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{"startDate": "2024-10-09T17:22:02-04:00", "endDate": "2025-04-15T09:45:00-04:00", "durationInDays": 187}, "awardPeriod": {"startDate": "2025-04-15T10:00:00-04:00"}, "contractPeriod": {"durationInDays": 720}, "enquiryPeriod": {"endDate": "2025-04-08T12:00:00-04:00", "startDate": "2024-10-09T17:22:02-04:00", "durationInDays": 180}, "mainProcurementCategory": "services", "additionalProcurementCategories": ["services"], "procurementMethod": "open", "procurementMethodDetails": "Licitaci\u00f3n P\u00fablica Nacional", "procuringEntity": {"id": "DNCP-SICP-CODE-157", "name": "Instituto de Previsi\u00f3n Social (IPS)"}, "criteria": [{"id": "1", "title": "Garant\u00eda de Mantenimiento de Ofertas", "description": "Los oferentes, proveedores o contratistas deber\u00e1n garantizar la seriedad de sus ofertas, mediante la garant\u00eda de mantenimiento de la oferta", "source": "tenderer", "requirementGroups": [{"id": "1-1", "description": "La garant\u00eda debe ser de un cierto porcentaje, periodo y tipo", "requirements": [{"id": "1-1-1", "title": "Porcentaje de la garantia", "expectedValue": "5"}, {"id": "1-1-2", "title": "Validez de la garantia en d\u00edas", "expectedValue": "180"}]}]}], "enquiries": [{"id": "8cc8ebf825779f58da15a816d12127fa-1", "date": "2025-03-21T10:29:30-04:00", "title": "MUESTRAS", "description": "Teniendo en cuenta el elevado costo de los productos solicitados en el presente llamado y que los mismos son con temperatura controlada, consultamos a la Convocante si pueden ser presentadas muestras vencidas en el proceso de evaluaci\u00f3n, esto a modo de evitar desv\u00edos de temperatura en productos que posteriormente ser\u00e1n entregados. Los mismos ser\u00e1n entregados al solo efecto de su verificaci\u00f3n como \"muestras\" a fin de corroborar que el producto corresponde a lo obrante en el Registro Sanitario aprobado por DNVS as\u00ed como lo declarado en la planilla de datos garantizados.", "answer": "Se aclara que se debe considerar lo establecido en la Secci\u00f3n Datos de la Convocatoria, en el apartado de Muestras, por lo que el Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-04-09T08:18:04-04:00"}, {"id": "c62167952a8bf411e7582e41bb4cd1c8-1", "date": "2025-02-19T18:08:34-04:00", "title": "Punto 7 Para productos monoclonales", "description": "EL PBC CITA CUANTO SIGUE: El producto biosimilar presentara copia autenticada del certificado de registro sanitario o Certificado de producto vigente otorgados por al menos dos de las siguientes autoridades de Vigilancia Sanitaria: EMA, FDA, Health Canad\u00e1, ANVISA o ANMAT.\nAl respecto solicitamos la reformulaci\u00f3n del referido requisito de la siguiente manera: El producto biosimilar presentara copia autenticada del certificado de registro sanitario o Certificado de producto vigente otorgada por cualquiera de las Agencias indicadas 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 \nDicha petici\u00f3n se justifica en consideraci\u00f3n que recientemente (29/05/2024) 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 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 y con el fin de no limitar la concurrencia a dicho proceso.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:45:01-04:00"}, {"id": "4e077ddf2cb58680dfc754186b937fa6-1", "date": "2025-02-20T08:38:48-04:00", "title": "ITEM 16 \u2013 ADALIMUMAB INYECTABLE", "description": "Con el fin de evitar posibles confusiones tanto para el oferente como para la entidad convocante durante el proceso de oferta y evaluaci\u00f3n, solicitamos ajustar el campo \"PRESENTACI\u00d3N EN DASM\" y modificarlo a \u201cPEN - Jeringa Prellenada\u201d, tal como se indica en el campo de FORMA FARMACEUTICA. Esta modificaci\u00f3n permitir\u00e1 unificar los criterios y brindar\u00e1 la oportunidad a un mayor n\u00famero de oferentes, asegurando as\u00ed las mejores condiciones de contrataci\u00f3n.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-03-18T11:47:40-04:00"}, {"id": "f5c416150018ccf1d1b9d85480e21b0c-1", "date": "2025-01-13T08:03:44-04:00", "title": "Experiencia requerida", "description": "Se solicita unificar criterios entre los puntos: EXPERIENCIA REQUERIDA y REQUISITOS DOCUMENTALES PARA EVALUACION DE LA EXPERIENCIA, quedando esta \u00faltima de la siguiente manera: Copia de Facturaciones, Contratos y/o recepciones finales, siendo v\u00e1lidos cualquiera de estos 3 documentos para respaldar la experiencia.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T08:01:20-04:00"}, {"id": "fb522d6a97e97d2201faa8bc841e4dbc-1", "date": "2025-01-10T11:05:20-04:00", "title": "Modalidad de Licitaci\u00f3n", "description": "Solicitamos a la convocante que modifique el llamado a la modalidad de Subasta a la Baja Electr\u00f3nica, para otorgar a la licitaci\u00f3n la mayor transparencia posible.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones. ", "dateAnswered": "2025-02-19T07:56:05-04:00"}, {"id": "d0820657eacc2b78065d33f204dec43e-1", "date": "2025-01-13T08:02:17-04:00", "title": "ITEM 13 - ADALIMUMAB INYECTABLE", "description": "Lo establecido en ESPECIFICACIONES TECNICAS - CPS para el \u00edtem 13 - Adalimumab Inyectable, no coincide con el VADEMECUM Institucional. Las especificaciones solicitados est\u00e1n limitando innecesariamente la participaci\u00f3n la mayor\u00eda de los potenciales oferentes direccionando a una sola marca. El IPS, ya manifest\u00f3 que no existe diferencia de efectos terap\u00e9uticos en ambas presentaciones emitiendo la resoluci\u00f3n RCA 074-020/23 unificando las especificaciones en un solo c\u00f3digo 11106.", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:59:25-04:00"}, {"id": "056ac03a81e13beb305ff370740e1f51-1", "date": "2025-02-19T19:29:57-04:00", "title": "Capacidad Tecnica y Requisitos Documentales para evaluar la capacidad t\u00e9cnica", "description": "En el punto 4. de la secci\u00f3n mencionada la Convocante requiere: \u201cPara productos Importados: copia autenticada del Certificado de Buenas Pr\u00e1cticas de Almacenamiento emitido a nombre del OFERENTE expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), adem\u00e1s de la copia autenticada del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n emitido por la agencia reguladora del pa\u00eds de origen a nombre del Fabricante del Producto Ofertado, dando cumplimiento a las Leyes vigentes LEY 7256/24 QUE MODIFICA EL ARTICULO 11\u00ba Y AMPLIA LA LEY N\u00ba 3283/2007 y RES. DINAVISA N\u00ba 148/2024 POR LA CUAL SE EMITE EL LISTADO ANUAL OFICIAL DE LOS PAISES EN CUMPLIMIENTO AL ART. 3 DE LA LEY N\u00ba 7256/24 y /o el Decreto N\u00ba17057/97 POR LA CUAL SE DISPONE LA VIGENCIA EN LA REPUBLICA DEL PARAGUAY DE LAS RESOLUCIONES ADOPTADAS POR EL GRUPO MERCADO COMUN DEL MERCOSUR, REFERENTES A REGLAMENTOS TECNICOS y/o Decreto N\u00ba6611 POR EL CUAL SE REGLAMENTA EL ART.24 DE LA LEY N\u00b0 1119/97, DE PRODUCTOS PARA LA SALUD Y OTROS, Y SE ESTABLECEN LOS REQUISTOS PARA PRODUCTOS BIOLOGICOS. Al respecto, entendemos que lo que requiere la Convocante es el Certificado de Buenas Practicas a nombre del fabricante del producto ofertado emitido por la agencia reguladora del pa\u00eds de origen; y, en caso de que dicho pa\u00eds no este clasificado como una Autoridad Sanitaria Estricta (ARES) o Autoridad Reguladora de Referencia con m\u00e1ximo nivel de madurez, seg\u00fan la Organizaci\u00f3n Mundial de la Salud (OMS), el oferente deber\u00e1 presentar Certificado de Buenas Pr\u00e1cticas 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. Favor confirmar el entendimiento.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-03-18T11:45:58-04:00"}, {"id": "d323deed506641c7f1b2d7886e230eec-1", "date": "2024-10-16T17:07:14-04:00", "title": "Requisitos documentales para la evaluaci\u00f3n de la experiencia", "description": "Solicitamos a la convocante incluir contratos en el inciso de Requisitos documentales para la evaluaci\u00f3n de la experiencia, esto a modo de unificar los criterios de la demostraci\u00f3n de experiencia", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.  ", "dateAnswered": "2025-01-07T11:02:42-04:00"}, {"id": "a61f52b3809798ee0b245da067489bd1-1", "date": "2025-01-12T17:25:13-04:00", "title": "\u00cdTEM 13. ADALIMUMAB INYECTABLE", "description": "Solicitamos a la Convocante establecer la presentaci\u00f3n de entrega del \u00edtem en cuesti\u00f3n conforme a lo establecido en el Vadem\u00e9cum Institucional vigente, considerando que conforme al Vadem\u00e9cum Institucional y la Res. C.A. N\u00ba 074-020/2023, la presentaci\u00f3n debe ser de la siguiente manera: PEN (40 mg/0,4 mL) / JERINGA PRELLENADA (40 mg/0,8 mL), Lo cual no coincide con la \u00fanica presentaci\u00f3n establecida en las bases y condiciones, la que dirige el \u00edtem a un solo producto en particular, sin justificaci\u00f3n t\u00e9cnica alguna.", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:58:36-04:00"}, {"id": "ab6ffa4fc9ad88a966b0673171bbc507-1", "date": "2024-10-17T09:38:49-04:00", "title": "\u00cdTEM 6. TRASTUZUMAB 600MG/5ML INYECTABLE", "description": "Solicitamos a la convocante verificar y modificar la concentraci\u00f3n requerida para el \u00edtem en particular, considerando que la concentraci\u00f3n disponible mayoritariamente en el mercado corresponde a Trastuzumab 440mg. Esto teniendo en cuenta que la indicaci\u00f3n para la concentraci\u00f3n requerida en el PBC se encuentra indicada para las mismas patolog\u00edas oncol\u00f3gicas que la concentraci\u00f3n de 440mg., ya que la posolog\u00eda utilizada para el producto es por mg/mL., y la concentraci\u00f3n requerida en el PBC representa un costo mucho m\u00e1s elevado comparado con la concentraci\u00f3n propuesta. Finalmente la  concentraci\u00f3n de 600mg requerida solo puede ser cotizada por una empresa en particular, limitando la participaci\u00f3n de potenciales oferentes al proceso.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-01-07T11:04:04-04:00"}, {"id": "fb6360177e0ea5643a8dd551262e2ca0-1", "date": "2024-10-17T08:51:10-04:00", "title": "Requisitos documentales para la evaluaci\u00f3n de la experiencia", "description": "Solicitamos a la convocante ampliar los documentos solicitados incluyendo CONTRATOS como documento que respaldan la experiencia requerida.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.  ", "dateAnswered": "2025-01-07T11:03:22-04:00"}, {"id": "27b0f2af8e1c9c7ad716176488efe73c-1", "date": "2024-10-16T17:37:19-04:00", "title": "Precios Referenciales", "description": "Se solicita a la convocante revisar los precios referenciales establecidos, ya que se encuentran por debajo del precio de mercado.", "answer": "El Oferente deber\u00e1 remitirse a los Datos Cargados en el SICP.", "dateAnswered": "2025-01-07T11:02:51-04:00"}, {"id": "629f24cf71f03c52950cfbb3cd0777cb-1", "date": "2025-01-10T11:04:05-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Solicitamos a la convocante aplicar el sistema de ABASTECIMIENTO SIMULTANEO en el ITEM  5 RITUXIMAB 500 MG, considerando que existen antecedentes de licitaciones con esta modalidad tanto en IPS como en el Ministerio (ver los siguientes ID: 422110 y 384153). Esta modalidad le ofrece a la instituci\u00f3n m\u00e1s opciones de compra y disminuye el riesgo de desabastecimiento.", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:55:51-04:00"}, {"id": "409295594695028d093a1d6b4d82e2fc-1", "date": "2025-02-20T08:22:18-04:00", "title": "PUNTO 4 CERTIFICADO DE BUENAS PRACTICAS", "description": "El PBC cita cuanto sigue: Para los productos importados: \u201ccopia autenticada del Certificado de Buenas Practicas de Almacenamiento emitido a nombre del OFERENTE expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), adem\u00e1s de la copia autenticada del Certificado de Buenas Practicas de Fabricaci\u00f3n emitido por la Agencia Reguladora del Pa\u00eds de Origen a nombre del Fabricante del Producto Ofertado, dando cumplimiento a las Leyes vigentes LEY 7256/24 QUE MODIFICA EL ARTICULO 11\u00ba Y AMPLIA LA LEY N\u00ba 3283/2007 y RES. DINAVISA N\u00ba 148/2024 POR LA CUAL SE EMITE EL LISTADO ANUAL OFICIAL DE LOS PAISES EN CUMPLIMIENTO AL ART. 3 DE LA LEY N\u00ba 7256/24 y /o el Decreto N\u00ba17057/97 POR LA CUAL SE DISPONE LA VIGENCIA EN LA REPUBLICA DEL PARAGUAY DE LAS RESOLUCIONES ADOPTADAS POR EL GRUPO MERCADO COMUN DEL MERCOSUR , REFERENTES A REGLAMENTOS TECNICOS y/o Decreto N\u00ba6611 POR EL CUAL SE REGLAMENTA EL ART.24 DE LA LEY N\u00b0 1119/97, DE PRODUCTOS PARA LA SALUD Y OTROS, Y SE ESTABLECEN LOS REQUISTOS PARA PRODUCTOS BIOLOGICOS\u201d.\nConviene aclarar a la convocante que en la actualidad existen pa\u00edses que ya no emiten Certificados de Buenas Pr\u00e1cticas de Fabricaci\u00f3n, tal es el caso de la Rep\u00fablica Popular China el cual desde el a\u00f1o 2019, ha reglamentado no emitir tales certificados, sino m\u00e1s bien emitir como \u00fanico documento la Licencia/Certificado de Fabricaci\u00f3n en el cual se refleja por un lado la habilitaci\u00f3n de la planta elaboradora y por otro el cumplimiento de las buenas pr\u00e1cticas de fabricaci\u00f3n. Es importante mencionarles que el ente regulador (DINAVISA) ya se ha expedido al respecto y la misma admite dichas licencias como documento suficiente para acreditar el cumplimiento de las buenas pr\u00e1cticas de fabricaci\u00f3n. En caso de duda solicitamos amablemente realizar la consulta al ente regulador, adem\u00e1s, como referencia citamos procesos licitatorios del IPS en donde se ha procedido a modificar este requisito (LPN N\u00ba 32/22, LPN N\u00ba 104/22, LPN N\u00ba 96/22 y LPN N\u00ba 99/22)\nPor todo esto, SOLICITAMOS A LA CONVOCANTE LA AMPLIACI\u00d3N DE DICHO REQUISITO DE LA SIGUIENTE MANERA: \u201cCopia autenticada del Certificado de Buenas Practicas de Almacenamiento emitido a nombre del OFERENTE expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), adem\u00e1s de la copia autenticada del Certificado de Buenas Practicas de Fabricaci\u00f3n o Licencia/Certificado de Fabricaci\u00f3n del fabricante emitido por la Agencia Reguladora del Pa\u00eds de Origen a nombre del Fabricante del Producto Ofertado, dando cumplimiento a las Leyes vigentes LEY 7256/24 QUE MODIFICA EL ARTICULO 11\u00ba Y AMPLIA LA LEY N\u00ba 3283/2007 y RES. DINAVISA N\u00ba 148/2024 POR LA CUAL SE EMITE EL LISTADO ANUAL OFICIAL DE LOS PAISES EN CUMPLIMIENTO AL ART. 3 DE LA LEY N\u00ba 7256/24 y /o el Decreto N\u00ba17057/97 POR LA CUAL SE DISPONE LA VIGENCIA EN LA REPUBLICA DEL PARAGUAY DE LAS RESOLUCIONES ADOPTADAS POR EL GRUPO MERCADO COMUN DEL MERCOSUR , REFERENTES A REGLAMENTOS TECNICOS y/o Decreto N\u00ba6611 POR EL CUAL SE REGLAMENTA EL ART.24 DE LA LEY N\u00b0 1119/97, DE PRODUCTOS PARA LA SALUD Y OTROS, Y SE ESTABLECEN LOS REQUISTOS PARA PRODUCTOS BIOLOGICOS\u201d", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-03-18T11:46:33-04:00"}, {"id": "3a059283b992c8842be2b5d203530a96-1", "date": "2025-01-13T08:02:42-04:00", "title": "ITEM 13 - ADALIMUMAB INYECTABLE", "description": "Lo establecido en ESPECIFICACIONES TECNICAS - CPS para el \u00edtem 13 - Adalimumab Inyectable, no coincide con el VADEMECUM Institucional. Las especificaciones solicitadas est\u00e1n limitando innecesariamente la participaci\u00f3n la mayor\u00eda de los potenciales oferentes direccionando a una sola marca. El IPS, previo an\u00e1lisis t\u00e9cnico, manifest\u00f3 que no existe diferencia de efectos terap\u00e9uticos en ambas presentaciones, produciendo para esto la resoluci\u00f3n de un solo c\u00f3digo de producto (11106) con las diferentes presentaciones/EE.TT.", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T08:00:10-04:00"}, {"id": "df2db878f8d93a7890c262e83d4ce67b-1", "date": "2024-10-15T14:56:48-04:00", "title": "\u00cdTEM 6 - TRASTUZUMAB", "description": "Para el \u00edtem 6 Trastuzumab solicitamos a la convocante verificar y modificar la concentraci\u00f3n requerida a la presentaci\u00f3n mayor\u00eda disponible en el mercado, considerando que la presentaci\u00f3n requerida a la fecha solo una empresa puede participar, sin olvidar que la concentraci\u00f3n requerida 600mg est\u00e1 limitada la indicaci\u00f3n por la que no puede aplicarse a todas las patolog\u00edas oncol\u00f3gica aprobadas comparando con la concentraci\u00f3n de Trastuzumab 440mg; solicitamos modificar a la presentaci\u00f3n de Trastuzumab 440 mg a fin de no limitar innecesariamente la participaci\u00f3n y evitar el direccionamiento a una sola empresa.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n", "dateAnswered": "2025-01-07T11:02:22-04:00"}, {"id": "c4b86ec3449293d6468cc9c3107ab112-1", "date": "2025-03-20T14:38:48-04:00", "title": "Experiencia requerida - CRITERIOS DE EVALUACION", "description": "En la pagina 15 del PBC, la Convocante ha indicado que se podr\u00e1 demostrar la experiencia en PROVISION DE MEDICAMENTOS con facturaciones de venta y/o contratos ejecutados; sin embargo en el apartado en el que se establece los requisitos documentales, no se ha indicado que se podr\u00e1 presentar contratos, conforme se observa solo sera valorada con la presentaci\u00f3n de Copia de facturaciones y/o recepciones finales que avalen la experiencia requerida. Solicitamos a la Convocante, gentilmente indicar que tambi\u00e9n ser\u00e1 admitida la presentaci\u00f3n de contratos a fin de evitar confusiones al momento de evaluar las ofertas.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-04-09T08:23:51-04:00"}, {"id": "52515e73d6df43601567efa596154d90-1", "date": "2024-10-16T17:37:40-04:00", "title": "P\u00e1g. 5 - Abastecimiento Simult\u00e1neo", "description": "Solicitamos la aplicaci\u00f3n de la modalidad de Abastecimiento simult\u00e1neo para las entregas, otorgando de esta forma la posibilidad de que la Convocante pueda contar con los productos adjudicados en tiempo y forma, asegurando la continuidad de los tratamientos sin interrupci\u00f3n a los pacientes.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.  ", "dateAnswered": "2025-01-07T11:02:57-04:00"}, {"id": "3f35ea100285db4f3a2f63338c957f8b-1", "date": "2025-02-20T08:33:34-04:00", "title": "REQUISITOS DOCUMENTALES PARA EVALUACION DE LA EXPERIENCIA", "description": "EL PBC CITA CUANTO SIGUE: \u201cCopia de facturaciones y/o recepciones finales que avalen la experiencia requerida\u201d\nSolicitamos a la convocante modificar de la siguiente manera: \u201cCopia de facturaciones o recepciones finales o Contratos que avalen la experiencia requerida\u201d esto debido a que de esta manera la misma asegura mayor participaci\u00f3n de potenciales oferentes.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:47:19-04:00"}, {"id": "6b7b9011f8cc20be817a2ba5753e0e40-1", "date": "2024-10-15T14:56:59-04:00", "title": "\u00cdTEM 6 - TRASTUZUMAB", "description": "Solicitamos a la Convocante modificar las Especificaciones T\u00e9cnicas del \u00edtem 6 TRASTUZUMAB 600 mg. a TRASTUZUMAB 440 mg. La presentaci\u00f3n de 440 mg. es de aplicaci\u00f3n endovenosa, la indicaci\u00f3n de uso es m\u00e1s amplia, pudiendo ser prescripta para c\u00e1ncer pulmonar, g\u00e1strico, de colon, mamas, endometrio y su precio es m\u00e1s conveniente para la Instituci\u00f3n. Adem\u00e1s, en plaza existen varias marcas de la presentaci\u00f3n de 440 mg., lo que posibilitar\u00e1 la participaci\u00f3n de mayor cantidad de oferentes, cumpliendo la Convocante con los principios de igualdad y libre competencia; econom\u00eda, eficacia y eficiencia y la mejor relaci\u00f3n costo beneficio en la adquisici\u00f3n.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n", "dateAnswered": "2025-01-07T11:02:29-04:00"}, {"id": "269b0906c68c949dfeb3f96207bc9112-1", "date": "2025-02-20T08:51:49-04:00", "title": "ITEM 16 - ADALIMUMAB", "description": "Para el \u00edtem 16- Adalimumab en la columna de presentaci\u00f3n DNCP se establece como \"INYECTOR\", y en la columna de presentaci\u00f3n en DASM, se establece que lo requerido es \"JERINGA PRELLENADA(40 MG/0,8 ML)\". Al respecto, entendemos que lo requerido por la Convocante para el \u00edtem en particular es ADALIMUMAB 40mg/0,8mL. en su presentaci\u00f3n de jeringa prellenada. Favor confirmar el entendimiento.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-03-18T11:48:13-04:00"}, {"id": "62de4fc795ccdf7ca1da0ff841684a82-1", "date": "2025-02-19T18:25:49-04:00", "title": "Experiencia requerida  y Requisitos documentales para la evaluaci\u00f3n de la experiencia", "description": "Solicitamos a la Convocante considerar la experiencia adquirida en el periodo 2024 e incluir el a\u00f1o 2024 como posibilidad de avalar la experiencia. Adem\u00e1s, considerar los certificados y/o actas de recepci\u00f3n final en provisi\u00f3n de medicamentos emitidos en el periodo 2024.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:45:35-04:00"}, {"id": "40adc748e5324607af7494bf2fced5ce-1", "date": "2025-03-21T10:46:33-04:00", "title": "Experiencia requerida", "description": "Favor unificar lo requerido en \"Experiencia requerida y en Requisitos documentales para la evaluaci\u00f3n\", en uno dice Facturaciones de venta y/o contratos, y en el otro dice Copia de facturaciones y/o recepciones finales. Esto genera confusi\u00f3n a la hora de preparar la oferta.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-04-09T08:24:04-04:00"}, {"id": "bf0cf3b742916b8eedd5d9317b096f1c-1", "date": "2025-02-20T08:38:54-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "Solicitamos a la entidad convocante que acepte como v\u00e1lida una certificaci\u00f3n emitida por DINAVISA, en la que conste la presentaci\u00f3n de los estudios requeridos: \u201cestudios precl\u00ednicos, cl\u00ednicos y de inmunogenicidad, propios y concluidos\u201d, para los productos biosimilares importados, tal como se detalla en el punto 7 del apartado \"CAPACIDAD T\u00c9CNICA\". Esta solicitud se fundamenta en la confidencialidad inherente a los documentos relacionados con el producto representado", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:47:52-04:00"}, {"id": "04de595fed4d7049158d015d242c34c6-1", "date": "2024-10-16T17:38:24-04:00", "title": "P\u00e1g. 21 \u2013 EETT", "description": "Para cumplir con uno de los principios de la Ley de Contrataciones respecto a la igualdad de competencia, solicitamos cambiar la concentraci\u00f3n del Trastuzumab de 600mg a 440mg, producto ofrecido por varias empresas en el mercado.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-01-07T11:03:12-04:00"}, {"id": "35d40dbe361e043fb3d64bcf26dc4e65-1", "date": "2025-02-19T19:45:48-04:00", "title": "Punto 7 Para productos monoclonales", "description": "Considerando la FDA de Estados Estados Unidos como organismo regulatorio de referencia global en cuanto a calidad y seguridad de los medicamentos que aprueba, solicitamos respetuosamente que las decisiones t\u00e9cnicas y regulatorias de dicho organismo sean consideradas igualmente v\u00e1lidas para los medicamentos biol\u00f3gicos originales como para los biosimilares. En tal sentido, hacemos notar que la FDA no otorga un Certificado de Registro f\u00edsico como solicita el PBC, sino que lo comunica de manera abierta en su sitio web. a su vez, solicitamos se apliquen en el texto los mismos criterios de documentaci\u00f3n para biosimilares aprobados por FDA y/o EMA que para los biol\u00f3gicos innovadores.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:46:11-04:00"}, {"id": "451d8bcbb6cfdf24dc745c6b8f48c62d-1", "date": "2024-10-17T09:00:03-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Dada la naturaleza y complejidad de los productos del presente llamado, se solicita a la entidad modificar el sistema de adjudicaci\u00f3n a \u201cSISTEMA DE ABASTECIMIENTO SIMULT\u00c1NEO\u201d para todos los \u00edtems. La aplicaci\u00f3n de este sistema busca la provisi\u00f3n ininterrumpida a la entidad recayendo la adjudicaci\u00f3n en m\u00e1s de un proveedor beneficiando al asegurado.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.  ", "dateAnswered": "2025-01-07T11:03:36-04:00"}, {"id": "606b60974a2a4907ac43a10fe9891750-1", "date": "2024-10-17T09:27:33-04:00", "title": "Capacidad t\u00e9cnica", "description": "Se solicita a la convocante diferenciar los requisitos documentales para productos Importados y Nacionales, debido a que algunos \u00edtems no aplican para ambos y lo establecido limita la participaci\u00f3n de forma innecesaria. En el caso de productos de origen nacional, es suficiente documentaci\u00f3n el Certificado de Registro Sanitario vigente emitido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), nuestra entidad reguladora local. En consecuencia, los puntos e) y f) deben ser excluidos para productos de origen nacional.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-01-07T11:03:54-04:00"}, {"id": "cd99b1b3439a2dbee5b2ecab6d51a62e-1", "date": "2025-01-09T16:18:42-04:00", "title": "Abastecimiento simult\u00e0neo", "description": "A la convocante. Solicitamos aplicar el  Abastecimiento simult\u00e1neo. en el \u00edtem 12, Infliximab 100 mg inyectable, existe antecedentes de entregas compartidas (ver LPN 120/23 ID: 435.607) del IPS, que se entrega bajo la modalidad de \"Abastecimiento Simult\u00e1neo\" Tambi\u00e9n en el llamado del MSPBS, en la LPN 101/2023, ID: 433.924, se entrega bajo esta modalidad de \"Abastecimiento Simult\u00e1neo\". En el caso de que no se aplique a todos, solicitamos considerar la aplicaci\u00f3n de \"Abastecimiento Simult\u00e1neo\" al \u00edtem mencionado .", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:55:30-04:00"}, {"id": "2960c50ee2aab00193ab33d2c381967b-1", "date": "2025-01-10T12:18:15-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Se solicita amablemente a la convocante aplicar el sistema de ABASTECIMIENTO SIMULTANEO para el ITEM  12 - INFLIXIMAB 100 MG, teniendo en cuenta que existen antecedentes de abastecimiento bajo esta modalidad, tanto para el IPS (Ej.: ID: 435.607) como para el Ministerio de Salud (Ej.: ID 433.924 y 404.465).  El Abastecimiento Simultaneo permite que la convocante tenga m\u00e1s de un proveedor para el \u00edtem, reduciendo as\u00ed el riesgo de desabastecimiento.", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:57:55-04:00"}, {"id": "1bdf3dd2558a61bea1c1d24a0d4c0426-1", "date": "2025-03-18T11:20:26-04:00", "title": "ITEM 6 - Trastuzumab Inyectable", "description": "En lo que respecta a la concentraci\u00f3n solicitada de 440 mg/vial, consultamos respetuosamente a la convocante sobre la posibilidad de ampliar la misma incluyendo la concentraci\u00f3n de 420 mg/vial, esta \u00faltima es la concentraci\u00f3n registrada ante las principales autoridades sanitarias internacionales como la EMA, la FDA, y otras entidades de referencia. Cabe destacar que la dosis efectiva en todos los casos es de 21 mg/mL, lo cual ha sido comprobada mediante estudios cl\u00ednicos y que se encuentra garantizada por ambas concentraciones. Solicitamos que se realice la ampliaci\u00f3n/modificaci\u00f3n correspondiente en el pliego, ajustando la especificaci\u00f3n de concentraci\u00f3n a 420 mg/vial y 440 mg/vial, de acuerdo con los registros y regulaciones vigentes.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-04-09T08:17:05-04:00"}, {"id": "cf6ce7b409132ef22a7ee490520e47c5-1", "date": "2025-02-19T19:06:36-04:00", "title": "Experiencia requerida", "description": "Solicitamos a la Convocante considerar la experiencia adquirida en el periodo 2024 e incluir el a\u00f1o 2024 como posibilidad de avalar la experiencia.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:45:51-04:00"}, {"id": "23ac759203b4043c5a64fa2b840a1e0e-1", "date": "2024-10-16T17:38:47-04:00", "title": "P\u00e1g. 32 - Porcentaje de multa.", "description": "Solicitamos respetuosamente a la Convocante modificar y disminuir el porcentaje de multa establecido que es de 0,10%, y que se observa, que el porcentaje de tasa de inter\u00e9s por mora por parte de la Contratante es de 0,01%, por tanto solicitamos que el porcentaje de multa sea igual al porcentaje de inter\u00e9s por mora por falta de pago por parte de la Convocante.", "answer": "Cuando se ingresa 0,1 %  el sistema de la DNCP agrega un cero adicional, este tipo de formato es com\u00fan en sistemas que manejan montos y porcentajes, aunque \"0,1\" y \"0,10\" representan el mismo valor. Por lo que se aclara que el valor del porcentaje de multas que ser\u00e1 aplicado por el atraso en la prestaci\u00f3n de servicios ser\u00e1 de: 0,1 %.", "dateAnswered": "2025-01-07T11:03:16-04:00"}, {"id": "f783f5ef57b31baf3a700727ad18f060-1", "date": "2025-01-10T11:49:40-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Solicitamos a la Convocante establecer la utilizaci\u00f3n de abastecimiento simultaneo, considerando que el mismo garantiza a la Convocante el abastecimiento de los productos por m\u00e1s de un proveedor, logrando de esta manera una atenci\u00f3n oportuna a los pacientes y otorgando una mayor oportunidad de competencia a todo potencial oferente que cumpla con las condiciones establecidas en el Pliego de Bases y Condiciones para la provisi\u00f3n de los productos requeridos.", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:57:29-04:00"}, {"id": "b7734dcb974fc7ff6d40f4a6a2ade0cd-1", "date": "2025-01-13T08:03:01-04:00", "title": "ADALIMUMAB INYECTABLE", "description": "Las especificaciones t\u00e9cnicas solicitadas para el item 13 Adalimumab est\u00e1n limitando la participaci\u00f3n de potenciales oferentes. Solicitamos a la convocante establecer las especificaciones t\u00e9cnicas de acuerdo a lo establecido a su vademecum institucional.", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T08:01:12-04:00"}, {"id": "35cb59165ddd9691e119b093a2847984-1", "date": "2024-10-17T09:55:35-04:00", "title": "\u00cdTEM 6. TRASTUZUMAB 600MG/5ML INYECTABLE", "description": "Solicitamos a la convocante verificar y modificar la concentraci\u00f3n requerida para el \u00edtem en particular, considerando que la concentraci\u00f3n disponible mayoritariamente en el mercado corresponde a Trastuzumab 440mg. \nEsta solicitud es realizada considerando que el activo requerido es utilizado para las mismas patolog\u00edas m\u00e9dicas independientemente de la concentraci\u00f3n total del producto. Pues la posolog\u00eda de uso en los pacientes es mg/mL. Y al requerir la concentraci\u00f3n de 600mg. espec\u00edficamente, la Convocante solamente se encuentra limitando la participaci\u00f3n de oferentes a una sola empresa en particular. \nFinalmente, se debe considerar que la compra de la concentraci\u00f3n de 600mg., representa un costo mucho m\u00e1s elevado comparado con la concentraci\u00f3n propuesta. Considerando que la \u00faltima adjudicaci\u00f3n para dicha concentraci\u00f3n es de Gs. 13.900.000 y el referencial para el presente llamado es de Gs. 14.922.213. En cambio, para la concentraci\u00f3n de 440mg. la \u00faltima adjudicaci\u00f3n es de solo Gs. 7.045.454.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-01-07T11:07:13-04:00"}, {"id": "8641cf15483e82b262102512d5b130ef-1", "date": "2025-02-20T08:25:35-04:00", "title": "Capacidad Tecnica - Requisitos documentales para evaluar la capacidad Tecnica", "description": "En el punto 7. requieren cuanto sigue: \"El producto biosimilar presentara copia autenticada del certificado de registro sanitario o Certificado de producto vigente otorgados por al menos dos de las siguientes autoridades de Vigilancia Sanitaria: EMA, FDA, Health Canad\u00e1, ANVISA o ANMAT.\" Solicitamos no limitar las autoridades de alta vigilancia sanitaria y considerar todos aquellos dispuestos en la Res. DINAVISA N\u00ba 148/2024. Esto a fin de no limitar la participaci\u00f3n de potenciales oferentes que contamos con la documentaci\u00f3n requerida, pero de otros pa\u00edses detallados en la Res. DINAVISA y nos encontramos interesados en participar del proceso de contrataci\u00f3n, dando cumplimiento a todos los dem\u00e1s requisitos y especificaciones tecnicas del PBC.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:47:06-04:00"}, {"id": "8091d852e9655f1642e54bc622eb1a2a-1", "date": "2024-10-17T09:24:48-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Considerando convocatorias anteriores de la Convocante y llamados en curso, se solicita  utilizar la modalidad de ABASTECIMIENTO SIMULTANEO, a fin de garantizar a la Convocante el abastecimiento de los productos por m\u00e1s de un proveedor, logrando de esta manera una atenci\u00f3n oportuna a los pacientes y otorgando una mayor oportunidad de competencia a todo potencial oferente que cumpla con las condiciones establecidas en el Pliego de Bases y Condiciones para la provisi\u00f3n de los productos requeridos.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.  ", "dateAnswered": "2025-01-07T11:03:43-04:00"}, {"id": "b7e485e57d3b5de789cfd7a3e77097ce-1", "date": "2025-02-19T18:09:30-04:00", "title": "Punto 7 Para productos monoclonales", "description": "En la versi\u00f3n 4, la convocante para el Punto 7 citaba cuanto sigue: \u201cEl producto biosimilar presentara copia autenticada del certificado de registro sanitario o Certificado de producto vigente otorgado por una de las Autoridades Sanitarias de Referencia conforme a la Ley N\u00b0 7256/24 \u00b4\u00b4Que modifica el Art.11 y ampl\u00eda la Ley N\u00b0 3283/07 \u00b4\u00b4De protecci\u00f3n de la informaci\u00f3n no divulgada y datos de prueba para los registros farmac\u00e9uticos\u00b4\u00b4 y Resoluci\u00f3n DINAVISA N\u00b0 148/2024 \u00b4\u00b4Por la cual se emite el listado anual oficial de los pa\u00edses en cumplimiento al Art.3 de la Ley N\u00b0 7256/24\u201d. \nSolicitamos a la convocante reformular dicho requisito como lo expresado en la versi\u00f3n mencionada puesto que la modificaci\u00f3n en la versi\u00f3n actual no se ajusta a los par\u00e1metros establecidos en el art\u00edculo 2\u00ba de la citada normativa (Resoluci\u00f3n DINAVISA N\u00b0 148/2024) y esto solo limita la concurrencia a dicho proceso.", "answer": "Se aclara que el listado oficial sigue vigente en tanto que el ente regulador emita el nuevo listado lo cual se menciona en la RS DINAVISA N\u00b0 148/24 art\u00edculo 3, por lo que el Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:45:14-04:00"}, {"id": "edaff39543a3306891dbc853c8f093cb-1", "date": "2024-10-17T09:27:27-04:00", "title": "Abastecimiento simultaneo", "description": "Favor contemplar la posibilidad de aplicar el sistema de abastecimiento simult\u00e1neo a todos los \u00edtems a fin de asegurar la provisi\u00f3n a la entidad.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.  ", "dateAnswered": "2025-01-07T11:03:48-04:00"}, {"id": "1f685b03fa679cd0faae57256ba9ff19-1", "date": "2025-02-20T08:59:08-04:00", "title": "ITEM 16 - ADALIMUMAB", "description": "Entendemos que lo requerido para el \u00edtem en cuesti\u00f3n corresponde al producto ADALIMUMAB 40mg./0,8mL. en su presentaci\u00f3n de jeringa prellenada, conforme a lo detallado en la columna  de presentaci\u00f3n en DASM. Por esta razon, solicitamos incluir en la columna de PRESENTAC\u00d3N DNCP la presentaci\u00f3n de \"JERINGA PRELLENADA\". Esto a fin de evitar posibles confusiones al momento de la evaluaci\u00f3n de ofertas.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-03-18T11:49:13-04:00"}, {"id": "4cb01ba13f2c1ca70e20001943e95c92-1", "date": "2025-02-19T13:52:25-04:00", "title": "ITEM 18 - TRASTUZUMAB EMTANSINA INYECTABLE", "description": "En en lo que respecta a la concentraci\u00f3n solicitada de 440 mg/vial, consultamos respetuosamente a la convocante sobre la posibilidad de ampliar la misma incluyendo la concentraci\u00f3n de 420 mg/vial, esta \u00faltima es la concentraci\u00f3n registrada ante las principales autoridades sanitarias internacionales como la EMA, la FDA, y otras entidades de referencia. Cabe destacar que la dosis efectiva en todos los casos es de 21 mg/mL, lo cual ha sido comprobada mediante estudios cl\u00ednicos y que se encuentra garantizada por ambas concentraciones. \nSolicitamos que se realice la ampliaci\u00f3n/modificaci\u00f3n correspondiente en el pliego, ajustando la especificaci\u00f3n de concentraci\u00f3n a 420 mg/vial y 440 mg/vial, de acuerdo con los registros y regulaciones vigentes.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:44:48-04:00"}, {"id": "0d8a4001a7cca3130327ab2be103e01b-1", "date": "2024-10-17T08:51:22-04:00", "title": "CAPACIDAD TECNICA / REQUISITOS DOCUMENTALES PARA EVALUAR EL CRITERIO DE CAPACIDAD T\u00c9CNICA", "description": "7 \u2013 PARA ANTICUERPOS MONOCLONALES\nSe solicita a la convocante diferenciar los requisitos documentales por Importados y Nacionales. Siendo para los productos de origen nacional suficiente documentaci\u00f3n la presentaci\u00f3n del Certificado de Registro Sanitario vigente con la inscripci\u00f3n MB emitido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA). En consecuencia, los puntos e) y f) deben ser excluidos para productos de origen nacional.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-01-07T11:03:30-04:00"}, {"id": "7f80f4108bb887120a5ba23be669778e-1", "date": "2025-02-19T21:15:25-04:00", "title": "Capacidad T\u00e9cnica - Requisitos Documentales para evaluar la capacidad t\u00e9cnica", "description": "Punto 7. Para anticuerpos monoclonales, inciso d) de la p\u00e1g. 15 del PBC, establecen: El producto biosimilar presentara copia autenticada del certificado de registro sanitario o certificado de producto vigente otorgados por una de las autoridades de vigilancia sanitaria: EMA, FDA, HEALTH Canad\u00e1, ANVISA o ANMAT. Al respecto, solicitamos a la Convocante ampliar la lista de autoridades reguladoras indicadas en dicho punto, conforme a lo dispuesto en la normativa vigente al respecto (Res. DINAVISA N\u00b0 148/2024).", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:46:20-04:00"}, {"id": "05e3608e081e57e4782befdb14ec938c-1", "date": "2025-01-10T13:09:09-04:00", "title": "EXPERIENCIA REQUERIDA", "description": "Para la evaluaci\u00f3n de la Experiencia solicitamos a la convocante que en Requisitos Documentales inciso 1 incluyan copias de contratos, la sugerencia es que:\nDonde dice:\n1-\tCopia de facturaciones y/o recepciones finales que avalen la experiencia requerida.\n\nDebe decir:\n1-\tCopia de Contratos y/o facturaciones y/o recepciones finales que avalen la experiencia requerida.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:58:08-04:00"}, {"id": "6424f356cf299356ee0bdd2c5897fd6e-1", "date": "2025-02-20T08:53:49-04:00", "title": "PUNTO 1- AUTORIZACION DEL FABRICANTE", "description": "La convocante solicita que para la firma del contrato el oferente presente la autorizaci\u00f3n del fabricante debidamente inscripta en el Registro P\u00fablico de Comercio SECCION REPRESENTACIONES. Con respecto a este requisito creemos pertinente mencionar que es la Direcci\u00f3n General de los Registros P\u00fablicos quien resuelve y define la SECCION y/o SERIE en la cual ser\u00e1 registrado un documento sometido a su consideraci\u00f3n, hall\u00e1ndose imposibilitado el profesional habilitado y/o interesado de escoger o elegir, la secci\u00f3n y/o serie en la cual desee que un documento sea registrado, por lo que mal podr\u00eda la convocante exigir que dicha documentaci\u00f3n se halle inscripta en una \u201csecci\u00f3n espec\u00edfica\u201d, cuando que es la misma D.G.RR.PP., bajo las directrices del Reglamento General T\u00e9cnico Registral de la Direcci\u00f3n General de Registros P\u00fablicos, quien define y resuelve la secci\u00f3n y/o serie en el cual ser\u00e1 inscripto las documentaciones que son sometidas a su consideraci\u00f3n para su inscripci\u00f3n.- \nQue en un tiempo anterior al a\u00f1o 2016, las documentaciones como ser Carta de Representaciones emitidas en el exterior del Pa\u00eds a favor de empresas locales, eran registradas en el Registro P\u00fablico de Comercio \u201cSecci\u00f3n Representaciones\u201d, pero que a partir del a\u00f1o 2016, con la entrada en vigencia del Reglamento General T\u00e9cnico Registral de la Direcci\u00f3n General de Registros P\u00fablicos, los mismos, ya no son registrados bajo \u201cREGISTRO ni SECCIONES\u201d, sino que fueron remplazados por \u201cMATRICULA y SERIE\u201d por lo cual la Secci\u00f3n de Representaciones ya no existe, en raz\u00f3n a ello solicitamos a la Convocante excluir que el documento solicitado se encuentre inscripto \u00fanicamente en la secci\u00f3n representaciones a fin de evitar confusiones en el Comit\u00e9 de Evaluaci\u00f3n al momento de evaluar los criterios exigidos en el PBC,  debiendo quedar el requisito de la siguiente manera \u201cAs\u00ed mismo, la documentaci\u00f3n podr\u00e1 ser presentada en copia simple, no obstante, para la firma del contrato la misma deber\u00e1 estar INSCRIPTA EN EL REGISTRO PUBLICO DE COMERCIO\u201d", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-03-18T11:48:33-04:00"}, {"id": "51d4ed94666a89a770e1cbaf27498830-1", "date": "2025-02-20T08:24:25-04:00", "title": "Capacidad T\u00e9cnica y Requisitos documentales para evaluar la capacidad t\u00e9cnica", "description": "Punto 7. Para anticuerpos monoclonales, inciso d) de la p\u00e1g. 15 del PBC, establecen:El producto biosimilar presentara copia autenticada del certificado de registro sanitario o Certificado de producto vigente otorgados por al menos dos de las siguientes autoridades de Vigilancia Sanitaria: EMA, FDA, Health Canad\u00e1, ANVISA o ANMAT.. Al respecto, solicitamos a la Convocante aclarar el motivo de la limitaci\u00f3n de los paises detallados, considerando que la lista de autoridades reguladoras estrictas o o Autoridad Reguladora de Referencia con m\u00e1ximo nivel de madurez seg\u00fan la OMS se encuentra detallada en la Res. DINAVISA N\u00b0 148/2024 y esta no se limita especificamente a los paises detallados en este punto. Adem\u00e1s, solicitamos a la Convocante requerir un solo registro sanitario conforme lo requiere la propia autoridad sanitaria en la normativa vigente respecto a los productos a adquirir. Esto a fin de no limitar la participaci\u00f3n de potenciales oferentes en el proceso de referencia.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:46:55-04:00"}, {"id": "f1fb018d7d7a8dfd5534441d2513735b-1", "date": "2025-01-10T10:59:23-04:00", "title": "Abastecimiento Simult\u00e1neo", "description": "Solicitamos a la convocante la aplicaci\u00f3n de la modalidad de Abastecimiento simult\u00e1neo en todos los items para las entregas, otorgando de esta forma la posibilidad de que la misma pueda contar con los productos adjudicados en tiempo y forma, asegurando la continuidad de los tratamientos sin interrupci\u00f3n a los pacientes", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:55:45-04:00"}, {"id": "ccfa4519546097a4d4c8059ad76b662c-1", "date": "2025-01-11T17:22:48-04:00", "title": "\u00cdTEM 13. ADALIMUMAB INYECTABLE", "description": "Solicitamos a la Convocante regirse por el Vadem\u00e9cum Institucional vigente para establecer las especificaciones t\u00e9cnicas del \u00edtem 13. ADALIMUMAB INYECTABLE, considerando que conforme al Vadem\u00e9cum Institucional y la Res. C.A. N\u00ba 074-020/2023, han realizado la unificaci\u00f3n de todos los c\u00f3digos para el producto en particular y establece especificaciones t\u00e9cnicas UNIFICADAS a ser utilizadas para la compra del producto.", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:58:29-04:00"}, {"id": "3b5a3f7a53c1b3d6dcad4189e1209506-1", "date": "2025-01-10T12:00:44-04:00", "title": "PLAN DE ENTREGA", "description": "En relaci\u00f3n al Plan de Entrega de los Bienes solicitamos a la convocante que los plazos de entrega se computen como D\u00cdAS H\u00c1BILES.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:57:47-04:00"}, {"id": "c06b2b30b7188bb1b324f77f33b33b78-1", "date": "2025-02-20T08:58:06-04:00", "title": "Capacidad t\u00e9cnica", "description": "Para productos Biosimilares importados la convocante solicita: \"El producto biosimilar presentara copia autenticada del certificado de registro sanitario o Certificado de producto vigente otorgados por al menos dos de las siguientes autoridades de Vigilancia Sanitaria: EMA, FDA, Health Canad\u00e1, ANVISA o ANMAT.\". Se solicita a la convocante aceptar al menos un registro sanitario o CPP de alta vigilancia, siendo suficiente aval de calidad la evaluaci\u00f3n de cualquiera de estas autoridades", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:48:44-04:00"}, {"id": "98dd0c1617371e195f79e5192df11251-1", "date": "2025-01-12T22:16:23-04:00", "title": "Experiencia requerida", "description": "Solicitamos a la Convocante considerar la experiencia adquirida en el periodo 2024 e incluir el a\u00f1o 2024 como posibilidad de avalar la experiencia.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:59:14-04:00"}, {"id": "8b455840724da2ea3c4a6d94766014d0-1", "date": "2024-10-17T09:38:01-04:00", "title": "ABASTECIMIENTO SIMULTANEO - \u00cdTEMS 3 Y 4", "description": "Teniendo en cuenta que los productos detallados en los \u00edtems mencionados cuentan con la posibilidad de provisi\u00f3n por varios proveedores disponibles en el mercado nacional. Solicitamos a la Convocante utilizar la modalidad de ABASTECIMIENTO SIMULTANEO para estos \u00edtems, a fin de garantizar a la Convocante el abastecimiento de los productos por m\u00e1s de un proveedor, logrando de esta manera una atenci\u00f3n oportuna a los pacientes y otorgando una mayor oportunidad de competencia a todo potencial oferente que cumpla con las condiciones establecidas en el Pliego de Bases y Condiciones para la provisi\u00f3n de los productos requeridos.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-01-07T11:03:58-04:00"}, {"id": "009bf4559298a6c9974381a122e2da6a-1", "date": "2025-01-10T13:10:05-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Solicitamos a la convocante aplicar el sistema de ABASTECIMIENTO SIMULTANEO en el ITEM  6 TRASTUZUMAB 440 MG, considerando que existen antecedentes de licitaciones con esta modalidad tanto en IPS (ID: 435607) como en el Ministerio (ID: 435607). Esta modalidad le ofrece a la instituci\u00f3n m\u00e1s opciones de compra y disminuye el riesgo de desabastecimiento.", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:58:18-04:00"}, {"id": "171e41674ef24ec1dce412f8e82f61e2-1", "date": "2025-01-12T20:00:08-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Considerando convocatorias anteriores de la Convocante y llamados en curso, se solicita utilizar la modalidad de ABASTECIMIENTO SIMULTANEO, a fin de garantizar a la Convocante el abastecimiento de los productos por m\u00e1s de un proveedor, logrando de esta manera una atenci\u00f3n oportuna a los pacientes y otorgando una mayor oportunidad de competencia a todo potencial oferente que cumpla con las condiciones establecidas en el Pliego de Bases y Condiciones para la provisi\u00f3n de los productos requeridos.", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:58:46-04:00"}, {"id": "d2e10bfc3acd45a1e64e0ae5ed00b256-1", "date": "2024-10-16T17:38:03-04:00", "title": "P\u00e1g. 9 - Muestras", "description": "Solicitamos a la convocante que las muestras de los \u00edtems ofertados, en caso de ser adjudicados, sean consideradas como parte de la primera entrega, considerando el elevado costo de algunos de los \u00edtems solicitados.", "answer": "Se aclara al oferente en caso de ser adjudicado se considerara la muestra como parte de la primera entrega. Pero se debe considerar el aparto de muestras donde dice: \u00b4\u00b4En el caso de que se presentaran procesos de impugnaci\u00f3n (protesta y/o denuncia) ante la Direcci\u00f3n Nacional de Contrataciones P\u00fablicas, las muestras de los \u00edtems, objeto de protesta, deber\u00e1n permanecer en las instalaciones de la unidad solicitante hasta tanto se resuelva los referidos procesos de impugnaci\u00f3n\u00b4\u00b4.", "dateAnswered": "2025-01-07T11:03:04-04:00"}, {"id": "99f8d31cdf73f8846747266ebceddf1c-1", "date": "2025-01-12T21:23:53-04:00", "title": "SISTEMA DE ABASTECIMIENTO SIMULT\u00c1NEO", "description": "Dada la naturaleza y complejidad de los productos del presente llamado, se solicita a la entidad modificar el sistema de adjudicaci\u00f3n a \u201cSISTEMA DE ABASTECIMIENTO SIMULT\u00c1NEO\u201d para todos los \u00edtems. La aplicaci\u00f3n de este sistema busca la provisi\u00f3n ininterrumpida a la entidad recayendo la adjudicaci\u00f3n en m\u00e1s de un proveedor beneficiando al asegurado.", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T07:59:05-04:00"}, {"id": "2e143909d04754339cdd3bb22d364da0-1", "date": "2024-10-15T14:57:21-04:00", "title": "\u00cdTEM 6 - TRASTUZUMAB", "description": "Para el \u00edtem 6, pedimos aclaraci\u00f3n del pedido, atendiendo a que actualmente la Instituci\u00f3n cuenta con contratos de licitaciones anteriores y stock suficiente del Trastuzumab 440 mg. Inclusive con ordenes pendientes de emitirse.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n", "dateAnswered": "2025-01-07T11:02:37-04:00"}, {"id": "4c23d6cc1537c581a93427cd7a3568f7-1", "date": "2025-02-20T08:58:11-04:00", "title": "Especificaciones t\u00e9cnicas", "description": "Para el Item 16 - ADALIMUMAB. Lo solicitado en Forma Farmac\u00e9utica, Presentaci\u00f3n DNCP y Presentaci\u00f3n en DASM no coinciden, favor unificar a: \"PEN - Jeringa Prellenada\" en los 3 requisitos.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-03-18T11:48:55-04:00"}, {"id": "b58d42e626a7442502cf929a3e49abe7-1", "date": "2025-02-20T08:34:26-04:00", "title": "Capacidad T\u00e9cnica y Requisitos documentales para evaluar la capacidad t\u00e9cnica", "description": "En el punto 7. requieren cuanto sigue: \"El producto biosimilar presentara copia autenticada del certificado de registro sanitario o Certificado de producto vigente otorgados por al menos dos de las siguientes autoridades de Vigilancia Sanitaria: EMA, FDA, Health Canad\u00e1, ANVISA o ANMAT.\" Solicitamos no limitar las autoridades de alta vigilancia sanitaria y considerar todos aquellos dispuestos en la Res. DINAVISA N\u00ba 148/2024. Adem\u00e1s, solicitamos considerar que conforme al Decreto 6611/16 la autoridad sanitaria nacional solamente requiere la presentaci\u00f3n de un certificado de producto o registro sanitario vigente emitido por una autoridad prevista en la Res. DINAVISA 148/2024, por lo que requerir 2 registros resulta limitativo para los potenciales oferentes que hemos dado cumplimiento a toda la normativa nacional para la libre comercializaci\u00f3n del producto en el territorio nacional. Estas solicitudes la realizamos a fin de no limitar la participaci\u00f3n de potenciales oferentes que contamos con la documentaci\u00f3n requerida, pero de otros pa\u00edses detallados en la Res. DINAVISA y nos encontramos interesados en participar del proceso de contrataci\u00f3n, dando cumplimiento a todos los dem\u00e1s requisitos y especificaciones tecnicas del PBC.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:47:29-04:00"}, {"id": "4aac856b63fbcb101dcbe2110052ecb8-1", "date": "2025-01-10T11:50:38-04:00", "title": "Item 1- Abciximab inyectable", "description": "Para el \u00edtem 1 - Abciximab inyectable, solicitamos que se actualice el precio referencial, debido a que el mismo se encuentra desfasado.", "answer": "El Oferente deber\u00e1 remitirse a los Datos Cargados en el SICP.", "dateAnswered": "2025-02-19T07:57:38-04:00"}, {"id": "f8d834f9a6bd29afa23cd4cb29ff3b74-1", "date": "2025-02-19T11:03:20-04:00", "title": "Requisitos documentales para la evaluaci\u00f3n de la experiencia", "description": "Se solicita unificar criterios entre lo expuesto en el apartado de \"EXPERIENCIA REQUERIDA\" y \"REQUISITOS DOCUMENTALES.....\" cambiando la redacci\u00f3n en esta \u00faltima de la siguiente forma: 1. Copia de facturaciones y/o contratos y/o recepciones finales que avalen la experiencia requerida.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:44:32-04:00"}, {"id": "f4f80afc8e3ec31029407301d62c6638-1", "date": "2025-02-20T08:38:58-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "Se solicita respetuosamente a la convocante considerar la aceptaci\u00f3n de al menos un (1) certificado de registro sanitario o Certificado de producto vigente (CPP) emitido por alguna de las siguientes autoridades de Vigilancia Sanitaria: EMA, FDA, Health Canad\u00e1, ANVISA o ANMAT. Consideramos que la presentaci\u00f3n de un \u00fanico certificado de registro o CPP es suficiente.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2025-03-18T11:48:04-04:00"}, {"id": "ab2c6fa2d2c40942afc6ad44ee36b7f2-1", "date": "2025-01-13T08:06:03-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Solicitamos respetuosamente a la convocante aplicar el sistema de adjudicaci\u00f3n por ABASTECIMIENTO SIMULT\u00c1NEO con el fin de dar participaci\u00f3n a la mayor cantidad de proveedores resguardando una provisi\u00f3n ininterrumpida. Lo solicitado a causa de que todos los productos solicitados en este proceso son de alta complejidad.", "answer": "El oferente deber\u00e1 remitirse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.", "dateAnswered": "2025-02-19T08:01:30-04:00"}, {"id": "4ea9edfbe040cbfc773c94242254cb10-1", "date": "2025-02-20T08:52:37-04:00", "title": "PUNTO 1- AUTORIZACION DEL FABRICANTE", "description": "Solicitamos  a la convocante modificar de la siguiente manera: Para representantes, Carta Poder vigente otorgada por el fabricante debidamente legalizado y consularizada o apostillado, para comercializar el producto ofertado e inscripta en el Registro P\u00fablico de Comercio. En caso que el oferente no sea el representante del producto ofertado, se deber\u00e1 de acreditar la cadena de autorizaciones hasta el fabricante o productor. Para oferentes que son titulares del registro sanitario cuya fabricaci\u00f3n del producto es tercerizada en el extranjero, presentar contrato/acuerdo de fabricaci\u00f3n vigente, legalizado y consularizada o apostillado. En caso de que el oferente no sea el titular del registro sanitario, se deber\u00e1 de acreditar la cadena de autorizaciones hasta el fabricante o productor. Para oferentes que son titulares del registro sanitario cuya fabricaci\u00f3n del producto es tercerizada en el \u00e1mbito local, presentar copia del contrato/acuerdo de fabricaci\u00f3n vigente autenticada por escribano P\u00fablico. En caso de que el oferente no sea el titular del registro sanitario, se deber\u00e1 de acreditar la cadena de autorizaciones hasta el fabricante o productor. Para productos de Origen Nacional cuyo oferente no sea el fabricante ni titular del registro sanitario, Copia de la Carta de autorizaci\u00f3n otorgada por el fabricante al oferente vigente para ofertar y comercializar el producto de su fabricaci\u00f3n autenticada por escribano P\u00fablico. Esto a modo de tener mayor participaci\u00f3n de potenciales oferentes.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2025-03-18T11:48:24-04:00"}], "lots": [{"id": "1ef8006c-2df0-68ba-9730-21a27edac2f0", "title": "5 - 5 - Rituximab inyectable", "status": "active", "statusDetails": "activo", "value": {"amount": 23199782800, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "5", "id": "5"}]}, {"id": "1efea0bc-8faf-6794-9b8d-f5e8277f4a05", "title": "16 - 16 - Pertuzumab Inyectable", "status": "active", "statusDetails": "activo", "value": {"amount": 44654024475, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "16", "id": "16"}]}, {"id": "1ef802de-9690-6a04-8ee5-a392f4fb22b2", "title": "7 - 7 - Tocilizumab Inyectable", "status": "active", "statusDetails": "activo", "value": {"amount": 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