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Sugerimos a la convocante modificar la redacci\u00f3n para evitar malos entendidos e inconvenientes a la hora de ofertar y evaluar dejando de la siguiente forma: \"Copia legalizada y consularizada y/o apostillada del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF) vigente, emitido por una agencia de alta vigilancia sanitaria reconocida por DINAVISA y/o agencias Regulatorias del MERCOSUR, vigente al momento de la apertura de oferta\"", "answer": "ADECUARSE A LA ADENDA Y AL PLIEGO DE BASES Y CONDICIONES ULTIMA VERSION ", "dateAnswered": "2025-10-03T15:45:51-04:00"}, {"id": "56d732b9c90822b68d05341f7608f931-1", "date": "2025-09-24T09:08:46-04:00", "title": "ESPECIFICAIONES T\u00c9CNICAS", "description": "En el ITEM 2 TOCILIZUMAB donde se indica la presentaci\u00f3n de entrega como \u201cINYECTOR\u201d, solicitamos aclarar si el requerimiento corresponde espec\u00edficamente est\u00e1 establecido de manera indistinta a ambas presentaciones.", "answer": "AJUSTARSE A LO DISPUESTO EN EL PLIEGO DE BASES Y CONDICIONES. EFECTIVAMENTE EL REQUERIMIENTO ESTA ESTABLECIDO DE MANERA INDISTINTA PARA AMBAS PRESENTACIONES. ", "dateAnswered": "2025-10-03T15:45:02-04:00"}, {"id": "eff561f23f8b4daa0a2766f884281b94-1", "date": "2025-09-24T09:51:12-04:00", "title": "MUESTRAS", "description": "Solicitamos excluir la presentaci\u00f3n de muestra por el alto costo del producto.\nDONDE DICE -Se requerir\u00e1 la presentaci\u00f3n de muestras. Se sugiere modificar de la siguiente manera: -NO se requerir\u00e1 la presentaci\u00f3n de muestras.", "answer": "AJUSTARSE AL PLIEGO DE BASES Y CONDICIONES ", "dateAnswered": "2025-10-03T15:49:55-04:00"}, {"id": "4b4540624752b1ccf35967003fa49107-1", "date": "2025-10-07T18:11:39-04:00", "title": "Capacidad T\u00e9cnica", "description": "Solicitamos amablemente modificar el siguiente inciso de la siguiente manera: Copia legalizada y consularizada y/o apostillada del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF) y/o CPP vigente, emitido por al menos dos agencias de alta o adecuada vigilancia sanitaria, que al momento de la expedici\u00f3n del registro sanitario haya sido considerada como tal por DINAVISA, o que actualmente figure en el listado anual oficial emitido por DINAVISA, la siguiente solicitud es a modo de dar mayor participaci\u00f3n a m\u00e1s oferentes.", "answer": "Ajustarse al Pliego de Bases y Condiciones. La exigencia de contar con Certificados de Buenas Pr\u00e1cticas de Fabricaci\u00f3n (BPF) emitidos por al menos dos agencias de alta o adecuada vigilancia sanitaria, que al momento de la expedici\u00f3n del registro sanitario haya sido considerada como tal por DINAVISA, o que actualmente figure en el listado anual oficial emitido por DINAVISA, responde a la naturaleza biol\u00f3gica y a la complejidad de los productos incluidos en el presente llamado, espec\u00edficamente Tocilizumab e Infliximab, ambos medicamentos biol\u00f3gicos de alta sensibilidad estructural y funcional.\nA diferencia de los productos de s\u00edntesis qu\u00edmica, los medicamentos biol\u00f3gicos se producen mediante sistemas celulares vivos, lo que conlleva variaciones inherentes entre lotes y una elevada dependencia del control del proceso de fabricaci\u00f3n. Cualquier desviaci\u00f3n en los par\u00e1metros productivos o en las condiciones ambientales puede impactar directamente en la estabilidad, pureza, inmunogenicidad y eficacia cl\u00ednica del producto final.\nPor ello, la verificaci\u00f3n de las Buenas Pr\u00e1cticas de Fabricaci\u00f3n por al menos dos agencias sanitarias tal como lo establece el PBC, constituye una medida de aseguramiento de calidad, ya que implica que la planta productora fue auditada bajo m\u00e1s de un marco regulatorio internacional exigente.\nDe esta forma, se garantiza que los sistemas de control de calidad, las condiciones ambientales y los procesos de validaci\u00f3n y trazabilidad se encuentren alineados con los est\u00e1ndares internacionales reconocidos. Esta verificaci\u00f3n reduce significativamente el riesgo de variaciones entre lotes o inconsistencias en la producci\u00f3n, aspecto cr\u00edtico trat\u00e1ndose de medicamentos biol\u00f3gicos.\nAsimismo, refuerza la seguridad y confiabilidad de los productos, especialmente teniendo en cuenta que est\u00e1n destinados a pacientes inmunocomprometidos o con enfermedades autoinmunes graves.\nEn este contexto, la solicitud de dos certificaciones de BPF busca asegurar un mayor grado de control y trazabilidad sobre los procesos de manufactura de estos medicamentos biol\u00f3gicos de alta complejidad, reduciendo los riesgos de variabilidad y garantizando la calidad, seguridad y eficacia del producto.\n", "dateAnswered": "2025-10-13T09:13:47-04:00"}, {"id": "a962c370c00b4754c8c4f7e290ccc14a-1", "date": "2025-09-24T11:21:29-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "\u2022\tPARA PRODUCTOS IMPORTADOS\nEn caso de que el titular del producto no sea el fabricante, se debe de presentar contrato/acuerdo de fabricaci\u00f3n vigente entre el FABRICANTE Y EL TITULAR del producto debidamente legalizado y consularizado o apostillado.-----\nSe solicita a la convocante aceptar contrato/acuerdo de fabricaci\u00f3n o en su defecto CPP o CLV en el que consten los terceros involucrados en la elaboraci\u00f3n del producto final. Es necesario resaltar que lo solicitado (contrato entre el fabricante y el titular) no es un requisito para el registro y comercializaci\u00f3n del producto ante el \u00f3rgano rector DINAVISA, seg\u00fan Resoluci\u00f3n DINAVISA N\u00b0 23/2024 Art. 4 Inc b) Listado de documentos requeridos, punto 8. \u201cDocumento en el cual conste la relaci\u00f3n con terceros involucrados en los procesos para la obtenci\u00f3n del producto final, desde el proceso de producci\u00f3n hasta el producto final, de darse la situaci\u00f3n.\u201d. De mantener este requisito, la entidad estar\u00eda limitando la participaci\u00f3n de potenciales oferentes, lo cual va en contra de los principios de libre concurrencia y competencia de las contrataciones p\u00fablicas.", "answer": "CORRESPONDE AJUSTARSE AL PLIEGO DE BASES Y CONDICIONES. CABE SE\u00d1ALAR QUE CONFORME A LO ESTABLECIDO EN LA RESOLUCION DINAVISA N\u00b0 233/24, ART 4 INC. B) PUNTO 9, ENTRE LOS DOCUMENTOS EXIGIDOS FIGURA \" LA PRESENTACION DEL CONTRATO DE REPRESENTACION O EN SU DEFECTO AL CONTRATO DE DISTRIBUCION O CONTRATO DE FABRICACION SEGUN CORRESPONDA.\" EN ESE SENTIDO, EL REQUISITO PREVISTO EN EL PLIEGO SE ENCUENTRA EN CONCORDANCIA CON LA NORMATIVA SANITARIA VIGENTE, RESULTANDO NECESARIO PARA RESPALDAR LA LEGALIDAD Y TRAZABILIDAD DEL PRODUCTO OFERTADO.  ", "dateAnswered": "2025-10-03T15:55:59-04:00"}, {"id": "5136c851701109f8d83439434ddd9219-1", "date": "2025-09-24T09:51:02-04:00", "title": "ESPECIFICAIONES T\u00c9CNICAS", "description": "En el ITEM 2 TOCILIZUMAB donde se indica la presentaci\u00f3n de entrega como \u201cINYECTOR\u201d, solicitamos modificar de la siguiente manera autoinyector y/o jeringa prellenada, esto a modo de dar mayor participaci\u00f3n a potenciales oferente.", "answer": "SE ACLARA QUE AL REFERIRNOS A INYECTOR EL T\u00c9RMINO COMPRENDE INDISTINTAMENTE A AUTOINYECTORES, JERINGAS PRELLENADAS, PLUMAS PRECARGADAS U OTRAS PRESENTACIONES EQUIVALENTES POR LO QUE NO RESULTA NECESARIO MODIFICAR LA REDACCION ESTABLECIDA EN EL PLIEGO DE BASES Y CONDICIONES ", "dateAnswered": "2025-10-03T15:48:42-04:00"}, {"id": "48f825043f0b85c9df284104e6ab1985-1", "date": "2025-09-23T17:52:48-04:00", "title": "Plan de entrega de los bienes", "description": "En relaci\u00f3n al Plan de Entrega de los Bienes solicitamos a la convocante que los plazos de entrega se computen como D\u00cdAS H\u00c1BILES.", "answer": "AJUSTARSE AL PLIEGO DE BASES Y CONDICIONES. EL PLAN DE ENTREGAS FUE ALABORADO EN BASE A LA NECESIDAD DEL PROGRAMA. 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