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"SICP+LP-24001-23-235070+001-001-0002157+4446511", "sourceSystem": "SICP", "value": {"currency": "PYG", "amount": 14407671}, "date": "2025-05-23T00:00:00-04:00", "payer": {"id": "DNCP-SICP-CODE-157", "name": "Instituto de Previsi\u00f3n Social (IPS)"}, "payee": {"name": "FUSA S.A.", "id": "PY-RUC-80011523-6"}, "requestDate": "2025-05-23T00:00:00-04:00", "finantialObligations": [{"id": "001-001-0002157", "bill": {"id": "001-001-0002157", "type": "FACTURA", "date": "2024-09-25T00:00:00-04:00", "amount": {"amount": 15388740, "currency": "PYG"}}, "retentions": [{"id": "1", "type": "tax", "name": "IVA", "amount": {"amount": 732797, "currency": "PYG"}}, {"id": "2", "type": "tax", "name": "RENTA", "amount": {"amount": 586238, "currency": "PYG"}}, {"id": "3", "type": "fee", "name": "MULTA", "amount": {"amount": 338552, "currency": "PYG"}}, {"id": "4", "type": "tax", "name": "RETENCION DNCP", "amount": {"amount": 56279, "currency": "PYG"}}, {"id": "5", "type": "fee", "name": "ISC", "amount": {"amount": 0, "currency": "PYG"}}, {"id": "6", "type": "fee", "name": "REPARO", "amount": {"amount": 0, "currency": "PYG"}}, {"id": "7", "type": "tax", "name": "RETENCION IVA", "amount": {"amount": 0, "currency": "PYG"}}]}], "financialCode": "LP-24001-23-235070"}, {"id": "SICP+LP-24001-23-235070+001-001-0003238+4532019", "sourceSystem": "SICP", "value": {"currency": "PYG", "amount": 18432779}, "date": "2025-12-23T00:00:00-04:00", "payer": {"id": "DNCP-SICP-CODE-157", "name": "Instituto de Previsi\u00f3n Social (IPS)"}, "payee": {"name": "FUSA S.A.", "id": "PY-RUC-80011523-6"}, "requestDate": "2025-12-23T00:00:00-04:00", "finantialObligations": [{"id": "001-001-0003238", "bill": {"id": "001-001-0003238", "type": "FACTURA", "date": "2025-02-13T00:00:00-04:00", "amount": {"amount": 19235925, "currency": "PYG"}}, "retentions": [{"id": "1", "type": "tax", "name": "IVA", "amount": {"amount": 915996, "currency": "PYG"}}, {"id": "2", "type": "tax", "name": "RENTA", "amount": {"amount": 732797, "currency": "PYG"}}, {"id": "3", "type": "fee", "name": "MULTA", "amount": {"amount": 0, "currency": "PYG"}}, {"id": "4", "type": "tax", "name": "RETENCION DNCP", "amount": {"amount": 70349, "currency": "PYG"}}, {"id": "5", "type": "fee", "name": "ISC", "amount": {"amount": 0, "currency": "PYG"}}, {"id": "6", "type": "fee", "name": "REPARO", "amount": {"amount": 0, "currency": "PYG"}}, {"id": "7", "type": "tax", "name": "RETENCION IVA", "amount": {"amount": 0, "currency": "PYG"}}]}], "financialCode": "LP-24001-23-235070"}]}, "awardID": "416984-fusa-s-a-52", "status": "active", "statusDetails": "Adjudicado", "dateSigned": "2023-06-01T12:00:00-04:00", "period": {"startDate": "2023-06-01T00:00:00-04:00", "endDate": "2025-06-01T00:00:00-04:00", "durationInDays": 720}, "value": {"amount": 967733309, "currency": "PYG"}, "documents": [{"id": "m3OMgbzqUEE=", "datePublished": "2023-12-05T14:31:24-04:00", "title": "292_23_fusa_s_a__1701353071296.pdf", "url": "https://www.contrataciones.gov.py/documentos/download/contrato/m3OMgbzqUEE%253D", "language": "es", "documentType": "contractSigned", "documentTypeDetails": "Orden de Compra o Contrato"}, {"id": "TZhLTIQZcdw=", "datePublished": "2023-12-05T14:31:24-04:00", "title": "292_23_fusa_s_a__anexo_1_1701353407181.pdf", "url": "https://www.contrataciones.gov.py/documentos/download/contrato/TZhLTIQZcdw%253D", "language": "es", "documentTypeDetails": "Nota de Aclaraci\u00f3n"}]}], "tender": {"id": "416984-lpn-sbe-104-22-adquisicion-medicamentos-biologicos-oncologicos-inmunosupresores-decl-1", "title": "LPN SBE 104-22 ADQUISICI\u00d3N DE MEDICAMENTOS BIOL\u00d3GICOS, ONCOL\u00d3GICOS, INMUNOSUPRESORES DECLARADOS DESIERTOS EN LA LPN 46/21 Y OTROS", "status": "complete", "awardCriteria": "priceOnly", "awardCriteriaDetails": "Por Item", "submissionMethod": ["electronicAuction"], "techniques": {"hasElectronicAuction": true}, "bidOpening": {"date": "2023-02-06T09:00:00-04:00", "address": {"streetAddress": "EDIFICIO CAJA CENTRAL, 1ER PISO SALA DE APERTURA - CONSTITUCION Y LUIS A. DE HERRERA"}}, "submissionMethodDetails": "Lugar entrega ofertas: EDIFICIO CAJA CENTRAL, 1ER PISO SALA DE APERTURA - CONSTITUCION Y LUIS A. DE HERRERA || Lugar entrega bien: Sistema SBE || Fecha entrega bien: Seg\u00fan documento del llamado", "eligibilityCriteria": "Restricciones: INHABILIDADES PREVISTAS EN EL ARTICULO 40 DE LA LEY 2051/03", "statusDetails": "Adjudicada", "enquiriesAddress": {"streetAddress": "Sistema SBE"}, "clarificationMeetings": [{"address": {"streetAddress": "Sistema SBE"}}], "mainProcurementCategoryDetails": "Bienes - Equipos, Productos e instrumentales M\u00e9dicos y de Laboratorio. Servicios asistenciales de salud", "hasEnquiries": true, "value": {"amount": 393675528504, "currency": "PYG"}, "datePublished": "2022-10-24T14:53:15-04:00", "tenderPeriod": {"startDate": "2023-01-31T08:00:00-04:00", "endDate": "2023-02-01T08:00:00-04:00", "durationInDays": 1}, "awardPeriod": {"startDate": "2023-02-06T09:00:00-04:00"}, "contractPeriod": {"durationInDays": 720}, "enquiryPeriod": {"endDate": "2022-10-28T10:00:00-04:00", "startDate": "2022-10-24T14:53:15-04:00", "durationInDays": 3}, "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": "45", "date": "2022-10-28T09:42:44-04:00", "title": "ITEM 5. FACTOR (9+2+7+10) + Prote\u00ednas Inyectable. ", "description": "Solicitamos a la Convocante establecer las especificaciones t\u00e9cnicas en rangos, considerando que actualmente en el mercado solo existen dos productos de similares caracter\u00edsticas a lo requerido por la Convocante con el registro sanitario correspondiente y los valores establecidos en las especificaciones t\u00e9cnicas para los principios activos no se encuentran dentro del margen de ninguno de estos. ", "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": "2023-01-24T14:52:52-04:00"}, {"id": "38", "date": "2022-10-28T09:30:32-04:00", "title": "Capacidad T\u00e9cnica", "description": "En la parte pertinente del \u00faltimo p\u00e1rrafo del punto 2. se solicita: Para el art\u00edculo 2), inciso d) y f) los documentos podr\u00e1n presentarse en copia simple, no obstante para la firma del contrato los mismos deber\u00e1n estar debidamente legalizados por el Ministerio de Relaciones Exteriores del Paraguay o apostillados, para el inciso b) estudios cl\u00ednicos, podr\u00e1n estar respaldados por una declaraci\u00f3n formalizada por el fabricante del producto ante Escribano o Notario P\u00fablico, autenticada y debidamente legalizada por el Ministerio de Relaciones Exteriores del Paraguay o apostillada, en la que se individualicen espec\u00edficamente los estudios que se presentan y se reconozca su autenticidad. Al respecto, solicitamos unificar el criterio aceptando para la presentaci\u00f3n de la oferta la nota del fabricante del producto respaldando los estudios presentados, sin la autenticaci\u00f3n y legalizaci\u00f3n o apostilla requerida, en concordancia con lo requerido para los incisos d) y f). Esto considerando que la documentaci\u00f3n requerida por el IPS no corresponde a un documento siquiera requerido por la DNVS, por lo que se deben realizar las gestiones para la obtenci\u00f3n de la documentaci\u00f3n solicitada, el cual conlleva cierto plazo de obtenci\u00f3n y resulta limitante para todos los proveedores de productos biosimilares que cuentan con todas las documentaciones requeridas y que han sido presentadas a la DNVS para la obtenci\u00f3n del registro sanitario respectivo. ", "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": "2023-01-24T14:51:32-04:00"}, {"id": "44", "date": "2022-10-28T09:38:57-04:00", "title": "ITEM 5. FACTOR (9+2+7+10) + Prote\u00ednas Inyectable. ", "description": "Solicitamos a la Convocante establecer las especificaciones t\u00e9cnicas en rangos, considerando que actualmente en el mercado solo existen dos productos de similares caracter\u00edsticas a lo requerido por la Convocante con el registro sanitario correspondiente y los valores establecidos en las especificaciones t\u00e9cnicas para los principios activos no se encuentran dentro del margen de ninguno de estos. ", "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": "2023-01-24T14:52:42-04:00"}, {"id": "26", "date": "2022-10-27T20:11:58-04:00", "title": "PRECIO REFERENCIAL ITEM N\u00ba 12  Heparina s\u00f3dica Inyectable", "description": "Solicitamos a la Convocante ajustar el precio referencial del \u00cdtem N\u00ba 12, esto en atenci\u00f3n a que el actual se encuentra desactualizado, tomando como referencia eventos anteriores tales como la LPN N\u00ba 45-22 ID 414.718 del MSPBS as\u00ed como la LPN 15-22 ID 409.970 del MSPBS. El precio sugerido es de Gs 76.150.", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP.", "dateAnswered": "2023-01-24T14:48:23-04:00"}, {"id": "19", "date": "2022-10-27T18:56:56-04:00", "title": "Porcentaje de Multas", "description": "La Convocante establece como porcentaje de multa el 0.1%. Al respecto, solicitamos a la misma la modificaci\u00f3n de dicho porcentaje a por lo menos el 0.01%. Esto considerando que los productos a ser adquiridos por la misma son de un muy alto costo y la mayor\u00eda de ellos corresponden a productos importados que son dif\u00edciles de mantener un stock y dependen de muchos agentes externos. Por lo que en caso de existir atrasos los costos serian demasiado elevados para ser solventados por el proveedor, considerando el atraso constante de la Convocante en los pagos a proveedores que deben solventar la compra de estos productos sin el pago de la Convocante por ellos en un largo plazo.   ", "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": "2023-01-24T14:47:03-04:00"}, {"id": "40", "date": "2022-10-28T09:30:54-04:00", "title": "CONSULTA 7 : UNIDAD DE COTIZACI\u00d3N \u0096 ITEM 27-  ( SOMATROPINA INYECTABLE \u0096 20 ui/ml", "description": "En el Pliego de Bases y Condiciones apartado Detalle de los productos con las respectivas especificaciones t\u00e9cnicas indica que la unidad de Cotizaci\u00f3n del \u00edtem 27 ( SOMATROPINA INYECTABLE \u0096 20 ui/ml), debe ser \u0085UNIDAD. En este sentido se solicita a la Convocante se sirva en aclarar si se refiere a Unidades Internacionales, como la LPN SBE 46/21 \u0096 ID  392.633, llamado que es  utilizado para establecer la estimaci\u00f3n de costos. \n\n", "author": {"name": "EXXEL TECHNOLOGIES S.A.E.", "id": "PY-RUC-80024779-5"}, "answer": "Se aclara al  oferente que 10 ui/ml si se refiere a UNIDADES INTERNACIONALES. El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-01-24T14:51:57-04:00"}, {"id": "1", "date": "2022-10-25T08:41:13-04:00", "title": "ITEM 3 - CARBOPLATINO 50 mg", "description": "Solicitamos a la convocante actualizar el precio referencial del ITEM 3 CARBOPLATINO 50 mg a Gs. 238.402 teniendo en cuenta el ultimo precio adjudicado por esta misma Instituci\u00f3n en el llamado con ID N\u00b0 392.633. El precio referencial actual se encuentra desfasado. ", "author": {"name": "MATHER COMPANY SRL", "id": "PY-RUC-80006850-5"}, "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP.", "dateAnswered": "2023-01-24T14:43:01-04:00"}, {"id": "37", "date": "2022-10-28T09:29:17-04:00", "title": "CONSULTA 6: UNIDAD DE COTIZACI\u00d3N \u0096 ITEM 14-  SOMATROPINA INYECTABLE \u0096 10 ui/ml", "description": "En el Pliego de Bases y Condiciones apartado Detalle de los productos con las respectivas especificaciones t\u00e9cnicas indica que la unidad de Cotizaci\u00f3n del \u00edtem 14 ( SOMATROPINA INYECTABLE \u0096 10 ui/ml), debe ser \u0085UNIDAD. En este sentido se solicita a la Convocante se sirva en aclarar si se refiere a  UNIDADES INTERNACIONALES, como la LPN SBE 46/21 \u0096 ID  392.633, llamado que es  utilizado para establecer la estimaci\u00f3n de costos. ", "author": {"name": "EXXEL TECHNOLOGIES S.A.E.", "id": "PY-RUC-80024779-5"}, "answer": "Se aclara al  oferente que 10 ui/ml si se refiere a UNIDADES INTERNACIONALES. El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-24T14:51:22-04:00"}, {"id": "14", "date": "2022-10-27T18:13:07-04:00", "title": "Capacidad T\u00e9cnica. ", "description": "En el Punto 2., inciso d. de la p\u00e1g. 16 del PBC, donde dice: El producto biosimilar debe contar con registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n vigentes otorgados por algunas de estas entidades de alta vigilancia DESCRITOS EN EL ARTICULO 4\u00b0 DEL DECRETO 6611, INCISOS a, c y d. como EMA, FDA, Health Canad\u00e1, o pa\u00edses con agencias certificadas como de Nivel IV en el continente americano por la OPS.. Al respecto,solicitamos aclarar los siguientes puntos: 1. Solicitan: \"Autorizaci\u00f3n de comercializaci\u00f3n\", al respecto se solicita aclarar a que documento espec\u00edficamente hace referencia cuando solicitan esto. 2. Solicitamos establecer la posibilidad de presentar Certificado de Buenas Practicas y/o Certificado del producto farmac\u00e9utico, considerando que conforme al Decreto N\u00ba 6611/16, estos documentos son los requeridos por la autoridad reguladora para la obtenci\u00f3n del registro sanitario y mal podr\u00eda la Convocante limitar de forma innecesaria el PBC con requisitos ni siquiera requeridos por la DNVS. ", "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": "2023-01-24T14:46:09-04:00"}, {"id": "2", "date": "2022-10-25T08:42:30-04:00", "title": "ITEM 7 - ETOPOSIDE 100 mg", "description": "Solicitamos a la convocante actualizar el precio referencial del ITEM 7 ETOPOSIDE 100 mg a Gs. 97.500 teniendo en cuenta el ultimo precio adjudicado por esta misma Instituci\u00f3n en el llamado con ID N\u00b0 392.633. El precio referencial actual se encuentra desfasado. ", "author": {"name": "MATHER COMPANY SRL", "id": "PY-RUC-80006850-5"}, "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP.", "dateAnswered": "2023-01-24T14:43:10-04:00"}, {"id": "15", "date": "2022-10-27T18:27:48-04:00", "title": "Capacidad T\u00e9cnica", "description": "En el Punto 4., inciso a. de la p\u00e1g. 16 del PBC, donde dice: a) Los productos farmac\u00e9uticos multifuente (seg\u00fan definici\u00f3n OMS) deber\u00e1n presentar sus estudios de demostraci\u00f3n de equivalencia terap\u00e9utica con el producto de referencia original. Al respecto, teniendo en cuenta 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.", "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": "2023-01-24T14:46:19-04:00"}, {"id": "43", "date": "2022-10-28T09:35:01-04:00", "title": "ITEM 6. DOXORRUBICINA / ADRIAMICINA INYECTABLE", "description": "Solicitamos a la Convocante aclarar si se aceptaran indistintamente ampolla / frasco ampolla, esto considerando que el producto corresponde a un polvo y de acuerdo al tipo de equipos utilizados en la elaboraci\u00f3n, el producto puede ser envasado en ampolla o frasco ampolla indistintamente, lo que no modifica la concentraci\u00f3n, indicaci\u00f3n y uso del 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": "2023-01-24T14:52:32-04:00"}, {"id": "7", "date": "2022-10-26T10:22:09-04:00", "title": "EXPERIENCIA REQUERIDA", "description": "Solicitamos a la convocante modificar la experiencia requerida a: demostrar la experiencia en provisi\u00f3n de medicamentos con facturaciones y/o contratos por un monto equivalente al 25% como m\u00ednimo del monto m\u00e1ximo ofertado en promedio de los a\u00f1os 2017, 2018, 2019, 2020 y 2021.", "author": {"name": "LABORATORIOS BAGO DEL PARAGUAY S.A.", "id": "PY-RUC-80011309-8"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-24T14:44:23-04:00"}, {"id": "18", "date": "2022-10-27T18:54:45-04:00", "title": "ITEM 5. FACTOR (9+2+7+10) + Prote\u00ednas Inyectable", "description": "Solicitamos a la Convocante aclarar si se aceptaran indistintamente ampolla / frasco ampolla, esto considerando que el producto corresponde a un polvo y de acuerdo al tipo de equipos utilizados en la elaboraci\u00f3n, el producto puede ser envasado en ampolla o frasco ampolla indistintamente, lo que no modifica la concentraci\u00f3n, indicaci\u00f3n y uso del 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": "2023-01-24T14:46:53-04:00"}, {"id": "36", "date": "2022-10-28T09:28:39-04:00", "title": " UNIDAD DE COTIZACI\u00d3N \u0096 ITEM 14-  SOMATROPINA INYECTABLE \u0096 10 ui/ml)", "description": "En el Pliego de Bases y Condiciones apartado Detalle de los productos con las respectivas especificaciones t\u00e9cnicas indica que la unidad de Cotizaci\u00f3n del \u00edtem 14 ( SOMATROPINA INYECTABLE \u0096 10 ui/ml), debe ser \u0085UNIDAD. En este sentido se solicita a la Convocante se sirva en aclarar si se refiere a  UNIDADES INTERNACIONALES, como la LPN SBE 46/21 \u0096 ID  392.633, llamado que es  utilizado para establecer la estimaci\u00f3n de costos. ", "author": {"name": "EXXEL TECHNOLOGIES S.A.E.", "id": "PY-RUC-80024779-5"}, "answer": "Se aclara al  oferente que 10 ui/ml si se refiere a UNIDADES INTERNACIONALES. El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-24T14:51:06-04:00"}, {"id": "5", "date": "2022-10-26T10:17:05-04:00", "title": "ITEM 6", "description": "Solicitamos a la convocante modificar la forma farmac\u00e9utica a polvo liofilizado para soluci\u00f3n inyectable. Se consulta tambien si es factible ofertar dicha forma farmac\u00e9utica", "author": {"name": "LABORATORIOS BAGO DEL PARAGUAY S.A.", "id": "PY-RUC-80011309-8"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-01-24T14:44:01-04:00"}, {"id": "23", "date": "2022-10-27T20:08:20-04:00", "title": "PRECIO REFERENCIAL ITEM N\u00ba 9 Factor 9 liofilizado inyectable-FACTOR IX LIOFILIZADO", "description": "Solicitamos a la Convocante ajustar el precio referencial del \u00cdtem N\u00ba 9, esto en atenci\u00f3n a que el actual se encuentra desactualizado, tomando como referencia eventos anteriores de vuestra Instituci\u00f3n, tal como la LPN N\u00ba 46-21 ID N\u00ba 392.633. El precio sugerido es de Gs 7.019.000", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP.", "dateAnswered": "2023-01-24T14:47:49-04:00"}, {"id": "33", "date": "2022-10-28T09:15:23-04:00", "title": "PLAZO DE ENTREGAS: ", "description": "El Pliego de Bases y Condiciones indica en el apartado Plan de Entrega de los bienes, cuanto sigue: \u0085CANTIDAD MINIMA - 20%: Hasta los 8 (ocho) d\u00edas calendarios. Con entregas que podr\u00e1n ser fraccionadas siempre dentro del mencionado plazo. - 80%: Hasta los 15 (quince) d\u00edas calendarios. Con entregas que podr\u00e1n ser fraccionadas siempre dentro del mencionado plazo. 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 ser\u00e1 de hasta 15 (quince) d\u00edas calendarios. Las \u00f3rdenes de Entrega podr\u00e1n ser fraccionadas de acuerdo a la necesidad del IPS, stock y el espacio disponible en DASM. (sic). Teniendo en cuenta que estos productos deben ser importados y que por la naturaleza de los mismos  su vencimiento te\u00f3rico no superan los 24  meses 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,  los cuales  generan dilaciones significativas en las importaciones. En este sentido, solicitamos a la Convocante analice la posibilidad de establecer el siguiente plan de entregas:  CANTIDAD MINIMA: - Primera Entrega Hasta el 20 % de la Cantidad M\u00ednima Adjudicada dentro de 15 d\u00edas corridos, con entregas que podr\u00e1n ser fraccionadas siempre dentro del mencionado plazo. \u0096 80%, hasta los 20 (veinte) d\u00edas calendarios. Con entregas que podr\u00e1n ser fraccionadas siempre dentro del mencionado plazo. 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": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-01-24T14:50:32-04:00"}, {"id": "3", "date": "2022-10-25T08:43:16-04:00", "title": "ITEM 10 - GLATIRAMER INYECTABLE", "description": "Solicitamos a la convocante actualizar el precio referencial del ITEM 10 - GLATIRAMER INYECTABLE a Gs. 1.222.800 teniendo en cuenta el ultimo precio adjudicado por esta misma Instituci\u00f3n en el llamado con ID N\u00b0 392.633. El precio referencial actual se encuentra desfasado. ", "author": {"name": "MATHER COMPANY SRL", "id": "PY-RUC-80006850-5"}, "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP.", "dateAnswered": "2023-01-24T14:43:42-04:00"}, {"id": "22", "date": "2022-10-27T20:06:59-04:00", "title": "PRECIO REFERENCIAL ITEM N\u00ba 5 Factor (9 + 2 + 7 + 10) + Prote\u00ednas Inyectable", "description": "Solicitamos a la Convocante ajustar el precio referencial del \u00cdtem N\u00ba 5, esto en atenci\u00f3n a que el actual se encuentra desfasado, tomando como referencia eventos anteriores de vuestra Instituci\u00f3n, tal como la LPN N\u00ba 46-21 ID N\u00ba 392.633. El precio sugerido es de Gs 8.524.700.", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-01-24T14:47:38-04:00"}, {"id": "20", "date": "2022-10-27T20:01:58-04:00", "title": "EXPERIENCIA REQUERIDA", "description": "En el apartado Requisitos para validar la Experiencia, se menciona cuanto sigue:\nDemostrar la experiencia en PROVISI\u00d3N 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: 2019 2020-2021. Para el caso de 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.\nCon respecto al apartado donde dice: Para el caso de 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.  Conviene aclarar a la convocante que la forma en la que se encuentra redactada da lugar a varias interpretaciones que pueden ocasionar cierta confusi\u00f3n a los oferentes al momento de elaborar sus ofertas, por lo cual, en base a nuestra interpretaci\u00f3n que creemos es la correcta, recomendamos que quede redactado de la siguiente manera:\nDemostrar la experiencia en PROVISI\u00d3N 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: 2019 2020-2021.\nI.\tPara productos nacionales: En caso de 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.\nII.\tPara productos importados: En caso de que el oferente no sea el titular del registro sanitario; dicha experiencia deber\u00e1 estar igualmente acreditada tanto por el oferente y el titular del registro sanitario.\n", "author": {"name": "EUROQUIMICA S.A.", "id": "PY-RUC-80061211-6"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-24T14:47:14-04:00"}, {"id": "30", "date": "2022-10-27T20:18:50-04:00", "title": "CAPACIDAD T\u00c9CNICA CERTIFICADO DE BUENAS PR\u00c1CTICAS ", "description": "En el caso de que el Oferente no sea el fabricante del Producto ofertado, deber\u00e1 presentar: \nPara los medicamentos Importados, deber\u00e1n presentar Certificado de Buenas Practicas de Fabricaci\u00f3n y Almacenamiento vigente emitido por la Agencia Reguladora del pa\u00eds de Origen. Con respecto a dicho requisito 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. En caso de duda solicitamos amablemente realizar la consulta al ente regulador.\nPor todo esto, solicitamos a la convocante la ampliaci\u00f3n de dicho requisito de la siguiente manera:\nCertificado de Buenas Practicas \nPara los medicamentos Importados, se deber\u00e1 presentar: \nCertificado de Buenas Practicas de Fabricaci\u00f3n y Almacenamiento o Licencia/Certificado de Fabricaci\u00f3n del fabricante del producto ofertado vigente emitido por la Agencia Reguladora del pa\u00eds de Origen.\n", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-24T14:49:05-04:00"}, {"id": "21", "date": "2022-10-27T20:03:37-04:00", "title": "EXPERIENCIA REQUERIDA", "description": "En el apartado Requisitos para validar la Experiencia, se menciona cuanto sigue:\nDemostrar la experiencia en PROVISI\u00d3N 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: 2019 2020-2021. Para el caso de 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.\nSolicitamos a la Convocante que EXCLUYA de los requisitos el siguiente p\u00e1rrafo: Para el caso de 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.\nEsta solicitud lo realizamos a fin de no limitar innecesariamente la concurrencia de potenciales oferentes que cuenten con los productos solicitados, privando al IPS la posibilidad de acceder a mejores precios, que de mantenerse el requisito en tales condiciones se estar\u00eda transgrediendo abiertamente los principios que rigen las compras p\u00fablicas: IGUALDAD Y LIBRE COMPETENCIA Y EFICIENCIA Y ECONOM\u00cdA. \n", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-24T14:47:26-04:00"}, {"id": "29", "date": "2022-10-27T20:16:29-04:00", "title": "CAPACIDAD TECNICA", "description": "Certificado de Buenas Practicas: El pliego de bases y condiciones solicita como criterio de evaluaci\u00f3n lo siguiente en sus puntos\nb. En el caso de que el Oferente no sea el fabricante del Producto ofertado , deber\u00e1 presentar: Certificado de Buenas Pr\u00e1cticas de Almacenamiento vigente, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), adem\u00e1s del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n vigente del Fabricante del producto ofertado, los cuales deber\u00e1n mantener su vigencia durante toda la duraci\u00f3n del contrato, y;\nd. Para los medicamentos Importados, deber\u00e1n presentar Certificado de Buenas Practicas de Fabricaci\u00f3n y Almacenamiento vigente emitido por la Agencia Reguladora del pa\u00eds de Origen.\nEntendemos que ambos requisitos corresponden a productos importados, por lo cual solicitamos a la Convocante que el mismo sea unificado, quedando de la siguiente manera:\nEn el caso de que el Oferente no sea el fabricante del Producto ofertado, deber\u00e1 presentar: Certificado de Buenas Pr\u00e1cticas de Almacenamiento vigente, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), adem\u00e1s del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n vigente del Fabricante del producto ofertado, los cuales deber\u00e1n mantener su vigencia durante toda la duraci\u00f3n del contrato.\n", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-24T14:48:56-04:00"}, {"id": "6", "date": "2022-10-26T10:19:42-04:00", "title": "CAPACIDAD FINANCIERA", "description": "Solicitamos a la convocante modificar el requerimiento de ratio de liquidez a: deber\u00e1 ser igual o mayor que 1 en promedio de los a\u00f1os 2019, 2020 y 2021.", "author": {"name": "LABORATORIOS BAGO DEL PARAGUAY S.A.", "id": "PY-RUC-80011309-8"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-01-24T14:44:15-04:00"}, {"id": "8", "date": "2022-10-26T10:25:41-04:00", "title": "PLAN DE ENTREGAS DE LOS BIENES", "description": "ENTREGA CANTIDAD MINIMA\n20% : HASTA LOS 8 D\u00cdAS CALENDARIOS\n80%: HASTA LOS 20 DIAS CALENDARIOS\nENTREGA CANTIDAD MAXIMA:\nEL PLAZO SERA DE 30 D\u00cdAS CALENDARIOS", "author": {"name": "LABORATORIOS BAGO DEL PARAGUAY S.A.", "id": "PY-RUC-80011309-8"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-01-24T14:44:29-04:00"}, {"id": "24", "date": "2022-10-27T20:09:27-04:00", "title": "PRECIO REFERENCIAL ITEM N\u00ba 11 Heparina bajo peso molecular Inyectable", "description": "Solicitamos a la Convocante ajustar el precio referencial del \u00cdtem N\u00ba 11, esto en atenci\u00f3n a que el actual se encuentra desactualizado, tomando como referencia eventos anteriores de vuestra Instituci\u00f3n, tal como la 46-21 ID N\u00ba 392.633. El precio sugerido es de Gs 58.480", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP.", "dateAnswered": "2023-01-24T14:47:59-04:00"}, {"id": "42", "date": "2022-10-28T09:32:53-04:00", "title": "ITEM 3. Carboplatino", "description": "Solicitamos a la Convocante aclarar si se aceptaran indistintamente ampolla / frasco ampolla, esto considerando que el producto corresponde a un polvo y de acuerdo al tipo de equipos utilizados en la elaboraci\u00f3n, el producto puede ser envasado en ampolla o frasco ampolla indistintamente, lo que no modifica la concentraci\u00f3n, indicaci\u00f3n y uso del 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": "2023-01-24T14:52:19-04:00"}, {"id": "35", "date": "2022-10-28T09:16:07-04:00", "title": "MUESTRAS PARA CONTROL DE CALIDAD", "description": "El Pliego de Bases y Condiciones en el apartado muestras para control de Calidad, punto Cantidad de los \u00edtems 16 (Insulina Degludec), 17 (Insulina Ultrarr\u00e1pida) y 21 (Liraglutide),  solicitan 15 unidades en concepto de muestras de calidad,  por lo que en este sentido considerando el alto costo de los medicamentos mencionados m\u00e1s arriba, y que la presentaci\u00f3n de lo solicitado podr\u00eda impactar negativamente  en los costos de la oferta, es que  solicitamos a la Convocante, se sirva em modificar el citado requisito, solicitando la presentaci\u00f3n de una Declaraci\u00f3n Jurada. ", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-01-24T14:50:54-04:00"}, {"id": "32", "date": "2022-10-28T09:14:34-04:00", "title": "PRESENTACI\u00d3N- (SOMATOTROPINA INYECTABLE \u0096 20 UI/ML). ", "description": "El Pliego de Bases y Condiciones en el \u00edtem 27 (Somatotropina Inyectable \u009620 ui/ml) solicita en su punto presentaci\u00f3n indica lo siguiente:  \u0085 Presentaci\u00f3n: KIT (sic). En este punto de forma a no restringir la participaci\u00f3n, solicitamos a la Convocante se sirva en analizar la posibilidad de modificar la presentaci\u00f3n a caja conteniendo cartuchos para dispositivo aplicador, otorgando la posibilidad de esta forma a  que los aplicadores sean proporcionados en forma independiente, a cada paciente que inicie el tratamiento.   ", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-01-24T14:50:18-04:00"}, {"id": "31", "date": "2022-10-28T09:12:56-04:00", "title": "PRESENTACI\u00d3N DE ENTREGA:  ITEM 27 (SOMATOTROPINA INYECTABLE \u0096 20 UI/ML): ", "description": "El Pliego de Bases y Condiciones en el \u00edtem  27  (Somatotropina Inyectable \u009620 ui/ml) solicita en su punto presentaci\u00f3n de entrega indica lo siguiente: \u0085Caja conteniendo cartuchos para dispositivo aplicador + aplicador (sic). Considerando que el pliego no hace menci\u00f3n a la frecuencia de entrega de los aplicadores, y que los aplicadores para este producto son reutilizables, se solicita a la Convocante que analice la posibilidad de que los aplicadores sean utilizados hasta su fecha de expiraci\u00f3n, y que deban ser renovados con un nuevo aplicador al vencimiento del anterior, salvo que los mismos presenten alg\u00fan desperfecto, en cuyo caso se proceder\u00e1 a la reposici\u00f3n inmediata.    Como referencia, en llamados anteriores, se solicitaba cuanto sigue: \u0085La Entrega de los Aplicadores se realizar\u00e1 seg\u00fan lo siguiente; Los aplicadores deben ser prove\u00eddos para cada paciente al momento de la primera entrega de la Hormona de Crecimiento y luego cada 6 meses al menos.  Ponemos esta a alternativa a consideraci\u00f3n de la Convocante, ya que la entrega de los aplicadores con cada entrega  para cada paciente impactar\u00e1 negativamente en la estructura de costos, lo cual afectar\u00eda el precio final de oferta.", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "El oferente deber\u00e1 ajustarse aEl oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico. lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-01-24T14:49:34-04:00"}, {"id": "28", "date": "2022-10-27T20:15:03-04:00", "title": "CAPACIDAD TECNICA ", "description": "Para productos Oncol\u00f3gicos Orales e Inyectables: Acido transretinoico, Carboplatino, Bleomicina, Metotrexato 500 mg Iny, Metotrexato 50 mg Iny, Metotrexato 2,5 mg Iny, Doxorrobucina, Paclitaxel, Etoposido, Hidroxiurea, Vinorelbine.\na. Registro y/o Certificado del producto ofertado, emitido por una Autoridad Sanitaria Reguladora de Alta Vigilancia. En ese sentido, la especialidad medicinal ofertada debe encontrarse registrada en: - FDA o EMA - O Los indicados de alta vigilancia en el Art 11 de la Ley 3283/2007. - 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.\nCon relaci\u00f3n al producto solicitado, creemos conveniente recordar al IPS que el mismo corresponde a un producto clasificado como sint\u00e9tico\nRespecto a los medicamentos sint\u00e9ticos, DINAVISA (seg\u00fan Ley N\u00b0 1119/97 De productos para la salud y otros y dem\u00e1s reglamentaciones) establece como requisito para su registro local, que en caso de que el elaborador de los medicamentos no sea de un pa\u00eds de alta o adecuada vigilancia, conforme lo mencionado en el Art. 11 de la Ley No. 3283/2007, se presente indefectiblemente: GMP/Aprobaci\u00f3n de planta emitido por cualquiera de los pa\u00edses mencionados en el Art. 11 de Ley 3283/2007 o por pa\u00edses certificados por la OPS como autoridades reguladoras de referencia regional del continente americano (NIVEL IV)  o Registro Sanitario emitido por cualquiera de los pa\u00edses mencionados en el Art. 11 de Ley 3283/2007 o por pa\u00edses certificados por la OPS como autoridades reguladoras de referencia regional del continente americano (NIVEL IV)  \u0096 Consularizado y Legalizado o Apostillado. \nSeguidamente, al realizar un comparativo del requerimiento establecido en el punto 3 del PBC y los requerimientos establecidos por la autoridad competente (DNVS), nos percatamos de que existen incongruencias entre lo solicitado por la Convocante y lo efectivamente requerido por la DNVS para el otorgamiento de los registros sanitarios de medicamentos sint\u00e9ticos en el pa\u00eds. \nEntonces, en base a lo manifestado, solicitamos a la convocante la reformulaci\u00f3n de dicho requisito, adecu\u00e1ndose a los requerimientos de la DNVS, quedando de la siguiente manera:\nPara productos Oncol\u00f3gicos Orales e Inyectables: : Acido transretinoico, Carboplatino, Bleomicina, Metotrexato 500 mg Iny, Metotrexato 50 mg Iny, Metotrexato 2,5 mg Iny, Doxorrobucina, Paclitaxel, Etoposido, Hidroxiurea, Vinorelbine.\n\nRegistro Sanitario o Certificado de Buenas pr\u00e1cticas, emitido por una Autoridad Sanitaria Reguladora de referencia, tales como:\na. FDA o EMA.\nb. O los pa\u00edses indicados en el Art 11 de la Ley 3283/2007.\nc. O Pa\u00edses certificados por la OPS como autoridades reguladoras de referencia regional del continente americano (NIVEL IV), ANMAT (Argentina), ANVISA (Brasil), INVIMA (Colombia) CECMED (Cuba), COFEPRIS (M\u00e9xico), Health Canad\u00e1 y FDA (USA), ISP (Chile).\n\n\n", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-24T14:48:44-04:00"}, {"id": "4", "date": "2022-10-26T10:15:16-04:00", "title": "ITEM 6", "description": "Solicitamos a la convocante ampliar la presentaci\u00f3n del producto a ampolla y/o frasco ampolla", "author": {"name": "LABORATORIOS BAGO DEL PARAGUAY S.A.", "id": "PY-RUC-80011309-8"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico. ", "dateAnswered": "2023-01-24T14:43:52-04:00"}, {"id": "10", "date": "2022-10-27T17:05:21-04:00", "title": "ITEM 9 - Factor 9 liofilizado", "description": "Se solicita a la convocante revisar el precio referencial establecido, el mismo se encuentra por debajo del precio actual del mercado.", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP.", "dateAnswered": "2023-01-24T14:44:49-04:00"}, {"id": "17", "date": "2022-10-27T18:38:54-04:00", "title": "Capacidad Tecnica", "description": "En el Punto 4., inciso d) de la p\u00e1g. 16 del PBC, la Convocante establece el siguiente requisito: Los productos multifuente cuyos principios activos se encuentren incluidos en el Listado de Medicamentos Esenciales de la OMS y que sean considerados de ventana terap\u00e9utica estrecha y/o atiendan enfermedades cr\u00edticas deber\u00e1n anexar reportes locales de Farmacovigilancia propios, siguiendo los indicadores de Farmacovigilancia de la OMS.  La Farmacovigilancia implica el desarrollo de un Plan de Gesti\u00f3n de Riesgos (PGR) basados en la planificaci\u00f3n de la misma con criterio proactivo. Esta planificaci\u00f3n deber\u00e1 contar con: - La notificaci\u00f3n: El reporte, que es el medio por el cual un reportante notifica sobre la presencia de una reacci\u00f3n adversa a un medicamento (RAM) o un problema relacionado a un medicamento en calidad y eficacia del medicamento (PRM) a un sistema de Farmacovigilancia. - Estrategias complementarias: descripci\u00f3n de las acciones realizadas para resolver o mitigar el evento adverso.\nAl respecto, es necesario aclarar que la farmacovigilancia abarca desde la comercializaci\u00f3n del producto y no se limita al desarrollo de un plan de gesti\u00f3n de riesgos, siendo estos eventos completamente distintos y que pueden realizarse sin ser dependientes, por tanto, solicitamos verificar lo detallado. \nAsimismo, cabe mencionar que al realizar un plan de gesti\u00f3n de riesgo como bien lo indica la Convocante con criterios proactivos, los cuales implican espec\u00edficamente la minimizaci\u00f3n de los posibles riesgos, la actividad propuesta en el plan de gesti\u00f3n de riesgo no necesariamente deber\u00e1 contar con una notificaci\u00f3n como lo pretende la Convocante. En vista de que al no ocurrir eventos adversos en consecuencia a los criterios proactivos llevados a cabo durante el desarrollo del plan de gesti\u00f3n de riesgo, no se contar\u00edan con fichas de notificaci\u00f3n propiamente, considerando que estos son elaborados espec\u00edficamente cuando se cuenta con una notificaci\u00f3n de evento adverso. \nAdem\u00e1s, es importante recordar que estas notificaciones son documentos confidenciales y no pueden ser divulgados a instancias distintas a la autoridad reguladora. \nFinalmente, recordamos que los problemas relacionados con la calidad y eficacia del producto no se tratan en el plan de gesti\u00f3n de riesgo, si dichos medicamentos no entraron en contacto con el paciente, por lo que no corresponde incluir problemas relacionados a medicamentos en el plan de gesti\u00f3n de riesgo conforme a lo solicitado en el PBC. \nPor tanto, en base a todo lo detallado, solicitamos a la Convocante replantear lo requerido, en base a lo que implica un trabajo de farmacovigilancia y considerando cual es la finalidad de la misma al requerir estos documentos.  \n", "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": "2023-01-24T14:46:43-04:00"}, {"id": "25", "date": "2022-10-27T20:10:37-04:00", "title": "PRECIO REFERENCIAL ITEM N\u00ba 8 Everolimus Comprimido", "description": "Solicitamos a la Convocante ajustar el precio referencial del \u00cdtem N\u00ba 8, esto en atenci\u00f3n a que el actual se encuentra desactualizado, tomando como referencia eventos anteriores de vuestra Instituci\u00f3n, tal como la 46-21 ID N\u00ba 392.633. El precio sugerido es de Gs 746.875", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP.", "dateAnswered": "2023-01-24T14:48:11-04:00"}, {"id": "16", "date": "2022-10-27T18:36:47-04:00", "title": "Capacidad T\u00e9cnica", "description": "En el Punto 4., inciso d) de la p\u00e1g. 16 del PBC, la Convocante establece el siguiente requisito: d) Los productos innovadores (Originales) solo deben presentar copia autenticada de Certificado de Libre Venta/CPP, emitido por una entidad regulatoria de referencia, FDA o EMA. \nAl respecto, consultamos a la Convocante el motivo por el cual la misma no solicita para los productos innovadores lo establecido en el inciso c) de este mismo punto, conforme es requerido para los dem\u00e1s oferentes. Esto considerando que corresponde al mismo principio activo y estos son los que se encuentran incluidos dentro del listado, no pudiendo disociarse el riesgo por ser un innovador o biosimilar / gen\u00e9rico como pretende la Convocante. Por tanto, en base a esto, se solicita requerir igualmente lo detallado en el inciso c. para los productos innovadores, considerando adem\u00e1s la variabilidad poblacional que existe entre el lugar donde se desarrollaron los estudios para productos innovadores y donde se utilizaran finalmente los mismos. \n", "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": "2023-01-24T14:46:32-04:00"}, {"id": "34", "date": "2022-10-28T09:16:03-04:00", "title": "Item N\u00ba 18: Especificaciones T\u00e9cnicas ", "description": "Donde dice: Interferon Beta Inyectable - INTERFERON BETA 1A 12.000.000 U.I\nSolicitamos a la Convocante, ampliar el rango de la concentraci\u00f3n para permitir la presentacion de potenciales oferentes para beneficio de la instituci\u00f3n, ya que lo solicitado no altera las caracteristicas y propiedades del producto, por lo que solicitamos ampliar el rango de la siguiente manera:\nDEBE DECIR: Interferon Beta inyectable- INTERFERON BETA 1A 6.000.000 U.I / 12.000.000 U.I., Inyectable, Jeringa prellenada ", "author": {"name": "INDEX S.A.C.I.", "id": "PY-RUC-80002742-6"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.", "dateAnswered": "2023-01-24T14:50:45-04:00"}, {"id": "13", "date": "2022-10-27T18:00:27-04:00", "title": "Experiencia requerida", "description": "1.\tEn el punto de referencia, en su parte pertinente se menciona cuanto sigue: Para el caso de 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. \nAl respecto, de dicho texto entendemos que la Convocante pretende lo siguiente: 1. Para productos nacionales: En caso de 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. 2. Para productos importados: En caso de que el oferente no sea el titular del registro sanitario; dicha experiencia deber\u00e1 estar igualmente acreditada tanto por el oferente y el titular del registro sanitario. \nFavor, recomendamos replantear lo requerido, estableciendo claramente esta interpretaci\u00f3n, a fin de evitar confusiones en los potenciales oferentes. \n", "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": "2023-01-24T14:45:56-04:00"}, {"id": "11", "date": "2022-10-27T17:12:07-04:00", "title": "EXPERIENCIA REQUERIDA", "description": "Demostrar la experiencia en Provisi\u00f3n 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: 2019 2020-2021. Para el caso de 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. - Se solicita aclarar si la experiencia requerida aplica para fabricantes extranjeros, o en su defecto, para productos importados. Esta solicitud solo limitar\u00eda la participaci\u00f3n de potenciales oferentes con impacto directo a la libre competencia y resultados negativos de costo-beneficio trasladados al asegurado.", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-24T14:45:14-04:00"}, {"id": "41", "date": "2022-10-28T09:31:15-04:00", "title": "Capacidad Tecnica. Punto 2", "description": "En el \u00faltimo p\u00e1rrafo del punto 2. de la p\u00e1g. 16 del PBC, se solicita: Para el art\u00edculo 2), inciso d) y f) los documentos podr\u00e1n presentarse en copia simple, no obstante para la firma del contrato los mismos deber\u00e1n estar debidamente legalizados por el Ministerio de Relaciones Exteriores del Paraguay o apostillados, para el inciso b) estudios cl\u00ednicos, podr\u00e1n estar respaldados por una declaraci\u00f3n formalizada por el fabricante del producto ante Escribano o Notario P\u00fablico, autenticada y debidamente legalizada por el Ministerio de Relaciones Exteriores del Paraguay o apostillada, en la que se individualicen espec\u00edficamente los estudios que se presentan y se reconozca su autenticidad. Al respecto, se solicita a la Convocante eliminar lo requerido para el inciso b), considerando que los estudios cl\u00ednicos no son pasibles de ser apostillados o legalizados. Adem\u00e1s, el requerimiento de respaldo por parte de una declaraci\u00f3n formalizada por el fabricante del producto no corresponde siquiera a una documentaci\u00f3n requerida por la autoridad reguladora. Mal podr\u00eda la Convocante requerir este tipo de documentaci\u00f3n cuando dichos estudios ya han sido presentados y autorizados por la DNVS a trav\u00e9s de la emisi\u00f3n del registro sanitario respectivo, documentaci\u00f3n suficiente para la libre comercializaci\u00f3n del producto en el territorio nacional. Siendo claramente la DNVS la autoridad con la potestad t\u00e9cnica y legal para la verificaci\u00f3n de los estudios mencionados. \u00bfO acaso el IPS pretende dejar sin validez la documentaci\u00f3n presentada y aceptada por la DNVS para la obtenci\u00f3n del registro sanitario?", "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": "2023-01-24T14:52:09-04:00"}, {"id": "9", "date": "2022-10-27T16:14:08-04:00", "title": "PRECIO REFERENCIAL ITEM N\u00ba 12 HEPARINA S\u00d3DICA INYECTABLE", "description": "Solicitamos amablemente a la convocante actualizar el precio referencial del ITEM 12 Heparina sodica Inyectable - a Gs. 76.150, teniendo en cuenta el ultimo precio adjudicado en el llamado con ID N\u00b0 414718. El precio referencial actual se encuentra desfasado. ", "author": {"name": "CENTRO MEDICO AMANECER S.A", "id": "PY-RUC-80007483-1"}, "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP.", "dateAnswered": "2023-01-24T14:44:36-04:00"}, {"id": "39", "date": "2022-10-28T09:30:52-04:00", "title": "Capacidad Tecnica", "description": "En el Punto 2., inciso c) de la p\u00e1g. 16 del PBC, se solicita: La evidencia pre-cl\u00ednica y cl\u00ednica de biocomparabilidad provendr\u00e1 de estudios realizados conforme a lineamientos de la OMS e ICH, en las mismas indicaciones aprobadas para el innovador de referencia, tal como descrito en el Art\u00edculo 8\u00b0 del Decreto 6611. Al respecto, solicitamos a la Convocante establecer claramente cuales son los lineamientos espec\u00edficos requeridos por la Convocante tanto por la OMS e ICH, considerando que estos materiales se componen de diferentes lineamientos pudiendo estos ser aplicables de acuerdo al tipo de estudios a ser realizados para la obtenci\u00f3n de los resultados. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00eda conocer de estos lineamientos para ofertar productos monoclonales, ya los est\u00e1ndares fueron bien establecidos por todos los organismos mencionados incluyendo el Decreto 6611/16.", "dateAnswered": "2023-01-24T14:51:44-04:00"}, {"id": "12", "date": "2022-10-27T17:14:05-04:00", "title": "Experiencia requerida", "description": "Demostrar la experiencia en Provisi\u00f3n 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: 2019 2020-2021. Se solicita a la convocante aclarar si ser\u00e1 suficiente con demostrar facturaci\u00f3n en uno de los tres a\u00f1os indicados.", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-24T14:45:26-04:00"}, {"id": "27", "date": "2022-10-27T20:13:29-04:00", "title": "PRECIO REFERENCIAL ITEM N\u00ba 13 Hidroxiurea capsula", "description": "Solicitamos a la Convocante ajustar el precio referencial del \u00cdtem N\u00ba 13, esto en atenci\u00f3n a que el actual se encuentra desfasado, tomando como referencia eventos anteriores de vuestra Instituci\u00f3n, tal como la LPN N\u00ba 124-19 ID N\u00ba 370.609. El precio sugerido es de Gs 6.480.", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP.", "dateAnswered": "2023-01-24T14:48:33-04:00"}], "lots": [{"id": "00q6SaqD4BQ=", "title": "6 - Doxorrubicina / Adriamicina Inyectable-DOXORRUBICINA (ADRIAMICINA)", "status": "active", "statusDetails": "Activo", "value": {"amount": 2009362176, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "6", "id": "1"}]}, {"id": "7tP8heOrvUU=", "title": "25 - Nilotinib Capsula-NILOTINIB", "status": "active", "statusDetails": "Activo", "value": {"amount": 44350380000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "25", "id": "1"}]}, {"id": "C2udhdFp6CU=", "title": "11 - Heparina bajo peso molecular Inyectable-HEPARINA DE BAJO PESO MOLECULAR", 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