Condiciones o aclaraciones ser\u00e1 realizada por correo electr\u00f3nico, para lo cual, se remitir\u00e1n las notas de consultas al correo declarado en el formulario de oferta del participante. El oferente deber\u00e1 remitir su respuesta en formato digital al mismo correo desde el cual se realiz\u00f3 la consulta\ny posteriormente la documentaci\u00f3n original deber\u00e1 ser presentada en la Mesa de Entrada de la UOC N\u00b0 03 INCAN, acompa\u00f1ado del reporte del correo remitido como respuesta.\"\nSolicitamos a la Convocante aceptar solo la respuesta por correo electr\u00f3nico obviando presentar en f\u00edsico la misma, de manera a agilizar el proceso de evaluaci\u00f3n de ofertas y optimizar recursos.", "answer": " LOS DOCUMENTOS FORMALES REQUERIDOS EN EL PLIEGO DE BASE Y CODICIONES SE PRESENTARA EN FORMA FISICA CON EL RESPALDO DEL CORREO, CONSIDERANDO SE CONSTITUYEN EN DOCUMENTOS RESPALDATORIOS DE LAS CONCLUSIONES DEL COMITE DE EVALUACION", "dateAnswered": "2025-02-21T12:47:44-04:00"}, {"id": "5e8cfa79f0908d0bf0eaea0dde9e8a56-1", "date": "2025-02-10T15:02:12-04:00", "title": "Validez de los productos", "description": "En el apartado de Periodo de Validez de la garant\u00eda de los bienes\" (p\u00e1g. 13)  la Convocante establece que el vencimiento de los medicamentos conforme al apartado de especificaciones t\u00e9cnicas de ser por lo menos de 12 meses contados a partir de la fecha de entrega en el lugar indicado en la orden de compra. Sin embargo, en las especificaciones t\u00e9cnicas, se establece que el vencimiento de medicamentos no deber\u00e1 ser inferior a 18 meses al momento de la entrega al Dto. de Farmacia - Banco de Drogas del Instituto Nacional de C\u00e1ncer. Teniendo en cuenta esta contradicci\u00f3n, solicitamos unificar los criterios a considerar. Solicitamos considerar que pr\u00e1cticamente el 100% del mercado de los productos pretendidos en el presente proceso responden a medicamentos importados por lo que sugerimos considerar los 12 meses de vencimiento como el plazo m\u00ednimo al momento de la entrega conforme se ha establecido  en el apartado de \"Periodo de Validez de la garant\u00eda de los bienes\".", "answer": "REMITIRSE A LA ADENDA N\u00b0 01", "dateAnswered": "2025-02-21T12:31:58-04:00"}, {"id": "e7de6862c90cd706b6e0823592ee1f98-1", "date": "2025-02-11T15:57:32-04:00", "title": "REQUERIMIENTO DOCUMENTAL - ITEM 5 - ITEM 6 - ITEM 7", "description": "Item 5 - Bortezomib Inyectable 3.5, Item 6 - Lenalidomida Capsula 25 mg, Item 7 - Lenalidomida Capsula 10 mg. Solicitamos respetuosamente a la Convocante incluir la solicitud de los certificados de equivalencia terap\u00e9utica de los mismos, a fin de dar cumplimiento a las normativas sanitarias vigentes.", "answer": "REMITIRSE A LA ADENDA N\u00b0 01", "dateAnswered": "2025-02-21T12:32:25-04:00"}, {"id": "8c1d73641722d861b43c5eb9ddb7f6ca-1", "date": "2025-02-10T15:51:06-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica.", "description": "En los Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica, p\u00e1g. 21, inc. h, requieren lo siguiente: \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 Nacional de Vigilancia Sanitaria, con antelaci\u00f3n de por lo menos 2 (dos) a\u00f1os.\u201d. Al respecto, solicitamos a la Convocante eliminar el criterio establecido considerando que conforme a las normativas aplicables, no existe ning\u00fan impedimento legal (menos aun de antig\u00fcedad de registro como pretende la Convocante) para la comercializaci\u00f3n de un producto en todo el territorio nacional siempre que esta haya obtenido el correspondiente registro sanitario emitido por la DINAVISA, el cual paso por los procesos de revisi\u00f3n, presentaci\u00f3n de documentaciones y dem\u00e1s criterios a trav\u00e9s de la autoridad reguladora nacional para su comercializaci\u00f3n en el pa\u00eds. Este requisito resulta sumamente limitativo y va en contra del principio de igualdad y libre competencia garantizados en la Ley 7021/22, y en contra del art. 22 del Decreto 6611/16 \u201cPor el cual se reglamenta el art\u00edculo 24 de la Ley N\u00ba 1119/1997, \u00abDe productos para la salud y otros\u00bb", "answer": "REMITIRSE A LA ADENDA N\u00b0 01", "dateAnswered": "2025-02-21T12:32:11-04:00"}, {"id": "e7b7f89b2d0bf44ae6233c2a488f58ab-1", "date": "2025-03-17T11:59:38-04:00", "title": "CAPACIDAD T\u00c9CNICA PARA PRODUCTOS IMPORTADOS", "description": "Para solidos orales (Lenalidomida 10 mg c\u00e1psulas y Lenalidomida 25 mg c\u00e1psulas):  Eliminar del PBC el requisito de la presentaci\u00f3n de \u201cEstudios 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\u201d, debido a que el mencionado principio activo no se encuentra listado en el ANEXO mencionado en la Resoluci\u00f3n DINAVISA N\u00b0 478/2023.", "answer": "En Capacidad T\u00e9cnica, se solicitan los documentos de manera a garantizar que el principio activo que ser\u00e1 suministrado al paciente cumpla con todos los requisitos de Seguridad, Calidad y Eficacia. Los productos son considerados de ventana terap\u00e9utica estrecha donde la mol\u00e9cula debe demostrar ser equivalente terap\u00e9utico al producto de referencia a fin de asegurar la calidad, seguridad y eficacia del medicamento. Los estudios solicitados se constituyen en los m\u00e9todos m\u00e1s id\u00f3neos para demostrar la equivalencia entre dos medicamentos.", "dateAnswered": "2025-03-26T10:48:58-04:00"}, {"id": "d273564ee9f41eb5a0bba72ae58239d2-1", "date": "2025-03-12T11:07:11-04:00", "title": "CAPACIDAD TECNICA", "description": "Solicitamos a la Convocante modificar el apartado 7; 1.1 Para f\u00e1rmacos utilizados para terapias dirigidas a blancos moleculares (lenalidomida, bortezomib): Para solidos orales (lenalidomida); ya que al tener Registro de Alta Vigilancia, no ser\u00eda necesario ning\u00fan estudio adicional.", "answer": "En Capacidad T\u00e9cnica, se solicitan los documentos de manera a garantizar que el principio activo que ser\u00e1 suministrado al paciente cumpla con todos los requisitos de Seguridad, Calidad y Eficacia. Los productos son considerados de ventana terap\u00e9utica estrecha donde la mol\u00e9cula debe demostrar ser equivalente terap\u00e9utico al producto de referencia a fin de asegurar la calidad, seguridad y eficacia del medicamento. 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