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Servicios asistenciales de salud", "id": 17}]}}, {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2", "identifier": {"id": "80035226-2", "legalName": "BIOTENG S.A.", "scheme": "PY-RUC"}, "roles": ["supplier", "tenderer", "enquirer"], "contactPoint": {"name": "MYRTA ELIZABETH CABALLERO - ERNESTO FIGUEREDO - RAUL FERREIRA-ANGEL COLMAN", "email": "licitaciones@bioteng.com.py", "faxNumber": "021-604477", "telephone": "0985-692055"}, "address": {"countryName": "Paraguay", "locality": "ASUNCION", "region": "Asunci\u00f3n", "streetAddress": "AVDA. AV. DEL CHACO C/CESAR LOPEZ MOREIRA 415 EDIF. THE TOP PISO 12 OFI. 02"}, "details": {"legalEntityTypeDetail": "S.A.", "activityTypes": ["goods", "services"], "categories": [{"name": "Consultor\u00edas, Asesor\u00edas e Investigaciones. Estudios y Proyectos de inversi\u00f3n", "id": 5}, {"name": "Adquisici\u00f3n y Locaci\u00f3n de inmuebles. Alquiler de muebles", "id": 3}, {"name": "Productos quimicos", "id": 16}, {"name": "Equipos, Productos e instrumentales M\u00e9dicos y de Laboratorio. Servicios asistenciales de salud", "id": 17}]}}, {"name": "Bioethic Pharma S.A.", "id": "PY-RUC-80058902-5", "identifier": {"id": "80058902-5", "legalName": "Bioethic Pharma S.A.", "scheme": "PY-RUC"}, "roles": ["supplier", "tenderer", "payee"], "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": "Equipos, Productos e instrumentales M\u00e9dicos y de Laboratorio. Servicios asistenciales de salud", "id": 17}, {"name": "Productos Alimenticios", "id": 14}, {"name": "Combustibles y Lubricantes", "id": 15}]}}, {"name": "EUROQUIMICA S.A.", "id": "PY-RUC-80061211-6", "identifier": {"id": "80061211-6", "legalName": "EUROQUIMICA S.A.", "scheme": "PY-RUC"}, "roles": ["supplier", "tenderer", "payee"], "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. Servicios asistenciales de salud", "id": 17}]}}, {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0", "identifier": {"id": "80074991-0", "legalName": "QUIMFA S.A.", "scheme": "PY-RUC"}, "roles": ["supplier", "tenderer"], "contactPoint": {"name": "OSCAR HARRISON -MARIA EUGENIA PALEARI DE HARRISON-ALDO HARRISON- ROBERT HARRISON- FELIPE SANABRIA", "email": "licitaciones@quimfa.com.py", "faxNumber": "021/289-4000", "telephone": "0994-139142", "url": "http://www.quimfa.com.py"}, "address": {"countryName": "Paraguay", "locality": "ASUNCION", "region": "Central", "streetAddress": "AVDA PRIMER PRESIDENTE E YRENDAGUE"}, "details": {"legalEntityTypeDetail": "S.A.", "activityTypes": ["goods"], "categories": [{"name": "Productos quimicos", "id": 16}, {"name": "Productos Alimenticios", "id": 14}, {"name": "Equipos, Productos e instrumentales M\u00e9dicos y de Laboratorio. Servicios asistenciales de salud", "id": 17}]}}, {"name": "LIVESTOCK SOCIEDAD ANONIMA", "id": "PY-RUC-80078252-6", "identifier": {"id": "80078252-6", "legalName": "LIVESTOCK SOCIEDAD ANONIMA", "scheme": "PY-RUC"}, "roles": ["enquirer"], "contactPoint": {"name": "FRANCISCO MARTINEZ- RAFAEL RUIZ WIEZELL", "email": "rafael@wiezellabogados.com", "telephone": " 986 11 88 16"}, "address": {"countryName": "Paraguay", "locality": "ASUNCION", "region": "Central", "streetAddress": "BULNES 830 C/ ESPA\u00d1A"}, "details": {"legalEntityTypeDetail": "S.A.", "activityTypes": ["goods", "services"], "categories": [{"name": "Equipos, Productos e instrumentales M\u00e9dicos y de Laboratorio. 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": ["supplier", "tenderer"], "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": "Utiles de oficina, Productos de papel y cart\u00f3n e impresos", "id": 11}, {"name": "Equipos, Productos e instrumentales M\u00e9dicos y de Laboratorio. Servicios asistenciales de salud", "id": 17}]}}, {"name": "MDE SURGICAL CARE", "id": "PY-RUC-DNCP-002036", "identifier": {"id": "DNCP-002036", "legalName": "MDE SURGICAL CARE", "scheme": "PY-RUC"}, "roles": ["enquirer"], "address": {"countryName": "Paraguay", "locality": "1000", "streetAddress": "14 DE JULIO N\u00b0 1283 ENTRE SAN COSME Y VIA FERREA"}, "details": {"legalEntityTypeDetail": "Consorcio", "activityTypes": ["goods"]}, "contactPoint": {"email": "licitaciones@mathercompany.com.py"}}], "tender": {"id": "1f024376-359e-6718-9fcd-d3eca8a7a753", "coveredBy": ["oferta_electronica"], "title": "LPN N\u00b0 05/2025 \"ADQUISICION DE MEDICAMENTOS PARA PACIENTES ONCOLOGICOS 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": "2025-08-26T09:00:00-04:00", "address": {"streetAddress": "A trav\u00e9s del portal, Apertura electr\u00f3nica"}}, "submissionMethodDetails": "Lugar entrega ofertas: A trav\u00e9s del portal, Oferta electr\u00f3nica", "statusDetails": "Adjudicada", "enquiriesAddress": {"streetAddress": "CONSULTAS VIRTUALES A TRAVES DEL PORTAL"}, "mainProcurementCategoryDetails": "Bienes - Medicamentos y Productos Farmaceuticos", "hasEnquiries": false, "value": {"amount": 48845195500, "currency": "PYG"}, "datePublished": "2025-06-06T15:16:16-04:00", "tenderPeriod": {"startDate": "2025-06-06T15:16:16-04:00", "endDate": "2025-08-26T09:00:00-04:00", "durationInDays": 80}, "awardPeriod": {"startDate": "2025-08-26T09:00:00-04:00"}, "contractPeriod": {"maxExtentDate": "2027-12-31T00:00:00-04:00"}, "enquiryPeriod": {"endDate": "2025-08-11T12:00:00-04:00", "startDate": "2025-06-06T15:16:16-04:00", "durationInDays": 65}, "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": "fd18b67d4cfb71f467ce80323f6ea1b0-1", "date": "2025-06-13T09:24:47-04:00", "title": "RUC DE LA CONVOCANTE", "description": "Podrian determinar especificamente el RUC del Instituto Nacional del Cancer / Ministerio de Salud P\u00fablica y Bienestar Social a efectos de la emisi\u00f3n de la garantia", "answer": "RUC 80000905-3 CORESPONDIENTE AL MINISTERIO DE SALUD  PUBLICA Y BIENESTAAR SOCIAL", "dateAnswered": "2025-07-14T14:55:58-04:00"}, {"id": "0510adf5a7706a58abeabdf279a840cb-1", "date": "2025-06-13T09:44:41-04:00", "title": "PRESENTACION DE DOCUMENTOS", "description": "Opatando la convocante por oferta electr\u00f3nica - Subasta a la baja. Podrian indicar si hay algun documento que debe presentarse luego en forma f\u00edsica", "answer": "REMITIRSE A LA RESOLUCION DNCP N\u00b0 232/2025", "dateAnswered": "2025-07-14T14:56:05-04:00"}, {"id": "0111c21236c0d538a68758621d286f37-1", "date": "2025-08-08T10:14:24-04:00", "title": "PARA INHIBIDORES DE LA TIROSINA QUINASA Y TERAPIAS DIRIGIDAS A BLANCOS MOLECULARES (Item 7 Palbociclib)", "description": "Solicitamos respetuosamente a la convocante la modificaci\u00f3n de los requisitos establecidos en los incisos B y E correspondientes al \u00cdtem 7 \u2013 Palbociclib, conforme a lo siguiente: \nCuando el pa\u00eds de origen del elaborador es clasificado conforme al Art. 1 de la LEY N\u00b0 7256/24 QUE MODIFICA EL ARTICULO 11\u00b0 Y AMPLIA LA LEY N\u00b03283/2007 DE PROTECCION DE LA INFORMACION NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMACEUTICOS y RES. DINAVISA N\u00b0 148/2024 POR LA CUAL SE EMITE EL LISTADO ANUAL OFICIAL DE LOS PAISES EN CUMPLIMIENTO AL ART. 3 DE LA LEY N\u00b07256/24, deber\u00e1 presentar el Certificado de Buenas Practicas de Fabricaci\u00f3n vigente o Licencia/Certificado de Fabricaci\u00f3n del producto ofertado o formar parte del MERCOSUR.\nCuando el pa\u00eds de origen del elaborador no es clasificado conforme al Art. 1 de la LEY N\u00b0 7256/24 QUE MODIFICA EL ARTICULO 11\u00b0 Y AMPLIA LA LEY N\u00b0 3283/2007 y RES. DINAVISA N\u00b0148/24 POR LA CUAL SE EMITE EL LISTADO ANUAL OFICIAL DE LOS PAISES EN CUMPLIMIENTO AL ART.3 DE LA LEY N\u00b0 7256/24 o no forme parte del MERCOSUR, deber\u00e1 presentar Certificado de Buenas Practicas de Fabricaci\u00f3n vigente emitido por la Agencia Reguladora de medicamentos del pa\u00eds de origen o Licencia/Certificado de Fabricaci\u00f3n vigente del producto ofertado. Adem\u00e1s, deber\u00e1 presentar el certificado de Buenas Practicas de fabricaci\u00f3n del fabricante vigente o Licencia/Certificado de Fabricaci\u00f3n vigente emitido por cualquiera de las agencias declaradas en la LEY N\u00b0 7256/24 y RES. DINAVISA N\u00b0 148/24 o el Registro Sanitario del producto ofertado emitido por cualquiera de las agencias declaradas en la Ley N\u00b07256/24. En caso de presentar documentaci\u00f3n emitida por el fabricante con el link web oficial de algunas de las documentaciones citadas anteriormente el mismo debe de estar autenticado por escribano p\u00fablico. \nEsto teniendo en cuenta que seg\u00fan las normativas vigentes emitidas por DINAVISA para la obtenci\u00f3n del Registro Sanitario de medicamentos de s\u00edntesis qu\u00edmica, exige \u00fanicamente: La presentaci\u00f3n del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF) vigente, o su constancia de renovaci\u00f3n en tr\u00e1mite, o alternativamente el Registro Sanitario del producto aprobado por una agencia reguladora correspondiente a un pa\u00eds enlistado en la Resoluci\u00f3n DINAVISA N\u00b0 148/2024, sus modificaciones y/o actualizaciones.", "answer": "Se han realizado adecuaciones. Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones", "dateAnswered": "2025-08-13T07:53:04-04:00"}, {"id": "d01f3fc1946b0a39a61e5095a771f3b0-1", "date": "2025-06-12T14:54:19-04:00", "title": "\u00cdTEM N\u00b0 7 - Palbociclib Comprimido", "description": "En las especificaciones t\u00e9cnicas solicitan \u201cPalbociclib comprimido\u201d, cabe mencionar que los Registros Sanitarios vigentes disponibles corresponden a forma farmac\u00e9utica: c\u00e1psulas duras. Ser\u00edan tan amables de modificar las especificaciones t\u00e9cnicas y dejarlo de la siguiente manera \u201cPalbociclib c\u00e1psulas duras\u201d de modo a garantizar mayor participaci\u00f3n de oferentes que cuentan con la forma farmac\u00e9utica c\u00e1psulas duras.", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2025-07-14T14:55:46-04:00"}, {"id": "ed46579a97f49cd92fb978ca3b0114a9-1", "date": "2025-06-17T11:22:24-04:00", "title": "CERTIFICADO DE REGISTRO", "description": "CERTIFICADO DE REGISTRO SANITARIO VIGENTE del \u00edtem ofertado expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA).\nConsulta: Solicitamos amablemente a la Convocante que el Registro Sanitario vigente expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) tenga una antig\u00fcedad de por lo menos 1 (un) a\u00f1o, ya que debido a lo delicado y sensible que es el tratamiento de las enfermedades oncol\u00f3gicas, la Instituci\u00f3n debe precautelar que los medicamentos que va a administrar a sus pacientes tengan una experiencia de uso en plaza de, por lo menos, ese tiempo.", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES.\n", "dateAnswered": "2025-07-14T14:57:46-04:00"}, {"id": "44ade4c4974348937107e9d1bd3e3830-1", "date": "2025-06-11T10:50:49-04:00", "title": "EETT \u2013 ITEM 5 METOTREXATO COMPRIMIDO", "description": "Con relaci\u00f3n al producto correspondiente al \u00cdtem 5, agradecer\u00edamos puedan aclarar la descripci\u00f3n del bien, se indica \u201cMetotrexato 500 mg en comprimido\u201d, sin embargo, hemos constatado que ninguna empresa posee registro sanitario ni comercializa dicha concentraci\u00f3n en comprimidos de 500 mg. En cambio, la presentaci\u00f3n disponible en el mercado con registro vigente corresponde a Metotrexato 500 mg inyectable.\nPor lo tanto, solicitamos se confirme si la descripci\u00f3n del producto debe ser corregida a:\n\"Metotrexato 500 mg inyectable\".", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2025-07-14T14:55:42-04:00"}, {"id": "a33f3fe4ee73adfbfce81f12424b6147-1", "date": "2025-07-29T11:28:18-04:00", "title": "Plazo de reposici\u00f3n de bienes", "description": "Se solicita a la entidad modificar el plazo de reposici\u00f3n a al menos 8 d\u00edas h\u00e1biles.", "answer": "Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-06T09:15:37-04:00"}, {"id": "4530903838e4ec36a4ce5c56541b2b16-1", "date": "2025-07-21T10:31:34-04:00", "title": "REQUISITOS DOCUMENTALES PARA EVALUAR LA CAPACIDAD T\u00c9CNICA", "description": "Para productos importados, y espec\u00edficamente en la secci\u00f3n donde se requiere la presentaci\u00f3n de Certificados de Libre Venta (CLV/CPP) y Certificados de Buenas de Fabricaci\u00f3n, solicitamos a la convocante que se incorpore, para todos los tipos de productos \u2014incluyendo anticuerpos monoclonales, f\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos moleculares, medicamentos de s\u00edntesis, medicamentos biol\u00f3gicos, entre otros\u2014 el siguiente texto aclaratorio:\n\u201cEn caso de presentarse documentaci\u00f3n emitida por el fabricante que incluya un enlace oficial (link web) para su verificaci\u00f3n, la misma deber\u00e1 estar autenticada por escribano p\u00fablico.\u201d", "answer": "Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-06T09:10:31-04:00"}, {"id": "05fd146dabb603d26fdffebb114b8fb9-1", "date": "2025-06-17T10:09:38-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica.", "description": "En los criterios de evaluaci\u00f3n la Convocante requiere lo siguiente: \"El producto biosimilar importado presentar\u00e1 certificados de Registro Sanitario y Autorizaci\u00f3n de Comercializaci\u00f3n vigentes, otorgados por  las Autoridades de Alta Vigilancia Sanitaria: EMA, FDA, Health Canad\u00e1, ANVISA, o ANMAT. El oferente deber\u00e1 presentar una Declaraci\u00f3n Jurada emitida por el Fabricante, 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.\" Al respecto, se solicita a la Convocante establecer que los paises a ser considerados son los establecidos en la Res. DNVS 148/24, considerando que conforme a la normativa vigente (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) es la DINAVISA (art. 3\u00ba de la ley 7256) la responsable de identificar a los pa\u00edses en un listado anual oficial siguiendo los criterios y par\u00e1metros establecidos en la norma. Por tanto, se solicita adecuarse a la normativa vigente, a fin de no limitar la participaci\u00f3n de potenciales oferentes, ya que limitar a solo 6 pa\u00edses del listado establecido en la norma, va en detrimento de prinpicios consagrados en la Ley 7021/22 y la Convocante corre el riesgo de contar con muchas menos ofertas susceptibles de ser adjudicadas y por ende, costos m\u00e1s elevados para los mismos productos disponibles en el mercado que cumplen con toda la documentaci\u00f3n necesaria que aseguran la calidad, seguridad y uso de los mismos.", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES\n\n", "dateAnswered": "2025-07-14T14:57:31-04:00"}, {"id": "1d99f9aa8c09239a09822aa9047666a6-1", "date": "2025-06-13T15:28:47-04:00", "title": "CAPACIDAD TECNICA- PUNTO 3 CERTIFICADO DE REGISTRO- INCISO \u201cE\u201d", "description": "\u201cEl producto biosimilar importado presentar\u00e1 certificados de Registro Sanitario y Autorizaci\u00f3n de Comercializaci\u00f3n vigentes, otorgados por las Autoridades de Alta Vigilancia Sanitaria: EMA, FDA, Health Canad\u00e1, ANVISA, o ANMAT.\u201d\nSolicitamos a la convocante modificar de la sgte manera: El producto biosimilar importado presentar\u00e1 certificados de Registro Sanitario y Autorizaci\u00f3n de Comercializaci\u00f3n vigentes, otorgados por las Autoridades de Alta Vigilancia Sanitaria conforme al Art. 1 de la LEY N\u00b0 7256/24 QUE MODIFICA EL ARTICULO 11\u00b0 Y AMPLIA LA LEY N\u00b0 3283/2007 y RES. DINAVISA N\u00b0 148/24. \nDicha petici\u00f3n se justifica en consideraci\u00f3n 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": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES\n\n", "dateAnswered": "2025-07-14T14:56:22-04:00"}, {"id": "96ecd04835e09a0f8d9584bf1bf4e702-1", "date": "2025-06-17T11:23:21-04:00", "title": "Para Anticuerpos Monoclonales", "description": "En la p\u00e1gina 21 del P.B.C. se establece: e) El producto biosimilar importado presentar\u00e1 certificados de Registro Sanitario y Autorizaci\u00f3n de Comercializaci\u00f3n vigentes, otorgados por las Autoridades de Alta Vigilancia Sanitaria: EMA, FDA, Health Canad\u00e1, ANVISA, o ANMAT. El oferente deber\u00e1 presentar una Declaraci\u00f3n Jurada emitida por el Fabricante, 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.\nConsulta: Solicitamos a la Convocante que establezca la siguiente redacci\u00f3n a efectos de garantizar la calidad de los productos a adquirir: \u201cEl producto biosimilar importado presentar\u00e1 Certificados de Registro Sanitario y Autorizaci\u00f3n de Comercializaci\u00f3n vigentes,  otorgados por al menos 2 (dos) de las siguientes Autoridades de Alta Vigilancia Sanitaria: EMA, FDA, Health Canad\u00e1, ANVISA, o ANMAT. El oferente deber\u00e1 presentar una Declaraci\u00f3n Jurada emitida por el Fabricante, 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. \nLas mencionadas Autoridades de Alta Vigilancia Sanitaria son las que otorgan la mayor confiablidad en lo que respecta a los procesos de control previos para la emisi\u00f3n del correspondiente registro sanitario y, en tal sentido, ello se traduce en mayor confiabilidad en lo que respecta a la eficacia y seguridad de los productos.", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES\n\n", "dateAnswered": "2025-07-14T14:57:54-04:00"}, {"id": "2271c7f110bfb6efeb2475e56b50ebfd-1", "date": "2025-07-18T10:07:57-04:00", "title": "fecha de competencia y otros", "description": "El nuevo sistema de SUBASTA A LA BAJA es lamentable, se presento como una facilidad, pero es cumplejo y solo restringe la participacion. La fecha de competencia es 2 de Julio 2025??? y la de Presentaci\u00f3n de Ofertas Electr\u00f3nicas es viernes, 25 de julio de 2025 - 10:00 y la fecha  de Apertura de Ofertas Electr\u00f3nicas lunes, 28 de julio de 2025 - 10:15. Es todo un absurdo, la competencia ya fue? ... en esa fecha ni siquiera se habia contestado las consultas?. Podrian colaborar con los oferentes dando una explicaci\u00f2n o si esa fecha del 2 de julio se mantiene o la van a modificar. Podrian evitar esta clase de llamado a traves de subasta a la baja hasta que este perfeccionado y brinde una cierta regularidad y SEGURIDAD JURIDICA", "answer": "La fecha de inicio de competencia y la fecha de Apertura Electr\u00f3nica de Ofertas consta en el Portal de Contrataciones P\u00fablicas bajo el ID 467316. En Convocatoria. Datos de la Convocatoria. Remitirse al link: https://www.contrataciones.gov.py/licitaciones/convocatoria/1f024376-359e-6718-9fcd-d3eca8a7a753.html ", "dateAnswered": "2025-08-06T08:44:21-04:00"}, {"id": "3a38459872598ec84b1f617e9a02ae07-1", "date": "2025-07-21T10:32:05-04:00", "title": "REQUISITOS DOCUMENTALES PARA EVALUAR LA CAPACIDAD T\u00c9CNICA", "description": "De la misma forma que est\u00e1n establecidos los requisitos para los Anticuerpos Monoclonales, solicitamos se detallen para los dem\u00e1s medicamentos ejemplo: F\u00e1rmacos Inhibidores de la Tirosina Quinasa y Terapias Dirigidas a Blancos Moleculares, Medicamentos de S\u00edntesis, Medicamentos Biol\u00f3gicos, etc.", "answer": "Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-06T09:10:49-04:00"}, {"id": "2a7a311f2b8a91ea87427ab307575bee-1", "date": "2025-07-29T10:56:00-04:00", "title": "CAMBIO DE MODALIDAD DE LLAMADO", "description": "El sistema de SBE siguen en fase de implementaci\u00f3n y presenta m\u00faltiples errores desde la carga de documentos hasta la etapa de subasta, se solicita a la entidad modificar el sistema a presentaci\u00f3n f\u00edsica hasta tanto la DNCP pueda resolver los inconvenientes que hoy el sistema est\u00e1 presentando.", "answer": "La Convocante opt\u00f3 por la modalidad de SBE Oferta Electronica. Se cuenta con llamados precedentes que se concretaron.", "dateAnswered": "2025-08-06T09:15:22-04:00"}, {"id": "f34df07f902230ab8813ada2f081edf6-1", "date": "2025-07-20T13:08:36-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "Se solicita respetuosamente a la convocante establecer requisitos para los \u201cf\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos moleculares\u201d de la misma forma que se establecieron para los ANTICUERPOS MONOCLONALES", "answer": "Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones", "dateAnswered": "2025-08-06T09:09:30-04:00"}, {"id": "cf3c87732fe641a550a0edc41c42cf91-1", "date": "2025-06-17T11:51:24-04:00", "title": "ITEM 7 PALBOCICLIB - FORMA FARMACEUTICA", "description": "Solicitamos a la convocante modificar la forma farmac\u00e9utica del \u00edtem 7 Palbocilib comprimido a PALBOCICLIB CAPSULAS, considerando que la forma farmac\u00e9utica solicitada no se comercializa en el mercado local.", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASE Y CONDICIONES", "dateAnswered": "2025-07-14T14:58:01-04:00"}, {"id": "70d780ebcda8d76d6334dc049e949b62-1", "date": "2025-07-18T10:08:09-04:00", "title": "Garantias y Decimales", "description": "La convocante nombra la Resolucion 232/25 para responder las consultas 6 y 8. La resoluci\u00f2n citada es absolutamente vaga e imprecisa podrian contestar en forma las citadas consultas. Respecto a la garantia dice \"podra\" se reitera la consulta la quieren firma electronica, Firmas fiscias Escaneadas, firma digital??", "answer": "El Articulo 5\u00b0 de la Resoluci\u00f3n DNCP N\u00b0 232/2025, establece que en los procedimientos de contrataci\u00f3n que empleen el m\u00f3dulo; en \u00e9ste caso el proceso bajo el ID 467316. Cuando la Garant\u00eda de Mantenimiento de Oferta sea instrumentada por medio de p\u00f3liza de seguros, la misma podr\u00e1 ser suscrita con firma electr\u00f3nica cualificada en las condiciones y t\u00e9rminos previstos por la Ley N\u00b0 6822/2021 o emitida a trav\u00e9s de p\u00f3liza electr\u00f3nica con firma digital, regulada por la Superintendencia de Seguros del Banco Central del Paraguay.", "dateAnswered": "2025-08-06T09:06:10-04:00"}, {"id": "cd5e23a05e1dbd19aaa37897c0473871-1", "date": "2025-06-13T15:29:08-04:00", "title": "EETT ITEM 7- PALBOCICLIB", "description": "Solicitamos a la convocante aclarar la presentaci\u00f3n solicitada en el \u00edtem 7, si la misma seria comprimido o se aceptaran tambi\u00e9n capsula?", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2025-07-14T14:57:10-04:00"}, {"id": "137871873ce62df2c55a9364072ec658-1", "date": "2025-06-17T08:52:42-04:00", "title": "\u00cdTEM N\u00b0 7 - PALBOCICLIB", "description": "Actualmente el mercado solo cuenta con la forma farmac\u00e9utica CAPSULAS, y en el caso de que exista solo habr\u00eda un solo oferente que se adapte a lo solicitado. Con el fin de dar oportunidad a la mayor cantidad de oferentes y no violar el principio de igualdad y concurrencia se solicita modificar la forma farmac\u00e9utica CAPSULAS.", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2025-07-14T14:57:24-04:00"}, {"id": "daa7ac5bb27dcc579b922da3b64e921f-1", "date": "2025-08-08T10:14:20-04:00", "title": "AUTORIZACION DEL FABRICANTE- CAPACIDAD TECNICA", "description": "Solicitamos  a la convocante incluir el siguiente requisito dentro de la documentaci\u00f3n correspondiente a la autorizaci\u00f3n del fabricante: \nPARA PRODUCTOS IMPORTADOS\nPara Oferentes Representantes: Carta Poder vigente otorgada por el titular del producto debidamente legalizado y consularizado o apostillado, para comercializar el producto ofertado \nEn caso de que el titular del producto no sea el fabricante, se debe de presentar contrato/acuerdo de fabricaci\u00f3n vigente entre el fabricante y el titular del producto debidamente legalizado y consularizado o apostillado.", "answer": "Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-13T08:04:28-04:00"}, {"id": "6f8735c607e99057a2933f6b13a54e06-1", "date": "2025-07-20T21:15:38-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "Solicitamos a la convocante establecer requisitos claros y diferenciados para los productos de origen Nacional y los importados.", "answer": "Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones", "dateAnswered": "2025-08-06T09:10:21-04:00"}, {"id": "b6c63d75631b0239d534b84be61fbef8-1", "date": "2025-06-13T16:11:29-04:00", "title": "EE.TT. ITEM 7- Palbociclib Comprimido", "description": "Solicitamos respetuosamente a la convocante, modificar la presentacion del ITEM 7- Palbociclib Comprimido, cambiar a la presentacion en Capsulas teniendo en cuenta que las presentaciones en Paraguay son todos en capsulas.", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2025-07-14T14:57:21-04:00"}, {"id": "ce3e9649df9c05bfe07236d6d903e3f1-1", "date": "2025-06-13T09:24:09-04:00", "title": "ESPECIFICACION TECNICA ITEM 11", "description": "Para el item 11 la convocante ha establecido la siguiente descripci\u00f3n TRASTUZUMAB+PERTUZUMAB INYECTABLE con una concentraci\u00f3n de 1200 mg. Esta descripci\u00f3n es limitante y contraviene el principio de libre participaci\u00f3n, como asimismo la forma en que las convocantes  ven\u00edan requiriendo el producto en ocasiones anteriores, beneficiando asi a unos pocos participantes en detrimento de la mayor\u00eda de oferentes, adem\u00e1s de ser t\u00e9cnicamente innecesaria. Se solicita modificar la  descripci\u00f3n dej\u00e1ndola establecida de la siguiente manera Trastuzumab 440mg.", "answer": "EL TRASTUZUMAB 440 MG, SE CONTEMPLARA EN PROXIMAS CONVOCATORIAS", "dateAnswered": "2025-07-14T14:55:50-04:00"}, {"id": "826bb86d81e155ed4c571d4c441b42a2-1", "date": "2025-07-17T10:19:09-04:00", "title": "MODALIDAD DEL LLAMADO", "description": "Solicitamos a la convocante aclarar cual ser\u00e1 la modalidad del llamado. Sera subasta a la baja electronica? Oferta Electronica? o entrega directa de sobre ?", "answer": "La modalidad del llamado es de Subasta a la Baja Electr\u00f3nica con Oferta Electr\u00f3nica. Oferta Electr\u00f3nica no contempla entrega f\u00edsica de ofertas (sobres)", "dateAnswered": "2025-08-06T08:44:03-04:00"}, {"id": "3167170a75eb17b5edf9d37dbb3c9821-1", "date": "2025-07-21T11:36:19-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica.", "description": "En el listado de requisitos la Convocante establece solo requisitos para productos que corresponden a la clasificaci\u00f3n de anticuerpos monoclonales. Considerando que en el listado de productos requeridos, existen diferentes tipos y no solo \"anticuerpos monoclonales\", se entiende que para las dem\u00e1s clasificaciones solo es requerida la presentaci\u00f3n de las dem\u00e1s documentaciones no aplicables a ese listado. Favor confirmar este entendimiento.", "answer": "Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-06T09:11:34-04:00"}, {"id": "785ead41b7310add060d846d7005500b-1", "date": "2025-06-13T09:45:17-04:00", "title": "DECIMALES", "description": "Siendo subasta a la baja - Oferta electronica, debe el oferente en su caso seguir ajustando los decimales para abajo como en el anterior sistema?; Si el oferente debe realizar esta operaci\u00f3n, como y donde sera aclarada o realizada?", "answer": "REMITIRSE A LA RESOLUCION DNCP N\u00b0 232/2025", "dateAnswered": "2025-07-14T14:56:09-04:00"}, {"id": "60d8a9ee3215b6081147152c375367a0-1", "date": "2025-06-17T11:21:56-04:00", "title": "Idioma de la oferta", "description": "La oferta deber\u00e1 ser presentada en idioma castellano o en su defecto acompa\u00f1ada de su traducci\u00f3n oficial, realizada por un traductor p\u00fablico matriculado en la Rep\u00fablica del Paraguay.\nLa convocante permitir\u00e1 la presentaci\u00f3n de cat\u00e1logos, anexos t\u00e9cnicos o folletos en idioma distinto al castellano y sin traducci\u00f3n.\nConsulta: Solicitamos amablemente a la Convocante que permita la presentaci\u00f3n de cat\u00e1logos, anexos t\u00e9cnicos o folletos en idioma distinto al castellano, acompa\u00f1ados de su traducci\u00f3n al castellano.", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES\n\n", "dateAnswered": "2025-07-14T14:57:42-04:00"}, {"id": "eee4f62c58c0b70ee6664fa9736273d3-1", "date": "2025-07-18T10:40:45-04:00", "title": "FECHAS", "description": "El sistema dice Fecha de Presentaci\u00f3n de Ofertas Electr\u00f3nicas. Puede la convocante contestar en forma desarrollada si requiere algun documento fisico. Ante la distorsi\u00f2n de fechas puede la convocante aclarar\nLa etapa de carga de propuestas cuando inicia\nLa etapa de la competencia cuando inicia\nLa presentaci\u00f3n de oferta electronica cuando inicia y cuando concluye\nLa apartura de oferta electronica cuando se realiza\nFavor  no contestar remirise al portal, ni remitirse a tal o cual resolucion. Se necesita una respesuta concreta en virtud a la importancia del llamado", "answer": "Las ofertas electr\u00f3nicas podr\u00e1n ser cargadas y presentadas desde la publicaci\u00f3n de la convocatoria hasta la fecha y hora l\u00edmite de presentaci\u00f3n de ofertas electr\u00f3nicas e inicio de la etapa competitiva indicadas en el SICP. La oferta podr\u00e1 ser modificada o retirada hasta antes de la fecha y hora l\u00edmite de presentaci\u00f3n de ofertas electr\u00f3nicas e inicio de la etapa competitiva que contempla 2 fases: Lances y Aleatorias. La oferta podr\u00e1 ser modificada o retirada hasta antes de la fecha y hora l\u00edmite de presentaci\u00f3n de ofertas electr\u00f3nicas e inicio de la etapa competitiva.\nUna vez generada el Acta de Sesi\u00f3n P\u00fablica Virtual, el oferente, toda vez que haya realizado lances durante la etapa competitiva, deber\u00e1 ajustar su listado de \u00edtems al precio final de la competencia electr\u00f3nica, a trav\u00e9s del m\u00f3dulo de ofertas electr\u00f3nicas, hasta la fecha y hora prevista para el acto de apertura de ofertas electr\u00f3nicas. El SICP habilitar\u00e1 \u00fanicamente la modificaci\u00f3n del precio unitario, los dem\u00e1s campos del \u00edtem se mantendr\u00e1n invariables. En caso de que el oferente no haya realizado lance durante la etapa competitiva, los precios permanecer\u00e1n invariables. \nCulminada la etapa de ajustes de precios de la oferta electr\u00f3nica, se proceder\u00e1 a la apertura de las ofertas electr\u00f3nicas, en el d\u00eda y hora fijados en las bases de la convocatoria de conformidad a las disposiciones establecidas en la Resoluci\u00f3n DNCP N\u00ba 232/2025.\nSe solicita remitirse al link  https://www.contrataciones.gov.py/dncp/subasta-a-la-baja-electronica/manuales-de-uso/\n", "dateAnswered": "2025-08-06T09:08:35-04:00"}, {"id": "de674bbadb263b2883b544d4e30d652a-1", "date": "2025-06-17T10:17:54-04:00", "title": "\u00cdTEM 1. ACIDO ZOLEDRONICO", "description": "En relaci\u00f3n al \u00edtem de referencia, entendemos que no existe inconveniente en que el producto detallado cuente con su solvente respectivo, ya que contar con el solvente respectivo, considerando que el producto corresponde a un polvo liofilizado facilita la aplicaci\u00f3n del producto al paciente.", "answer": "LA FORMA FARMACEUTICA ES INYECTABLE . LA PRESENTACION DEBE RESPONDER A LA AUTORIZADA POR LA DIRECCION NACIONAL DE VIGILANCIA SANITARIA.", "dateAnswered": "2025-07-14T14:57:35-04:00"}, {"id": "e80b541fc1019c0085a036c686568a19-1", "date": "2025-07-20T13:07:47-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "Recordamos a la convocante que el Decreto 6611/16 se encuentra abrogada y la normativa vigente para la emisi\u00f3n de registros sanitarios es la Resoluci\u00f3n DINAVISA 233/2024, en consecuencia, sugerimos a la convocante la siguiente redacci\u00f3n: \u201cEn caso de necesidad o duda la convocante e trav\u00e9s del Comit\u00e9 Evaluador podr\u00e1 solicitar al oferente o a La Direcci\u00f3n Nacional de Vigilancia Sanitaria toda la documentaci\u00f3n presentada por el oferente a la mencionada Direcci\u00f3n de conformidad a la Resoluci\u00f3n DINAVISA 233/2024 \u201cPOR LA CUAL SE ESTABLECEN LOS REQUISITOS PARA LA EMISI\u00d3N DEL REGISTRO SANITARIO DE MEDICAMENTOS BIOL\u00d3GICOS\u201d y sus actualizaciones. La presentaci\u00f3n de la oferta en el marco del presente llamado implica la autorizaci\u00f3n del oferente para acceder a dicha documentaci\u00f3n.\u201d", "answer": "Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-06T09:09:10-04:00"}, {"id": "626d36c3ad2aca3612953f281eedfdec-1", "date": "2025-07-21T11:36:09-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica.", "description": "En el PBC establecen el siguiente criterio: \"El producto biosimilar importado presentar\u00e1 certificados de Registro Sanitario y Autorizaci\u00f3n de Comercializaci\u00f3n vigentes, otorgados por al menos 2 (dos) Autoridades de Alta Vigilancia Sanitaria EMA,FDA,HEALT CANADA,ANVISA o ANMAT.\" Al respecto, se solicita a la Convocante establecer que los paises a ser considerados son los establecidos en la Res. DNVS 148/24, considerando que conforme a la normativa vigente (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) es la DINAVISA (art. 3\u00ba de la ley 7256) la responsable de identificar a los pa\u00edses en un listado anual oficial siguiendo los criterios y par\u00e1metros establecidos en la norma. Por tanto, se solicita adecuarse a la normativa vigente, a fin de no limitar la participaci\u00f3n de potenciales oferentes, ya que limitar a solo 6 pa\u00edses del listado establecido en la norma, va en detrimento de principios consagrados en la Ley 7021/22 y la Convocante corre el riesgo de contar con muchas menos ofertas susceptibles de ser adjudicadas y por ende, costos m\u00e1s elevados para los mismos productos disponibles en el mercado que cumplen con toda la documentaci\u00f3n necesaria que aseguran la calidad, seguridad y uso de los mismos.", "answer": "Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-06T09:11:26-04:00"}, {"id": "fbc184564b2235f7d61770f00e474d48-1", "date": "2025-07-17T12:40:38-04:00", "title": "INICIO DE COMPETENCIA.", "description": "Se solicita amablemente a la convocante, aclarar cual es la fecha de inico de competencia, debido a que en el portal figrura 2/07/2025.", "answer": "La fecha de inicio de competencia consta en el Portal de Contrataciones P\u00fablicas bajo el ID 467316. En Convocatoria. Datos de la Convocatoria. Remitirse al link: https://www.contrataciones.gov.py/licitaciones/convocatoria/1f024376-359e-6718-9fcd-d3eca8a7a753.html", "dateAnswered": "2025-08-06T08:44:21-04:00"}, {"id": "3e23fa75e86e053ed2af530e081898fc-1", "date": "2025-06-17T11:50:48-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "f. Para productos de Origen Nacional cuyo oferente no sea el fabricante, Copia de la Carta Poder de autorizaci\u00f3n otorgada\npor el fabricante al oferente vigente para ofertar y comercializar el producto de su fabricaci\u00f3n autenticada por escribano\nP\u00fablico.  - ---- Favor confirmar su la Carta Poder se refiere al formulario de Autorizaci\u00f3n del Fabricante adjunto en los formularios del PBC", "answer": "REMITIRSE AL PUNTO 1 AUTORIZACION DEL FABRICANTE\n\n", "dateAnswered": "2025-07-14T14:57:57-04:00"}, {"id": "4db12bdc76b70131f78788a36c7a52b6-1", "date": "2025-06-13T15:28:58-04:00", "title": "CAPACIDAD TECNICA- PUNTO 5. CERTIFICADO DE BUENAS PRACTICAS", "description": "El PBC cita lo siguiente: \u201cCuando el pa\u00eds de origen del elaborador no es clasificado conforme al Art. 1 de la LEY N\u00b0 7256/24 QUE MODIFICA EL ARTICULO 11\u00b0 Y AMPLIA LA LEY N\u00b0 3283/2007 y RES. DINAVISA N\u00b0 148/24 POR LA CUAL SE EMITE EL LISTADO ANUAL OFICIAL DE LOS PAISES EN CUMPLIMIENTO AL ART.3 DE LA LEY N\u00b0 7256/24 o no forme parte del MERCOSUR, deber\u00e1 presentar Certificado de Buenas Practicas de Fabricaci\u00f3n vigente emitido por la Agencia Reguladora de medicamentos del pa\u00eds de origen o Licencia/Certificado de Fabricaci\u00f3n vigente del producto ofertado. Adem\u00e1s, deber\u00e1 presentar el certificado de Buenas Practicas de fabricaci\u00f3n del fabricante vigente o Licencia/Certificado de Fabricaci\u00f3n vigente emitido por una de las agencias declaradas en la LEY N\u00b0 7256/24 y RES. DINAVISA N\u00b0 148/24\u201d\nAl respecto amablemente recomendamos la reformulaci\u00f3n del requisito de la siguiente manera: Cuando el pa\u00eds de origen del elaborador no es clasificado conforme al Art. 1 de la LEY N\u00b0 7256/24 QUE MODIFICA EL ARTICULO 11\u00b0 Y AMPLIA LA LEY N\u00b0 3283/2007 y RES. DINAVISA N\u00b0 148/24 POR LA CUAL SE EMITE EL LISTADO ANUAL OFICIAL DE LOS PAISES EN CUMPLIMIENTO AL ART.3 DE LA LEY N\u00b0 7256/24 o no forme parte del MERCOSUR, deber\u00e1 presentar Certificado de Buenas Practicas de Fabricaci\u00f3n vigente emitido por la Agencia Reguladora de medicamentos del pa\u00eds de origen o Licencia/Certificado de Fabricaci\u00f3n vigente del producto ofertado. Adem\u00e1s, deber\u00e1 presentar el certificado de Buenas Practicas de fabricaci\u00f3n del fabricante vigente o Licencia/Certificado de Fabricaci\u00f3n O REGISTRO SANITARIO vigente emitido por una de las agencias declaradas en la LEY N\u00b0 7256/24 y RES. DINAVISA N\u00b0 148/24. \nEsto considerando que las reglamentaciones vigentes emitidas por DINAVISA exigen \u00fanicamente la presentaci\u00f3n INDISTINTA del GMP o bien del Registro Sanitario para el otorgamiento de un registro sanitario.", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES\n\n", "dateAnswered": "2025-07-14T14:57:04-04:00"}, {"id": "8938693d214b2ccb9ccf7eb37f04b799-1", "date": "2025-08-04T16:36:46-04:00", "title": "PARA INHIBIDORES DE LA TIROSINA QUINASA Y TERAPIAS DIRIGIDAS A BLANCOS MOLECULARES", "description": "Solicito a la Convocante modificar en el PBC en el inciso b. El producto importado ofertado presentar\u00e1 certificados de Registro Sanitario y Autorizaci\u00f3n de Comercializaci\u00f3n vigentes de las siguientes Autoridades de Alta Vigilancia Sanitaria EMA, FDA, HEALTH CANADA, ANVISA o ANMAT que es por el titular del producto en origen a fin de brindar mayor oportunidad de participaci\u00f3n a los oferentes.", "answer": "Se han realizado adecuaciones. Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-13T07:51:09-04:00"}, {"id": "0d818d94bd7916e1fb64af65cd8fc456-1", "date": "2025-08-08T10:14:53-04:00", "title": "CAPACIDAD TECNICA- DECLARACION JURADA LINK WEB", "description": "Para productos importados solicitamos a la convocante agregar al inciso b \u201cEn caso de presentarse documentaci\u00f3n emitida por el fabricante que incluya un enlace oficial (link web) para su verificaci\u00f3n, la misma deber\u00e1 estar autenticada por escribano p\u00fablico\u2019\u2019", "answer": "Se han realizado adecuaciones. Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-13T08:05:54-04:00"}, {"id": "d01e97c80e4d1d40882524f182b38d72-1", "date": "2025-08-08T10:14:41-04:00", "title": "PARA INHIBIDORES DE LA TIROSINA QUINASA Y TERAPIAS DIRIGIDAS A BLANCOS MOLECULARES (Item 7 Palbociclib)", "description": "Solicitamos a la convocante la modificaci\u00f3n del inciso D correspondiente a los productos Inhibidores de la Tirosina Quinasa, \nDE: Los productos deber\u00e1n contar con Registro Sanitario Vigente, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), con antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os\nA: Los productos deber\u00e1n contar con Registro Sanitario Vigente, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), al momento de la oferta, en cumplimiento de la normativa vigente. Cabe se\u00f1alar que, una vez aprobado el Registro Sanitario por DINAVISA, el producto queda autorizado para su comercializaci\u00f3n, conforme a lo dispuesto por la autoridad reguladora.\nLa exigencia de contar con un Registro Sanitario con una antig\u00fcedad m\u00ednima de tres (3) a\u00f1os limita la participaci\u00f3n de productos debidamente aprobados y vigentes por la autoridad competente.", "answer": "Se realizaron adecuaciones. Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-13T08:05:02-04:00"}, {"id": "16437490d74fd5b95cd4e64286fce731-1", "date": "2025-07-18T10:08:21-04:00", "title": "DECIMALES", "description": "La convocante nombra la Resolucion 232/25 para responder las consultas 6 y 8. La resoluci\u00f2n citada es absolutamente vaga e imprecisa podrian contestar en forma las citadas consultas. Respecto al ajuste de los decimales, podrian definir el procedimiento", "answer": "Una vez culminada la competencia, el Oferente tendr\u00e1 tiempo de ajustar sus precios electr\u00f3nicamente hasta el d\u00eda de la Apertura de Ofertas indicada en el SICP. Una vez confirmado el precio ya no ser\u00e1 factible modificar. Los decimales deben ser ajustados para abajo.", "dateAnswered": "2025-08-06T09:08:03-04:00"}, {"id": "4173ab47f22cd01ddc0a265adf5af7d4-1", "date": "2025-06-13T15:28:37-04:00", "title": "CAPACIDAD TECNICA- PUNTO 3 CERTIFICADO DE REGISTRO. PARA ANTICUERPOS MONOCLONALES", "description": "\u201cLos productos biol\u00f3gicos, sean innovadores o biosimilares presentaran copia de Certificado de Libre Venta, emitido por una entidad reguladora de referencia FDA o EMA\u201d\nSolicitamos a la convocante modificar de la sgte manera: Los productos biol\u00f3gicos, sean innovadores o biosimilares presentaran copia de Certificado de Libre Venta, emitido por una entidad reguladora de origen. Esto en vista que la DNVS solicita CLV de origen como requisito para registrar productos seg\u00fan RES DNVS N\u00ba 233/24.", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2025-07-14T14:56:16-04:00"}, {"id": "03f8cb29c48fd60d3146b952ca0dec03-1", "date": "2025-06-13T09:24:28-04:00", "title": "Garantia", "description": "Notamos que este llamado es una Subasta a la Baja bajo la modalidad tambien de oferta electronica. En caso de optar por poliza como garantia de mantenieminto de oferta, indisitnamente puede el oferente subir  poliza con firmas electronicas (digital) o el formato pdf de la poliza con firmas olografas de los responsables de la compa\u00f1ia", "answer": "REMITIRSE A LA RESOLUCION DNCP N\u00b0 232/2025", "dateAnswered": "2025-07-14T14:55:54-04:00"}, {"id": "092339d16ab5e4d4a3bb26d676ef7929-1", "date": "2025-06-13T09:44:25-04:00", "title": "POLIZA - GARANTIA", "description": "De optar por poliza como garant\u00eda, cual ser\u00e1 el formato aceptado por la convocante en virtud a la confusa redacci\u00f3n de la nueva ley que solo genera mayor e innecesaria burocracia para la presentaci\u00f2n de ofertas. Favro individualizar: Formato digital / firmas elctronicas / firmas fisicas o cualquiera de ellas mientras el objeto de la oferta este debidamente asegurado", "answer": "REMITIRSE A LA RESOLUCION DNCP N\u00b0 232/2025", "dateAnswered": "2025-07-14T14:56:01-04:00"}, {"id": "54655525b5005e12e6640792f30f4a6f-1", "date": "2025-07-20T12:29:04-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "3. CERTIFICADO DE REGISTRO: A fin de no limitar la participaci\u00f3n a potenciales oferentes y lograr las mejores condiciones de contrataci\u00f3n en cuanto a precio y calidad en resguardo del inter\u00e9s p\u00fablico recomendamos excluir el requisito de la antig\u00fcedad de 18 meses de emisi\u00f3n en los registros sanitarios emitidos por la DINAVISA. Sugerencia de redacci\u00f3n: \u201cRegistro Sanitario expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) vigente\u201d", "answer": "Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-06T09:08:59-04:00"}, {"id": "8ca9f9c0715908d62d8aec05948fb16f-1", "date": "2025-06-17T11:23:01-04:00", "title": "Para Anticuerpos Monoclonales", "description": "En la p\u00e1gina 20 del P.B.C. se establece: \u201ca) Los productos biol\u00f3gicos innovadores presentar\u00e1n copia autenticada de Certificado de Libre Venta, emitido por una entidad regulatoria de referencia, FDA o EMA. El oferente deber\u00e1 presentar una Declaraci\u00f3n Jurada emitida por el Fabricante, 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.\nConsulta: Solicitamos a la Convocante eliminar la exigencia de la presentaci\u00f3n de una Declaraci\u00f3n Jurada emitida por el Fabricante, en la que se exprese \u00e9ste que cumple con este requisito, ya que con la presentaci\u00f3n del Certificado de Libre Venta, emitido por una de las entidades regulatorias de referencia, FDA o EMA se demuestra fehacientemente la calidad del producto innovador ofertado.", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES\n\n", "dateAnswered": "2025-07-14T14:57:50-04:00"}, {"id": "dc88662d805346ec1dd645c9b914baeb-1", "date": "2025-06-13T15:29:18-04:00", "title": "EETT ITEM 7 PALBOCILIB", "description": "Solicitamos a la convocante modificar la presentaci\u00f3n del \u00edtem 7 de comprimido a CAPSULAS, esto en vista que la presentaci\u00f3n solicitada actualmente no se comercializa en el mercado local por lo que la convocante no podr\u00e1 satisfacer la necesidad del mismo.", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2025-07-14T14:57:17-04:00"}, {"id": "e3efe2d506e8bf7107c71a53ed57aa05-1", "date": "2025-07-21T10:32:30-04:00", "title": "REQUISITOS DOCUMENTALES PARA EVALUAR LA CAPACIDAD T\u00c9CNICA", "description": "Solicitamos a la convocante que los requisitos t\u00e9cnicos aplicables a los \u201cF\u00c1RMACOS INHIBIDORES DE LA TIROSINA QUINASA Y TERAPIAS DIRIGIDAS A BLANCOS MOLECULARES\u201d sean definidos con el mismo nivel de especificidad, criterios t\u00e9cnicos y documentaci\u00f3n requerida que los establecidos para los ANTICUERPOS MONOCLONALES.", "answer": "Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-06T09:11:03-04:00"}, {"id": "8a9907ac1d476eb5fa95d875d1a5c3c2-1", "date": "2025-06-13T09:46:05-04:00", "title": "SOLICITUD DE DOCUMENTOS Y PLAZO", "description": "Solicitamos se establezca especificamente que la documentaci\u00f3n requerida por el comit\u00e9 Evalauador pueda ser remitida unicamente por mail y que la convocante establezca previamente el plazo razonable de 48 hrs para su respuesta.", "answer": "REMITIRSE A LA VERSION 2 DE PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2025-07-14T14:56:13-04:00"}, {"id": "df960ed8526b8d05c12b08c91fbb2ab0-1", "date": "2025-07-21T11:35:47-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica.", "description": "La Convocante establece cuanto sigue: \"3. CERTIFICADO DE REGISTRO\nEl Registro Sanitario expedido por la Direcci\u00f3n Nacional de Vigilancia  Sanitaria (DINAVISA) debe estar vigente y contar como m\u00ednimo con una antig\u00fcedad de 18 meses.\" Al respecto, consultamos a la Convocante que pretende garantizar con este criterio. Recordamos a la misma que conforme a la normativa vigente,no existen limitaciones para la venta en todo el territorio nacional de productos que cuenten con el certificado de registro sanitario expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria. Favor rever este criterio.", "answer": "Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-06T09:11:13-04:00"}, {"id": "9d9914726cea3e13e4349719b92283ea-1", "date": "2025-06-17T10:18:17-04:00", "title": "Item 5. METOTREXATO", "description": "En relaci\u00f3n al \u00edtem de referencia entendemos que existe un error en la consignaci\u00f3n de la forma farmac\u00e9utica requerida en el PBC (COMPRIMIDO), debiendo ser la forma farmac\u00e9utica correcta \"Soluci\u00f3n Inyectable\". Esto considerando la concentraci\u00f3n e indicaci\u00f3n m\u00e9dica del producto para ese tipo de concentraciones, favor confirmar este entendimiento.", "answer": "REMITIRSE A LA VERSION 2 DEL PLIEGO DE BASES Y CONDICIONES", "dateAnswered": "2025-07-14T14:57:39-04:00"}, {"id": "b76374fd4275593b1a53d1122bdc2666-1", "date": "2025-07-20T12:45:51-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "Para Anticuerpos Monoclonales, punto f. \u201cEn caso de ofertar un producto de origen nacional, se presentar\u00e1 certificado de Registro Sanitario emitido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA)\u201d. A efectos de promover el origen y empleo nacional se recomienda a la convocante eximir la presentaci\u00f3n de los estudios descriptos en los puntos b., c. y d., teniendo en cuenta adem\u00e1s, que estos documentos ya fueron verificados y aprobados por la DINAVISA siendo innecesario volver a proveerlos.", "answer": "Remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-08-06T09:09:22-04:00"}], "lots": [{"id": "1f0243dd-5d4e-6594-9149-c30db8ce2a1d", "title": "4 - 4 - Metotrexato comprimido", "status": "active", "statusDetails": "activo", "value": {"amount": 109560000, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "4", "id": "4"}]}, {"id": "1f061afc-3df4-6294-a26a-532b88933fa5", "title": "6 - 6 - Oxaliplatino inyectable", "status": "active", "statusDetails": "activo", "value": {"amount": 1130558000, "currency": "PYG"}, "openContractType": "cantidad", 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