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ITEM 6, ITEM 7", "description": "En la ultima versi\u00f3n del PBC, publicada en fecha 23 de junio de 2025, fueron modificados los \u201cSuministros Requeridos\u201d pasando a solicitarse 2 \u00edtems distintos para lo que inicialmente era el Item N\u00ba 3. La particularidad de esta modificaci\u00f3n radica en el hecho de que, aparte de anteriormente ser un solo item y ahora 2, es que dicho producto es requerido en presentaciones de entrega distintas: ampolla (item 6), vial (item 7). Esta cuesti\u00f3n, traer\u00e1 aparejados varios inconvenientes al momento de evaluar las ofertas ya que en la misma adenda se incluyo la siguiente observaci\u00f3n: \u201cpara los \u00edtems 06 y 07 se adjudicar\u00e1 solo uno, el que resulte mas conveniente al MSPBS teniendo en cuenta precio y cumplimiento de especificaciones t\u00e9cnicas.\u201d, la cual es total y completamente inaplicable atendiendo a que, bien podr\u00eda darse el caso de que para un item haya productos de origen nacional (con el certificado correspondiente) y para el otro no, como as\u00ed tambi\u00e9n debido al hecho de que ambos tienen precios referenciales distintos, y tambi\u00e9n el hecho de que este llamado preve la posibilidad de abastecimiento simultaneo. Solicitamos que estos dos items sean unificados en uno solo, previendo la posibilidad de ofertas en cualquiera de las dos presentaciones.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2025-07-10T09:23:39-04:00"}, {"id": "0b9e651af12efe897fe2c6e54034d873-1", "date": "2025-06-26T11:46:03-04:00", "title": "SUMINISTROS Y ESPECIFICACIONES T\u00c9CNICAS \u2013 DEXAMETASONA INY, ITEM 6, ITEM 7", "description": "Se solicita a la convocante aclarar: que procedimiento utilizar\u00e1 para distribuir el abastecimiento simult\u00e1neo siendo que se estar\u00e1n ofertando \u00edtems distintos pero solo uno se adjudicar\u00e1.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2025-07-10T09:24:15-04:00"}, {"id": "d3a9a4293cf8451069b33e5ee948f48f-1", "date": "2025-04-16T11:35:52-04:00", "title": "Especificaciones t\u00e9cnicas", "description": "Item 3 - DEXAMETAZONA \t4 MG/ML\tINYECTABLE\tAMPOLLA X 2 ML. La convocante solo se limita a responder \"AJUSTARSE AL PLIEGO\" al pedido de ampliaci\u00f3n de presentaci\u00f3n sin existir un argumento t\u00e9cnico indispensable para establecer este requisito limitando la participaci\u00f3n y violando el principio de igualdad y libre competencia. Se solicita a la convocante reconsiderar su postura y ampliar la presentaci\u00f3n solicitada a Ampolla/Fco Ampolla/Vial", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2025-06-24T08:32:02-04:00"}, {"id": "8fd66465252c63b88179fe942a094cfb-1", "date": "2025-04-03T10:53:41-04:00", "title": "Muestras", "description": "La convocante expresa: Para medicamentos, las muestras deber\u00e1n cumplir con los requisitos de etiquetado establecidos en la Norma MERCOSUR/GMC/RES N\u00b0 23/95. Solicitamos a la convocante actualizar y establecer como normativa el Decreto N\u00b0 2479-2024, que reglamenta y establecen los requisitos para la emisi\u00f3n y renovaci\u00f3n del registro sanitario de medicamentos.", "answer": "Ajustarse al Pliego de Bases y Condiciones. Se informa que la Norma MERCOSUR/GMC/RES N\u00b0 23/95 contin\u00faa vigente y de aplicaci\u00f3n obligatoria para los Estados Parte del MERCOSUR, incluyendo la Rep\u00fablica del Paraguay, en lo que respecta a los requisitos de etiquetado de medicamentos para su comercializaci\u00f3n y control sanitario.\nPor su parte, el Decreto N\u00b0 2479/2024 complementa dicha normativa en el \u00e1mbito nacional, reglamentando los requisitos para la emisi\u00f3n y renovaci\u00f3n del registro sanitario ante la autoridad competente (DINAVISA).\nEn ese sentido, ambas normativas son complementarias y no excluyentes, por lo que se mantienen como referencia en el proceso licitatorio. \n", "dateAnswered": "2025-04-14T14:00:02-04:00"}, {"id": "bc645678fe7e80bf6fe480e4d11da523-1", "date": "2025-06-26T11:45:54-04:00", "title": "SUMINISTROS Y ESPECIFICACIONES T\u00c9CNICAS \u2013 DEXAMETASONA INY, ITEM 6, ITEM 7", "description": "Se solicita a la convoncate aclarar: que procedimiento utilizar\u00e1 para aplicar el margen de preferencia nacional sobre los importados en el caso de que un oferente nacional oferte el item 6 y un importado oferte el item 7, siendo que la convocante expresa: \u201cObservaci\u00f3n: para los \u00edtems 06 y 07 se adjudicar\u00e1 solo uno, el que resulte m\u00e1s conveniente al MSPBS teniendo en cuenta precio y cumplimiento de especificaciones t\u00e9cnicas.\u201d", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2025-07-10T09:24:01-04:00"}, {"id": "7c1b584ef55761e48479e37b87885b86-1", "date": "2025-04-02T17:24:55-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica.", "description": "En el punto de referencia la Convocante requiere lo siguiente: \"Copia Legalizada y consularizada y/o apostillada del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n vigente, emitido por la Agencia Reguladora de Medicamentos correspondiente al pa\u00eds de origen.\" Al respecto, se solicita a la Convocante establecer que en caso que el pa\u00eds de origen no sea un pa\u00eds del Listado emitido por DNVS en la Res. DNVS 148/2024, adem\u00e1s del documento emitido en origen deber\u00e1 incluir un Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n vigente de uno de los pa\u00edses detallados en la normativa mencionado. A fin de dar fiel cumplimiento a lo dispuesto en la Ley N\u00b07256/2024,", "answer": "Ajustarse al Pliego de Bases y Condiciones. ", "dateAnswered": "2025-04-14T13:44:50-04:00"}, {"id": "8f1070b1894458cf8a27a1f0e41ec9b9-1", "date": "2025-04-03T10:53:54-04:00", "title": "MUESTRAS", "description": "En el inciso b) de Muestras la Convocante establece lo siguiente: \"An\u00e1lisis de la muestra: La comisi\u00f3n evaluadora se reserva el derecho de solicitar m\u00e1s muestras de aquellos \u00edtems que sean necesarios para realizar pruebas de calidad en el Centro Multidisciplinario de Investigaciones Tecnol\u00f3gicas de la UNA (CEMIT- UNA) u otra instituci\u00f3n que la convocante considere pertinente. Los productos ser\u00e1n muestreados por el personal t\u00e9cnico del laboratorio que realizara los controles de calidad en presencia de Personal del MSPBS. Debe labrarse acta del procedimiento.\" Y en el \u00faltimo p\u00e1rrafo del mismo punto establecen cuanto sigue: \"La comisi\u00f3n evaluadora se reserva el derecho de solicitar m\u00e1s muestras de aquellos \u00edtems que sean necesarios para realizar pruebas de calidad en el Centro Multidisciplinario de Investigaciones Tecnol\u00f3gicas de la UNA (CEMIT- UNA) u otra instituci\u00f3n que la convocante considere pertinente.\". Al respecto, solicitamos a la Convocante establecer claramente cuales son las pruebas de calidad (an\u00e1lisis / determinaciones, etc.) que se realizar\u00e1n a los productos a ser analizados por el CEMIT-UNA u otro laboratorio que la Convocante considere pertinente. Recordamos que los criterios de evaluaci\u00f3n deben ser establecidos de forma clara, objetiva e imparcial, a fin de evitar favorecer indebidamente a alg\u00fan oferente en detrimento de otro. Adem\u00e1s, es necesario considerar que cada lote de un producto farmac\u00e9utico se somete a controles de calidad conforme a la farmacopea utilizada por cada fabricante. Por tanto, se debe considerar este documento para evaluar los an\u00e1lisis u otras determinaciones que requieran para cada producto en particular.\tFavor establecer especificamente cuales son las pruebas de calidad a realizar a cada producto y que resultados ser\u00edan suficientes en base a normativa/farmacopea de referencia para considerar que se han logrado los controles de calidad especificos.", "answer": "Ya se dio respuesta en la Consulta 04.-", "dateAnswered": "2025-04-14T15:42:33-04:00"}, {"id": "f06589e9c57d27694f96e96e97084c0a-1", "date": "2025-04-03T10:31:35-04:00", "title": "Muestras", "description": "La convocante solicita: Para inyectables de peque\u00f1o volumen ser\u00e1n verificados:\nRegistro Sanitario, la presentaci\u00f3n, marca, lote, vencimiento, y fabricante, los cuales deber\u00e1n estar impresos en el embalaje primario. --- Lo solicitado es de imposible cumplimiento para ampollas de 2 a 4 mL, afectando directamente a los \u00edtems 1, 3 y 5", "answer": "Ajustarse a lo establecido en el Pliego de Bases y Condiciones. Los medicamentos deber\u00e1n cumplir con los requisitos de etiquetado establecidos en la Norma MERCOSUR/GMC/RES N\u00b0 23/95.", "dateAnswered": "2025-04-14T13:57:48-04:00"}, {"id": "53abee01c374e7f500a977efac4bbd38-1", "date": "2025-06-26T11:57:07-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "En el apartado de ABASTECIMIENTO SIMULTANEO dice: \u201cLa convocante adjudicar\u00e1 el Contrato bajo el Sistema de Abastecimiento Simult\u00e1neo, por cada ITEM a los oferentes. --- Solicitamos a la entidad explicar como aplicar\u00e1 el abastecimiento simult\u00e1neo de la cotizaci\u00f3n de dos \u00edtems ofertados (Item 6 y 7) y su correspondiente margen de preferencia por producci\u00f3n nacional si la entidad pretende adjudicar solo uno de ellos pero recibiendo ofertas en ambos \u00edtems", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2025-07-10T09:24:38-04:00"}, {"id": "86d9c8e1b089739b266c1c2401dbe16d-1", "date": "2025-04-03T11:21:10-04:00", "title": "MUESTRAS", "description": "En el inciso c) Revisi\u00f3n de antecedentes del punto detallado la Convocante establece cuanto sigue: \"La comisi\u00f3n evaluadora podr\u00e1 recabar informe t\u00e9cnico sobre la calidad y experiencia en el uso de las marcas de los productos ofertados, si existieren notas de reclamos referentes al inconveniente en el uso o calidad del medicamento debidamente justificada ser\u00e1 tenida en cuenta para su descalificaci\u00f3n en el \u00edtem.\" Solicitamos aclarar cuales serian los criterios para considerar que las notas de reclamos sobre inconvenientes en el uso o calidad del medicamento son debidamente justificadas para la descalificaci\u00f3n de una oferta para cada \u00edtem en particular. Reiteramos a la Convocante que la misma debe establecer criterios claros, objetivos e imparciales al momento de establecer criterios que descalifican a una oferta susceptible de adjudicaci\u00f3n para cualquier \u00edtem del proceso. Recordamos que existe un marco legal para inconvenientes en el uso y/o calidad de un producto y el organismo regulador de este tipo de cuestiones es la Direcci\u00f3n Nacional de Vigilancia Sanitaria, coordinada para este caso a trav\u00e9s de la Direcci\u00f3n de Vigilancia de Tecnolog\u00eda Sanitaria, conforme a la Res. DINAVISA N\u00ba 340/2024. Se solicita considerar la normativa vigente al momento de establecer criterios de esta \u00edndole en los pliegos de bases y condiciones.", "answer": "Se informa que, conforme al principio de objetividad que rige los procesos de contrataci\u00f3n p\u00fablica, toda observaci\u00f3n o reclamo que pudiera incidir en la evaluaci\u00f3n de las ofertas ser\u00e1 considerada \u00fanicamente si cuenta con respaldo documental verificable y debidamente justificado, ya sea a trav\u00e9s de informes t\u00e9cnicos emitidos por la autoridad sanitaria competente (DINAVISA), instituciones de salud p\u00fablica, o constancias oficiales de no conformidades registradas en procesos anteriores.\nAsimismo, se aclara que la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), en virtud de la Resoluci\u00f3n DINAVISA N\u00ba 340/2024, es el organismo nacional competente para la vigilancia postcomercializaci\u00f3n y control de calidad de los productos farmac\u00e9uticos. No obstante, en el contexto del presente llamado, la convocante se reserva la facultad de considerar antecedentes negativos debidamente documentados, siempre que se ajusten a los principios de legalidad, objetividad, transparencia y respeto al debido proceso, con el fin de resguardar el inter\u00e9s p\u00fablico y garantizar la adquisici\u00f3n de productos seguros y eficaces.\n", "dateAnswered": "2025-04-14T15:42:43-04:00"}, {"id": "ab3c8c801c18b998e27db0f9094d406e-1", "date": "2025-06-26T11:46:14-04:00", "title": "SUMINISTROS Y ESPECIFICACIONES T\u00c9CNICAS", "description": "Sugerimos a la entidad convocante unificar el Item 6 y 7 - Dexametasona Inyectable a 1 solo, permitiendo en el campo \u201cPRESENTACION DE ENTREGA\u201d cotizar AMPOLLA/VIAL. Esta medida facilitar\u00e1 la aplicaci\u00f3n del abastecimiento simult\u00e1neo de los m\u00e1rgenes de preferencias por producto y empleo nacional. En caso de que la entidad considere innecesaria dicha unificaci\u00f3n, recomendamos que se establezca de manera clara el procedimiento de evaluaci\u00f3n correspondiente, a fin de evitar, de forma involuntaria e innecesaria la restricci\u00f3n del derecho a la libre competencia.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2025-07-10T09:24:29-04:00"}, {"id": "fb031bbe9e8d15fb8e521fae2c674628-1", "date": "2025-03-28T12:37:38-04:00", "title": "EETT Item 3 DEXAMETASONA", "description": "Lo solicitado con respecto a la EETT, que se presta a confusi\u00f3n:\nItem 3. DEXAMETAZONA:\n\u2022\tConcentraci\u00f3n: 4 MG/ML \n\u2022\tPresentaci\u00f3n: AMPOLLA X 2 ML\nFavor aclarar con respecto a la presentaci\u00f3n solicitada del producto (Ampolla x 2mL), si \u00e9sta equivaldr\u00eda  a la concentraci\u00f3n de 8 mg/ampolla de 2 mL, puesto que en la EETT solicitan como 4mg/mL.", "answer": "S\u00ed, efectivamente una ampolla de 2 mL con concentraci\u00f3n de 4 mg/mL equivale a un contenido total de 8 mg/2 mL de dexametasona por ampolla.", "dateAnswered": "2025-04-14T13:42:17-04:00"}, {"id": "b3b36b37c292d328e87c712aff3d9595-1", "date": "2025-06-25T10:31:07-04:00", "title": "ESPECIFICACIONES TECNICAS ITEM N\u00ba 2", "description": "Solicitamos a la convocante modificar la presentaci\u00f3n del \u00edtem 2 de la siguiente manera: Envase de 100 ml con sistema cerrado. La petici\u00f3n debe a que al referirse a envase la misma da apertura de manera general de oferentes que cuenten con la presentaci\u00f3n de VIAL/FRASCO/SACHET y otros, cumpliendo con la Ley 7021/22 Art 4. Inciso D- Igualdad y Libre Competencia.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2025-07-10T09:21:58-04:00"}, {"id": "1fd3b4de0104be544525e35705447adf-1", "date": "2025-05-05T11:10:01-04:00", "title": "Plan de entrega", "description": "Solicitamos a la convocante aumentar 5 d\u00edas h\u00e1biles mas, el plazo de entrega propuesto en el PBC teniendo en cuenta la cantidad solicitada y el tiempo de elaboraci\u00f3n/importaci\u00f3n de los productos.", "answer": "Ajustarse al Pliego de Bases y Condiciones.-", "dateAnswered": "2025-06-24T08:36:01-04:00"}, {"id": "9fcec874f706370ba0544dc7d288ca0a-1", "date": "2025-06-25T10:09:23-04:00", "title": "EETT ITEM 2- CIPROFLOXACINA", "description": "Solicitamos a la convocante modificar las especificaciones t\u00e9cnicas en cuanto a la presentaci\u00f3n del \u00edtem 2- Ciprofloxacina de la sgte manera: Envase de 100 ml con sistema cerrado. \nEsto en vista que la convocante con las EETT solicitadas actualmente cierra la posibilidad de ofertar a 8 posibles oferentes el producto solicitado. Adem\u00e1s, en la versi\u00f3n 1 y versi\u00f3n 2 la misma convocante solicit\u00f3 ENVASE y resulta llamativo el cambio de las EETT en esta nueva versi\u00f3n, cuando que al referirse a envase la misma da apertura a una pluralidad de oferentes que cuenten con la presentaci\u00f3n de VIAL/FRASCO/SACHET y otros.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2025-07-10T09:21:28-04:00"}, {"id": "38c8d5bdaec60fad4c81ac690360b9f7-1", "date": "2025-07-10T11:46:16-04:00", "title": "Precios referenciales \u00edtems 6 y 7", "description": "Considerando la \"Metodolog\u00eda de evaluaci\u00f3n combinada\" que aplica para los \u00edtems 6 y 7 y contempla la comparaci\u00f3n de precios de ambos \u00edtems por igual, podr\u00eda por favor la convocante explicar el sentido de tener precios referenciales distintos para ambos \u00edtems? o si se trata solamente de un error, cu\u00e1l ser\u00e1 el precio unitario de referencia a considerar para la elaboraci\u00f3n de la oferta?", "answer": "Se aclara que para la confecci\u00f3n de los precios referenciales se ha procedido conforme a la normativa que regula dicha actividad. No obstante, como resultado del estudio se obtuvieron precios distintos. Es por ello que a los efectos de la comparaci\u00f3n de los precios ofertados se tendr\u00e1 en cuenta el precio referencial de cada \u00edtem ofertado, es decir, el comit\u00e9 comparar\u00e1 el precio ofertado para el \u00edtem 6 con el referencial del \u00edtem 6 y as\u00ed tambi\u00e9n con las ofertas para el \u00edtem 7. Vale mencionar que el comit\u00e9 cuenta con la facultad discrecional de aceptar los precios ofertados, siempre y cuando los mismos sean \"razonables\" y se encuentren debidamente justificados.\n\n\n", "dateAnswered": "2025-07-11T16:21:14-04:00"}, {"id": "996ae5b9e89dfa73f511fb8a499799a4-1", "date": "2025-04-16T11:43:40-04:00", "title": "Muestras", "description": "La convocante expresa lo siguiente: \"la convocante se reserva la facultad de considerar antecedentes negativos debidamente documentados,\": al respecto, solicitamos detallar y especificar cuales son los mecanismos y canales para que un \"antecedente negativo\" sea debidamente documentado.", "answer": "Ajustarse a lo establecido en la respuesta a la Consulta N.\u00ba 11. Se reitera que las documentaciones consideradas como antecedentes negativos debidamente documentados incluyen: informes t\u00e9cnicos emitidos por la autoridad sanitaria competente (DINAVISA), instituciones de salud p\u00fablica, as\u00ed como constancias oficiales de no conformidades debidamente registradas en procesos anteriores.", "dateAnswered": "2025-06-24T08:35:30-04:00"}, {"id": "436b3347f91b61a9f1e500af6ff187b8-1", "date": "2025-04-03T10:30:24-04:00", "title": "Especificaciones t\u00e9cnicas", "description": "Para el \u00edtem 3 - Dexametazona. Solicitamos a la convocante aceptar indistintamente la presentaci\u00f3n AMPOLLA/VIAL con el objeto de no limitar la participaci\u00f3n de forma innecesaria.", "answer": "Ajustarse al Pliego de Bases y Condiciones. ", "dateAnswered": "2025-04-14T13:45:06-04:00"}, {"id": "c5f2ebdb7af223e5781e7ece9de91ffb-1", "date": "2025-04-02T17:08:41-04:00", "title": "Muestras", "description": "En el inciso b) de Muestras la Convocante establece lo siguiente: \"An\u00e1lisis de la muestra: La comisi\u00f3n evaluadora se reserva el derecho de solicitar m\u00e1s muestras de aquellos \u00edtems que sean necesarios para realizar pruebas de calidad en el Centro Multidisciplinario de Investigaciones Tecnol\u00f3gicas de la UNA (CEMIT- UNA) u otra instituci\u00f3n que la convocante considere pertinente. Los productos ser\u00e1n muestreados por el personal t\u00e9cnico del laboratorio que realizara los controles de calidad en presencia de Personal del MSPBS. Debe labrarse acta del procedimiento.\" Al respecto, solicitamos a la Convocante establecer claramente cuales son las pruebas de calidad (an\u00e1lisis / determinaciones, etc.) que se realizar\u00e1n a los productos a ser analizados por el CEMIT-UNA u otro laboratorio que la Convocante considere pertinente. Recordamos que los criterios de evaluaci\u00f3n deben ser establecidos de forma clara, objetiva e imparcial, a fin de evitar favorecer indebidamente a alg\u00fan oferente en detrimento de otro. Sin  que cada lote de un producto farmac\u00e9utico se somete a controles de calidad conforme a la farmacopea utilizada por cada fabricante. Por tanto, se debe considerar este documento para evaluar los an\u00e1lisis u otras determinaciones que requieran para cada producto en particular.", "answer": "Se informa que las pruebas de calidad que realizar\u00e1 el CEMIT-UNA u otros laboratorios designados por la Convocante estar\u00e1n basadas en los m\u00e9todos establecidos en farmacopeas oficiales reconocidas (USP, BP, Ph.Eur, entre otras) o m\u00e9todos validados  del fabricante de origen y ajustadas a las caracter\u00edsticas espec\u00edficas de cada medicamento, conforme a su forma farmac\u00e9utica, composici\u00f3n y principio activo.\nLos an\u00e1lisis podr\u00e1n incluir, entre otros, los siguientes ensayos: identificaci\u00f3n del principio activo, determinaci\u00f3n de contenido, pH, aspecto, pruebas de esterilidad (si corresponde), uniformidad de contenido, entre otras determinaciones que resulten pertinentes seg\u00fan la normativa aplicable.\n", "dateAnswered": "2025-04-14T15:41:48-04:00"}, {"id": "62963b6bd6c4c578dff69aa3c493fd60-1", "date": "2025-05-05T11:14:47-04:00", "title": "Interes por mora", "description": "Solicitamos a la Convocante evaluar y unificar el porcentaje de multa, junto con la tasa de inter\u00e9s por mora por parte de la Contratante a la falta de pago al proveedor, es decir unificar el porcentaje a 0,01 para ambos requisitos, a fin de brindar una igualdad entre oferente y convocante.", "answer": "Ajustarse al PBC.-", "dateAnswered": "2025-06-24T08:37:26-04:00"}, {"id": "45893e03f3f301ba75e3faf301c4422b-1", "date": "2025-03-28T12:51:40-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "En el punto \u201cPara Productos importados sint\u00e9ticos: Adem\u00e1s del Registro Sanitario emitido por DINAVISA, se debe presentar copia Legalizada y consularizada y/o apostillada del Registro Sanitario o CLV o CPP vigente, emitido por la Agencia Reguladora de Medicamentos correspondiente al pa\u00eds de origen.\u201d Solicitamos amablemente a la Convocante exclusi\u00f3n de este requisito adicional justificando nuestra solicitud con los siguientes puntos:\n1.\tCumplimiento normativo: El Registro Sanitario emitido por DINAVISA ya garantiza que el producto ha sido evaluado y aprobado conforme a las normativas nacionales, lo cual asegura su calidad, seguridad y eficacia.\n2.\tNormativas internacionales: El registro por parte de la autoridad competente del pa\u00eds de origen, que cumple con est\u00e1ndares internacionales, tambi\u00e9n asegura que el producto ha pasado por rigurosos controles de calidad. Dado que DINAVISA ya valida el cumplimiento de normativas, entendemos que este paso adicional de legalizaci\u00f3n, consularizaci\u00f3n o apostilla podr\u00eda resultar redundante.\n3.\tFacilitaci\u00f3n de tr\u00e1mites: La eliminaci\u00f3n de esta exigencia permitir\u00eda agilizar los procedimientos administrativos, reduciendo tiempos y costos innecesarios para los importadores, sin comprometer la calidad ni seguridad del producto.", "answer": "Ajustarse al Pliego de Bases y Condiciones. Si bien la documentaci\u00f3n mencionada es presentada durante el tr\u00e1mite de registro sanitario ante DINAVISA, su validez y vigencia no necesariamente abarca los cinco a\u00f1os que puede durar dicho registro.\nPor tal motivo, se solicita la presentaci\u00f3n actualizada de dicha documentaci\u00f3n.\n", "dateAnswered": "2025-04-14T13:43:09-04:00"}, {"id": "bcb8a8c9ade9ab8ece59d5aeab2426c9-1", "date": "2025-04-02T17:24:47-04:00", "title": "Requisitos documentales para evaluar la capacidad t\u00e9cnica", "description": "En el punto de referencia la Convocante requiere lo siguiente: \"Adem\u00e1s del Registro Sanitario emitido por DINAVISA, se debe presentar copia Legalizada y consularizada y/o apostillada del Registro Sanitario o CLV o CPP vigente, emitido por la Agencia Reguladora de Medicamentos correspondiente al pa\u00eds de origen.\" Al respecto, se solicita a la Convocante establecer que en caso que el pa\u00eds de origen no sea un pa\u00eds del Listado emitido por DNVS en la Res. DNVS 148/2024, adem\u00e1s del documento emitido en origen deber\u00e1 incluir un registro sanitario o CLV o CPP vigente de uno de los pa\u00edses detallados en la normativa mencionado. A fin de dar fiel cumplimiento a lo dispuesto en la Ley N\u00b07256/2024.", "answer": "Ajustarse al Pliego de Bases y Condiciones. ", "dateAnswered": "2025-04-14T13:44:40-04:00"}, {"id": "ff12ea1834680b81c144102c3fdac246-1", "date": "2025-04-01T09:17:41-04:00", "title": "Plan de entrega", "description": "Solicitamos a la Convocante modificar el plazo de entrega teniendo en cuenta la cantidad solicitada en el presente llamado, quedando como sigue: 1 era Entrega de la cantidad m\u00ednima adjudicada: Hasta 20% de la cantidad m\u00ednima adjudicada: El proveedor tendr\u00e1 hasta los 60 (sesenta) d\u00edas corridos para la entrega contados a partir de la recepci\u00f3n de la orden de compra, emitida por la Direcci\u00f3n General de Gesti\u00f3n de Insumos Estrat\u00e9gicos En Salud, seg\u00fan necesidad y stock de los servicios dependientes del MSP y BS. 2da Entrega de la cantidad m\u00ednima adjudicada: Hasta 30% de la cantidad m\u00ednima adjudicada: El proveedor tendr\u00e1 hasta los 90 (noventa) d\u00edas corridos para la entrega contados a partir de la recepci\u00f3n de la orden de compra, emitida por la Direcci\u00f3n General de Gesti\u00f3n de Insumos Estrat\u00e9gicos En Salud, seg\u00fan necesidad y stock de los servicios dependientes del MSP y BS. Saldo de la cantidad minima: El proveedor tendr\u00e1 hasta los 120 (ciento veinte) d\u00edas corridos para la entrega contados a partir de la recepci\u00f3n de la orden de compra, emitida por la Direcci\u00f3n General de Gesti\u00f3n de Insumos Estrat\u00e9gicos En Salud, seg\u00fan necesidad y stock de los servicios dependientes del MSP y BS. Cantidad maxima: A ser fraccionadas seg\u00fan necesidad y stock de los servicios dependientes del MSP y BS. Las \u00f3rdenes de compra ser\u00e1n emitidas una vez emitida la totalidad de las cantidades m\u00ednimas, con plazos de entrega de hasta 120 (ciento veinte) d\u00edas corridos, contados a partir de la recepci\u00f3n de las \u00f3rdenes de compra emitida por la Direcci\u00f3n General de Gesti\u00f3n de Insumos Estrat\u00e9gicos en Salud.", "answer": "Ajustarse al Pliego de Bases y Condiciones. El plan de entrega es realizado en base a las necesidades del MSPBS. 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