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"language": "es", "documentType": "awardNotice", "format": "text/html"}], "items": [{"id": "oS8tQXKRWSfhE1rAthNySQ==", "description": "TACROLIMUS CAPSULA-TACROLIMUS 1MG CAP", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51201504-001", "description": "Tacrolimus capsula", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51201504-001"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51201504", "description": "Tacrolimo", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51201504"}], "quantity": 196600, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 16545, "currency": "PYG"}}, "relatedLot": "0fnhbruJCWQ=", "attributes": [{"value": "INDIA", "name": "Procedencia", "id": "1"}, {"value": "UNIDAD", "name": "Presentacion", "id": "2"}, {"value": "INDIA", "name": "Fabricante", "id": "3"}, {"value": "TACROLIMUS 1MG BAUEL TOP", "name": "Marca", "id": "4"}, {"value": "TACROLIMUS 1MG BAUEL TOP", "name": "Modelo", "id": "5"}, {"name": "Relacion Medida", "id": "6", "value": "UNIDAD"}, {"name": "Orden", "value": "13", "id": "7"}]}]}], "tender": {"id": "430314-lpn-sbe-45-23-adquisicion-medicamentos-biologicos-oncologicos-inmunosupresores-decla-1", "title": "LPN SBE 45-23 ADQUISICION DE MEDICAMENTOS BIOLOGICOS, ONCOLOGICOS, INMUNOSUPRESORES DECLARADOS DESIERTOS EN LA LPN 99/22 Y OTROS - SOLPED 1130000301", "status": "complete", "awardCriteria": "priceOnly", "awardCriteriaDetails": "Por Item", "submissionMethod": ["electronicAuction"], "techniques": {"hasElectronicAuction": true}, "bidOpening": {"date": "2023-11-28T10:00:00-04:00", "address": {"streetAddress": "CAJA CENTRAL IPS, CONSTITUCION Y HERRERA, 1R PISO, SALA DE APERTURAS"}}, "submissionMethodDetails": "Lugar entrega ofertas: CAJA CENTRAL IPS, CONSTITUCION Y HERRERA, 1R PISO, DPTO LICITACIONES || Lugar entrega bien: Sistema SBE || Fecha entrega bien: Seg\u00fan documento del llamado", "eligibilityCriteria": "Restricciones: 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Servicios asistenciales de salud", "hasEnquiries": true, "value": {"amount": 126054806390, "currency": "PYG"}, "datePublished": "2023-07-26T15:02:23-04:00", "tenderPeriod": {"startDate": "2023-11-24T08:00:00-04:00", "endDate": "2023-11-27T08:00:00-04:00", "durationInDays": 3}, "awardPeriod": {"startDate": "2023-11-28T10:00:00-04:00"}, "contractPeriod": {"durationInDays": 720}, "enquiryPeriod": {"endDate": "2023-08-01T10:00:00-04:00", "startDate": "2023-07-26T15:02:23-04:00", "durationInDays": 5}, "mainProcurementCategory": "goods", "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": "3"}, {"id": "1-1-2", "title": "Validez de la garantia en d\u00edas", "expectedValue": "180"}]}]}], "enquiries": [{"id": "13", "date": "2023-07-31T19:58:05-04:00", "title": "CAPACIDAD TECNICA PUNTO 1.4 \u0096 MEDICAMENTOS INMUNOSUPRESORES:", "description": "En el PBC actual se menciona \u00fanicamente:\nb)\tAgencias reguladoras de Alta Vigilancia de los pa\u00edses indicados en el art. 11 de la Ley N\u00b0 3283/07, Ley de protecci\u00f3n de la informaci\u00f3n no divulgada y datos de prueba para los registros farmac\u00e9uticos;\nc)\tLas dem\u00e1s Agencias Reguladoras de los Pa\u00edses indicados en el Art. 11 de la Ley 3283/07;\nd)\tAgencias Reguladoras de la EMA (European Medicines Agency);\nSolicitamos agregar como punto a) a los Pa\u00edses certificados por OPS como autoridades reguladoras de referencia regional del continente americano (Nivel IV), tales como: ANMAT (Argentina), ANVISA (Brasil), INVIMA (Colombia), CECMED (Cuba), COFEPRIS (M\u00e9xico), HEALTH CANADA y FDA (USA), ISP (Instituto de Salud P\u00fablica de Chile).\n", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "El oferente deber\u00e1 remitirse al Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-10-04T13:46:10-04:00"}, {"id": "10", "date": "2023-07-31T19:56:16-04:00", "title": "CAPACIDAD TECNICA PUNTO 1.3 \u0096 DOCUMENTOS PARA PRODUCTOS ONCOLOGICOS:", "description": "En el PBC actual se menciona \u00fanicamente: O Pa\u00edses certificados por OPS como autoridades reguladoras de referencia regional del continente americano (Nivel IV), ANMAT (Argentina), ANVISA (Brasil), INVIMA (Colombia), CEDMED (Cuba),COFEPRIS (M\u00e9xico), HEALTH CANADA y FDA (USA). Solicitamos adem\u00e1s incluir al ISP (Chile) al igual en los dem\u00e1s apartados del presente PBC a fin de unificar criterios.", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "El oferente deber\u00e1 remitirse al Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-10-04T13:45:11-04:00"}, {"id": "9", "date": "2023-07-31T19:54:30-04:00", "title": "CAPACIDAD TECNICA INCISO 4 \u0096 CERTIFICADO DE BUENAS PRACTICAS (EN IDIOMA ESPA\u00d1OL)", "description": "En el PBC actual INCISO 4) Para productos importados se solicita: 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 3283/2007, 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.\nCon respecto al apartado donde dice: 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. Conviene 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.\nPor todo esto, solicitamos a la convocante la ampliaci\u00f3n de dicho requisito de la siguiente manera:\nPara productos Importados: Certificado de Buenas Pr\u00e1cticas de Almacenamiento emitido a nombre del OFERENTE expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) y Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n o Licencia/Certificado de Fabricaci\u00f3n del producto ofertado emitido por la Agencia Reguladora del Pa\u00eds de Origen, a nombre del Fabricante del Producto Ofertado. En caso de que los productos ofertados sean de Origen de la Rep\u00fablica Popular de China y otros pa\u00edses  que a la fecha no emitan el Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n deber\u00e1n presentar Registro y/o Certificado del Producto Ofertado emitido por una Autoridad Sanitaria Reguladora de Alta Vigilancia, adecu\u00e1ndose a la Leyes vigentes Ley 3283/2007, y 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 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.\nEs importante traer a la vista que esta modificaci\u00f3n ya ha sido introducida por el IPS en varios llamados importantes tales como: LPN 32/2022 \u0096 ID:414.194, LPN 99/2022 \u0096 ID:416599, LPN 96/2022 \u0096 ID: 416711, entre otros.", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-10-04T13:44:58-04:00"}, {"id": "7", "date": "2023-07-31T19:40:35-04:00", "title": "Capacidad Tecnica", "description": "En el apartado de requisito documental para evaluar la capacidad t\u00e9cnica 1.4 Para f\u00e1rmacos inmunosupresores como Azatioprina, ciclosporina A, Tacrolimus, la convocante solo contempla requisitos para productos importados, no asi para productos de origen nacional, sin embargo en el mercado existen disponibles marcas de fabricaci\u00f3n nacional, por lo que solicitamos, ampliar y aplicar los requerimientos conforme estipula la agencia reguladora nacional DNVS quien, vela por la calidad seguridad y eficacia de los medicamentos, tal y como se contempla en los dem\u00e1s apartados de otros productos. Esto a fin de no limitar la participaci\u00f3n de potenciales oferentes nacionales del producto en cuesti\u00f3n. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse al Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-10-04T13:44:21-04:00"}, {"id": "11", "date": "2023-07-31T19:56:48-04:00", "title": "CAPACIDAD TECNICA PUNTO 1.3 \u0096 MEDICAMENTOS ONCOLOGICOS ORALES E INYECTABLES:", "description": "En vista de que los productos requeridos son considerados como medicamentos sint\u00e9ticos por la DNVS, la misma exige la presentaci\u00f3n del Certificado de Buenas Practicas de Fabricaci\u00f3n del fabricante O Registro sanitario emitida por agencias reguladoras de alta vigilancia, por lo cual solicitamos reformular el presente requisito seg\u00fan se detalla:\nRegistro o Certificaci\u00f3n de Buenas Pr\u00e1cticas de fabricaci\u00f3n del producto ofertado, emitido por una Autoridad Sanitaria Reguladora de Alta Vigilancia. En ese sentido, la especialidad medicinal ofertada deber\u00e1 ser emitida por:\n- FDA o EMA.\n-  O los indicados de alta vigilancia en el Art 11 de la Ley 3283/2007.\n- O Pa\u00edses certificados por la OPS como autoridades reguladoras de referencia regional del continente americano (Nivel IV), ANMAT (Argentina), ANVISA (Brasil), INVIMA (Colombia), CEDMED (Cuba), COFEPRIS (M\u00e9xico), HEALTH CANADA, FDA (USA), ISP (Instituto de Salud P\u00fablica de Chile).\n", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "El oferente deber\u00e1 remitirse al Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-10-04T13:45:33-04:00"}, {"id": "15", "date": "2023-07-31T20:03:05-04:00", "title": "EETT - ITEM 14", "description": "Entendemos que la cantidad de inmunoglobulina que la convocante desea adquirir es de 5 gramos por cada unidad de producto. Por tanto, solicitamos puedan aceptar indistintamente la presentaci\u00f3n de 5g/100ml o 5g/50ml, considerando que ambas presentaciones aportan la misma cantidad de activo requerido. Esto teniendo en cuenta que las interpretaciones de concentraciones se declaran por unidad de dosificaci\u00f3n conforme a la necesidad del paciente, siempre en gramos del activo por kilogramos del paciente, a fin de administrar la cantidad exacta de gramos necesaria conforme a la indicaci\u00f3n, por lo que ambas presentaciones cubrir\u00edan la necesidad de los pacientes (no siendo una limitante la cantidad de mL. que contenga el producto). ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-10-04T13:46:37-04:00"}, {"id": "4", "date": "2023-07-31T19:22:05-04:00", "title": "MUESTRAS", "description": "La convocante expresa: Una muestra de cada \u00edtem ofertado, tal como ser\u00e1 entregado en DASM. --- favor clarar si lo solicitado es en cuanto al envase primario o la presentaci\u00f3n final de entrega. Ejemplo: (presentaci\u00f3n final de entrega) los comprimidos son entregados en paquetes de 100 blister seg\u00fan solicitud expresa del PBC, prest\u00e1ndose a mal interpretaciones la solicitud de muestra \"Tal como ser\u00e1 entregado en DASM\"", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico, se aclara que lo solicitado es en cuanto al envase primario. ", "dateAnswered": "2023-10-04T13:41:29-04:00"}, {"id": "6", "date": "2023-07-31T19:30:40-04:00", "title": "CAPACIDAD T\u00c9CNICA", "description": "La convocante solicita: 4-Certificado de Buenas Practicas (En idioma Espa\u00f1ol).-- Solicitamos respetuosamente a la convocante aceptar Certificado de Buenas pr\u00e1cticas en Idioma de origen con su traducci\u00f3n al espa\u00f1ol emitido por traductor p\u00fablico", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-10-04T13:42:01-04:00"}, {"id": "3", "date": "2023-07-31T14:10:40-04:00", "title": "EXPERIENCIA REQUERIDA: ", "description": "En el Pliego de Bases y Condiciones se solicita demostrar la experiencia en PROVISION DE MEDICAMENTOS, con facturaciones de venta y/o contratos ejecutados por un monto equivalente al 25 % como m\u00ednimo del monto m\u00e1ximo ofertado en la presente licitaci\u00f3n, en promedio en los a\u00f1os: 2020- 2021-2022. Para el caso DE MEDICAMENTOS NACIONALES Y que el oferente no sea el fabricante y/o el titular del registro sanitario de los medicamentos, dicha experiencia deber\u00e1 estar igualmente acreditada por el oferente, por el titular del registro sanitario y el fabricante del producto que se oferta. Para el caso de MEDICAMENTOS IMPORTADOS y que el oferente no sea el fabricante y/o el titular del registro sanitario de los medicamentos, dicha experiencia deber\u00e1 estar igualmente acreditada por el oferente, por el titular del registro sanitario y el fabricante del producto que se oferta. En lo que respecta a la experiencia de este \u00faltimo (el fabricante extranjero), dicha experiencia podr\u00e1 ser igualmente acreditada con una declaraci\u00f3n jurada en la cual se indique claramente que el mismo cumple con dichos porcentajes. Con respecto al citado requerimiento para los productos IMPORTADOS, se solicita que la experiencia sea demostrada solo por el proveedor y no as\u00ed por el fabricante, ya que este primero es quien asume las obligaciones con el estado.", "author": {"name": "EXXEL TECHNOLOGIES S.A.E.", "id": "PY-RUC-80024779-5"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-10-04T13:40:34-04:00"}, {"id": "14", "date": "2023-07-31T19:58:53-04:00", "title": "ITEM 14 INMUNOGLOBULINA POLIVANTE", "description": "Comprendemos que la convocante requiere en el proceso de referencia inmunoglobulina polivalente en una concentraci\u00f3n de 5 gramos en total, por lo que solicitamos expresar la concentraci\u00f3n requerida en gramos considerando que en el mercado se encuentran disponibles presentaciones de 50ml y 100 ml con la concentraci\u00f3n de 5 gramos, cumpliendo de esta forma con la necesidad y lo requerido en el PBC. Esta solicitud la realizamos a fin de que la Convocante cuente con un mayor n\u00famero de ofertas y a fin de no limitar de manera innecesaria la participaci\u00f3n de potenciales oferentes, garantizando los principios de econom\u00eda y eficiencia como as\u00ed tambi\u00e9n el de igualdad y libre competencia dispuestos en la normativa vigente. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-10-04T13:46:28-04:00"}, {"id": "2", "date": "2023-07-31T14:09:55-04:00", "title": "PLAZO DE ENTREGA: ", "description": "El Pliego de Bases y Condiciones en la Secci\u00f3n Plan de entrega de los bienes \u0096 Cronograma de entregas: \u0085CANTIDAD M\u00c1XIMA: Con Orden de Entrega de la Direcci\u00f3n de Log\u00edstica de Suministros de Salud, una vez emitida la totalidad de las cantidades m\u00ednimas, el plazo de entrega ser\u00e1 de hasta 20 (veinte) d\u00edas calendarios. Las \u00d3rdenes de Entrega podr\u00e1n ser fraccionadas de acuerdo a la necesidad del IPS, stock y espacio disponible en el DASM.(Sic) Considerando que: estos productos deben ser importados y que a su vez, pasan por rigurosos procesos de aseguramiento de calidad para asegurar la eficacia y la estabilidad del producto que pueden extenderse hasta  4  meses, sumado al tiempo de tr\u00e1nsito y desaduanaje por la coyuntura actual por la que se atraviesa a nivel global, por la disminuci\u00f3n de los itinerarios a\u00e9reos y las escasa disponibilidad de espacio en las aeronaves, los cuales  generan dilaciones significativas en las importaciones. En este sentido, solicitamos a la Convocante analice la posibilidad de establecer la entrega de la CANTIDADES MAXIMAS:  CANTIDAD M\u00c1XIMA: Con Orden de Entrega de la Direcci\u00f3n de Log\u00edstica de Suministros de Salud, una vez emitida la totalidad de las cantidades m\u00ednimas, el plazo de entrega ser\u00e1 de hasta 30 (treinta) d\u00edas calendarios. Las \u00d3rdenes de Entrega podr\u00e1n ser fraccionadas de acuerdo a la necesidad del IPS, stock y espacio disponible en el DASM.", "author": {"name": "EXXEL TECHNOLOGIES S.A.E.", "id": "PY-RUC-80024779-5"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-10-04T13:40:20-04:00"}, {"id": "12", "date": "2023-07-31T19:57:24-04:00", "title": "CAPACIDAD TECNICA PUNTO 1.4 \u0096 DOCUMENTOS PARA FARMACOS INMUNOSUPRESORES", "description": "Al respecto de los requisitos solicitados en el presente apartado, es importante aclarar a la convocante que los productos: Azatioprina, Ciclosporina A y Tacrolimus, son productos clasificados como MEDICAMENTOS SINTETICOS por lo cual no se encuentran afectados por el Decreto N\u00ba 6611/16, por lo tanto, a fin de evitar confusi\u00f3n al momento de la presentaci\u00f3n y evaluaci\u00f3n de la documentaci\u00f3n solicitada, peticionamos la reformulaci\u00f3n del requisito de la siguiente manera:\nEl producto ofertado deber\u00e1 presentar estudio de Bioequivalencia comparable con el producto de referencia (se entender\u00e1 por producto de referencia a aquel que se encuentre autorizado por una Agencia Reguladora de Alta Vigilancia sobre la base de datos completos de calidad, seguridad, eficacia e Inmunogenicidad), O estar registrado ante algunas de las agencias reguladoras de referencia indicadas en el numeral 1), 2), 3) y 4)\n1.\tAgencias reguladoras de Alta Vigilancia de los pa\u00edses indicados en el art. 11 de la Ley N\u00b0 3283/07, Ley de protecci\u00f3n de la informaci\u00f3n no divulgada y datos de prueba para los registros farmac\u00e9uticos;\n2.\tLas dem\u00e1s Agencias Reguladoras de los Pa\u00edses indicados en el Art. 11 de la Ley 3283/07;\n3.\tAgencias Reguladoras de la EMA (European Medicines Agency);\n4.\tPa\u00edses certificados por OPS como autoridades reguladoras de referencia regional del continente americano (Nivel IV), tales como: ANMAT (Argentina), ANVISA (Brasil), INVIMA (Colombia), CECMED (Cuba), COFEPRIS (M\u00e9xico), HEALTH CANADA y FDA (USA), ISP (Instituto de Salud P\u00fablica de Chile).\n", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "El oferente deber\u00e1 remitirse al Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-10-04T13:45:52-04:00"}, {"id": "8", "date": "2023-07-31T19:45:56-04:00", "title": "Capacidad Tecnica", "description": "En el punto 1.4 Para f\u00e1rmacos Para f\u00e1rmacos inmunosupresores como Azatioprina, ciclosporina A, Tacrolimus, solicitan lo siguiente: \na) El producto ofertado deber\u00e1 presentar estudio de Bioequivalencia  comparable con el producto de referencia ( se entender\u00e1 por producto de referencia a aquel que se encuentre autorizado por una Agencia Reguladora de Alta Vigilancia sobre la base de datos completos de calidad, seguridad, eficacia e Inmunogenicidad, utilizados para demostrar Biocomparabilidad de un medicamento Biol\u00f3gico , caso a caso, seg\u00fan naturaleza de producto en concordancia con el inciso e) del Art. 2) de Decreto N\u00b06611/16 , o estar registrado ante algunas de las agencias reguladoras de referencia indicadas en el inciso a. numeral 1) , 2) , 3) , y 4)\nb) Agencias reguladoras de Alta Vigilancia de los pa\u00edses indicados en el art. 11 de la Ley N\u00b0 3283/2007, Ley de protecci\u00f3n de la informaci\u00f3n no divulgada y datos de prueba para los registros farmac\u00e9uticos\nc)  A las dem\u00e1s Agencias Reguladoras de los Pa\u00edses indicados O los indicados en el Art 11 de la Ley 3283/2007.\nd)  Agencias Reguladoras de la EMA (European Medicines Agency)\nLos documentos de los productos importados ofertados , deber\u00e1n estar debidamente legalizados por el Ministerio de Relaciones del Paraguay o apostillados.\nConsiderando que existen productos de fabricaci\u00f3n nacional, para los cuales no resulta un requisito por parte de la autoridad sanitaria contar con la documentaci\u00f3n detallada para la obtenci\u00f3n del registro sanitario respectivo. Se solicita eliminar dicha solicitud para productos de origen nacional y establecer claramente que estos requisitos solo aplican a productos importados y no as\u00ed a productos nacionales, considerando que este requerimiento a productos nacionales solo limita de forma innecesaria la participaci\u00f3n de potenciales oferentes.\n", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse al Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-10-04T13:44:37-04:00"}, {"id": "5", "date": "2023-07-31T19:26:26-04:00", "title": "Capacidad Financiera", "description": "Se solicita a la convocante analizar los periodos de 2020, 2021 y 2022 con el objeto de calificar la situaci\u00f3n financiera del oferente.", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-10-04T13:41:45-04:00"}, {"id": "1", "date": "2023-07-27T16:20:01-04:00", "title": "Vencimiento de los medicamentos ", "description": "Buenas tardes \n\nSolicitamos que el vencimiento de los productos sean iguales o superiores a 15 meses al momento de la entrega en la DASM. 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"simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "12", "id": "1"}]}, {"id": "s4QoO5Ihk1A=", "title": "14 - Acetato de leuprolida inyectable-LEUPROLIDE (LEUPRORELINA)", "status": "active", "statusDetails": "Activo", "value": {"amount": 2711893800, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "14", "id": "1"}]}, {"id": "xHUBewVU6fA=", "title": "11 - MELFALAN INYECTBLE- MELFALAN", "status": "active", "statusDetails": "Activo", "value": {"amount": 3668055720, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "11", "id": "1"}]}], "items": [{"id": "/J4BhnUIXuiE3DWFJ8pnBg==", "description": "ENZALUTAMIDA CAPSULA-ENZALUTAMIDA 40 MG CAPSULA", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51111804-9999", "description": "Enzalutamida Capsula", "uri": 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