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Inciso b) de las secciones detalladas la Convocante requiere lo siguiente: \nPARA MEDICAMENTOS BIOLOGICOS DE 2\u00b0 GENERACION, FARMACOS INHIBIDORES DE LA TIROSINA QUINASA Y TERAPIAS DIRIGIDAS A BLANCOS MOLECULARES, PROTEINAS RECOMBINANTES.\nPara f\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos moleculares: para el Imatinib (Cristal Beta), Nintedanib, palbociclib (inhibidor de ciclinas CK4 y CK6)\nb) El producto ofertado debe contar con Registro emitido por una de las Agencias Reguladoras de Referencias como: EMA, FDA, Health Canad\u00e1 o de Agencias de Referencias indicados en la LEY N\u00b0 7256/2024 de  PROTECCI\u00d3N DE LA INFORMACI\u00d3N NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMAC\u00c9UTICOS en su Art\u00edculo 1.- Modificase el Articulo 11 y ampliase la Ley N 3283/2007 \"DE PROTECCION DE LA INFORMACION NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMAC\u00c9UTICOS\", con antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os.  \nEn relaci\u00f3n al mencionado requisito solicitamos aclarar cuanto sigue: \u00bfEn qu\u00e9 disposici\u00f3n legal se basa la Convocante para establecer la obligatoriedad de presentar este tipo de documentaciones con una antig\u00fcedad especifica? Esto considerando que, conforme a la normativa vigente es funci\u00f3n de la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) establecer los requisitos y exigencias para la obtenci\u00f3n de un registro sanitario que garantiza a cualquier empresa que lo posea la libre comercializaci\u00f3n del producto en todo el territorio nacional. Por tanto, en caso de requerir la presentaci\u00f3n de este tipo de documentaci\u00f3n, solicitamos a la Convocante ce\u00f1irse obligatoriamente a lo dispuesto en la normativa vigente para este tipo de medicamentos, en este caso espec\u00edfico en la Res. DINAVISA N\u00ba 84/2021, requiriendo solamente la presentaci\u00f3n del documento sin ning\u00fan tipo de antig\u00fcedad requerida conforme se detalla en la normativa. 3. Finalmente, solicitamos a la Convocante establecer el listado de pa\u00edses conforme a lo dispuesto en la Resoluci\u00f3n DINAVISA N\u00ba 148/2024 \u201cPor la cual se emite el listado anual oficial de los pa\u00edses en cumplimiento al art\u00edculo 3\u00ba de la Ley 7256/2024\u201d. Ya que la Ley 7256/2024 no establece el listado de pa\u00edses, sino que designa a la DINAVISA como entidad encargada de emitir el listado anual oficial de pa\u00edses.", "answer": "El oferente deber\u00e1 ajustarse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:42:16-04:00"}, {"id": "3be5eeacb282a9294cdb7fba33cb8332-1", "date": "2024-08-27T14:31:41-04:00", "title": "Capacidad T\u00e9cnica", "description": "D\u00f3nde dice \u201cLos productos deber\u00e1n contar con Registro Sanitario Vigente, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), con antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os\u201d, solicitamos a la convocante eliminar el requisito de antig\u00fcedad \u201cde por lo menos 3 a\u00f1os del Registro Sanitario\u201d. Es sabido que una vez la Autoridad Sanitaria otorgue el Registro Sanitario, ya se tiene autorizaci\u00f3n para comercializar un producto, sin necesidad de tener antig\u00fcedad en el mercado. Esto para cumplir con los Principios de Igualdad y Libre Competencia.", "answer": "El oferente deber\u00e1 ajustarse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:39:24-04:00"}, {"id": "e94a6ea8fef7a09e11361c13026377b1-1", "date": "2024-08-30T08:28:43-04:00", "title": "CAPACIDAD TECNICA -  PUNTO 7 - INC D", "description": "El Pliego del presente llamado, en el t\u00edtulo CAPACIDAD T\u00c9CNICA - PUNTO 7 PARA MEDICAMENTOS BIOL\u00d3GICOS DE 2\u00b0 GENERACI\u00d3N, F\u00c1RMACOS INHIBIDORES DE LA TIROSINA QUINASA Y TERAPIAS DIRIGIDAS A BLANCOS MOLECULARES , PROTE\u00cdNAS RECOMBINANTES. Para f\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos moleculares: para el Imatinib (Cristal Beta), Nintedanib, palbociclib (inhibidor de ciclinas CK4 y CK6), ha establecido como requisito y condici\u00f3n el inc d que dice:\n\u201c d) Los productos deber\u00e1n contar con Registro Sanitario Vigente, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), con antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os\u201d\n\nEl complemento del requisito exigido en el inc d, l\u00e9ase \u201ccon antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os\u201d, se constituye en una lim\u00edtate para la participaci\u00f3n en igualdad de condiciones a los proveedores que tienen la solvencia t\u00e9cnica, econ\u00f3mica y legal para participar en el llamado y que han obtenido ante la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) los Registros Sanitario exigidos en un plazo menor al establecido. Establecer una antig\u00fcedad al requisito resulta una restricci\u00f3n para participar en el llamado. En virtud a los principios de Igualdad y libre competencia, solicitamos de la convocante proceda a la modificaci\u00f3n del requisito, suprimiendo el complemento \u201ccon antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os\u201d", "answer": "El oferente deber\u00e1 ajustarse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:40:52-04:00"}, {"id": "8b6b7a390fcb6638dbfa3a122f607ac2-1", "date": "2024-08-27T14:42:09-04:00", "title": "Capacidad T\u00e9cnica", "description": "En los requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica se establece el siguiente requisito: \u201cLos productos deber\u00e1n contar con Registro Sanitario Vigente, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), con antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os\u201d. Al respecto, solicitamos a la Convocante eliminar el criterio establecido considerando que conforme a las normativas aplicables, no existe ning\u00fan impedimento legal para la comercializaci\u00f3n de un producto en todo el territorio nacional siempre que esta haya obtenido el correspondiente registro sanitario emitido por la DNVS, el cual paso por los procesos de revisi\u00f3n, presentaci\u00f3n de documentaciones y dem\u00e1s criterios a trav\u00e9s de la autoridad reguladora nacional para su comercializaci\u00f3n en el pa\u00eds. Este requisito resulta sumamente limitativo y va en contra del principio de igualdad y libre competencia garantizados en la Ley 7021/22, y en contra del art. 6 de la Ley 1119/97 \u201cde productos para la salud y otros\u201d y el Art. 22 del Decreto 6611/16 por citar las normativas m\u00e1s relevantes.", "answer": "El oferente deber\u00e1 ajustarse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:39:36-04:00"}, {"id": "b1bf8b01332972e63751e6517abbe53d-1", "date": "2024-09-03T13:02:30-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Solicitamos a la Convocante establecer la utilizaci\u00f3n del abastecimiento simultaneo para todos los \u00edtems del proceso. Considerando que el sistema de abastecimiento simultaneo garantiza a la Convocante el abastecimiento de los productos por m\u00e1s de un proveedor, logrando de esta manera una atenci\u00f3n oportuna a los pacientes y otorgando una mayor oportunidad de competencia a todo potencial oferente que cumpla con las condiciones establecidas en el Pliego de Bases y Condiciones para la provisi\u00f3n de todos los productos requeridos.", "answer": "El oferente deber\u00e1 ajustar al Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:42:54-04:00"}, {"id": "77779c96d8ee75579fb2bdded98268bd-1", "date": "2024-09-04T15:05:40-04:00", "title": "ITEM 2", "description": "Solicitamos a la convocante analizar la posibilidad de establecer en el PBC la descripci\u00f3n del ITEM 2 IMATINIB CRISTAL BETA  a IMATINIB 100 MG COMPRIMIDOS, debido a que la actividad farmacol\u00f3gica del imatinib es la misma independientemente de su forma cristalina. Tanto el imatinib en su forma est\u00e1ndar como en la forma cristal beta inhiben la tirosina quinasa y son igualmente efectivos en el tratamiento de enfermedades como la leucemia mieloide cr\u00f3nica (LMC) y los tumores del estroma gastrointestinal (GIST). Por lo tanto, la especificaci\u00f3n de una forma cristalina particular no agrega valor terap\u00e9utico adicional", "answer": "El oferente deber\u00e1 ajustar al Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:43:28-04:00"}, {"id": "d905c59e4fa231c0d1439086c0c95502-1", "date": "2024-08-30T15:30:14-04:00", "title": "Capacidad T\u00e9cnica", "description": "Los productos deber\u00e1n contar con Registro Sanitario emitido por DNVS, con antelaci\u00f3n m\u00ednima de 3 a\u00f1os. \u00bfQu\u00e9 garant\u00eda brinda la antig\u00fcedad del fabricante? El cumplimiento se encuentra cubierto por los antecedentes del oferente y las p\u00f3lizas exigidas en el PBC. Llevando el ejemplo al absurdo, \u00bfpor qu\u00e9 no exigir experiencia de 3 a\u00f1os de todos los proveedores del fabricante?\nSolicitamos a la Convocante que EXCLUYA de los requisitos antig\u00fcedad del registro. Esta solicitud lo realizamos a fin de no limitar innecesariamente la concurrencia de potenciales oferentes que cuenten con los productos solicitados, privando a la Convocante de la posibilidad de acceder a mejores precios. Adem\u00e1s de mantenerse el requisito en tales condiciones se estar\u00e1 transgrediendo abiertamente los principios que rigen las compras p\u00fablicas:\nIGUALDAD Y LIBRE COMPETENCIA Y EFICIENCIA Y ECONOMIA.\u201d", "answer": "El oferente deber\u00e1 ajustarse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:41:08-04:00"}, {"id": "dfbfb92cae35bfea3d81562d4f27f9df-1", "date": "2024-10-28T09:54:10-04:00", "title": "ITEM 2. IMATINIB CRISTA BETA - CAPSULA (CRISTAL BETA)", "description": "Entendemos que para el \u00edtem de referencia se aceptara indistintamente comprimido / capsula, considerando que en forma farmac\u00e9utica se establecen ambas formas, en descripci\u00f3n se menciona \"capsula\" y en presentaci\u00f3n de entrega \"comprimido\", favor confirmar este entendimiento.", "answer": "El oferente deber\u00e1 ajustarse al Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-29T14:48:08-04:00"}, {"id": "11b8c7c130fc69435a73f389fb4d84d5-1", "date": "2024-09-04T18:01:44-04:00", "title": "CERTIFICADO DE BUENAS PRACTICAS- PARA PRODUCTOS IMPORTADOS", "description": "El PBC cita cuanto sigue: \u201cPara productos Importados: copia autenticada del Certificado de Buenas Practicas de Almacenamiento emitido a nombre del OFERENTE expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), adem\u00e1s de la copia autenticada del Certificado de Buenas Practicas de Fabricaci\u00f3n emitido por la Agencia Reguladora del Pa\u00eds de Origen a nombre del Fabricante del Producto Ofertado, dando cumplimiento a las Leyes vigentes LEY 7256/24 QUE MODIFICA EL ARTICULO 11\u00ba Y AMPLIA LA LEY N\u00ba 3283/2007 y RES. DINAVISA N\u00ba 148/2024 POR LA CUAL SE EMITE EL LISTADO ANUAL OFICIAL DE LOS PAISES EN CUMPLIMIENTO AL ART. 3 DE LA LEY N\u00ba 7256/24 y /o el Decreto N\u00ba17057/97 POR LA CUAL SE DISPONE LA VIGENCIA EN LA REPUBLICA DEL PARAGUAY DE LAS RESOLUCIONES ADOPTADAS POR EL GRUPO MERCADO COMUN DEL MERCOSUR , REFERENTES A REGLAMENTOS TECNICOS y/o Decreto N\u00ba6611 POR EL CUAL SE REGLAMENTA EL ART.24 DE LA LEY N\u00b0 1119/97, DE PRODUCTOS PARA LA SALUD Y OTROS , Y SE ESTABLECEN LOS REQUISTOS PARA PRODUCTOS BIOLOGICOS\u201d\nSolicitamos a la convocante 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 en alguno de los pa\u00edses indicados como de alta vigilancia en la LEY N\u00b0 7256/2024, teniendo en cuenta que hay pa\u00edses que no emiten el certificado como tal sino que ingresando a la p\u00e1gina oficial de la entidad emisora se podr\u00eda constatar el cumplimiento de las mismas, ya que entendemos que la convocante busca asegurar que los productos ofertados importados cumplen con las garant\u00edas de calidad, seguridad y eficacia, como ejemplo citamos a la FDA.", "answer": "El oferente deber\u00e1 ajustar al Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:43:46-04:00"}, {"id": "acc3efade0b268cf37c0839407f205f4-1", "date": "2024-08-27T17:16:15-04:00", "title": "Capacidad T\u00e9cnica", "description": "Favor modificar el siguiente requisito:\nb) El producto ofertado debe contar con Registro emitido por una de las Agencias Reguladoras de Referencias como: EMA, FDA, Health Canad\u00e1 o de Agencias de Referencias indicados en la LEY N\u00b0 7256/2024 de PROTECCI\u00d3N DE LA INFORMACI\u00d3N NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMAC\u00c9UTICOS en su Articulo 1.- Modificase el Articulo 11 y ampliase la Ley N 3283/2007 \"DE PROTECCION DE LA INFORMACION NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMAC\u00c9UTICOS\", con antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os.\nDe la siguiente manera:\nb) El producto ofertado debe contar copia Legalizada y consularizada y/o apostillada del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n vigente y/o Certificado de Registro Sanitario emitido por una de las Agencias Reguladoras de Referencias como: EMA, FDA, Health Canad\u00e1 o de Agencias de Referencias indicados en la LEY N\u00b0 7256/2024 de PROTECCI\u00d3N DE LA INFORMACI\u00d3N NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMAC\u00c9UTICOS en su Articulo 1.- Modificase el Articulo 11 y ampliase la Ley N 3283/2007 \"DE PROTECCION DE LA INFORMACION NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMAC\u00c9UTICOS\".\nEste pedido es a fin de dar mayor participaci\u00f3n a m\u00e1s oferentes.", "answer": "El oferente deber\u00e1 ajustarse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:40:25-04:00"}, {"id": "6e43b8f20af64ee1c9eea0c7c3218cb2-1", "date": "2024-09-02T17:04:08-04:00", "title": "DOCUMENTOS PARA EVALUAR LA CAPACIDAD TECNICA: Para f\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos moleculares: Para el Imatinib (Cristal Beta), Nintedanib, Palbociclib (inhibidor de ciclinas CK4 y CK6)", "description": "El PBC requiere la siguiente documentaci\u00f3n:\nb) El producto ofertado debe contar con Registro emitido por una de las Agencias Reguladoras de Referencia como: EMA, FDA, Health Canad\u00e1 o de Agencias de Referencia indicados en la LEY 7256/24, que en su art\u00edculo 1) Modificase el Art. 11 de la Ley N\u00ba 3283/2007, con antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os.\nd) Los productos deber\u00e1n contar con Registro Sanitario vigente, expedido por la DINAVISA, con antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os.\nCon relaci\u00f3n a la antig\u00fcedad de 3 a\u00f1os exigida para el Registro sanitario emitido por la DINAVISA y para el Registro sanitario emitido por una agencia reguladora de referencia,  establecida para los puntos b) y d) solicitamos a la convocante la exclusi\u00f3n de la antig\u00fcedad esto considerando que, conforme a la normativa vigente es funci\u00f3n de la DINAVISA establecer los requisitos y exigencias para la obtenci\u00f3n de un registro sanitario que garantiza a cualquier empresa que lo posea la libre comercializaci\u00f3n del producto en todo el territorio nacional, por otro lado \u201cla antig\u00fcedad\u201d exigida no encuentra ning\u00fan sustento en la normativa legal ni regulatoria nacional.", "answer": "El oferente deber\u00e1 ajustarse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:41:49-04:00"}, {"id": "2a0a7fa573d3d744e890754d952bcdce-1", "date": "2024-09-02T23:29:49-04:00", "title": "Capacidad T\u00e9cnica y Requisitos documentales para evaluar la capacidad t\u00e9cnica", "description": "En el punto 7. Inciso d) de las secciones detalladas la Convocante requiere lo siguiente: \nPARA MEDICAMENTOS BIOLOGICOS DE 2\u00b0 GENERACION, FARMACOS INHIBIDORES DE LA TIROSINA QUINASA Y TERAPIAS DIRIGIDAS A BLANCOS MOLECULARES, PROTEINAS RECOMBINANTES.\nPara f\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos moleculares: para el Imatinib (Cristal Beta), Nintedanib, palbociclib (inhibidor de ciclinas CK4 y CK6)\n\nd) Los productos deber\u00e1n contar con Registro Sanitario Vigente, expedido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA), con antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os.\n\nAl respecto, solicitamos a la Convocante eliminar el criterio establecido considerando que conforme a las normativas aplicables, no existe ning\u00fan impedimento legal para la comercializaci\u00f3n de un producto en todo el territorio nacional siempre que esta haya obtenido el correspondiente registro sanitario emitido por la DINAVISA, el cual paso por los procesos de revisi\u00f3n, presentaci\u00f3n de documentaciones y dem\u00e1s criterios a trav\u00e9s de la autoridad reguladora nacional para su comercializaci\u00f3n en el pa\u00eds. Este requisito resulta sumamente limitativo y va en contra del principio de igualdad y libre competencia garantizados en la Ley 7021/22, y en contra del art. 6 de la Ley 1119/97 \u201cde productos para la salud y otros\u201d, entre otros.", "answer": "El oferente deber\u00e1 ajustarse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:42:26-04:00"}, {"id": "62008eb815f4fab6c6f9f761a6056ee6-1", "date": "2024-09-04T18:01:49-04:00", "title": "PUNTO 7 PARA MEDICAMENTOS BIOLOGICOS DE 2\u00b0 GENERACION, FARMACOS INHIBIDORES DE LA TIROSINA QUINASA Y TERAPIAS DIRIGIDAS A BLANCOS MOLECULARES , PROTEINAS RECOMBINANTES- INCISO B", "description": "El PBC cita cuanto sigue: \u201cEl producto ofertado debe contar con Registro emitido por una de las Agencias Reguladoras de Referencias como: EMA, FDA, Health Canad\u00e1 o de Agencias de Referencias indicados en la LEY N\u00b0 7256/2024 de PROTECCI\u00d3N DE LA INFORMACI\u00d3N NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMAC\u00c9UTICOS en su Articulo 1.- Modificase el Articulo 11 y ampliase la Ley N 3283/2007 \"DE PROTECCION DE LA INFORMACION NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMAC\u00c9UTICOS\", con antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os\u201d\nSolicitamos a la convocante a incluir para los casos de productos importados LINK WEB oficial donde se puede acreditar que el fabricante cuenta con Certificado de Registro sanitario vigente en alguno de los pa\u00edses indicados como de alta vigilancia en la LEY N\u00b0 7256/2024, teniendo en cuenta que hay pa\u00edses que no emiten el Registro Sanitario como tal sino que ingresando a la p\u00e1gina oficial de la entidad emisora se podr\u00eda constatar el cumplimiento de las mismas, ya que entendemos que la convocante busca asegurar que los productos ofertados importados cumplen con las garant\u00edas de calidad, seguridad y eficacia, como ejemplo citamos a la FDA.", "answer": "El oferente deber\u00e1 ajustarse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:43:57-04:00"}, {"id": "fa15479a82328c7d81d2352cc296f2d9-1", "date": "2024-09-04T14:55:13-04:00", "title": "Abastecimiento Simultaneo", "description": "Se solicita a la convocante considerar la inclusi\u00f3n del \u00cdTEM 2 IMATINIB CRISTAL BETA en el sistema de adjudicaci\u00f3n por abastecimiento simult\u00e1neo, dado que el objetivo de este sistema es prevenir el desabastecimiento de la instituci\u00f3n en caso de que el \u00fanico proveedor adjudicado no pueda cumplir con el suministro.", "answer": "El oferente deber\u00e1 ajustar al Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:43:18-04:00"}, {"id": "121168ec1b4877aed3e01ab9124dd1c0-1", "date": "2024-08-27T14:42:16-04:00", "title": "Capacidad T\u00e9cnica", "description": "D\u00f3nde dice \u201cEl producto ofertado debe contar con Registro emitido por una de las Agencias Reguladoras de Referencias como: EMA, FDA, Health Canad\u00e1 o de Agencias de Referencias indicados en la LEY N\u00b0 7256/2024 de PROTECCI\u00d3N DE LA INFORMACI\u00d3N NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMAC\u00c9UTICOS en su Articulo 1.- Modificase el Articulo 11 y ampliase la Ley N 3283/2007 \"DE PROTECCION DE LA INFORMACION NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMAC\u00c9UTICOS\", con antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os\u201d, solicitamos a la convocante eliminar el requisito de antig\u00fcedad del Registro en un Pa\u00eds de Alta Vigilancia de por lo menos 3 a\u00f1os. Es sabido que una vez la Autoridad Sanitaria de cada pa\u00eds otorgue la autorizaci\u00f3n de comercializaci\u00f3n, \u00e9sta no requiere ning\u00fan tiempo adicional para su comercializaci\u00f3n. Esto para cumplir con los Principios de Igualdad y Libre Competencia.", "answer": "El oferente deber\u00e1 ajustarse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:39:55-04:00"}, {"id": "0fc1392cae9f92bebbe5523bfc1bd5a1-1", "date": "2024-09-03T11:54:30-04:00", "title": "Especificaciones T\u00e9cnicas del \u00edtem 1. ETANERCEPT INYECTABLE.", "description": "Solicitamos a la Convocante regirse por el Vadem\u00e9cum Institucional vigente para establecer las especificaciones t\u00e9cnicas del \u00edtem 1. Etanercept 50mg., considerando que conforme al Vadem\u00e9cum Institucional y la Res. C.A. N\u00ba 005-014/2024, han realizado la unificaci\u00f3n de todos los c\u00f3digos para el producto en particular y establece especificaciones t\u00e9cnicas \u00fanicas a ser utilizadas para la compra del producto.", "answer": "El oferente deber\u00e1 ajustar al Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:42:42-04:00"}, {"id": "2cbc9df750a51abb633fd536106917fb-1", "date": "2024-08-30T08:28:31-04:00", "title": "CAPACIDAD TECNICA - PUNTO 7 - INC B", "description": "El Pliego del presente llamado, en el t\u00edtulo CAPACIDAD T\u00c9CNICA - PUNTO 7 PARA MEDICAMENTOS BIOL\u00d3GICOS DE 2\u00b0 GENERACI\u00d3N, F\u00c1RMACOS INHIBIDORES DE LA TIROSINA QUINASA Y TERAPIAS DIRIGIDAS A BLANCOS MOLECULARES , PROTE\u00cdNAS RECOMBINANTES. Para f\u00e1rmacos inhibidores de la tirosina quinasa y terapias dirigidas a blancos moleculares: para el Imatinib (Cristal Beta), Nintedanib, palbociclib (inhibidor de ciclinas CK4 y CK6), ha establecido como requisito y condici\u00f3n el inc b que dice:  \n\u201cb) El producto ofertado debe contar con Registro emitido por una de las Agencias Reguladoras de Referencias como: EMA, FDA, Health Canad\u00e1 o de Agencias de Referencias indicados en la LEY N\u00b0 7256/2024 de PROTECCI\u00d3N DE LA INFORMACI\u00d3N NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMAC\u00c9UTICOS en su Articulo 1.- Modificase el Articulo 11 y ampliase la Ley N 3283/2007 \"DE PROTECCION DE LA INFORMACION NO DIVULGADA Y DATOS DE PRUEBA PARA LOS REGISTROS FARMAC\u00c9UTICOS\", con antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os.\u201d\n\nEl complemento del requisito exigido en el inc b, l\u00e9ase \u201ccon antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os\u201d, se constituye en una lim\u00edtate para la participaci\u00f3n en igualdad de condiciones a los proveedores que tienen la solvencia t\u00e9cnica, econ\u00f3mica y legal para participar en el llamado y que han obtenido ante las Agencias Reguladoras los Registros exigidos en un plazo menor al establecido. Establecer una antig\u00fcedad al requisito resulta una restricci\u00f3n para participar en el llamado. En virtud a los principios de Igualdad y libre competencia, solicitamos de la convocante proceda a la modificaci\u00f3n del requisito, suprimiendo el complemento \u201ccon antelaci\u00f3n de por lo menos 3 (tres) a\u00f1os\u201d", "answer": "El oferente deber\u00e1 ajustarse a la \u00faltima versi\u00f3n del Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:40:39-04:00"}, {"id": "3894154edd6671847139026ef957cca1-1", "date": "2024-09-04T18:10:46-04:00", "title": "Sistema de adjudicacion", "description": "Solicitamos a la convocante modificar el sistema de adjudicaci\u00f3n PARA TODOS LOS ITEMS de la sgte manera: a. 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. b. 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. c. 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. \nEsto atendiendo que la convocante de esta manera garantiza el abastecimiento de los productos por m\u00e1s de un proveedor, y a su vez este sistema de adjudicaci\u00f3n tiene como objetivo prevenir el desabastecimiento de la instituci\u00f3n en caso de que el \u00fanico proveedor adjudicado no pueda cumplir con los planes de entrega de los mismos.", "answer": "El oferente deber\u00e1 ajustar al Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:44:25-04:00"}, {"id": "801a9467833e6ea35efdd7bb2494192d-1", "date": "2024-09-04T14:54:57-04:00", "title": "ITEM 2", "description": "Para maximizar la participaci\u00f3n de oferentes y no limitar la presentaci\u00f3n de ofertas potencialmente beneficiosas, solicitamos amablemente modificar la descripci\u00f3n del \u00cdTEM 2 IMATINIB CRISTAL BETA de la siguiente manera: Donde actualmente dice \"Imatinib (Cristal Beta) Comprimido\", deber\u00eda decir \"Imatinib Comprimido\", dado que en ambas descripciones la actividad farmacol\u00f3gica b\u00e1sica del imatinib permanece sin cambios.", "answer": "El oferente deber\u00e1 ajustar al Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:43:05-04:00"}, {"id": "d9080b1d33b9d07fcf56706704371289-1", "date": "2024-09-04T18:01:53-04:00", "title": "ABASTECIMIENTO SIMULT\u00c1NEO", "description": "Considerando las Convocatorias anteriores de vuestra instituci\u00f3n y llamados en curso, se solicita a la Convocante modificar el Sistema de adjudicaci\u00f3n a ABASTECIMIENTO SIMULTANEO y que la misma quede 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.", "answer": "El oferente deber\u00e1 ajustar al Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:44:10-04:00"}, {"id": "c421ff885a3a7a0c0ce81b172deb8288-1", "date": "2024-08-27T16:17:12-04:00", "title": "Plan de entrega de los bienes", "description": "El PBC solicita para la Cantidad M\u00ednima - 20%: Hasta los 8 (ocho) d\u00edas calendarios. Con entregas que podr\u00e1n ser fraccionadas siempre dentro del mencionado plazo.. Por tanto solicitamos a la Convocante extender el plazo de entrega de los bienes a por lo menos 20 d\u00edas calendarios, teniendo en cuenta todo el proceso de fabricaci\u00f3n de los bienes.", "answer": "El oferente deber\u00e1 ajustar al Pliego de Bases y Condiciones.-", "dateAnswered": "2024-10-28T07:40:09-04:00"}], "lots": [{"id": "1ef2f068-315f-68c0-80b5-6d68f5d165e5", "title": "1 - 1 - Etanercept Inyectable", "status": "active", "statusDetails": "activo", "value": {"amount": 38526616000, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "1", "id": "1"}]}, {"id": "1ef2f072-7c33-645a-a74c-050daafe293b", "title": "3 - 3 - Nintedanib Capsula", "status": "active", "statusDetails": "activo", "value": {"amount": 38033001000, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "3", "id": "3"}]}, {"id": "1ef2f075-4fa2-6ad2-8693-1924654f66ac", "title": "4 - 4 - Palbociclib Capsula", "status": "active", "statusDetails": "activo", "value": {"amount": 37027800000, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "4", "id": "4"}]}, {"id": "1ef2f06e-7aa1-6262-a803-07beecf808e8", "title": "2 - 2 - Imatinib Cristal Beta Capsula", "status": "active", "statusDetails": "activo", "value": {"amount": 34748250000, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "2", "id": "2"}]}], "items": [{"id": "1ef2f072-7c35-682c-a858-050daafe293b", "description": "Nintedanib Capsula", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51111705-9998", "description": "Nintedanib Capsula", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51111705-9998"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51111705", "description": "Mitotan", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51111705"}], "quantity": 93000, "minQuantity": 46500, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 408957, "currency": "PYG"}}, "relatedLot": "1ef2f072-7c33-645a-a74c-050daafe293b", "attributes": [{"name": "Presentacion", "value": "UNIDAD", "id": "1"}, {"name": "Orden", "value": "3", "id": "2"}]}, {"id": "1ef2f075-4fa5-661a-9597-1924654f66ac", "description": "Palbociclib Capsula", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51111998-9996", "description": "Palbociclib Capsula", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51111998-9996"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51111998", "description": "Agentes Antitumorales Varios", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51111998"}], "quantity": 36000, "minQuantity": 18000, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 1028550, "currency": "PYG"}}, "relatedLot": "1ef2f075-4fa2-6ad2-8693-1924654f66ac", "attributes": [{"name": "Presentacion", "value": "UNIDAD", "id": "1"}, {"name": "Orden", "value": "4", "id": "2"}]}, {"id": "1ef2f068-3162-6a5c-bb0a-6d68f5d165e5", "description": "Etanercept Inyectable", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51142101-9999", "description": "Etanercept Inyectable", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51142101-9999"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51142101", "description": "Antiinflamatorios varios", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51142101"}], "quantity": 14500, "minQuantity": 7250, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 2657008, "currency": "PYG"}}, "relatedLot": "1ef2f068-315f-68c0-80b5-6d68f5d165e5", "attributes": [{"name": "Presentacion", "value": "KIT - JUEGO", "id": "1"}, {"name": "Orden", "value": "1", "id": "2"}]}, {"id": "1ef2f06e-7aa6-62f8-9c1e-07beecf808e8", "description": "Imatinib Cristal Beta Capsula", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51111705-005", "description": "Imatinib Cristal Beta Capsula", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51111705-005"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51111705", "description": "Mitotan", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51111705"}], "quantity": 250000, "minQuantity": 125000, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 138993, "currency": "PYG"}}, "relatedLot": "1ef2f06e-7aa1-6262-a803-07beecf808e8", "attributes": [{"name": "Presentacion", "value": "UNIDAD", "id": "1"}, {"name": "Orden", "value": "2", "id": "2"}]}], "tenderers": [{"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, {"name": "DISTRIBUIDORA LA POLICLINICA S. 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