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"type": "tax", "name": "RENTA", "amount": {"amount": 2180190, "currency": "PYG"}}, {"id": "3", "type": "fee", "name": "MULTA", "amount": {"amount": 0, "currency": "PYG"}}, {"id": "4", "type": "tax", "name": "RETENCION DNCP", "amount": {"amount": 209298, "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": 817571, "currency": "PYG"}}]}], "financialCode": "LP-24001-24-238820"}]}, "awardID": "416711-guayaki-sa-38", "status": "active", "statusDetails": "Adjudicado", "dateSigned": "2023-08-24T12:00:00-04:00", "period": {"startDate": "2023-08-24T00:00:00-04:00", "endDate": "2025-08-24T00:00:00-04:00"}, "value": {"amount": 1876200000, "currency": "PYG"}, "documents": [{"id": "D9eMtFb+NWA=", "datePublished": "2024-04-30T09:33:18-04:00", "title": "329_23_guayaki_s_a__1714052151749.pdf", "url": "https://www.contrataciones.gov.py/documentos/download/contrato/D9eMtFb%252BNWA%253D", "language": "es", "documentType": "contractSigned", "documentTypeDetails": "Orden de Compra o Contrato"}, {"id": "YSeuqMW10rA=", "datePublished": "2024-04-30T09:33:18-04:00", "title": "estado_adjudicado_lpn_96_22_1714052157795.pdf", "url": "https://www.contrataciones.gov.py/documentos/download/contrato/YSeuqMW10rA%253D", "language": "es", "documentTypeDetails": "Nota de Aclaraci\u00f3n"}, {"id": "YJlrMXB1S9w=", "datePublished": "2024-04-30T09:33:18-04:00", "title": "aclaracion_uglc_lpn_sbe_96_22_1713271178060.pdf", "url": "https://www.contrataciones.gov.py/documentos/download/contrato/YJlrMXB1S9w%253D", "language": "es", "documentTypeDetails": "Nota de Aclaraci\u00f3n"}, {"id": "1nXPSJ2Z/Oo=", "datePublished": "2024-04-30T09:33:18-04:00", "title": "anexo_b_02_17_guayaki_sa_1713271057373.pdf", "url": "https://www.contrataciones.gov.py/documentos/download/contrato/1nXPSJ2Z%252FOo%253D", "language": "es", "documentTypeDetails": "Nota de Aclaraci\u00f3n"}, {"id": "HfenvzjPxxM=", "datePublished": "2024-04-30T09:33:18-04:00", "title": "aclaracion_uglc_lpn_sbe_96_22_1712844632079.pdf", "url": "https://www.contrataciones.gov.py/documentos/download/contrato/HfenvzjPxxM%253D", "language": "es", "documentTypeDetails": "Nota de Aclaraci\u00f3n"}, {"id": "UN7JrayHgfs=", "datePublished": "2024-04-30T09:33:18-04:00", "title": "anexo_b_02_17_guayaki_sa_1714052226439.pdf", "url": "https://www.contrataciones.gov.py/documentos/download/contrato/UN7JrayHgfs%253D", "language": "es", "documentTypeDetails": "Nota de Aclaraci\u00f3n"}, {"id": "gQmo4LEinfY=", "datePublished": "2024-04-30T09:33:18-04:00", "title": "anexo_b_02_17_guayaki_sa_1712844707651.pdf", "url": "https://www.contrataciones.gov.py/documentos/download/contrato/gQmo4LEinfY%253D", "language": "es", "documentTypeDetails": "Nota de Aclaraci\u00f3n"}]}], "tender": {"id": "416711-lpn-96-22-adquisicion-medicamentos-desglosados-stock-critico-asegurados-ips-1", "title": "LPN 96-22 ADQUISICI\u00d3N DE MEDICAMENTOS DESGLOSADOS CON STOCK CRITICO PARA ASEGURADOS DEL IPS", "status": "complete", "awardCriteria": "priceOnly", "awardCriteriaDetails": "Por Item", "submissionMethod": ["inPerson"], "bidOpening": {"date": "2023-01-19T09:00:00-04:00", "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: Seg\u00fan documento del llamado || 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": "A TRAVES DE SICP"}, "mainProcurementCategoryDetails": "Bienes - Equipos, Productos e instrumentales M\u00e9dicos y de Laboratorio. Servicios asistenciales de salud", "hasEnquiries": true, "value": {"amount": 120088393700, "currency": "PYG"}, "datePublished": "2022-09-30T18:26:17-04:00", "tenderPeriod": {"startDate": "2022-09-30T18:26:17-04:00", "endDate": "2023-01-19T08:45:00-04:00", "durationInDays": 110}, "awardPeriod": {"startDate": "2023-01-19T09:00:00-04:00"}, "enquiryPeriod": {"endDate": "2022-10-17T10:00:00-04:00", "startDate": "2022-09-30T18:26:17-04:00", "durationInDays": 16}, "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"}]}]}], "enquiries": [{"id": "3628728577b9df89b32e93eee7ece9d7", "date": "2022-10-11T10:22:43-04:00", "title": "Precio Referencial LOTE N\u00b0 14", "description": "Solicitamos respetuosamente a la convocante revisar el precio referencial del LOTE N\u00b0 14, ya que el mismo se encuentra muy por debajo del precio real del mercado, e incluso muy por debajo del precio referencial en llamados anteriores. Por lo cual limita la posibilidad de presentar ofertas y competir por un precio razonable.", "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP", "dateAnswered": "2023-01-13T13:14:45-04:00"}, {"id": "92c4618d38496633f66a8d6ddcef104f", "date": "2022-10-14T15:16:32-04:00", "title": "PRECIO REFERENCIAL - LOTE 17", "description": "Solicitamos a la Convocante modificar el precio referencial consignado para los items que componen el Lote 17 - FUROSEMIDA INYECTABLE, ya que los mismos se encuentran desfasados actualmente con los precios del mercado.", "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP", "dateAnswered": "2023-01-16T08:16:23-04:00"}, {"id": "29aef6f581eac79f07091d7e078824b4", "date": "2022-10-11T10:23:30-04:00", "title": "Precio Referencial LOTE N\u00b0 28", "description": "Solicitamos respetuosamente a la convocante revisar el precio referencial del LOTE N\u00b0 28, ya que el mismo se encuentra muy por debajo del precio real del mercado, e incluso muy por debajo del precio referencial en llamados anteriores. Por lo cual limita la posibilidad de presentar ofertas y competir por un precio razonable.", "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP", "dateAnswered": "2023-01-13T14:16:02-04:00"}, {"id": "67bbcf2269c57f1c74b6bb5cf009df44", "date": "2022-10-12T17:24:40-04:00", "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.\n1.\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.\n2.\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.", "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:04:42-04:00"}, {"id": "03548755e65bf02a119a050e36554fcc", "date": "2022-10-14T15:21:03-04:00", "title": "PRECIO REFERENCIAL - LOTE 6", "description": "Solicitamos a la Convocante modificar el precio referencial consignado para los items que componen el Lote 6 - ANTIGRIPAL FORMULA MINIMA (ANTITERMICO, ANTIHISTAMINICO, DESCONGESTIVO VASOCONSTRICTOR), ya que los mismos se encuentran desfasados actualmente con los precios del mercado.", "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP", "dateAnswered": "2023-01-16T08:16:33-04:00"}, {"id": "6b7a9231a08e579aec15a62c630cd597", "date": "2022-10-14T16:31:47-04:00", "title": "PORCENTAJE DE MULTA", "description": "El PBC establece el siguiente porcentaje de multa de 0,10 %. Solicitamos a la Convocante unificar el porcentaje de multa a 0.01% tal como lo establece en el porcentaje de Tasa de Interes por Mora.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico", "dateAnswered": "2023-01-16T08:16:43-04:00"}, {"id": "7ae04fbfac765780a5df3999da59e1f7", "date": "2022-10-14T11:36:25-04:00", "title": "RATIOS FINANCIEROS", "description": "Solicitamos a la convocante que el ratio de liquidez sea igual o mayor a 1 en promedio a los a\u00f1os 2019, 2020 y 2021", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico", "dateAnswered": "2023-01-16T08:15:44-04:00"}, {"id": "4174c6b499f5b22a509052bb69e8ef38", "date": "2022-10-05T15:32:01-04:00", "title": "Lote 10 Item 2  Carbamazepina 200 mg/ml Suspensi\u00f3n", "description": "En la Lpn 99 se adjudico Carbamazepina 200 mg/ml Suspensi\u00f3n de los cuales nos dicen que no emiten orden porque los m\u00e9dicos no recetan m\u00e1s. Este llamado vence el contrato recien el 31/12/2023.  Si no se mueve este producto para que piden nuevamente Carbamazepina 200 mg/ml Suspensi\u00f3n.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico", "dateAnswered": "2023-01-13T13:08:17-04:00"}, {"id": "65d63c3c280f1b8c98d4f7fce077f6d7", "date": "2022-10-17T08:34:22-04:00", "title": "HIALURONATO DE SODIO /ACIDO HIALURONICO 25/20 mg INYECTABLE .JERINGA PRELLENADA", "description": "En el PBC, se solicita la siguiente documentaci\u00f3n: \n\nCopia autenticada de Certificaci\u00f3n emitido por algunas de las agencias Reguladoras de Referencia Regional (NIVEL IV) Reconocidas por la Organizaci\u00f3n Panamericana de la Salud (OPS), como ANVISA de Brasil, ANMAT de Argentina, INVIMA de Colombia, CECMED de Cuba , COFEPRIS DE MEXICO; FDA y/o EMA  u otros que cuenten con Certificaciones seg\u00fan las Normas ISO 13485. Traducido al idioma Espa\u00f1ol.\n\nTeniendo en cuenta que el producto en cuesti\u00f3n corresponde a una especialidad farmac\u00e9utica y el criterio no aclara a que certificaci\u00f3n hace referencia, se solicita a la Convocante establecer claramente la documentaci\u00f3n requerida para dicho punto considerando la clasificaci\u00f3n correspondiente al producto en particular.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n", "dateAnswered": "2023-01-16T08:17:54-04:00"}, {"id": "af8d9316f92fa817a8f39153af01129f", "date": "2022-10-11T19:20:17-04:00", "title": "LOTE 9", "description": "Solicitamos a la Convocante establecer claramente la unidad de medida correspondiente a la concentraci\u00f3n del producto en cada item que compone el mismo. Esto a fin de evitar confusiones por parte de los potenciales oferentes.", "answer": "Se aclara que la Unidad de medida para la Concentraci\u00f3n es Unidad para cada \u00cdtem, por otro lado tambi\u00e9n se aclara que la presentaci\u00f3n de entrega solicitada en el PBC es de Ampolla para el \u00cdtem 1 y Frasco Ampolla (Vial) para el \u00cdtem 2, pudiendo el oferente presentarse en el \u00cdtem de su preferencia.", "dateAnswered": "2023-01-16T08:04:05-04:00"}, {"id": "69dceae001a251b8a073cb701b050545", "date": "2022-10-12T18:12:37-04:00", "title": "LOTE DESGLOSADO%", "description": "Se solicita a la convocante aclarar conforme a llamados anteriores si en cada lote se deber\u00e1 cotizar indistintamente cualquiera de los \u00edtems detallados y si se adjudicar\u00e1 solamente un \u00edtem (el de menor precio y que cumpla con todas las especificaciones t\u00e9cnicas del PBC).", "answer": "Se aclara que el oferente podr\u00e1 cotizar indistintamente cualquiera de los \u00cdtems detallados en cada Lote, el sistema de adjudicaci\u00f3n es por Abastecimiento Simultaneo, por lo tanto podr\u00e1 adjudicarse hasta 3 \u00cdtems en cada Lote (el de menor precio y que cumpla con todas las especificaciones t\u00e9cnicas del PBC).", "dateAnswered": "2023-01-16T08:14:37-04:00"}, {"id": "220a5dde4dadff02d222c440b2e5db59", "date": "2022-10-12T18:12:26-04:00", "title": "LOTE N\u00ba 25 \u2013 \u00cdTEM N\u00ba 2 \u2013 LEVOFLOXACINA INYECTABLE%", "description": "Solicitamos a la convocante la ampliaci\u00f3n de las especificaciones de la presentaci\u00f3n de entrega del producto levofloxacina, quedando de la siguiente manera: Frasco ampolla, sistema cerrado con doble puerto de inyecci\u00f3n, libre de l\u00e1tex y DEHP.\nCon esto el IPS garantizar\u00e1 que los productos a ser administrados al paciente otorguen las garant\u00edas de esterilidad del producto ya que la manipulaci\u00f3n humana es m\u00ednima, por otro lado al ser libre de l\u00e1tex y DEHP se evita comprometer la salud de los pacientes evitando la contaminaci\u00f3n con estos tipos de sustancias tan nocivas para la salud. Todo esto a fin de dar cumplimiento a lo establecido en la Ley N\u00ba 4659/12 donde dice \u201cEn fluidoterapia intravenosa, los envases deber\u00e1n asegurar la esterilidad del fluido suministrado durante la recepci\u00f3n del paciente en su tratamiento mediante sistemas cerrados de infusi\u00f3n\u201d.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico", "dateAnswered": "2023-01-16T08:14:22-04:00"}, {"id": "4b731134fd38af165adf4b399d28769e", "date": "2022-10-12T18:11:53-04:00", "title": "LOTE N\u00ba 16 \u2013 \u00cdTEM N\u00ba 1 \u2013 FLUCONAZOL INYECTABLE%", "description": "Solicitamos a la convocante la ampliaci\u00f3n de las especificaciones de la presentaci\u00f3n de entrega del producto fluconazol, quedando de la siguiente manera: Frasco ampolla, sistema cerrado con doble puerto de inyecci\u00f3n, libre de l\u00e1tex y DEHP.\nCon esto el IPS garantizar\u00e1 que los productos a ser administrados al paciente otorguen las garant\u00edas de esterilidad del producto ya que la manipulaci\u00f3n humana es m\u00ednima, por otro lado al ser libre de l\u00e1tex y DEHP se evita comprometer la salud de los pacientes evitando la contaminaci\u00f3n con estos tipos de sustancias tan nocivas para la salud. Todo esto a fin de dar cumplimiento a lo establecido en la Ley N\u00ba 4659/12 donde dice \u201cEn fluidoterapia intravenosa, los envases deber\u00e1n asegurar la esterilidad del fluido suministrado durante la recepci\u00f3n del paciente en su tratamiento mediante sistemas cerrados de infusi\u00f3n\u201d.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico", "dateAnswered": "2023-01-16T08:11:32-04:00"}, {"id": "8dba444585007a77cdd7226a024b9e1b", "date": "2022-10-12T17:35:28-04:00", "title": "**LOTE 15 - FILGRASTIM", "description": "Se solicita a la convocante aclarar si la concentraci\u00f3n solicitada corresponde a 300 mcg.", "answer": "Se aclara al oferente que 30.000.000 UI es equivalente a 300 mcg", "dateAnswered": "2023-01-16T08:05:39-04:00"}, {"id": "96287ff831e17db7d4bc111a7ca59256", "date": "2022-10-14T11:36:10-04:00", "title": "SISTEMA DE ADJUDICACION", "description": "Solicitamos a la convocante aclarar si en un LOTE puede ser ofertado solamente un \u00edtem.", "answer": "Se aclara al oferente que en un LOTE puede cotizarse m\u00e1s de un \u00edtem", "dateAnswered": "2023-01-16T08:15:25-04:00"}, {"id": "ef0f7e61258f571a56b0bcb07c4337e9", "date": "2022-10-14T16:43:17-04:00", "title": "PLAN DE ENTREGA - CANTIDAD MINIMA", "description": "El PBC Solicita - 20%: Hasta los 8 (ocho) d\u00edas calendarios. Con entregas que podr\u00e1n ser fraccionadas siempre dentro del mencionado plazo. Solicitamos a la Convocante ampliar el plazo a por los menos 15 d\u00edas calendarios el plazo para la entrega del 20% de la Cantidad m\u00ednima, teniendo en cuenta el tiempo que conlleva el proceso de fabricaci\u00f3n de los bienes solicitados.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico", "dateAnswered": "2023-01-16T08:17:06-04:00"}, {"id": "3dcbe925eb05c3d87c9d0d10ffa87e39", "date": "2022-10-12T18:11:43-04:00", "title": "CAPACIDAD T\u00c9CNICA \u2013 HIALURONATO DE SODIO/ACIDO HIALUR\u00d3NICO 25/20MG. INYECTABLE. JERINGA PRELLENADA%", "description": "En cuanto al producto, solicita la siguiente documentaci\u00f3n:\nCopia autenticada de Certificaci\u00f3n emitido por algunas de las agencias Reguladoras de Referencia Regional (NIVEL IV) Reconocidas por la Organizaci\u00f3n Panamericana de la Salud (OPS), como ANVISA de Brasil, ANMAT de Argentina, INVIMA de Colombia, CECMED de Cuba , COFEPRIS DE MEXICO; FDA y/o EMA  u otros que cuenten con Certificaciones seg\u00fan las Normas ISO 13485. Traducido al idioma Espa\u00f1ol.\n\nCon relaci\u00f3n al producto solicitado, creemos conveniente recordar al IPS que el mismo corresponde a un producto clasificado como \u201cdispositivo m\u00e9dico\u201d.\nRespecto a los dispositivos m\u00e9dicos, la DINAVISA (seg\u00fan Res. 669/16 \u201cPor el cual se reglamenta el Art\u00edculo 4\u00b0 inciso B) de la Ley N\u00b0 4659/12 \u201cQue implementa Procedimientos de seguridad y Mecanismos de Prevenci\u00f3n de Riesgos para los Profesionales de la Salud y Pacientes\u201d, Estableciendo Normas Para la Obtenci\u00f3n del Registro Sanitario de Productos Considerados Dispositivos M\u00e9dicos, Material Cortopunzantes y Equipos de Protecci\u00f3n Individual\u201d) en su art. 4) Inc. D) establece que para el registro local de dispositivos m\u00e9dicos se debe presentar: \u201cDocumentaci\u00f3n acreditando fehacientemente el cumplimento de las normas de calidad en los procesos de producci\u00f3n BPF/GMP otorgada por la Autoridad Sanitaria, competente en origen o certificado ISO/CE/UL/FDA/ TUVF- otorgado por la entidad certificadora de origen\u201d\n\nSeguidamente, al realizar un comparativo del requerimiento establecido en el 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 dispositivos m\u00e9dicos 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 los productos: HIALURONATO DE SODIO/ACIDO HIALUR\u00d3NICO 25/20MG. INYECTABLE. JERINGA PRELLENADA\nSe solicita la siguiente documentaci\u00f3n:\n\u201cDocumentaci\u00f3n acreditando fehacientemente el cumplimento de las normas de calidad en los procesos de producci\u00f3n BPF/GMP otorgada por la Autoridad Sanitaria, competente en origen o certificado ISO/CE/UL/FDA/ TUVF- otorgado por la entidad certificadora de origen\u201d\n\nEsta modificaci\u00f3n ya ha sido incluida en llamados anteriores tales como la LPN N\u00ba 99/19 (ID N\u00ba 367517), en donde la misma convocante accedi\u00f3 a modificar su PBC para con el mismo producto.", "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:10:41-04:00"}, {"id": "0a5614613333efd0a51571cf6ce39fac", "date": "2022-10-11T19:11:07-04:00", "title": "Capacidad Tecnica", "description": "En relaci\u00f3n a dicho punto, solicitamos a la Convocante incluir como requisito para productos importados la presentaci\u00f3n del certificado de buenas pr\u00e1cticas del fabricante del producto y/o Certificado de Libre Venta del producto emitido por pa\u00edses aceptados conforme a la Ley 3283/2007", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico", "dateAnswered": "2023-01-13T14:17:06-04:00"}, {"id": "921d72dc04674e400a7023f5309cbf3f", "date": "2022-10-17T09:22:50-04:00", "title": "Experiencia requerida", "description": "Donde dice 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: 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; Solicitamos a la convocante que este punto pueda quedar de la siguiente manera Demostrar la experiencia en PROVISION DE MEDICAMENTOS Y/O INSUMOS MEDICOS Y/O BIENES 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", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:18:32-04:00"}, {"id": "c4c325768dc203495c933825dd513ceb", "date": "2022-10-11T19:11:17-04:00", "title": "Capacidad Tecnica", "description": "En el punto 1.2 Para farmacos como Ac. Zoledronico, solicitan lo siguiente: Registro y/o Certificado del producto ofertado, emitido por una Autoridad Sanitaria Reguladora de Alta Vigilancia como:\na.      FDA o EMA.\nb.     O los indicados de alta vigilancia en el Art 11 de la Ley 3283/2007.\nc.      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), ISP (Chile).  Considerando que existen productos de fabricaci\u00f3n nacional, para los cuales no resulta un requisito necesario para contar con el registro sanitario emitido por la autoridad nacional. 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.", "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico. \u00daltima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:03:44-04:00"}, {"id": "c54e5750f7b3731f743c6a6e8656fec5", "date": "2022-10-12T18:35:08-04:00", "title": "P/ HIALURONATO DE SODIO/ACIDO HIALUR\u00d3NICO 25/20MG. INYECTABLE. JERINGA PRELLENADA CON RELACI\u00d2N A LA CAPACIDAD T\u00c9CNICA+", "description": "En funci\u00f3n al PBC donde se requiere de la siguiente documentaci\u00f3n:\n\n\u2022\tCopia autenticada de Certificaci\u00f3n emitido por algunas de las agencias Reguladoras de Referencia Regional (NIVEL IV) Reconocidas por la Organizaci\u00f3n Panamericana de la Salud (OPS), como ANVISA de Brasil, ANMAT de Argentina, INVIMA de Colombia, CECMED de Cuba , COFEPRIS DE MEXICO; FDA y/o EMA  u otros que cuenten con Certificaciones seg\u00fan las Normas ISO 13485. Traducido al idioma Espa\u00f1ol.\n\nInterpretamos que la Convocante ha OMITIDO que el producto de referencia est\u00e1 clasificado como \u201cdispositivo m\u00e9dico\u201d.\nLa reglamentaci\u00f3n vigente, establecida por la DINAVISA (seg\u00fan Res. 669/16 \u201cPor el cual se reglamenta el Art\u00edculo 4\u00b0 inciso B) de la Ley N\u00b0 4659/12 \u201cQue implementa Procedimientos de seguridad y Mecanismos de Prevenci\u00f3n de Riesgos para los Profesionales de la Salud y Pacientes\u201d, Estableciendo Normas Para la Obtenci\u00f3n del Registro Sanitario de Productos Considerados Dispositivos M\u00e9dicos, Material Cortopunzantes y Equipos de Protecci\u00f3n Individual\u201d) en su art. 4) Inc. D) establece que para el registro local de dispositivos m\u00e9dicos se debe presentar: \u201cDocumentaci\u00f3n acreditando fehacientemente el cumplimento de las normas de calidad en los procesos de producci\u00f3n BPF/GMP otorgada por la Autoridad Sanitaria, competente en origen o certificado ISO/CE/UL/FDA/ TUVF- otorgado por la entidad certificadora de origen\u201d.\n\nEn funci\u00f3n a lo descrito se solicita respetuosamente a la Convocante, se sirva de reformular el requisito del PBC en cumplimiento a lo establecido por la DINAVISA, y por consiguiente a como m\u00ednimo:\n\nPara los productos: HIALURONATO DE SODIO/ACIDO HIALUR\u00d3NICO 25/20MG. INYECTABLE. JERINGA PRELLENADA\nConsiderar cumplido el requerimiento con la presentaci\u00f3n de la siguiente documentaci\u00f3n:\n\u201cDocumentaci\u00f3n acreditando fehacientemente el cumplimento de las normas de calidad en los procesos de producci\u00f3n BPF/GMP otorgada por la Autoridad Sanitaria, competente en origen o certificado ISO/CE/UL/FDA/ TUVF- otorgado por la entidad certificadora de origen\u201d\n\nEl presente pedido de modificaci\u00f3n tambi\u00e9n se sustenta en que  \u00e9sta modificaci\u00f3n ya ha sido considerada e incluida en procesos licitatorios anteriores tales como la LPN N\u00ba 99/19 (ID N\u00ba 367517), donde la entidad ha realizado la modificaci\u00f3n planteada.", "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:14:51-04:00"}, {"id": "0eb7b75d86b62272df301488978b055e", "date": "2022-10-11T19:11:12-04:00", "title": "Capacidad Tecnica", "description": "En el inciso 1.2 solicitan para farmacos como Ac. Zoledronico la presentaci\u00f3n del Registro y/o Certificado del producto ofertado, emitido por una Autoridad Sanitaria Reguladora de Alta Vigilancia. Al respecto, solicitamos a la Convocante aclarar que estos requisitos solo aplican a productos importados y no as\u00ed a productos nacionales, siendo suficiente para productos de origen nacional contar con el registro sanitario del producto en cuesti\u00f3n. teniendo en cuenta que existen oferentes con productos de fabricaci\u00f3n nacional, para los cuales no resulta un requisito contar con los documentos detallados en dicho inciso para la obtenci\u00f3n del certificado de registro sanitario.", "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico. Ultima Versi\u00f3n", "dateAnswered": "2023-01-16T08:03:32-04:00"}, {"id": "d3944c5a0be9fe635a041d0210a93358", "date": "2022-10-12T17:35:11-04:00", "title": "**PRECIO REFERENCIAL \u2013 ASPARAGINASA", "description": "Solicitamos a la convocante la actualizaci\u00f3n del precio referencial del Lote 7 Asparaginasa, atendiendo a que el precio actual se encuentra desactualizado con respecto a los precios actuales de mercado. Es importante mencionar que el precio fijado por la DINAVISA es de G. 4.200.000.-", "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP", "dateAnswered": "2023-01-16T08:05:22-04:00"}, {"id": "bd5df4a0d5085b1d031d0a94149ac501", "date": "2022-10-14T16:43:13-04:00", "title": "SISTEMA DE ADJUDICACION", "description": "Se solicita amablemente a la convocante aclarar conforme a llamados anteriores si en cada lote se deber\u00e1 cotizar indistintamente cualquiera de los \u00edtems detallados y si se adjudicar\u00e1 solamente un solo \u00edtem, el que cumpla con todos los requerimientos del PBC.", "answer": "Se aclara que el oferente podr\u00e1 cotizar indistintamente cualquiera de los \u00cdtems detallados en cada Lote, el sistema de adjudicaci\u00f3n es por Abastecimiento Simultaneo, por lo tanto podr\u00e1 adjudicarse hasta 3 \u00cdtems en cada Lote (el de menor precio y que cumpla con todas las especificaciones t\u00e9cnicas del PBC).", "dateAnswered": "2023-01-16T08:16:56-04:00"}, {"id": "139248230deb8997f77ba67b25548732", "date": "2022-10-10T13:18:18-04:00", "title": "LOTE 1 ACIDO ACETIL SALICILICO COMPRIMIDO", "description": "En la LPN N\u00ba 99/19 ID N\u00ba 367.517 solicitaron ACIDO ACETIL SALICILICO COMPRIMIDO 100 -125 mg COMPRIMIDO/COMPRIMIDO MICROCAPSULA. Solicitamos a la convocante ampliar la presentaci\u00f3n del producto de referencia de la siguiente manera: COMPRIMIDO/COMPRIMIDO MICROCAPSULA de manera a brindar mayor oportunidad de participaci\u00f3n a potenciales oferentes.", "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-13T13:12:43-04:00"}, {"id": "753053b15fc7d051ffd59e263217ddea", "date": "2022-10-11T19:11:21-04:00", "title": "Capacidad Tecnica", "description": "En el punto 1.2 Para farmacos como Ac. Zoledronico, solicitan lo siguiente: Registro y/o Certificado del producto ofertado, emitido por una Autoridad Sanitaria Reguladora de Alta Vigilancia como: a. FDA o EMA. b. O los indicados de alta vigilancia en el Art 11 de la Ley 3283/2007. c. 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), ISP (Chile). Al respecto, se solicita a la convocante incluir y aclarar los requisitos para productos de fabricaci\u00f3n NACIONAL. Cabe resaltar que queda fuera de lugar establecer requisitos que el ente regulador (DNVSA) no requiera para la autorizaci\u00f3n de comercializaci\u00f3n dentro del territorio nacional.", "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico. Ultima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:03:54-04:00"}, {"id": "2fdcaa1386ba60efbcdcf25b3d75a95f", "date": "2022-10-14T11:35:56-04:00", "title": "ESPECIFICACIONES TECNICAS", "description": "Solicitamos a la convocante especificar la presentaci\u00f3n de entrega en las especificaciones t\u00e9cnicas debido a que no figura correctamente en el PBC publicado.", "answer": "El oferente deber\u00e1 remitirse al Pliego Electr\u00f3nico \u00daltima Versi\u00f3n", "dateAnswered": "2023-01-16T08:15:14-04:00"}, {"id": "885389a2f7c3ab3d1fc78734598918bb", "date": "2022-10-11T19:20:29-04:00", "title": "Capacidad Tecnica", "description": "En el \u00faltimo inciso de dicho criterio se establece: \nPara los productos:\nHIALURONATO DE SODIO /ACIDO HIALURONICO 25/20 mg INYECTABLE .JERINGA PRELLENADA\nSe solicita la siguiente documentaci\u00f3n:\nCopia autenticada de Certificaci\u00f3n emitido por algunas de las agencias Reguladoras de Referencia Regional (NIVEL IV) Reconocidas por la Organizaci\u00f3n Panamericana de la Salud (OPS), como ANVISA de Brasil, ANMAT de Argentina, INVIMA de Colombia, CECMED de Cuba , COFEPRIS DE MEXICO; FDA y/o EMA  u otros que cuenten con Certificaciones seg\u00fan las Normas ISO 13485. Traducido al idioma Espa\u00f1ol. Al respecto, solicitamos a la Convocante aclarar a que se refiere cuando hacen menci\u00f3n a \"certificaci\u00f3n emitida\"., estar\u00eda hablando de presentar el GMP y/o CLV del producto? Adem\u00e1s, en relaci\u00f3n al requerimiento de Norma ISO 13485, solicitamos a la Convocante aclarar en que casos se deber\u00e1 presentar la misma, considerando que esta es aplicada exclusivamente para dispositivos m\u00e9dicos.", "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico. \u00daltima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:04:16-04:00"}, {"id": "2889824e26948945ad968efead0243bc", "date": "2022-10-14T15:16:08-04:00", "title": "PRECIO REFERENCIAL - LOTE 15", "description": "Solicitamos a la Convocante modificar el precio referencial consignado para los items que componen el Lote 15 - FILGRASTIM INYECTABLE, ya que los mismos se encuentran desfasados actualmente con los precios del mercado.", "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP", "dateAnswered": "2023-01-16T08:16:12-04:00"}, {"id": "d4041faf38bb8feef6dfe65ca2be9e99", "date": "2022-10-12T18:00:08-04:00", "title": "Experiencia%", "description": "En referencia al PBC, donde se cita Requisitos para validar la Experiencia, como 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. \nPara 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 manifestamos respetuosamente a la Convocante, que la forma en la que se encuentra establecido el requisito tiende a confundir hacia una interpretaci\u00f3n err\u00f3nea, por ello y para una mejor comprensi\u00f3n del Oferente, solicitamos se sirvan de replantear el requisito a al menos cuanto sigue:\nEl Oferente para acreditar la experiencia en PROVISI\u00d3N DE MEDICAMENTOS, deber\u00e1 presentar 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 al 2021.\nI.\tSe considerar\u00e1 como v\u00e1lida la documentaci\u00f3n que demuestre que en caso de que el oferente no sea el fabricante y/o el titular del registro sanitario de los medicamentos, que la experiencia deber\u00e1 estar igualmente acreditada por el oferente, por el titular del registro sanitario y el fabricante del producto que se oferta. (P/ productos nacionales):\nII.\tSe considerar\u00e1 como v\u00e1lida la documentaci\u00f3n que demuestre que en caso de que el oferente no sea el titular del registro sanitario; que la experiencia deber\u00e1 estar igualmente acreditada tanto por el oferente y el titular del registro sanitario. (P/ productos importados)", "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:10:12-04:00"}, {"id": "fa5c68536dbcc2e994232a355c821ebb", "date": "2022-10-17T09:52:06-04:00", "title": "LOTE 25 \u2013 LEVOFLOXACINA", "description": "Favor incluir la presentaci\u00f3n: FRASCO adem\u00e1s de las ya incluidas: SACHET/FRASCO AMPOLLA. Esto permitir\u00e1 a la convocante la mayor cantidad de ofertas posibles", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico", "dateAnswered": "2023-01-16T08:19:17-04:00"}, {"id": "b9c9446964e55746cd3228be1a07acd3", "date": "2022-10-06T16:08:00-04:00", "title": "CONFORMACION DE PRECIOS REFERENCIALES", "description": "SOLICITAMOS A LA CONVOCANTE ACLARAR SI LA COMPOSICI\u00d3N DE PRECIOS REFERENCIALES SE DA POR LA SUMA DE PRECIOS DE CADA ITEM QUE CONFORMAN LOS LOTES? DADO QUE SE VISUALIZAN INCONSISTENCIAS EN ALGUNOS PRECIOS.", "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP", "dateAnswered": "2023-01-13T13:10:17-04:00"}, {"id": "1e0cbfcd8fc1d778485041bdb8f329f2", "date": "2022-10-12T17:29:15-04:00", "title": "**CAPACIDAD T\u00c9CNICA - ASPARAGINASA", "description": "Con relaci\u00f3n a lo establecido en el P.B.C.  En cuanto al producto ASPARAGINASA (p\u00e1gina 18)\nLa convocante solicita: la presentaci\u00f3n de: a. Registro o Certificaci\u00f3n del producto ofertado, emitido por alguna de las Agencias Reguladoras de Referencias seg\u00fan lo dispuesto en el Art. 4\u00b0 del decreto 6611 POR EL CUAL SE REGLAMENTA EL ART\u00cdCULO 24 DE LA LEY N\u00b0 1119/1997, DE PRODUCTOS PARA LA SALUD Y OTROS, Y SE ESTABLECEN LOS REQUISITOS PARA EL REGISTRO DE MEDICAMENTOS BIOL\u00d3GICOS.\nAl respecto, del documento es importante recordar al Instituto de Previsi\u00f3n Social que el producto ASPARAGINASA es una droga hu\u00e9rfana fundamental en el tratamiento de la leucemia linfobl\u00e1stica aguda desde hace d\u00e9cadas, pero que se ha dejado de producir por grandes laboratorios por cuestiones de \u00edndole comercial (no les interesa). La producci\u00f3n de esta droga est\u00e1 supeditada a laboratorios de India y China que cuentan con certificaciones locales e internacionales, pero que en su gran mayor\u00eda no cuentan con Registros de esta droga en pa\u00edses considerados de alta vigilancia/adecuada vigilancia. Actualmente en el mercado nacional, existe un solo registro sanitario de Asparaginasa cuya elaboraci\u00f3n cuenta con una certificaci\u00f3n internacional de alta vigilancia (Aprobaci\u00f3n de planta elaboradora) que garantiza la calidad la seguridad y eficacia de este producto. A Esto se suma que dicho producto se encuentra en el mercado local hace m\u00e1s de 3 a\u00f1os sin reportar reacciones adversas. Por todo esto solicitamos que para esta droga de alta necesidad para los ni\u00f1os se solicite en forma excepcional y suficiente solamente la Aprobaci\u00f3n de Planta.\nMotivo por el cual se solicita a la convocante la reformulaci\u00f3n del requisito solicitado, de la siguiente manera:\nPara el producto ASPARAGINASA:\na. Certificaci\u00f3n de buenas pr\u00e1cticas de fabricaci\u00f3n del fabricante del producto ofertado, emitido por alguna de las Agencias Reguladoras de Referencias seg\u00fan lo dispuesto en el Art. 4\u00b0 del decreto 6611 POR EL CUAL SE REGLAMENTA EL ART\u00cdCULO 24 DE LA LEY N\u00b0 1119/1997, DE PRODUCTOS PARA LA SALUD Y OTROS, Y SE ESTABLECEN LOS REQUISITOS PARA EL REGISTRO DE MEDICAMENTOS BIOL\u00d3GICOS.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico", "dateAnswered": "2023-01-16T08:04:54-04:00"}, {"id": "eaeaa30c83ad892b555fa096e2f61430", "date": "2022-10-14T16:45:27-04:00", "title": "PLAN DE ENTREGA CANTIDAD MINIMA", "description": "El PBC solicita - 80%: Hasta los 20 (veinte) d\u00edas calendarios. Con entregas que podr\u00e1n ser fraccionadas siempre dentro del mencionado plazo. Solicitamos a la Convocante aumentar el plazo a por los 30 d\u00edas calendarios para la entrega del 80% de la Cantidad M\u00ednima teniendo en cuenta el tiempo que conlleva el proceso de fabricaci\u00f3n de los bienes.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico", "dateAnswered": "2023-01-16T08:17:14-04:00"}, {"id": "f27d21d33f2cc593de0fb991664c1b1a", "date": "2022-10-05T13:59:55-04:00", "title": "SUMINISTRO REQUERIDOS- EE.TT", "description": "Solicitamos  a la convocante verificar en el PBC, en el apartado detalle de los productos con las respectivas especificaciones t\u00e9cnicas, no se visualiza el campo de presentaci\u00f3n.", "answer": "El oferente deber\u00e1 remitirse al Pliego Electr\u00f3nico \u00daltima Versi\u00f3n", "dateAnswered": "2023-01-13T13:07:58-04:00"}, {"id": "bddf9b3dc65043c72b34cc10f40765f5", "date": "2022-10-12T18:11:48-04:00", "title": "REQUISITOS DOCUMENTALES PARA DISPOSITIVOS M\u00c9DICOS%", "description": "Corresponde aclarar a la convocante que en el presente llamado en el Lote N\u00ba 20 (\u00edtem N\u00ba 1, 2, 3, 4) se solicita un producto clasificado por la DINAVISA como dispositivo m\u00e9dico, por lo cual solicitamos que la convocante separe en el apartado \u201cREQUISITOS DOCUMENTAL PARA EVALUAR CAPACIDAD T\u00c9CNICA\u201d los documentos que deber\u00e1n ser presentados por los oferentes en caso de cotizar especialidades farmac\u00e9uticas y/o dispositivos m\u00e9dicos, espec\u00edficamente en los puntos:\ne) Certificado de Buenas Pr\u00e1cticas (Traducido al idioma espa\u00f1ol). Atendiendo que los fabricantes de dispositivos m\u00e9dicos no se encuentran obligados a contar con GMP ya que los procesos de fabricaci\u00f3n son acreditados por normas internacionales tal como se menciona en la resoluci\u00f3n 669/16 art. 4) Inc. D) \u201cDocumentaci\u00f3n acreditando fehacientemente el cumplimento de las normas de calidad en los procesos de producci\u00f3n BPF/GMP otorgada por la Autoridad Sanitaria, competente en origen o certificado ISO/CE/UL/FDA/ TUVF- otorgado por la entidad certificadora de origen\u201d por lo tanto dicho requisito solamente aplicar\u00eda para especialidades farmac\u00e9uticas.\nf) Acta de Fijaci\u00f3n de precios (identificar cada lote/\u00edtem ofertado seg\u00fan PBC). Atendiendo a que la DINAVISA (ente regulador) no emite Acta de Fijaci\u00f3n de precios para dispositivos m\u00e9dicos por lo tanto dicho requisito solamente aplicar\u00eda para especialidades farmac\u00e9uticas.", "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:10:55-04:00"}, {"id": "99d4f78bc26be4605dcfc3c603c3757b", "date": "2022-10-17T08:33:50-04:00", "title": "Capacidad T\u00e9cnica - HIALURONATO DE SODIO /ACIDO HIALURONICO 25/20 mg INYECTABLE .JERINGA PRELLENADA", "description": "En el PBC para el producto HIALURONATO DE SODIO /ACIDO HIALURONICO 25/20 mg INYECTABLE .JERINGA PRELLENADA, se solicita la siguiente documentaci\u00f3n:\n\nCopia autenticada de Certificaci\u00f3n emitido por algunas de las agencias Reguladoras de Referencia Regional (NIVEL IV) Reconocidas por la Organizaci\u00f3n Panamericana de la Salud (OPS), como ANVISA de Brasil, ANMAT de Argentina, INVIMA de Colombia, CECMED de Cuba , COFEPRIS DE MEXICO; FDA y/o EMA  u otros que cuenten con Certificaciones seg\u00fan las Normas ISO 13485. Traducido al idioma Espa\u00f1ol.\n\nEn relaci\u00f3n a esta solicitud y considerando que en el mercado existen indistintamente registros sanitarios emitidos por la DNVS como dispositivos m\u00e9dicos y especialidades farmac\u00e9uticas, se solicita a la Convocante establecer el criterio de evaluaci\u00f3n teniendo en cuenta el tipo de registro emitido para cada caso, a fin de no limitar la participaci\u00f3n de potenciales oferentes y obtener mejores ofertas.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:17:43-04:00"}, {"id": "2a55090ccd46ce5eba1d40171d37d54f", "date": "2022-10-12T17:21:45-04:00", "title": "ABASTECIMIENTO SIMULTANEO +", "description": "Con relaci\u00f3n a lo establecido en el P.B.C. p\u00e1gina 5 que reza:\nAbastecimiento simult\u00e1neo\nEl sistema de abastecimiento simult\u00e1neo para esta licitaci\u00f3n ser\u00e1:\nSer\u00e1 por \u00cdTEM y ser\u00e1 utilizada la Modalidad de Contrato Abierto por Cantidades M\u00ednimas y Cantidades M\u00e1ximas o por Monto M\u00ednimo y Monto M\u00e1ximo de la siguiente manera:\na. La adjudicaci\u00f3n recaer\u00e1 como m\u00e1ximo en las 3 (tres) mejores ofertas. La adjudicaci\u00f3n se distribuir\u00e1 de la siguiente forma: 50% para la oferta mejor calificada, 30% para la segunda mejor oferta calificada y 20% para la tercera mejor oferta calificada; quienes acepten adecuar su precio al de la oferta evaluada como la m\u00e1s baja.\nb. En caso de que exista 2 (dos) ofertas: La adjudicaci\u00f3n se distribuir\u00e1 de la siguiente forma: 60% para la oferta mejor calificada y 40% para la segunda mejor oferta calificada; quien deber\u00e1 aceptar adecuar su precio al de la oferta evaluada como la m\u00e1s baja.\nc. En caso de que exista 1 (una) sola oferta, y \u00e9sta cumpla con todos los requisitos establecidos en el pliego de bases y condiciones del presente llamado, oferte por la cantidad m\u00e1xima de todos los \u00edtems y tenga la capacidad para ejecutar el contrato, la Convocante podr\u00e1 adjudicar a dicha oferta por la totalidad de lo ofertado.\nLa cantidad m\u00ednima corresponde al 50% (cincuenta por ciento), de la cantidad m\u00e1xima adjudicada en cada caso.\nAsimismo a fines aclaratorios se hace constar que el valor de las cantidades m\u00e1ximas se\u00f1aladas es nominal y que el compromiso en obligaci\u00f3n de pago por parte de la convocante ser\u00e1 exclusivamente partiendo de las cantidades m\u00ednimas y las cantidades efectivamente entregadas. En consecuencia el oferente adjudicatario no podr\u00e1 obligar ni reclamar a la convocante la ejecuci\u00f3n total del monto nominal, para cuyo caso la convocante podr\u00e1 solicitar la liquidaci\u00f3n del contrato.\nLa aplicaci\u00f3n del margen de preferencia se realizar\u00e1 a los efectos de la distribuci\u00f3n de la proporci\u00f3n de adjudicaci\u00f3n conforme a lo establecido en la Circular DNCP N\u00b0 11/2019.-\nFavor solicitamos a la convocante ACLARAR si EL SISTEMA DE ADJUDICACI\u00d3N efectivamente ser\u00e1 en abastecimiento simult\u00e1neo para todos los \u00edtems.", "answer": "SE ACLARA QUE LA ADJUDICACION SERA POR ABASTECIMIENTO SIMULTANEO, EN CADA LOTE PODRAN SER ADJUDICADOS HASTA 3 ITEMS (el de menor precio y que cumpla con todas las especificaciones t\u00e9cnicas y documentaciones solicitadas en el PBC).", "dateAnswered": "2023-01-16T08:04:28-04:00"}, {"id": "81b540c3095a4da3992cf3a0de1212a7", "date": "2022-10-17T09:32:59-04:00", "title": "PBC DE EETT", "description": "Solicitamos a la conovcante corregir el escaneado del PBC en las Especificaciones tecnicas de los productos solicitados porque NO SE VISUALIZAN CORRECTAMENTE.", "answer": "El oferente deber\u00e1 remitirse al Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:18:45-04:00"}, {"id": "d1b1ed662b014a3df5865c5cd43ebded", "date": "2022-10-17T08:33:40-04:00", "title": "CAPACIDAD TECNICA - REQUISITO DOCUMENTAL", "description": "En el PBC, para el \u00edtem de HIALURONATO DE SODIO /ACIDO HIALURONICO 25/20 mg INYECTABLE .JERINGA PRELLENADA\n\nSe solicita la siguiente documentaci\u00f3n:\n\nCopia autenticada de Certificaci\u00f3n emitido por algunas de las agencias Reguladoras de Referencia Regional (NIVEL IV) Reconocidas por la Organizaci\u00f3n Panamericana de la Salud (OPS), como ANVISA de Brasil, ANMAT de Argentina, INVIMA de Colombia, CECMED de Cuba , COFEPRIS DE MEXICO; FDA y/o EMA  u otros que cuenten con Certificaciones seg\u00fan las Normas ISO 13485. Traducido al idioma Espa\u00f1ol. \n\nAl respecto,  se solicita considerar que el producto en cuesti\u00f3n, conforme a registros sanitarios emitidos por la DNVS corresponden a Especialidades farmac\u00e9uticas, no as\u00ed a un dispositivo medico. Por lo que se solicita establecer claramente los requisitos de cumplimiento como una especialidad farmac\u00e9utica, requiriendo para el mismo la presentaci\u00f3n del GMP y/o CLV del producto emitido por algunas de las agencias Reguladoras de Referencia Regional (NIVEL IV) Reconocidas por la Organizaci\u00f3n Panamericana de la Salud (OPS), como ANVISA de Brasil, ANMAT de Argentina,  INVIMA de Colombia, CECMED de Cuba , COFEPRIS DE MEXICO; FDA y/o EMA .", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:17:34-04:00"}, {"id": "159ba3f71987d49ac21637dc2a502215", "date": "2022-10-11T10:22:58-04:00", "title": "Precio Referencial LOTE N\u00b0 4", "description": "Solicitamos respetuosamente a la convocante revisar el precio referencial del LOTE N\u00b0 4, ya que el mismo se encuentra muy por debajo del precio real del mercado, e incluso muy por debajo del precio referencial en llamados anteriores. Por lo cual limita la posibilidad de presentar ofertas y competir por un precio razonable.", "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP", "dateAnswered": "2023-01-13T13:20:05-04:00"}, {"id": "afa4184afbf947b30309129fd3ce4a3a", "date": "2022-10-14T13:45:35-04:00", "title": "EXPERIENCIA REQUERIDA%", "description": "En el apartado Requisitos para validar la Experiencia, se menciona cuanto sigue:\nCertificado de Buenas Practicas (TRADUCIDO EN IDIOMA ESPA\u00d1OL)\nb. En el caso de que el Oferente no sea el fabricante del Producto ofertado, deber\u00e1 presentar: Copia autenticada del Certificado de Buenas Pr\u00e1cticas de Almacenamiento, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), adem\u00e1s del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n del Fabricante del producto ofertado, los  cuales deber\u00e1n mantener su vigencia durante toda la duraci\u00f3n del contrato.\nCon respecto al apartado donde dice: adem\u00e1s del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n 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. 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 (TRADUCIDO EN IDIOMA ESPA\u00d1OL)\nb. En el caso de que el Oferente no sea el fabricante del Producto ofertado, deber\u00e1 presentar: Copia autenticada del Certificado de Buenas Pr\u00e1cticas de Almacenamiento, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), adem\u00e1s del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n del Fabricante o Licencia/Certificado de Fabricaci\u00f3n del producto ofertado, los  cuales deber\u00e1n mantener su vigencia durante toda la duraci\u00f3n del contrato.", "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:16:00-04:00"}, {"id": "66f5e848c8dccc27456b950f32e2f3fd", "date": "2022-10-17T09:47:27-04:00", "title": "Experiencia Requerida", "description": "Solicitamos a la convocante considerar facturaciones y/o contratos para demostrar experiencia en los a\u00f1os 2017 - 2018-2019-2020-2021", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico", "dateAnswered": "2023-01-16T08:19:09-04:00"}, {"id": "6dd72303fd5c8e94a80e4d616342a952", "date": "2022-10-11T10:23:13-04:00", "title": "Precio Referencial LOTE N\u00b0 15", "description": "Solicitamos respetuosamente a la convocante revisar el precio referencial del LOTE N\u00b0 15, ya que el mismo se encuentra muy por debajo del precio real del mercado, e incluso muy por debajo del precio referencial en llamados anteriores. Por lo cual limita la posibilidad de presentar ofertas y competir por un precio razonable.", "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP", "dateAnswered": "2023-01-13T14:15:28-04:00"}, {"id": "02aa035f95620292adc525adcd8cc501", "date": "2022-10-14T16:46:59-04:00", "title": "PLAN DE ENTREGA CANTIDAD MAXIMA", "description": "El PBC solicita - plazo ser\u00e1 de hasta 20 (veinte) 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. Solicitamos a la Convocante aumentar el plazo a por los menos 30 d\u00edas calendarios, teniendo en cuenta el plazo del proceso de fabricaci\u00f3n de los bienes.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico", "dateAnswered": "2023-01-16T08:17:25-04:00"}, {"id": "5c69e196caf169646701e88f92578ef7", "date": "2022-10-14T09:28:24-04:00", "title": "ESPECIFICACIONES TECNICAS - LOTE 1 - ITEM 2", "description": "El PBC Solicita Acido Acetil Salic\u00edlico de 125 MG en forma farmac\u00e9utica comprimido microc\u00e1psula. Solicitamos a a la Convocante eliminar la exigencia de \"microc\u00e1psula\", y dejar la forma farmac\u00e9utica en comprimido, ya que con dicho requisito se encuentra limitando la participaci\u00f3n, y por ende en virtud a los principios consagrados en la Ley de Contrataciones Publicas, y a fin de brindar mayor oportunidad de participaci\u00f3n a los oferentes, realizamos la presente solicitud.", "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n.", "dateAnswered": "2023-01-16T08:15:04-04:00"}, {"id": "0788e002f8734234b5319759f543ba04", "date": "2022-10-12T17:35:34-04:00", "title": "**CAPACIDAD T\u00c9CNICA \u2013 FILGRASTIM", "description": "Con relaci\u00f3n a lo establecido en el P.B.C.  En cuanto al producto FILGRASTIM (p\u00e1gina 18)\nLa convocante solicita: la presentaci\u00f3n de: e. Solo para factores de crecimiento de colonias (filgrastim): Los biosimilares deber\u00e1n presentar estudios de inmunogenicidad comparables al biol\u00f3gico innovador de referencia.\n\nAl respecto, es importante recordar al IPS que el producto filgrastim es un medicamento biol\u00f3gico de primera generaci\u00f3n.\n\nRespecto a los medicamentos biol\u00f3gicos sean estos innovadores o biosimilares de primera generaci\u00f3n, la DINAVISA (seg\u00fan Decreto N\u00ba 6611/16 Por el cual se reglamenta el Art\u00edculo 24 de la Ley N\u00b0 1119/1997, \u201cDe Productos para la Salud y otros\u201d, y se establecen los Requisitos para el Registro de Medicamentos Biol\u00f3gicos.)\u201d Entre sus requisitos establece textualmente la presentaci\u00f3n de: Estudios de eficacia, seguridad e inmunogenicidad, sin que estos deban ser comparables con el innovador de referencia.\nPor lo tanto, al realizar un comparativo del requerimiento establecido en el 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 biol\u00f3gicos 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:\n1.1. Para productos biol\u00f3gicos de 1ra. Generaci\u00f3n: Filgrastim\ne. Solo para factores de crecimiento de colonias (filgrastim): Los biosimilares deber\u00e1n presentar estudios de inmunogenicidad.", "answer": "Estudios de eficacia, seguridad comparables con el innovador de referencia. (es la \u00fanica manera de demostrar la eficacia y seguridad de un biol\u00f3gico compar\u00e1ndolo con el innovador de referencia ). Y por supuesto de la inmunogenicidad.\nEl oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico.\n", "dateAnswered": "2023-01-16T08:09:59-04:00"}, {"id": "594bb72030097c80ef90bc8da218910e", "date": "2022-10-17T09:21:29-04:00", "title": "Experiencia Requerida", "description": "La convocante expresa: 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\nigualmente 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 a respaldar sera sobre el 25% del item ofertado en el que el oferente no es el fabricante/titular y no sobre el total de la oferta.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico Ultima Versi\u00f3n", "dateAnswered": "2023-01-16T08:18:18-04:00"}, {"id": "7c8c4a11fd7268fc1a454a20185f09f7", "date": "2022-10-06T16:08:18-04:00", "title": "LOTE 17", "description": "Solicitamos a la convocante revisar el precio referencial del lote en cuesti\u00f3n, ya que el mismo se encuentra muy por debajo del precio real del mercado, e incluso muy por debajo del precio referencial de llamados anteriores. Por lo cual limita la posibilidad de recibir ofertas y permitir una competencia libre y justa entre potenciales oferentes.", "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en los Datos Cargados en el SICP", "dateAnswered": "2023-01-13T13:12:05-04:00"}, {"id": "6d07478c6d873189952058f5cd05cf82", "date": "2022-10-14T11:36:19-04:00", "title": "EXPERIENCIA REQUERIDA", "description": "Solicitamos a la convocante ampliar los a\u00f1os de facturaciones y/o contratos para demostrar -experiencia requerida en promedio de 2018-2019-2020-2021.", "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego Electr\u00f3nico", "dateAnswered": "2023-01-16T08:15:34-04:00"}, {"id": "a370d655975e1cdb627b84a6f17ddb83", "date": "2022-10-17T09:52:39-04:00", "title": "COTIZACI\u00d3N", "description": "Favor aclarar si se puede cotizar m\u00e1s de un \u00edtem en cada Lote. Esto ayudar\u00eda a la entidad a recibir mejores ofertas para cada Lote solicitado,.", "answer": "Se aclara al oferente que si se puede cotizar m\u00e1s de un \u00cdtem en cada Lote.", "dateAnswered": "2023-01-16T08:19:28-04:00"}, {"id": "7375759dea5eb45b80f03404a7fa222e", "date": "2022-10-12T17:29:25-04:00", "title": "**CAPACIDAD T\u00c9CNICA \u2013 ACIDO ZOLEDR\u00d3NICO", "description": "Con relaci\u00f3n a lo solicitado por la convocante (p\u00e1g. 18:\n1.2. Para f\u00e1rmacos como: Ac. Zoledr\u00f3nico.\nRegistro y/o Certificado del producto ofertado, emitido por una Autoridad Sanitaria Reguladora de Alta Vigilancia como:\na. FDA o EMA.\nb. O los indicados de alta vigilancia en el Art 11 de la Ley 3283/2007.\nc. O Pa\u00edses certificados por 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\nCon relaci\u00f3n al producto solicitado, creemos conveniente recordar al IPS que el mismo corresponde a un producto clasificado como \u201csint\u00e9tico\u201d\nRespecto a los medicamentos sint\u00e9ticos, DINAVISA (seg\u00fan Ley N\u00b0 1119/97 \u201cDe productos para la salud y otros\u201d 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: \u201cGMP/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)  \u201co\u201d 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)  \u2013 Consularizado y Legalizado o Apostillado\u201d. \nSeguidamente, al realizar un comparativo del requerimiento establecido en el punto 1.2 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:\n1.2. Para f\u00e1rmacos como: Ac. Zoledr\u00f3nico.\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. 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