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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, adem\u00e1s, como referencia citamos procesos licitatorios del IPS en donde se ha procedido a modificar este requisito (LPN N\u00ba 32/22, LPN N\u00ba 104/22, LPN N\u00ba 96/22 y LPN N\u00ba 99/22)\nPor todo esto, SOLICITAMOS A LA CONVOCANTE LA AMPLIACI\u00d3N DE DICHO REQUISITO DE LA SIGUIENTE MANERA: Certificado de Buenas Pr\u00e1cticas: - En el caso de que el Oferente no sea el fabricante del Producto ofertado, deber\u00e1 presentar: Certificado de Buenas Pr\u00e1cticas de Almacenamiento, del oferente, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) del Ministerio de Salud P\u00fablica y Bienestar Social, adem\u00e1s del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n del Fabricante o Licencia/Certificado de Fabricaci\u00f3n del fabricante 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 la Adenda N\u00b0 1.", "dateAnswered": "2025-05-27T09:58:39-04:00"}, {"id": "2a3f2a3e62a537891b9d732acf536cd1-1", "date": "2025-05-12T09:38:36-04:00", "title": "CAPACIDAD TECNICA INCISO J. PARA MEDICAMENTOS ONCOLOGICOS PUNTO B", "description": "El PBC cita cuanto sigue: b) Copia autenticada del Registro o Certificado del producto ofertado, emitido por alguna de las Agencias Reguladoras de medicamentos de un pa\u00eds de referencia, EMA, FDA, Health Canad\u00e1, del MERCOSUR o seg\u00fan Ley 3.283/07 y sus modificaciones y ampliaciones (Resoluci\u00f3n DINAVISA N\u00b0148/2024).\nSolicitamos a la convocante a incluir para los casos de productos importados LINK WEB oficial donde se puede acreditar que el fabricante cuenta con Buenas Pr\u00e1cticas de Fabricaci\u00f3n vigente o Certificado de Registro sanitario vigente en alguno de los pa\u00edses indicados como de alta vigilancia, es m\u00e1s que suficiente para dar por cumplido con el requisito, ya que entendemos que la convocante busca asegurar que los productos ofertados importados cumplen con las garant\u00edas de calidad, seguridad y eficacia.", "answer": "Se aclara que lo solicitado es el \u00b4\u00b4registro 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