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SE REDUCE LA AGRESION HEPATICA EN PACIENTES POLIMEDICADOS COMO SON LOS PACIENTES ONCOLOGICOS. FAVOR AJUSTARSE AL PBC.\n", "dateAnswered": "2022-09-15T12:26:09-04:00"}, {"id": "1", "date": "2022-09-13T12:19:19-04:00", "title": "ITEM 1 - ABIRATERONA  500 MG COMPRIMIDOS", "description": "En relaci\u00f3n al \u00cdtem 1 - ABIRATERONA 500 MG COMPRIMIDOS solicitamos amablemente a la convocante si podr\u00eda modificar la concentraci\u00f3n solicitada  A LA DE 250 MG (CAJA X 120 COMPRIMIDOS)  ya que por la concentraci\u00f3n solicitada actualmente el n\u00famero de proveedores se reduce a 1 y  la mayor\u00eda de los proveedores que importan este producto disponen la concentraci\u00f3n 250 mg  . De esta manera se dar\u00eda mayores oportunidades a m\u00e1s oferentes que puedan ofertar el producto.", "author": {"name": "TASSOS SA", "id": "PY-RUC-80078413-8"}, "answer": "LA PRESENTACION SOLICITADA POR EL CUERPO MEDICO DEL MEDICAMENTO ABIRATERONA DE 500 MG PERMITE MAYOR ADHERENCIA AL TRATAMIENTO AL REDUCIR EL 50% DE COMPRIMIDOS  A SER INGERIDOS POR EL PACIENTE .\nSE REDUCE LA AGRESION HEPATICA EN PACIENTES POLIMEDICADOS COMO SON LOS PACIENTES ONCOLOGICOS.\nFAVOR AJUSTARSE AL PBC.", "dateAnswered": "2022-09-14T09:21:44-04:00"}, {"id": "4", "date": "2022-09-15T08:40:31-04:00", "title": "Capacidad tecnica", "description": "Para el punto g Certificados de buenas practicas de fabricacion o registro sanitario debidamente legalizada o apostillada vigente otorgado por las agencias reguladoras previstas en el art 11 de la ley 3.283, este requerimiento seria para productos importados favor especificar que lo requerido aplica para productos importados, en vista de que dicho requerimiento no aplica para productos de elaboracion nacional conforme a lo requerido por la agencia reguladora nacional", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "AJUSTARSE A LA ADENDA N\u00b0 1", "dateAnswered": "2022-09-19T13:44:38-04:00"}, {"id": "8", "date": "2022-10-05T18:05:08-04:00", "title": "Capacidad Tecnica y Requisito documental para evaluar la capacidad tecnica", "description": "A trav\u00e9s de este medio solicitamos establecer claramente los requisitos aplicables exclusivamente para productos importados y los aplicables a productos nacionales, considerando que en ambos puntos del PBC se establecen de forma distinta y repetitiva la presentaci\u00f3n de documentaciones sin la aclaraci\u00f3n respectiva. espec\u00edficamente en cuanto a los documentos referentes a certificados de buenas practicas y/o registros en el exterior. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "FAVOR AJUSTARSE AL PBC", "dateAnswered": "2022-10-06T11:57:11-04:00"}, {"id": "5", "date": "2022-09-15T08:46:04-04:00", "title": "capacidad tecnica", "description": "En capacidad tecnica, no contempla la posibilidad de la participacion para productos de origen nacional, por lo que solicitamos a la convocante realizar la aclaracion de requerimiento de documentos para productos importados y productos nacionales a fin de no limitar la participacion de oferentes", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "AJUSTARSE A LA ADENDA N\u00b0 1", "dateAnswered": "2022-09-19T13:44:46-04:00"}, {"id": "6", "date": "2022-09-15T08:49:58-04:00", "title": "capacidad tecnica", "description": "conforme a lo requerido en el PBC en el apartado de capacidad tecnica, solicitamos incluir el requerimiento de acta de precio del producto ofertado emitido por la agencia reguladora nacional tal como lo estipula la legislacion ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "AJUSTARSE A LA ADENDA N\u00b0 1", "dateAnswered": "2022-09-19T13:44:53-04:00"}, {"id": "3", "date": "2022-09-15T08:30:43-04:00", "title": "item 1", "description": "Para el item 1 Abiraterona 500 mg comprimidos solicitamos a la convocante ampliar o aceptar la presentacion de entrega de caja x 60 a caja x 30 a 60 compimidos, esta solicitud no afecta la concentracion requerida como asi tampoco la calidad seguridad y eficacia del mismo, por lo que solicitamos puedan acceder a lo solicitado a fin de ampliar la participacion de los potenciales oferentes", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "FAVOR AJUSTARSE AL PBC", "dateAnswered": "2022-09-15T13:47:48-04:00"}, {"id": "7", "date": "2022-10-05T18:01:04-04:00", "title": "Capacidad Tecnica", "description": "En el apartado mencionado, inciso m), ultimo parrafo la Convocante menciona: El producto ofertado deber\u00e1 estar registrado en:  FDA o EMA, o los pa\u00edses indicados de alta vigilancia seg\u00fan el Art\u00edculo 11 de la ley 3282/2007, o en Pa\u00edses certificados por la OPS como autoridades reguladoras de referencia regional (ANMAT, ANVISA,INVIMA,CEDMED,COFEPRIS,HEALTH CANADA). Adem\u00e1s, en el inciso n) del mismo requerimiento establecen: Los productos innovadores (Originales) solo deben presentar copia autenticada del Certificado de Libre Venta/CPP, emitido por una entidad regulatoria de referencia, FDA o EMA. Al respecto, solicitamos aclarar que dichos requerimientos son exclusivos para productos importados considerando lo detallado en el PBC en cuanto a productos de origen nacional. 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