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Ser\u00e1n documentos suficientes para demostrar el cumplimiento de este requisito?\n", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:22:17-04:00"}, {"id": "31", "date": "2022-10-21T15:49:39-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "17.\tEn el Plan de farmacovigilancia del producto, se deber\u00e1 considerar, de acuerdo a la Gu\u00eda correspondiente los siguientes puntos:\n* Actividades para continuar con un control de inmunogenicidad.- A la convocante: Esta solicitud no corresponde al plan de farmacovigilancia porque son parte de los datos pre-cl\u00ednicos de seguridad. Esto est\u00e1 respaldado por la normativa ICH S6 (R1) de evaluaci\u00f3n de datos pre-cl\u00ednicos de productos biotecnol\u00f3gicos. Se solicita su revisi\u00f3n y exclusi\u00f3n.\n", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:27:21-04:00"}, {"id": "52", "date": "2022-10-21T17:39:30-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica.", "description": "En la p\u00e1gina 24/16 del P.B.C. punto 16 dice: Deber\u00e1n presentar como m\u00ednimo cuatro reportes locales del Informe Peri\u00f3dico de Seguridad (PSUR), que hayan sido entregados a DINAVISA, durante la comercializaci\u00f3n del producto.\nSolicitamos a la Convocante excluir este requisito ya que cuando la D.N.V.S., autoriza la venta de un  medicamento otorg\u00e1ndole el Registro Sanitario y el Acta de Fijaci\u00f3n de Precios, el medicamento se encuentra habilitado para la venta en el mercado paraguayo. Exigir lo establecido en ese punto atenta contra la libre competencia.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:46:36-04:00"}, {"id": "21", "date": "2022-10-21T13:57:52-04:00", "title": "VENCIMIENTO DE PRODUCTOS", "description": "PAG. 27/46 Para aquellos medicamentos cuyo vencimiento sea inferior a 18 meses adem\u00e1s de la autorizaci\u00f3n de la DGGIES se deber\u00e1 presentar P\u00f3liza de Seguro por el 100 % del monto del producto con identificaci\u00f3n del numero de lote, que ser\u00e1n entregados u original en la oficina de Contratos y Garant\u00edas de la DGGIES y el duplicado en el Parque Sanitario que corresponda. Solicitamos amablemente  a la convocantes que la p\u00f3liza solicitada sea a partir de 12 meses del vto del producto, atendiendo que los medicamentos  solicitados , por su naturaleza en la mayoria de los casos son enviados de Origen con vto menor a lo estipulado.", "author": {"name": "TASSOS SA", "id": "PY-RUC-80078413-8"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:21:25-04:00"}, {"id": "6", "date": "2022-10-19T18:54:23-04:00", "title": "ITEM 8 ", "description": "Solicitamos respetuosamente a la convocante revisar el precio referencial del ITEM N\u00b0 8, ya que el mismo se encuentra muy por debajo del precio real del mercado, e incluso muy por debajo del precio referencial en llamados anteriores. Por lo cual limita la posibilidad de presentar ofertas y competir por un precio razonable.", "author": {"name": "SCAVONE HERMANOS SA", "id": "PY-RUC-80001916-4"}, "answer": "Favor considerar los t\u00e9rminos ya establecidos por la Convocante.", "dateAnswered": "2022-11-18T14:58:14-04:00"}, {"id": "19", "date": "2022-10-21T07:02:30-04:00", "title": "CAPACIDAD TECNICA", "description": "El pliego indica en su punto 18 El producto biol\u00f3gico (innovador o biosimilar), deber\u00e1 incluir una gu\u00eda de manejo y preparaci\u00f3n del producto y\nsu aplicaci\u00f3n al paciente, elaborado y firmado por el Director t\u00e9cnico, con certificaci\u00f3n de firma. El requisito es limitante y t\u00e9cnicamente extempor\u00e1neo para la oferta, lo descripto corresponde a una etapa del tratamiento, para lo descripto es suficiente los cat\u00e1logos, prospectos. Solicitamos su exclusi\u00f3n y/o modificaci\u00f3n a la documentaci\u00f3n l\u00f3gica y razonable", "author": {"name": "LIBRA PARAGUAY S.A.", "id": "PY-RUC-80023379-4"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:20:46-04:00"}, {"id": "60", "date": "2022-10-22T10:02:52-04:00", "title": "EETT ITEM N\u00ba 13 FULVESTRANT INYECTABLE", "description": "Solicitamos a la Convocante ampliar la presentaci\u00f3n de entrega de la siguiente manera vial o jeringa prellenada. Esto no afecta de ning\u00fan modo la eficacia del producto a ser ofertado. De la misma manera la Convocante asegura mayor participaci\u00f3n de potenciales oferentes, as\u00ed como su abastecimiento permanente. ", "author": {"name": "EUROQUIMICA S.A.", "id": "PY-RUC-80061211-6"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:48:59-04:00"}, {"id": "42", "date": "2022-10-21T17:06:04-04:00", "title": "Experiencia requerida", "description": "En relaci\u00f3n a la experiencia en uso y comercializaci\u00f3n en Paraguay de productos biosimilares, solicitamos a la Convocante ampliar el requisito a por lo menos los a\u00f1os 2018, 2019, 2020 y 2021, esto a fin de otorgar un mayor margen de posibilidades a los oferentes interesados en participar del proceso. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:33:14-04:00"}, {"id": "69", "date": "2022-10-22T19:58:22-04:00", "title": "PBC \u0096 Requisito documental para evaluar capacidad t\u00e9cnica- P\u00e1gs. 24/46. Punto 11", "description": "En el caso de productos biosimilares \u00bfCu\u00e1l es el fundamento t\u00e9cnico para solicitar estos estudios que ya fueron presentados como parte de los requisitos para la obtenci\u00f3n del registro sanitario de medicamentos biosimilares por comparabilidad \u0096 Art. 8 Decreto 6611/16? \u00bfAcaso la obtenci\u00f3n del RS no es suficiente para comercializar un medicamento en territorio paraguayo conforme lo establece el Art. 22 del Decreto 6611/16?", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:22:49-04:00"}, {"id": "12", "date": "2022-10-20T16:26:28-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "En el punto 10. la Convocante establece: \"Para productos biosimilar presentar\u00e1 certificados de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n vigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA,FDA, Health Canada, ANVISA o ANMAT.\" Al respecto,solicitamos aclarar los siguientes puntos: 1. Solicitan: \"Autorizaci\u00f3n de comercializaci\u00f3n\", al respecto se solicita aclarar a que documento espec\u00edficamente hace referencia cuando solicitan esto.\n2.\tSolicitamos establecer la posibilidad de presentar Certificado de Buenas Practicas y/o Certificado del producto farmac\u00e9utico, considerando que conforme al Decreto N\u00ba 6611/16, estos documentos son los requeridos por la autoridad reguladora para la obtenci\u00f3n del registro sanitario y mal podr\u00eda la Convocante limitar de forma innecesaria el PBC con requisitos ni siquiera requeridos por la DNVS. \n3.\tSolicitamos ampliar las autoridades reguladoras indicadas en dicho punto, conforme a lo dispuesto en la normativa vigente al respecto (Art. 4 del Decreto 6611/16). ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las modificaciones introducidas en la ultima versi\u00f3n del PbyC.", "dateAnswered": "2022-11-18T15:17:19-04:00"}, {"id": "50", "date": "2022-10-21T17:38:21-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica.", "description": "En la p\u00e1gina 24/16 del P.B.C. punto 10 dice: Para productos biosimilar presentar\u00e1 certificados de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n vigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA, FDA, Health Canada, ANVISA o ANMAT. El producto biosimilar deber\u00e1 contar con Registro Sanitario emitido por DNVS, con antelaci\u00f3n m\u00ednima de 3 a\u00f1os. \nSolicitamos a la Convocante excluir este requisito ya que cuando la D.N.V.S., autoriza la venta de un  medicamento otorg\u00e1ndole el Registro Sanitario y el Acta de Fijaci\u00f3n de Precios, el medicamento se encuentra habilitado para la venta en el mercado paraguayo. Exigir lo establecido en ese punto atenta contra la libre competencia.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:45:56-04:00"}, {"id": "18", "date": "2022-10-21T06:55:01-04:00", "title": "CAPACIDAD TECNICA", "description": "El pliego indica 16. Deber\u00e1n presentar como m\u00ednimo cuatro reportes locales del Informe Peri\u00f3dico de Seguridad (PSUR), que hayan sido entregados a DINAVISA, durante la mercializaci\u00f3n del producto:\nEn el Plan de farmacovigilancia del producto, se deber\u00e1 considerar, de acuerdo a la Gu\u00eda correspondiente los\nsiguientes puntos:\nEfectos adversos raros y especialmente peligrosos.\nActividades para continuar con un control de inmunogenicidad.-\nTener un procedimiento adecuado de trazabilidad del biosimilar y distinguirlo del producto de referencia.-\nEn caso de intercambio entre el innovador y el biosimilar, se deber\u00e1 presentar un plan que considere estos aspectos. A que se refiere con estos reportes?: si el producto no ha generado ning\u00fan reporte adverso, la condici\u00f3n es absurda, limitante y restrictiva, no existe par\u00e1metro legal para introducir este requerimiento, solicitamos su exclusi\u00f3n", "author": {"name": "LIBRA PARAGUAY S.A.", "id": "PY-RUC-80023379-4"}, "answer": "Favor ajustarse y considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:20:00-04:00"}, {"id": "89", "date": "2022-10-24T07:48:37-04:00", "title": "Vencimiento de los productos", "description": "En la secci\u00f3n de SUMINISTROS REQUERIDOS, en el detalle de las especificaciones t\u00e9cnicas, punto: vencimiento la Convocante establece que los vencimientos deben de ser de 18 meses contados a partir de la fecha de entrega en el lugar indicado en la Orden de Compra. Si por la naturaleza de los mismos o por necesidad de la Instituci\u00f3n no se puede cumplir con este requisito, la recepci\u00f3n del producto deber\u00e1 ser autorizada por la Direcci\u00f3n General de Insumos Estrat\u00e9gicos. Adem\u00e1s establecen que los productos con vencimiento de 18 meses o menos, la recepci\u00f3n del producto aparte de ser autorizada por la Direcci\u00f3n General de Gesti\u00f3n de Insumos Estrat\u00e9gicos en Salud con la presentaci\u00f3n de DDJJ de Compromiso de Canje, debe acompa\u00f1ar una P\u00f3liza de Seguro por el 100% del monto del producto. Al respecto, considerando que: * Se trata de productos que pasan por rigurosos procesos de aseguramiento de calidad para asegurar la eficacia y la estabilidad del producto que pueden extenderse hasta 3 meses, sumado al tiempo de tr\u00e1nsito y desaduanaje que en promedio se extiende tambi\u00e9n por otros 3 meses para poder entregar los productos a la Convocante en tiempo y forma. * Para poder cumplir con el plan de entregas establecido por el pliego de bases y condiciones requiere contar con un stock de seguridad para dar respuesta inmediata a las necesidades de la Convocante. * El requerimiento de una p\u00f3liza de seguro para medicamentos con vencimiento mayor a 12 meses podr\u00eda incidir de forma negativa en la estructura de costos del proceso. Por tanto, solicitamos a la Convocante analice la posibilidad de modificar su segundo p\u00e1rrafo, solicitando Carta Compromiso de Canje y P\u00f3liza de Seguro por el 100% del monto del producto a ser entregado, para productos con vencimiento inferior a 12 meses.", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:44:51-04:00"}, {"id": "66", "date": "2022-10-22T19:51:39-04:00", "title": "Punto 10 - PBC pag. 24/46", "description": "Solicitan: Para productos biosimilar presentar\u00e1 certificados de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n\nvigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA, FDA, Health Canada, ANVISA o\nANMAT. El producto biosimilar deber\u00e1 contar con Registro Sanitario emitido por DNV, con antelaci\u00f3n m\u00ednima\nde 3 a\u00f1os.\n\nConsulta: Desconocemos el documento autorizaci\u00f3n de comercializaci\u00f3n, \u00bfes equivalente un CLV o CPP?.", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:21:57-04:00"}, {"id": "45", "date": "2022-10-21T17:16:19-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica. Punto 10", "description": "En el PBC se establece: \"Para productos biosimilar presentar\u00e1 certificados de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n vigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA,FDA, Health Canada, ANVISA o ANMAT.\" Al respecto, solicitamos ampliar las autoridades reguladoras indicadas en dicho punto, conforme a lo dispuesto en la normativa vigente (Art. 4 del Decreto 6611/16).", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:41:20-04:00"}, {"id": "73", "date": "2022-10-22T20:12:58-04:00", "title": "Vencimiento de los Productos", "description": "Considerando la naturaleza del mismo, solicitamos a la convocante exigir la P\u00f3liza para productos con vencimiento menores a 15 meses, y tambi\u00e9n solicitamos que consideren la Declaracion Jurada  por la cual el oferente se compromete en caso de ser adjudicados a canjear los insumos con 3 meses antes de su vencimiento.", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:23:51-04:00"}, {"id": "1", "date": "2022-10-18T16:47:27-04:00", "title": "Vencimiento", "description": "En donde dice: Para aquellos medicamentos cuyo vencimiento sea inferior a 18 meses adem\u00e1s de la autorizaci\u00f3n de la DGGIES se deber\u00e1\npresentar P\u00f3liza de Seguro por el 100 % del monto del producto con identificaci\u00f3n del numero de lote, que ser\u00e1n\nentregados u original en la oficina de Contratos y Garant\u00edas de la DGGIES y el duplicado en el Parque Sanitario que\ncorresponda. Solicitamos a la convocantes que la poliza se solicite a partir de \"menor a 15 meses\", atendiendo que los medicamentos importados, mayormente no llegan con vencimiento largos. ", "author": {"name": "Bioethic Pharma S.A.", "id": "PY-RUC-80058902-5"}, "answer": "Favor considerar la ultima versi\u00f3n del PbyC.", "dateAnswered": "2022-11-15T10:30:08-04:00"}, {"id": "5", "date": "2022-10-19T15:16:58-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica, punto 16", "description": "En donde dice: 16. Deber\u00e1n presentar como m\u00ednimo cuatro reportes locales del Informe Peri\u00f3dico de Seguridad (PSUR), que hayan sido entregados a DINAVISA, durante la comercializaci\u00f3n del producto: Este pedido no corresponde bajo ninguna concepto legal. Una vez que DINAVISA, autorice la venta del producto, est\u00e1 legalmente autorizado a vender, a\u00fan cuando se trate de un pedido en licitaciones. Para estos casos, existen los Certificados de An\u00e1lisis y si el MSP lo desea, autorizar a CEMIT, para que analice el medicamento. Solicitamos a la convocante excluir de su requerimiento porque solo favorece a los \"originales\" y cercena el derecho legitimo de la libre competencia. ", "author": {"name": "Bioethic Pharma S.A.", "id": "PY-RUC-80058902-5"}, "answer": "Favor considerar la ultima versi\u00f3n del PbyC.", "dateAnswered": "2022-11-18T14:48:35-04:00"}, {"id": "54", "date": "2022-10-22T09:19:43-04:00", "title": "SISTEMA DE ADJUDICACION ", "description": "Considerando las Convocatorias anteriores se solicita a la Convocante modificar el Sistema de adjudicaci\u00f3n a ABASTECIMIENTO SIMULTANEO y que la misma quede de la siguiente manera:\nEn caso de presentarse un solo oferente en un \u00edtem, se le adjudicara el 100% del monto del \u00edtem correspondiente.\nDe existir dos oferentes en el \u00edtem, ser\u00e1n consideradas para la oferta solvente m\u00e1s baja: el 60% del monto del contrato; y al oferente que presente la segunda oferta solvente evaluada como la m\u00e1s baja: el 40% del monto del contrato para dicho \u00edtem.\nDe existir tres oferentes en el \u00edtem, ser\u00e1n consideradas para la oferta solvente m\u00e1s baja: el 50% del monto del contrato; al oferente que presente la segunda oferta solvente evaluada como la m\u00e1s baja: el 30% del contrato; al oferente que presente la tercera oferta solvente evaluada como la m\u00e1s baja: el 20% del contrato para dicho \u00edtem. \n", "author": {"name": "EUROQUIMICA S.A.", "id": "PY-RUC-80061211-6"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:46:59-04:00"}, {"id": "97", "date": "2022-11-16T16:21:42-04:00", "title": "PRECIO REFERENCIAL ITEM 20", "description": "EL PRECIO REFERENCIAL DEL ITEM 20 DOCETAXEL TRIHIDRATO 80 MG. FIJADO PARA ESTA LICITACION SE ENCUENTRA MUY POR DEBAJO DE LOS PRECIOS ACTUALES EN PLAZA. SOLICITAMOS A LA CONVOCANTE LA CORRECCION CORRESPONDIENTE.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "Favor ajustarse y considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T17:42:58-04:00"}, {"id": "8", "date": "2022-10-20T13:59:00-04:00", "title": "Sistema de Adjudicaci\u00f3n", "description": "Solicitamos que el Sistema de Adjudicaci\u00f3n sea de Abastecimiento Simult\u00e1neo, con ello la convocante evitar\u00eda el riesgo de poder quedar desabastecida.", "author": {"name": "LIBRA PARAGUAY S.A.", "id": "PY-RUC-80023379-4"}, "answer": "Favor considerar las modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T14:59:13-04:00"}, {"id": "37", "date": "2022-10-21T16:32:38-04:00", "title": "Plan de Entrega", "description": "Se solicita considerar el siguiente plan de entrega:\nCantidad M\u00ednima: \u00b7 1ra. Entrega: Hasta el 10 % de la cantidad m\u00ednima adjudicada. El oferente tendr\u00e1 un plazo de hasta 10\n(diez) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. \u00b7 2\u00ba Entrega: Hasta\nel 30% de la cantidad m\u00ednima adjudicada. Seg\u00fan necesidad del servicio. El oferente tendr\u00e1 un plazo de hasta 20 (veinte) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. \u00b7 3\u00ba Entrega: Hasta el 50% de\nla cantidad m\u00ednima adjudicada. Seg\u00fan necesidad del servicio. El oferente tendr\u00e1 un plazo de hasta 30 (treinta) d\u00edas corridos\npara la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN.\n\nCantidad m\u00e1xima: A ser emitida una vez recibida la totalidad de las cantidades m\u00ednimas, con plazos de entrega de hasta\n30 (treinta) d\u00edas a ser contados a partir de la recepci\u00f3n de la orden de compra por parte del proveedor.", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:28:27-04:00"}, {"id": "81", "date": "2022-10-23T09:41:24-04:00", "title": "PBC \u0096 Requisito documental para evaluar capacidad t\u00e9cnica- P\u00e1gs. 24/46. Punto 19", "description": "Los productos biol\u00f3gicos innovadores presentar\u00e1n copia autenticada de Certificado de Libre Venta, emitido por una entidad regulatoria de referencia, FDA o EMA. Entonces, si el CLV para productos biosimilares es emitido por FDA o EMA; no es necesario presentar los estudios mencionados en el Punto 11?", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones establecidas en el PbyC.", "dateAnswered": "2022-11-18T17:28:40-04:00"}, {"id": "39", "date": "2022-10-21T16:45:10-04:00", "title": "Requisitos documentales para la evaluaci\u00f3n de la experiencia", "description": "Dice: Para productos biosimilares: Experiencia de uso y comercializaci\u00f3n en Paraguay. No se especifica cuales son los documentos a evaluar para experiencia de uso y comercializaci\u00f3n en Paraguay.", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:28:47-04:00"}, {"id": "56", "date": "2022-10-22T09:24:47-04:00", "title": "REQUISITO DOCUMENTAL PARA EVALUAR LA CAPACIDAD TECNICA", "description": "En el punto N\u00ba 16 La convocante establece el siguiente requisito Deber\u00e1n presentar como m\u00ednimo cuatro reportes locales del Informe Peri\u00f3dico de Seguridad (PSUR), que hayan sido entregados a DINAVISA, durante la comercializaci\u00f3n del producto: En el Plan de farmacovigilancia del producto, se deber\u00e1 considerar, de acuerdo a la Gu\u00eda correspondiente los siguientes puntos: Efectos adversos raros y especialmente peligrosos. Actividades para continuar con un control de inmunogenicidad.- Tener un procedimiento adecuado de trazabilidad del biosimilar y distinguirlo del producto de referencia.- En caso de intercambio entre el innovador y el biosimilar, se deber\u00e1 presentar un plan que considere estos aspectos. Al respecto de este requerimiento pedimos a la Convocante aclarar la reglamentaci\u00f3n en la que se basa para establecer dicho requisito como un criterio de evaluaci\u00f3n, dado que si el producto a ser ofertado no ha presentado efectos adversos no se pueden presentar los reportes a la Autoridad Sanitaria Reguladora DNVS.", "author": {"name": "EUROQUIMICA S.A.", "id": "PY-RUC-80061211-6"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:47:19-04:00"}, {"id": "20", "date": "2022-10-21T09:34:53-04:00", "title": "Sistema de abastecimiento simult\u00e1neo", "description": "Estimados se\u00f1ores de la Administraci\u00f3n Convocante, solicitamos afablemente que consideren modificar los t\u00e9rminos del pliego de bases y condiciones de la LPN Nro. 91/2022 para la Adquisici\u00f3n de medicamentos oncol\u00f3gicos para el INCAN y otros Centros Oncol\u00f3gicos del MSP y BS respecto al sistema de adjudicaci\u00f3n a ser utilizado en la convocatoria, permitiendo el sistema de abastecimiento simult\u00e1neo para el suministro del medicamento individualizado bajo el \u00cdTEM Nro. 3. Proponemos que se efect\u00fae tal modificaci\u00f3n debido a que en licitaciones anteriores ya se ha demostrado que este sistema de abastecimiento simult\u00e1neo para determinados \u00edtems favorece a la econom\u00eda, eficiencia y capacidad de cumplimiento de los objetivos de la Administraci\u00f3n Contratante. Adem\u00e1s, este sistema de abastecimiento simult\u00e1neo garantizar\u00e1 la satisfacci\u00f3n de las necesidades del sistema de salud de nuestro pa\u00eds, sobre todo teniendo en consideraci\u00f3n que el \u00cdTEM Nro. 3 se trata de un medicamento bastante demandado en el sector oncol\u00f3gico.\nDem\u00e1s est\u00e1 decir que este sistema especial de adjudicaci\u00f3n favorecer\u00e1 la competitividad y la concurrencia de los oferentes favoreciendo la posici\u00f3n de la Administraci\u00f3n Contratante. En ese sentido, solicitamos por favor que se tenga en consideraci\u00f3n esta propuesta y se proceda a adendar el pliego de bases y condiciones", "author": {"name": "PHARMA INTERNATIONAL SA", "id": "PY-RUC-80018716-4"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:21:05-04:00"}, {"id": "24", "date": "2022-10-21T15:24:38-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "Punto 10. Para productos biosimilar presentar\u00e1 certificados de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n\nvigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA,FDA, Health Canada, ANVISA o\nANMAT. A la convocante: El certificado de registro sanitario es el documento que autoriza la comercializaci\u00f3n, por lo que no corresponde solicitar Registro y Autorizaci\u00f3n. Aclarar que documento espec\u00edficamente es el requerido al solicitar AUTORIZACI\u00d3N DE COMERCIALIZACI\u00d3N.", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:25:31-04:00"}, {"id": "28", "date": "2022-10-21T15:37:00-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "Punto 16. Deber\u00e1n presentar como m\u00ednimo cuatro reportes locales del Informe Peri\u00f3dico de Seguridad (PSUR), que\nhayan sido entregados a DINAVISA, durante la comercializaci\u00f3n del producto. - Se solicita a la convocante especificar los productos que deber\u00e1n presentar dicho requisito, siendo que no es aplicable a todos los productos solicitados en esta convocatoria.", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:26:18-04:00"}, {"id": "74", "date": "2022-10-22T20:16:58-04:00", "title": "Plan de entrega de los bienes", "description": "Cantidad M\u00ednima:\n1ra. Entrega: Hasta el 10 % de la cantidad m\u00ednima adjudicada. El oferente tendr\u00e1 un plazo de hasta 10\n(diez) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. \n2\u00ba Entrega: Hasta el 30% de la cantidad m\u00ednima adjudicada. Seg\u00fan necesidad del servicio. El oferente tendr\u00e1 un plazo de hasta 15 (quince) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. \u00b7 \n3\u00ba Entrega: Hasta el 50% de la cantidad m\u00ednima adjudicada. Seg\u00fan necesidad del servicio. El oferente tendr\u00e1 un plazo de hasta 20 (veinte) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. \u00b7\nSaldo: Seg\u00fan necesidad del Servicio, con \u00f3rdenes de compra emitidas con plazos de hasta 30 (treinta) d\u00edas corridos a ser\ncontados a partir de la recepci\u00f3n de la misma por el proveedor.\nCantidad m\u00e1xima: A ser emitida una vez recibida la totalidad de las cantidades m\u00ednimas, con plazos de entrega de hasta\n30 (treinta) d\u00edas a ser contados a partir de la recepci\u00f3n de la orden de compra por parte del proveedor.", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:24:04-04:00"}, {"id": "88", "date": "2022-10-23T15:39:22-04:00", "title": "CAPACIDAD TECNICA", "description": "La convocante ha resuelto indebidamente en este llamado agregar en experiencia requerida el p\u00e1rrafo: Los productos biosimilares deber\u00e1n contar con experiencia de uso y comercializaci\u00f3n en Paraguay con facturaciones de ventas y/o contratos ejecutados en los a\u00f1os 2019, 2020, y 2021, por un monto m\u00ednimo del 50% (cincuenta) por ciento del valor total del producto solicitado en dicha licitaci\u00f3n. Lo expuesto no es razonable y atenta contra el principio de igualdad, y tampoco se menciona en llamados anteriores, raz\u00f3n por la cual solicitamos sea excluido", "author": {"name": "INNOVAPHARMA S.R.L", "id": "PY-RUC-80005431-8"}, "answer": "Favor considerar las modificaciones introducidas a la ultima versi\u00f3n del PbyC.", "dateAnswered": "2022-11-18T17:36:07-04:00"}, {"id": "23", "date": "2022-10-21T15:16:15-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "Punto 4. Fotocopia autenticada del Certificado de Registro Sanitario vigente, expedido por la Direcci\u00f3n de Vigilancia\nSanitaria del MSPBYS, o certificado actualizado (vigencia no mayor a 6 meses) de que encuentra en tr\u00e1mites\nde renovaci\u00f3n. Recordamos a la convocante que la vigencia de el certificado o constancia de encontrarse en tr\u00e1mite tiene una validez de 1 a\u00f1o, por este motivo lo solicitado en cuanto a vigencia es improcedente.", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:24:55-04:00"}, {"id": "22", "date": "2022-10-21T15:07:56-04:00", "title": "Experiencia requerida", "description": "La convocante solicita: Los productos biosimilares deber\u00e1n contar con experiencia de uso y comercializaci\u00f3n en Paraguay con facturaciones de ventas y/o contratos ejecutados en los a\u00f1os 2019, 2020, y 2021, por un monto m\u00ednimo del 50% (cincuenta) por ciento del valor total del producto solicitado en dicha licitaci\u00f3n.\n\nSolicitamos aclarar si el requisito es cumplir en cada a\u00f1o el 50% del total ofertado o es suficiente con la sumatoria de los 3 a\u00f1os.", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:22:02-04:00"}, {"id": "96", "date": "2022-11-16T16:03:40-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "Estimados se\u00f1ores de la Administraci\u00f3n Convocante, solicitamos afablemente que consideren modificar los t\u00e9rminos del pliego de bases y condiciones de la LPN Nro. 91/2022 para la Adquisici\u00f3n de medicamentos oncol\u00f3gicos para el INCAN y otros Centros Oncol\u00f3gicos del MSP y BS -Versi\u00f3n 5- publicado en fecha 15 de noviembre de 2022 respecto a los requisitos documentales para evaluar la capacidad t\u00e9cnica de las ofertas presentadas. Tal es as\u00ed que en la convocatoria se utiliza el sistema de adjudicaci\u00f3n de abastecimiento simult\u00e1neo para el suministro de determinados medicamentos -entre ellos el individualizado bajo el \u00cdTEM Nro. 3- y a los efectos de evaluar la capacidad t\u00e9cnica de este producto se han suprimido determinados requerimientos esenciales que deber\u00edan volver a incluirse para la evaluaci\u00f3n de este \u00cdTEM Nro. 3. En ese sentido entre los requisitos indispensables a ser tenidos en consideraci\u00f3n para que prime la libre competencia, eficiencia y capacidad entre todos los oferentes que ofrezcan el \u00cdTEM Nro. 3 se debe solicitar que \u00e9stos re\u00fanan las siguientes aristas/capacidades: Requisito documental para evaluar la capacidad t\u00e9cnica: Punto 10. Para productos biosimilares deber\u00e1n presentar certificados de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n vigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA, FDA, HEALTH CANAD\u00c1, ANVISA o AMMAT. El producto biosimilar deber\u00e1 contar con Registro Sanitario emitido por DNV, con antelaci\u00f3n m\u00ednima de 3 a\u00f1os. Cabe aclarar que solicitamos que se utilice esta redacci\u00f3n para dejar perfectamente sentados todos los requerimientos que deben ser tenidos en cuenta al evaluar productos biosimilares y la redacci\u00f3n actual del punto 10 se encuentra escueta. As\u00ed tambi\u00e9n solicitamos que entre los requisitos documentales para evaluar la capacidad t\u00e9cnica sea nuevamente incluido el punto 16 bajo los siguientes t\u00e9rminos: Para productos biosimilares deber\u00e1n presentar como m\u00ednimo cuatro reportes locales del Informe Peri\u00f3dico de Seguridad (PSUR), que hayan sido entregados a DINAVISA durante la comercializaci\u00f3n del producto. \nRatificamos que estas modificaciones favorecer\u00e1n el sistema de evaluaci\u00f3n y adquisici\u00f3n de los mejores productos para el INCAN y otros Centros Oncol\u00f3gicos del MSP y BS", "author": {"name": "PHARMA INTERNATIONAL SA", "id": "PY-RUC-80018716-4"}, "answer": "Favor ajustarse y considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T17:42:51-04:00"}, {"id": "3", "date": "2022-10-19T14:22:12-04:00", "title": "SISTEMA DE ADJUDICACI\u00d3N", "description": "Solicitamos a la convocante aplicar el sistema de adjudicaci\u00f3n por abastecimiento simultaneo con el fin de dar mayor participaci\u00f3n a posibles oferentes, as\u00ed tambi\u00e9n salvaguardar la libre competencia y provisi\u00f3n de los medicamentos.", "author": {"name": "MATHER COMPANY SRL", "id": "PY-RUC-80006850-5"}, "answer": "Favor considerar la ultima versi\u00f3n del PbyC.", "dateAnswered": "2022-11-18T14:47:21-04:00"}, {"id": "57", "date": "2022-10-22T09:35:06-04:00", "title": "REQUISITOS PARA EVALUAR LA EXPERIENCIA ", "description": "La convocante solicita para los productos biosimilares contar con una experiencia de uso y comercializaci\u00f3n en Paraguay con facturaciones de ventas y/o contratos ejecutados en los a\u00f1os 2019, 2020 y 2021 por un monto m\u00ednimo de 50%. Pedimos a la Convocante que dicho requerimiento sea unificado de la siguiente manera Demostrar la experiencia en provisi\u00f3n de bienes en MEDICAMENTOS a trav\u00e9s de copias de contratos y/o Facturaciones de Ventas por un monto equivalente al 50 % (cincuenta) por ciento de lo ofertado en la presente licitaci\u00f3n, en cualquiera de los siguientes a\u00f1os: 2019, 2020,2021 Esto a modo de no limitar innecesariamente la participaci\u00f3n a potenciales oferentes y de manera a respetar el principio de igualdad y libre competencia consagrado en la Ley N\u00ba 2051/03.", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:47:39-04:00"}, {"id": "53", "date": "2022-10-21T17:40:17-04:00", "title": "ITEM 6. GEMCITABINA ", "description": "En las especificaciones tecnicas se solicita la concentraci\u00f3n de 1mg. Al respecto, solicitamos verificar la misma, considerando que en el mercado no se encuentra la concentraci\u00f3n establecida. Entendemos que se pretende adquirir una concentraci\u00f3n de 1000mg. o 1g.", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:46:47-04:00"}, {"id": "91", "date": "2022-10-24T07:52:10-04:00", "title": "PLAN DE ENTREGAS", "description": "El PBC solicita Cantidades m\u00ednimas solicitadas Hasta 10% de la cantidad m\u00ednima adjudicada: La primera Orden de Compra, ser\u00e1 emitida dentro de los 15 (quince) d\u00edas corridos posteriores a la firma del contrato donde el proveedor tendr\u00e1 hasta los 10 (diez) d\u00edas corridos para la entrega contados a partir de la recepci\u00f3n de la orden de compra. Solicitamos a la Convocante ampliar el plazo de entrega a por los 20 (veinte) d\u00edas calendarios para la entrega de los productos, teniendo en cuenta el tiempo de fabricaci\u00f3n y adecuaci\u00f3n de los mismos conforme al PBC.", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:45:16-04:00"}, {"id": "2", "date": "2022-10-19T11:06:17-04:00", "title": "Abastecimiento Simultaneo ", "description": "Estimados convocantes. Solicitamos que el sistema de abastecimiento pase a ser \"Simult\u00e1neo\" a fin de asegurar abastecimientos. ", "author": {"name": "Bioethic Pharma S.A.", "id": "PY-RUC-80058902-5"}, "answer": "Favor considerar la ultima versi\u00f3n del PbyC.", "dateAnswered": "2022-11-18T14:47:06-04:00"}, {"id": "77", "date": "2022-10-22T21:02:09-04:00", "title": "Punto 4 - Registro Sanitario Vigente", "description": "Solicitan: Fotocopia autenticada del Certificado de Registro Sanitario vigente, expedido por la Direcci\u00f3n de Vigilancia\nSanitaria del MSPBYS, o certificado actualizado (vigencia no mayor a 6 meses) de que encuentra en tr\u00e1mites\nde renovaci\u00f3n.\nConsulta: Siendo que DINAVISA emite por \u00fanica vez el Certificado, con una validez de 1 a\u00f1o. Solicitamos a la convocante adecuar sus exigencias a lo establecido por la entidad reguladora, es decir que el Certificado pueda valer 1 a\u00f1o.  ", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:25:24-04:00"}, {"id": "9", "date": "2022-10-20T14:03:14-04:00", "title": "Plan de entrega de los bienes", "description": "En donde dice: Cantidad M\u00ednima: \u00b7 1ra. Entrega: Hasta el 10 % de la cantidad m\u00ednima adjudicada. El oferente tendr\u00e1 un plazo de hasta 10\n(diez) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. \u00b7 2\u00ba Entrega: Hasta\nel 30% de la cantidad m\u00ednima adjudicada. Seg\u00fan necesidad del servicio. El oferente tendr\u00e1 un plazo de hasta 10 (diez) d\u00edas\ncorridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. \u00b7 3\u00ba Entrega: Hasta el 50% de\nla cantidad m\u00ednima adjudicada. Seg\u00fan necesidad del servicio. El oferente tendr\u00e1 un plazo de hasta 10 (diez) d\u00edas corridos\npara la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. \u00b7 se solicita amablemente a a la convocante ampliar los plazos de entrega, considerando tiempo de producci\u00f3n para los productos locales y tiempo de importaci\u00f3n para los productos locales.", "author": {"name": "FARMACEUTICA PARAGUAYA S.A.", "id": "PY-RUC-80006276-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:07:35-04:00"}, {"id": "82", "date": "2022-10-23T09:57:54-04:00", "title": "Vencimiento de los Productos", "description": "Solicitamos a la convocante considerar para la entrega un vencimiento de 15 meses y para poliza un vencimiento de 12 meses o menor, ya que los productos en cuesti\u00f3n en su mayor\u00eda son importados y dif\u00edcilmente lleguen con 18 meses al pais, y debemos importar por lo menos la cantidad minima y mantener en nuestros dep\u00f3sitos en espera de la emision por parte del administrador del contrato segun necesidad de la insitucion. ", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:44:03-04:00"}, {"id": "47", "date": "2022-10-21T17:29:30-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica. Punto 16", "description": "En dicho criterio la Convocante establece: \"Deber\u00e1n presentar como m\u00ednimo cuatro reportes locales del Informe Peri\u00f3dico de Seguridad (PSUR), que hayan sido entregados a DINAVISA, durante la comercializaci\u00f3n del producto\" En relaci\u00f3n al requisito establecido, solicitamos a la Convocante aclarar en que reglamentaci\u00f3n se basa al solicitar este documento, considerando que este documento no es exigible siquiera por la autoridad reguladora, por lo que esto resulta limitante.", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:44:51-04:00"}, {"id": "7", "date": "2022-10-20T09:01:33-04:00", "title": "\u00cdTEM 13 - FULVESTRANT 250 MG - PRESENTACION", "description": "Pagina 27/46 especificaciones t\u00e9cnicas: Solicitamos a la Convocante muy respetuosamente modificar la presentaci\u00f3n solicitada a cuanto sigue: KIT conteniendo 2 jeringas pre rellenadas / KIT conteniendo frasco ampolla de vidrio de 5 ml c/u acompa\u00f1ado de kit de administraci\u00f3n:2 jeringas y 4 agujas, atendiendo que en el mercado hay dos presentaciones del producto solicitado. Con esto la convocante garantiza mayor cantidad de oferentes que puedan participar del proceso.", "author": {"name": "TASSOS SA", "id": "PY-RUC-80078413-8"}, "answer": "Favor considerar los t\u00e9rminos iniciales ya establecidos por la Convocante.", "dateAnswered": "2022-11-18T14:58:49-04:00"}, {"id": "32", "date": "2022-10-21T16:07:07-04:00", "title": "CAPACIDAD TECNICA", "description": "Para el producto Trastuzumab, en el punto 16. no aclara si el Informe peri\u00f3dico de Seguridad solo deber\u00e1n ser reportes locales o si pueden ser del pa\u00eds de origen.", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:27:30-04:00"}, {"id": "99", "date": "2022-11-16T17:52:03-04:00", "title": "Punto 10. de Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "En el punto de referencia, la Convocante no detalla todos los paises habilitados conforme al Art. 4 del Decreto 6611/16. Por dicha raz\u00f3n, reiteramos ampliar las autoridades reguladoras indicadas en dicho punto, conforme a lo dispuesto en la normativa vigente al respecto (Art. 4 del Decreto 6611/16). O en todo caso aclarar que se aceptan documentaciones emitidas por los paises detallados en el Decreto mencionado, a fin de evitar la falta de los mismos. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor ajustarse y considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T17:43:15-04:00"}, {"id": "29", "date": "2022-10-21T15:40:23-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "Favor aclarar donde inicia y termina el punto 16 al igual que el punto 17.", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:26:26-04:00"}, {"id": "87", "date": "2022-10-23T15:33:12-04:00", "title": "CAPACIDAD TECNICA", "description": "Item 10, donde dice: Para productos biosimilar presentar\u00e1 certificados de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n vigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA,FDA, Health Canada, ANVISA o ANMAT. El producto biosimilar deber\u00e1 contar con Registro Sanitario emitido por DNV, con antelaci\u00f3n m\u00ednima de 3 a\u00f1os. \nAl momento de que DINAVISA otorga el Registro Sanitario, y posterior Acta de Precios, los medicamentos tienen habilitada la venta en todo el territorio, incluido participar en Licitaciones. Solicitamos a la convocante excluir este punto, pues el mismo atenta contra la libre competencia\n", "author": {"name": "INNOVAPHARMA S.R.L", "id": "PY-RUC-80005431-8"}, "answer": "Favor considerar los t\u00e9rminos actuales del PbyC.", "dateAnswered": "2022-11-18T17:35:31-04:00"}, {"id": "70", "date": "2022-10-22T19:58:53-04:00", "title": "PBC \u0096 Requisito documental para evaluar capacidad t\u00e9cnica- P\u00e1gs. 24/46. Punto 16", "description": "\u00bfEs posible presentar reportes de Informes Peri\u00f3dicos de Seguridad de otros pa\u00edses en los cuales se tenga una experiencia m\u00e1s prolongada de uso del medicamento? En caso afirmativo, cu\u00e1les? Podr\u00edan utilizarse de lugares donde el producto fue aprobado por las autoridades competentes?", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:23:03-04:00"}, {"id": "33", "date": "2022-10-21T16:20:10-04:00", "title": "CAPACIDAD TECNICA", "description": "Pagina 24/46 \u0096 punto 16 del PBC menciona: Deber\u00e1n presentar como m\u00ednimo cuatro reportes locales del Informe Peri\u00f3dico de Seguridad (PSUR), que hayan sido entregados a DINAVISA, durante la comercializaci\u00f3n del producto: En el Plan de Farmacovigilancia del producto, se deber\u00e1 considerar, de acuerdo a la Gu\u00eda correspondiente los siguientes puntos: \n-Efectos adversos raros y especialmente peligrosos. \n-Actividades para continuar con un control de inmunogenicidad. -\n- Tener un procedimiento adecuado de trazabilidad del biosimilar y distinguirlo del producto de referencia. - \nSolicitamos amablemente a la Convocante aclarar si este punto solo de aplica solo a productos BIOLOGICOS / BIOSIMILARES y no a todos los dem\u00e1s \u00edtems solicitados.\n", "author": {"name": "TASSOS SA", "id": "PY-RUC-80078413-8"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:27:39-04:00"}, {"id": "14", "date": "2022-10-20T17:01:16-04:00", "title": "ABATECIMIENTO SIMULTANEO", "description": "Solicitamos que se aplique el sistema de abastecimiento simult\u00e1neo, con el fin de evitar desabastecimientos.", "author": {"name": "LABORATORIOS BAGO DEL PARAGUAY S.A.", "id": "PY-RUC-80011309-8"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:18:08-04:00"}, {"id": "71", "date": "2022-10-22T19:59:32-04:00", "title": "PBC \u0096 Requisito documental para evaluar capacidad t\u00e9cnica- P\u00e1gs. 24/46. Punto 19", "description": "Los productos biol\u00f3gicos innovadores presentar\u00e1n copia autenticada de Certificado de Libre Venta, emitido por una entidad regulatoria de referencia, FDA o EMA. Entonces, si el CLV para productos biosimilares es emitido por FDA o EMA; no es necesario presentar los estudios mencionados en el Punto 11?", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:23:15-04:00"}, {"id": "27", "date": "2022-10-21T15:36:11-04:00", "title": "VENCIMIENTO ", "description": "El Pliego de Bases y Condiciones en el apartado  Detalle de los productos con las respectivas especificaciones t\u00e9cnicas , punto Vencimiento indica cuanto sigue: \u0085El vencimiento m\u00ednimo medicamentos no deber\u00e1 ser inferior a 18 meses (diez y ocho) meses al momento de la entrega en los parques sanitarios, si por la naturaleza del mismo o por necesidad de la Instituci\u00f3n no se puede cumplir con este requisito la recepci\u00f3n del articulo deber\u00e1 ser autorizada por la Direcci\u00f3n Log\u00edstica de la Direcci\u00f3n General de Gesti\u00f3n en Insumos Estrat\u00e9gicos en Salud. Para aquellos medicamentos cuyo vencimiento sea inferior a 18 meses adem\u00e1s de la autorizaci\u00f3n de la DGGIES se deber\u00e1 presentar P\u00f3liza de Seguro por el 100 % del monto del producto con identificaci\u00f3n del n\u00famero de lote, que ser\u00e1n entregados u original en la oficina de Contratos y Garant\u00edas de la DGGIES y el duplicado en el Parque Sanitario que corresponda.\nLa validez de dicha p\u00f3liza deber\u00e1 ser por 3 meses posteriores a la fecha del vencimiento del articulo a entregar. Adem\u00e1s, deber\u00e1n Presentar Declaraci\u00f3n Jurada por la cual el oferente se compromete en caso de ser adjudicados a canjear los insumos 6 meses antes de su vencimiento , previo informe de los responsables de la Direcci\u00f3n de Log\u00edstica dependiente de la Direcci\u00f3n General de Gesti\u00f3n de insumos Estrat\u00e9gicos (sic).   Los \u00edtems objeto de este llamado se tratan de productos biol\u00f3gicos que se obtienen mediante el empleo de organismos o c\u00e9lulas vivas, cuyo vencimiento te\u00f3rico no supera los 24  meses debido a esta condici\u00f3n, y que a su vez, pasa por rigurosos procesos de aseguramiento de calidad para asegurar la eficacia y la estabilidad del producto que pueden extenderse hasta 4 meses, sumado al tiempo de tr\u00e1nsito y desaduanaje que en promedio se extiende tambi\u00e9n por otros 4 meses para poder entregar los productos a la Convocante en tiempo y forma.  Para poder cumplir con el plan de entregas establecido por el pliego de bases y condiciones requiere contar con un stock de seguridad para dar respuesta inmediata a las necesidades de la Convocante.  El requerimiento de una p\u00f3liza de seguro para medicamentos con vencimiento mayor a 12 meses podr\u00eda incidir de forma negativa en la estructura de costos del proceso. Solicitamos que: La Convocante analice la posibilidad de modificar su segundo p\u00e1rrafo, solicitando Carta Compromiso de Canje y P\u00f3liza de Seguro por el 100% del monto del producto a ser entregado, para productos con vencimiento inferior a 12 meses.\n\n", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:26:05-04:00"}, {"id": "55", "date": "2022-10-22T09:23:29-04:00", "title": "REQUISITO DOCUMENTAL PARA EVALUAR LA CAPACIDAD TECNICA", "description": "En el punto N\u00ba 10 la Convocante solicita lo siguiente Para productos biosimilar presentar\u00e1 certificados de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n vigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA, FDA, Health Canada, ANVISA o ANMAT. El producto biosimilar deber\u00e1 contar con Registro Sanitario emitido por DNV, con antelaci\u00f3n m\u00ednima de 3 a\u00f1os. Solicitamos a la convocante excluir el requerimiento de que el registro sanitario deber\u00e1 contar con una m\u00ednima antelaci\u00f3n de 3 a\u00f1os, teniendo en cuenta que una vez emitido el registro sanitario y acta de precios por la Autoridad Sanitaria Reguladora DNVS, el mismo se encuentra autorizado para la comercializaci\u00f3n. Por lo tanto dicho requerimiento no hace m\u00e1s que liminar innecesariamente la participaci\u00f3n de potenciales oferentes, transgrediendo as\u00ed el principio que igualdad y libre competencia de la Ley N\u00ba 2051/03.", "author": {"name": "EUROQUIMICA S.A.", "id": "PY-RUC-80061211-6"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:47:09-04:00"}, {"id": "11", "date": "2022-10-20T14:35:05-04:00", "title": "Item 18 Fluoruracilo", "description": "Atendiendo a que existen varias presentaciones de este producto en el mercado, y por el principio de igualdad y libre competencia establecidos en la Ley de Contrataciones, solicitamos se cambien las especificaciones t\u00e9cnicas, permitiendo la cotizaci\u00f3n de dosis de 250mg tambi\u00e9n y en viales de 50ml.", "author": {"name": "LIBRA PARAGUAY S.A.", "id": "PY-RUC-80023379-4"}, "answer": "Favor considerar los t\u00e9rminos iniciales ya establecidos por la Convocante.", "dateAnswered": "2022-11-18T15:16:37-04:00"}, {"id": "58", "date": "2022-10-22T09:42:07-04:00", "title": "REQUISITO DOCUMENTAL PARA EVALUAR LA CAPACIDAD TECNICA", "description": "La convocante solicita la presentaci\u00f3n de los siguientes documentos para evaluar la capacidad t\u00e9cnica: Caracterizaci\u00f3n fisicoqu\u00edmica igual al producto biol\u00f3gico innovador de referencia, El producto biosimilar deber\u00e1 incluir sus estudios cl\u00ednicos, propios, multic\u00e9ntricos, randomizados, en la indicaci\u00f3n m\u00e1s referente al producto. El producto biosimilar deber\u00e1 presentar estudios de farmacocin\u00e9tica y farmacodinamia comparables al biol\u00f3gico innovador. Cabe resaltar que los documentos citados son considerados de car\u00e1cter confidencial por los elaboradores de los productos a ser ofertados, los cuales son remitidos exclusivamente para su presentaci\u00f3n ante la Autoridad Sanitaria Reguladora DNVS para la obtenci\u00f3n del  Registro Sanitario, previa evaluaci\u00f3n de los mismos. Una vez obtenido el registro Sanitario con la nomenclatura MB, dicho registro resulta suficiente autorizaci\u00f3n para su comercializaci\u00f3n en el territorio Nacional. Por lo cual solicitamos que los requisitos mencionados en el PBC sean excluidos, a modo de no limitar la participaci\u00f3n de los oferentes. A su vez amparados en el Art. 22 de la Ley N\u00ba 6611/16 que manifiesta lo siguiente  De cumplir el titular del registro Sanitario con todos los requerimientos  de este Decreto y habiendo la Direcci\u00f3n Nacional de Vigilancia Sanitaria DNVS  otorgado la autorizaci\u00f3n de comercializaci\u00f3n, a trav\u00e9s del correspondiente registro Sanitario, podr\u00e1 comercializar los productos biol\u00f3gicos afectados a este decreto dentro del territorio de la rep\u00fablica del Paraguay, por s\u00ed mismo o por representaci\u00f3n concedida., siendo las documentaciones mencionadas en el presente decreto suficientes para ser utilizadas en todos los procesos de adquisici\u00f3n como garant\u00eda de calidad, seguridad y eficacia de los medicamentos biol\u00f3gicos. ", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "Favor ajustarse y  considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:48:10-04:00"}, {"id": "79", "date": "2022-10-23T09:40:21-04:00", "title": "PBC \u0096 Requisito documental para evaluar capacidad t\u00e9cnica- P\u00e1gs. 24/46. Punto 11", "description": "En el caso de productos biosimilares \u00bfCu\u00e1l es el fundamento t\u00e9cnico para solicitar estos estudios que ya fueron presentados como parte de los requisitos para la obtenci\u00f3n del registro sanitario de medicamentos biosimilares por comparabilidad \u0096 Art. 8 Decreto 6611/16? \u00bfAcaso la obtenci\u00f3n del RS no es suficiente para comercializar un medicamento en territorio paraguayo conforme lo establece el Art. 22 del Decreto 6611/16?", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor ajustarse y considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:27:37-04:00"}, {"id": "36", "date": "2022-10-21T16:26:32-04:00", "title": "CAPACIDAD T\u00c9CNICA", "description": "No queda claro que documentos solicitan para cada tipo de producto. Favor especificar los documentos solicitados para cada \u00edtem", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:28:09-04:00"}, {"id": "86", "date": "2022-10-23T15:23:23-04:00", "title": "SISTEMA DE ABASTECIMIENTO", "description": "Se solicita a la convocante aplicar el sistema de abastecimiento simultaneo, a fin de dar mayor participaci\u00f3n a posibles oferentes, como tambi\u00e9n salvaguardar la libre competencia y provisi\u00f3n de los medicamentos en tiempo y forma.", "author": {"name": "INNOVAPHARMA S.R.L", "id": "PY-RUC-80005431-8"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:44:38-04:00"}, {"id": "16", "date": "2022-10-21T06:37:26-04:00", "title": "EXPERIENCIA REQUERIDA", "description": "La convocante ha resuelto indebidamente en este llamado agregar en experiencia el siguiente p\u00e1rrafo: Los productos biosimilares deber\u00e1n contar con experiencia de uso y comercializaci\u00f3n en Paraguay con facturaciones de\nventas y/o contratos ejecutados en los a\u00f1os 2019, 2020, y 2021, por un monto m\u00ednimo del 50% (cincuenta) por ciento del valor total del producto solicitado en dicha licitaci\u00f3n. Esta exigencia no se encuentra en ning\u00fan pliego anterior, no es razonable y atenta contra el principio de igualdad, solicitamos su exclusi\u00f3n", "author": {"name": "LIBRA PARAGUAY S.A.", "id": "PY-RUC-80023379-4"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:18:40-04:00"}, {"id": "62", "date": "2022-10-22T19:38:21-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica -Punto 11 - PAg.ag. 24/46", "description": ". Solicitamos aclarar si el producto es solicitado como Medicamento Biologico o como Medicamento Biosimilar por comp\u00e1rabilidad. En el decreto 6611/2016 se establecen requisitos para el Registro Sanitario de Medicamentos biol\u00f3gicos Capitulo II, Art 6 ; Requisitos para el Registro sanitario de Medicamentos Biologicos Innovadores, Capitulo III, Art 7; y Requisitos y Lineamientos para el Registro Sanitario de medicamentos Biosimilares por comparabilidad, Capitulo IV, Art 8. \nLo que se solicita en este punto 11 se solicita en el capitulo IV es decir para registrar un Medicamento Biosimilar, no asi para el Registro de un medicamento Biol\u00f3gico. \nFavor aclarar\n", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Se aclara que corresponde a productos Biosimilares.", "dateAnswered": "2022-11-18T15:50:42-04:00"}, {"id": "30", "date": "2022-10-21T15:44:50-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "En el Plan de farmacovigilancia del producto, se deber\u00e1 considerar, de acuerdo a la Gu\u00eda correspondiente los\nsiguientes puntos:\n* Efectos adversos raros y especialmente peligrosos..... A la convocante: Los efectos adversos y especialmente peligrosos est\u00e1n contemplados en el prospecto de informaci\u00f3n al m\u00e9dico, y los nuevos efectos adversos encontrados son reportados en el Informe Peri\u00f3dico de Seguridad (PSUR), solicitamos que sea excluido ya que no corresponden al plan de farmacovigilancia.", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:26:48-04:00"}, {"id": "93", "date": "2022-10-24T07:54:48-04:00", "title": "PLAN DE ENTREGAS", "description": "En relaci\u00f3n a los plazos establecidos para la entrega solicitamos a la Convocante ampliar los mismos a al menos 20 dias corridos para las cantidades minimas y 30 dias corridos para las cantidades maximas, considerando que los productos requeridos son productos especificos de alto costo, y la Convocante solicita vencimientos sumamente altos, por lo que mantenerlos en un stock elevado conllevan sobrecostos muy altos para los potenciales oferentes. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:45:29-04:00"}, {"id": "63", "date": "2022-10-22T19:42:49-04:00", "title": "Punto 16 - Requisitos para demostrar capacidad t\u00e9cnica. Pag. 24/46", "description": "Favor Aclarar si para los productos que se hayan registrado aqu\u00ed hace muy poco tiempo podr\u00eda presentar los reportes de los pa\u00edses en donde ya se han utilizado.", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor consideras las modificaciones establecidas en el PbyC.", "dateAnswered": "2022-11-18T17:26:40-04:00"}, {"id": "94", "date": "2022-11-16T12:48:21-04:00", "title": "CAPACIDAD TECNICA", "description": "Solicitamos a la convocante modificar el Punto 12. a la siguiente forma. Autorizaci\u00f3n del Fabricante para los Representantes y/o Distribuidores.\nAs\u00ed mismo, la documentaci\u00f3n podr\u00e1 ser presentada en copia simple, no obstante, para la firma del Contrato la misma deber\u00e1 estar inscripta en el Registro P\u00fablico de Comercio Secci\u00f3n\nRepresentaciones.\n", "author": {"name": "LABORATORIOS BAGO DEL PARAGUAY S.A.", "id": "PY-RUC-80011309-8"}, "answer": "Favor ajustarse y considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T17:42:22-04:00"}, {"id": "15", "date": "2022-10-20T17:30:01-04:00", "title": "EXPERIENCIA REQUERIDA", "description": "Solicitamos a la convocante modificar Experiencia requerida por un monto equivalente al 25% de lo ofertado en promedio de los siguientes a\u00f1os 2017-2018-2019-2020-2021", "author": {"name": "LABORATORIOS BAGO DEL PARAGUAY S.A.", "id": "PY-RUC-80011309-8"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:18:24-04:00"}, {"id": "68", "date": "2022-10-22T19:57:52-04:00", "title": "PBC \u0096 Requisito documental para evaluar capacidad t\u00e9cnica- P\u00e1gs. 24/46. Punto 10", "description": "Teniendo en cuenta que el Registro Sanitario constituye: i) la autorizaci\u00f3n otorgada por la autoridad competente, para distribuir y comercializar una especialidad farmac\u00e9utica en el mercado paraguayo; ii) se emite luego cumplidos todos los requisitos y exigencias de la normativa vigente \u00bfCu\u00e1l es el fundamento para excluir productos que no hayan obtenido Registro Sanitario con antelaci\u00f3n m\u00ednima de 3 a\u00f1os? \n\u00bfNo constituye esta condici\u00f3n una transgresi\u00f3n al principio de igualdad y libre competencia previsto en el Art. 4 de la Ley N\u00b0 2051/03?\nCu\u00e1l es la l\u00f3gica de permitir la compra del producto en una farmacia determina; pero prohibir su participaci\u00f3n en procesos de contrataci\u00f3n?\n", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:22:31-04:00"}, {"id": "49", "date": "2022-10-21T17:37:06-04:00", "title": "Experiencia requerida.", "description": "En la p\u00e1gina 22/46 del P.B.C. se establece: Los productos biosimilares deber\u00e1n contar con experiencia de uso y comercializaci\u00f3n en Paraguay con facturaciones de ventas y/o contratos ejecutados en los a\u00f1os 2019, 2020, y 2021, por un monto m\u00ednimo del 50% (cincuenta) por ciento del valor total del producto solicitado en dicha licitaci\u00f3n.\nSolicitamos a la Convocante excluir este requisito porque limita la participaci\u00f3n de oferentes.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:45:21-04:00"}, {"id": "75", "date": "2022-10-22T20:22:30-04:00", "title": "Requisitos documentales para la evaluaci\u00f3n de la experiencia", "description": "1. Copias de Contratos y/o facturaciones\n2. Para Productos biosimilares: Experiencia de uso y comercializaci\u00f3n en Paraguay.\n\nConsulta: para el punto 2  a que documentos exactamente se refieren?", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:24:21-04:00"}, {"id": "13", "date": "2022-10-20T16:43:57-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "En el punto 16. la Convocante establece cuanto sigue: \"Deber\u00e1n presentar como m\u00ednimo cuatro reportes locales del Informe Peri\u00f3dico de Seguridad (PSUR), que hayan sido entregados a DINAVISA, durante la comercializaci\u00f3n del producto\". Al respecto, solicitamos a la Convocante aclarar en que reglamentaci\u00f3n se basa al solicitar los mismos, considerando que estos no son requisitos establecidos por la autoridad reguladora. Por tanto, la Convocante al solicitar documentaciones ni siquiera exigibles por el organismo regulador, se encuentra limitando la participaci\u00f3n de potenciales oferentes en detrimento de los principios consagrados en la Ley 2051/03. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:17:53-04:00"}, {"id": "95", "date": "2022-11-16T15:33:14-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica.", "description": "Estimados se\u00f1ores de la Administraci\u00f3n Convocante, solicitamos afablemente que consideren modificar los t\u00e9rminos del pliego de bases y condiciones de la LPN Nro. 91/2022 para la Adquisici\u00f3n de medicamentos oncol\u00f3gicos para el INCAN y otros Centros Oncol\u00f3gicos del MSP y BS -Versi\u00f3n 5- publicado en fecha 15 de noviembre de 2022 respecto a los requisitos documentales para evaluar la capacidad t\u00e9cnica de las ofertas presentadas. Tal es as\u00ed que en la convocatoria se utiliza el sistema de adjudicaci\u00f3n de abastecimiento simult\u00e1neo para el suministro de determinados medicamentos -entre ellos el individualizado bajo el \u00cdTEM Nro. 3- y a los efectos de evaluar la capacidad t\u00e9cnica de este producto se han suprimido determinados requerimientos esenciales que deber\u00edan volver a incluirse para la evaluaci\u00f3n de este \u00cdTEM Nro. 3. En ese sentido entre los requisitos indispensables a ser tenidos en consideraci\u00f3n para que prime la libre competencia, eficiencia y capacidad entre todos los oferentes que ofrezcan el \u00cdTEM Nro. 3 se debe solicitar que \u00e9stos re\u00fanan las siguientes aristas/capacidades: Requisito documental para evaluar la capacidad t\u00e9cnica: Punto 10. Para productos biosimilares deber\u00e1n presentar certificados de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n vigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA, FDA, HEALTH CANAD\u00c1, ANVISA o AMMAT. El producto biosimilar deber\u00e1 contar con Registro Sanitario emitido por DNV, con antelaci\u00f3n m\u00ednima de 3 a\u00f1os. Cabe aclarar que solicitamos que se utilice esta redacci\u00f3n para dejar perfectamente sentados todos los requerimientos que deben ser tenidos en cuenta al evaluar productos biosimilares y la redacci\u00f3n actual del punto 10 se encuentra escueta. As\u00ed tambi\u00e9n solicitamos que entre los requisitos documentales para evaluar la capacidad t\u00e9cnica sea nuevamente incluido el punto 16 bajo los siguientes t\u00e9rminos: Para productos biosimilares deber\u00e1n presentar como m\u00ednimo cuatro reportes locales del Informe Peri\u00f3dico de Seguridad (PSUR), que hayan sido entregados a DINAVISA durante la comercializaci\u00f3n del producto. \nRatificamos que estas modificaciones favorecer\u00e1n el sistema de evaluaci\u00f3n y adquisici\u00f3n de los mejores productos para el INCAN y otros Centros Oncol\u00f3gicos del MSP y BS", "author": {"name": "PHARMA INTERNATIONAL SA", "id": "PY-RUC-80018716-4"}, "answer": "Favor ajustarse y considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T17:42:32-04:00"}, {"id": "10", "date": "2022-10-20T14:09:45-04:00", "title": "Item 20 Docetaxel", "description": "Solicitamos se cambien las especificaciones t\u00e9cnicas teniendo en cuenta que el efecto terap\u00e9utico lo ejerce el docetaxel no as\u00ed la cantidad de mol\u00e9culas de agua que contenga en su estructura. De esa forma cumplir el principio de igualdad y la libre competencia.", "author": {"name": "LIBRA PARAGUAY S.A.", "id": "PY-RUC-80023379-4"}, "answer": "La Convocante se mantiene en los t\u00e9rminos inicialmente establecidos, teniendo en cuenta, el mecanismo de acci\u00f3n que ejerce el docetaxel, al interrumpir la red microtubular en las celular.", "dateAnswered": "2022-11-18T15:14:09-04:00"}, {"id": "43", "date": "2022-10-21T17:12:12-04:00", "title": "Punto 10. de Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "En el punto 10. la Convocante establece: \"Para productos biosimilares presentar certificado de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n vigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA,FDA, Health Canad\u00e1, ANVISA o ANMAT.\" Al respecto se solicita amablemente a la Convocante aclarar a que documentaci\u00f3n espec\u00edficamente se refiere cuando menciona \"autorizaci\u00f3n de comercializaci\u00f3n\". Recordamos que conforme al Decreto 6611/16, para la comercializaci\u00f3n del producto se puede presentar indistintamente el Certificado de Buenas Practicas y/ certificado del producto farmac\u00e9utico. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:34:21-04:00"}, {"id": "48", "date": "2022-10-21T17:34:23-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica. Punto 16", "description": "En dicho punto, la Convocante establece: \nEn el Plan de farmacovigilancia del producto, se deber\u00e1 considerar, de acuerdo a la Gu\u00eda correspondiente los siguientes puntos:\n- Efectos adversos raros y especialmente peligrosos.\n- Actividades para continuar con un control de inmunogenicidad.-\n- Tener un procedimiento adecuado de trazabilidad del biosimilar y distinguirlo del producto de referencia.-\n- En caso de intercambio entre el innovador y el biosimilar, se deber\u00e1 presentar un plan que considere estos aspectos.\nAl respecto, solicitamos aclarar cuanto sigue: \n1. Solicitamos aclarar a que gu\u00eda hace referencia la Convocante al mencionar lo detallado.\n2.  Esto quiere decir que en caso de ser adjudicados, el proveedor tendr\u00e1 acceso total a los pacientes, fichas t\u00e9cnicas de los mismos, m\u00e9dicos tratantes y personal de los servicios para la ejecuci\u00f3n del plan solicitado, considerando que este y los dem\u00e1s requisitos establecidos en el punto 16, se desarrollan en un ambiente espec\u00edficamente hospitalario y para poder realizar los procedimientos y planes, el proveedor debe contar con el acceso irrestricto a toda la informaci\u00f3n necesaria. \n3. Se solicita establecer claramente a que productos espec\u00edficos es aplicado el criterio establecido en dicho punto, considerando que los estudios de inmunogenicidad no pueden ser aplicados a todos los productos detallados en las EETT.\n4. En el \u00faltimo p\u00e1rrafo de dicho criterio hacen referencia a innovador y el biosimilar, solicitamos aclarar si este criterio establecido en el punto 16. Es exclusivo para productos biol\u00f3gicos y a que productos espec\u00edficamente. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:45:04-04:00"}, {"id": "100", "date": "2022-11-16T17:54:24-04:00", "title": "Punto 11. Requisitos documentales para evaluar la capacidad tecnica", "description": "En relaci\u00f3n al punto de referencia, solicitamos a la Convocante aclarar los siguientes puntos: 1.\tEn relaci\u00f3n al requisito se solicita a la Convocante especificar qu\u00e9 tipo de caracterizaci\u00f3n fisicoqu\u00edmica es la requerida. \n2.\tCuando la Convocante hace menci\u00f3n a indicaci\u00f3n m\u00e1s referente al producto. Solicitamos aclarar para cada producto cual es la indicaci\u00f3n m\u00e1s referente que considera la Convocante, esto a fin de evitar subjetividades. \n3.\tSe solicita aclarar que criterios y datos espec\u00edficos evaluara la Convocante sobre estos estudios requeridos, a fin de garantizar la presentaci\u00f3n de las documentaciones conforme a los criterios que ser\u00e1n evaluados para cada caso. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor ajustarse y considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T17:43:27-04:00"}, {"id": "83", "date": "2022-10-23T10:00:58-04:00", "title": "Cronograma de Entregas", "description": "Favor considerar ampliar los plazos de entrega, desde la segunda entrega en adelante, considerando que se deben realizar muchos tramites administrativos para la entrega de los mismos, sea por la distancia y se podria presentar el caso de solicitar autorizacion de entrega. ", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:44:16-04:00"}, {"id": "92", "date": "2022-10-24T07:52:14-04:00", "title": "ITEM 13- PRECIO REFERENCIAL", "description": "Solicitamos aclaraci\u00f3n si en el \u00edtem 13 - Fulvestrant el precio referencial de Gs. 7.732.000 seria por Caja conteniendo 2 jeringas prellenadas / Caja conteniendo frasco ampolla de vidrio de 5 ml c/u o lo solicitado seria por unidad?", "author": {"name": "TASSOS SA", "id": "PY-RUC-80078413-8"}, "answer": "Favor ajustarse y considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:46:45-04:00"}, {"id": "26", "date": "2022-10-21T15:34:30-04:00", "title": "PLAZO DE ENTREGA: ", "description": "El Pliego de Bases y Condiciones indica en el apartado Plan de Entrega de los bienes, cuanto sigue: \u0085Cantidad M\u00ednima: \u00b7 1ra. Entrega: Hasta el 10 % de la cantidad m\u00ednima adjudicada. El oferente tendr\u00e1 un plazo de hasta 10 (diez) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. \u00b7 2\u00ba Entrega: Hasta el 30% de la cantidad m\u00ednima adjudicada. Seg\u00fan necesidad del servicio. El oferente tendr\u00e1 un plazo de hasta 10 (diez) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. \u00b7 3\u00ba Entrega: Hasta el 50% de la cantidad m\u00ednima adjudicada. Seg\u00fan necesidad del servicio. El oferente tendr\u00e1 un plazo de hasta 10 (diez) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN.  Saldo: Seg\u00fan necesidad del Servicio, con \u00f3rdenes de compra emitidas con plazos de hasta 10 (diez) d\u00edas corridos a ser contados a partir de la recepci\u00f3n de la misma por el proveedor. Cantidad m\u00e1xima: A ser emitida una vez recibida la totalidad de las cantidades m\u00ednimas, con plazos de entrega de hasta 10 (diez) d\u00edas a ser contados a partir de la recepci\u00f3n de la orden de compra por parte del proveedor (sic). Teniendo en cuenta que estos productos deben ser importados y que por la naturaleza de los mismos  su vencimiento te\u00f3rico no superan los 24  meses y que a su vez, pasan por rigurosos procesos de aseguramiento de calidad para asegurar la eficacia y la estabilidad del producto que pueden extenderse hasta  4  meses, sumado al tiempo de tr\u00e1nsito y desaduanaje,  los cuales  generan dilaciones significativas en las importaciones. En este sentido, solicitamos a la Convocante analice la posibilidad de establecer el siguiente plan de entregas:  CANTIDAD MINIMA: - Primera Entrega Hasta el 10 % de la Cantidad M\u00ednima Adjudicada dentro de 15 d\u00edas corridos de recepcionada la Orden de Compra emitida por el INCAN. Segunda Entrega: Hasta el 30% de la cantidad m\u00ednima adjudicada. Seg\u00fan necesidad del servicio. El oferente tendr\u00e1 un plazo de hasta 20 (veinte) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. Tercera Entrega: Hasta el 50% de la cantidad m\u00ednima adjudicada. Seg\u00fan necesidad del servicio. El oferente tendr\u00e1 un plazo de hasta 30 (treinta) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN.  SALDO: Seg\u00fan necesidad del Servicio, con \u00f3rdenes de compra emitidas con plazos de hasta 30 (treinta) d\u00edas corridos a ser contados a partir de la recepci\u00f3n de la misma por el proveedor. CANTIDAD M\u00c1XIMA: A ser emitida una vez recibida la totalidad de las cantidades m\u00ednimas, con plazos de entrega de hasta 30 (treinta) d\u00edas a ser contados a partir de la recepci\u00f3n de la orden de compra por parte del proveedor (sic).\n\n", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:25:57-04:00"}, {"id": "78", "date": "2022-10-23T09:39:45-04:00", "title": "PBC \u0096 Requisito documental para evaluar capacidad t\u00e9cnica- P\u00e1gs. 24/46. Punto 10", "description": "Teniendo en cuenta que el Registro Sanitario constituye: i) la autorizaci\u00f3n otorgada por la autoridad competente, para distribuir y comercializar una especialidad farmac\u00e9utica en el mercado paraguayo; ii) se emite luego cumplidos todos los requisitos y exigencias de la normativa vigente \u00bfCu\u00e1l es el fundamento para excluir productos que no hayan obtenido Registro Sanitario con antelaci\u00f3n m\u00ednima de 3 a\u00f1os? \n\u00bfNo constituye esta condici\u00f3n una transgresi\u00f3n al principio de igualdad y libre competencia previsto en el Art. 4 de la Ley N\u00b0 2051/03?\nCu\u00e1l es la l\u00f3gica de permitir la compra del producto en una farmacia determina; pero prohibir su participaci\u00f3n en procesos de contrataci\u00f3n?\n", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor ajustarse y considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:26:08-04:00"}, {"id": "35", "date": "2022-10-21T16:23:24-04:00", "title": "CAPACIDAD TECNICA", "description": "Dice: En caso de intercambio entre el innovador y el biosimilar, se deber\u00e1 presentar un plan que considere estos\naspectos. Solicitamos respetuosamente a la convocante excluir lo solicitado para productos que ya cuentan con experiencia de uso local como el trastuzumab.", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:27:57-04:00"}, {"id": "61", "date": "2022-10-22T19:36:11-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica- Punto 10 PBC -Pag. 24/46 ", "description": "1. La  Autorizacion de comercializaci\u00f3n vigente es el CLV, que ya fue presentado para la obtenci\u00f3n del RS.  SE recomienda omitir este punto que limita la participaci\u00f3n.-\n2. Que es DNV?\n", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:49:57-04:00"}, {"id": "38", "date": "2022-10-21T16:42:54-04:00", "title": "PLAN DE ENTREGA DE LOS BIENES.", "description": "El Plan de entregas de los bienes, p\u00e1gina 28 del P.B.C, establece el siguiente Plan de Entregas: Cantidad M\u00ednima: * 1ra. Entrega: Hasta el 10 % de la cantidad m\u00ednima adjudicada. El oferente tendr\u00e1 un plazo de hasta 10 (diez) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. * 2\u00ba Entrega: Hasta el 30% de la cantidad m\u00ednima adjudicada. Seg\u00fan necesidad del servicio. El oferente tendr\u00e1 un plazo de hasta 10 (diez) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. * 3\u00ba Entrega: Hasta el 50% de la cantidad m\u00ednima adjudicada. Seg\u00fan necesidad del servicio. El oferente tendr\u00e1 un plazo de hasta 10 (diez) d\u00edas corridos para la entrega a partir de la recepci\u00f3n de la Orden de Compra emitida por el INCAN. \nSaldo: Seg\u00fan necesidad del Servicio, con \u00f3rdenes de compra emitidas con plazos de hasta 10 (diez) d\u00edas corridos a ser contados a partir de la recepci\u00f3n de la misma por el proveedor.\nCantidad m\u00e1xima: A ser emitida una vez recibida la totalidad de las cantidades m\u00ednimas, con plazos de entrega de hasta\n10 (diez) d\u00edas a ser contados a partir de la recepci\u00f3n de la orden de compra por parte del proveedor.\n\nSolicitamos a la Convocante que la 1ra. Entrega de hasta el 10 % de la cantidad m\u00ednima adjudicada tenga un plazo de hasta 10 (diez) d\u00edas corridos para la entrega, pero que las dem\u00e1s entregas, desde la segunda hasta completar la cantidad total adjudicada tenga un plazo de hasta 20 (veinte) d\u00edas corridos para la entrega.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:28:39-04:00"}, {"id": "4", "date": "2022-10-19T15:02:29-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica, punto 10", "description": "En donde dice: Para productos biosimilar presentar\u00e1 certificados de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n\nvigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA,FDA, Health Canada, ANVISA o\nANMAT. El producto biosimilar deber\u00e1 contar con Registro Sanitario emitido por DNV, con antelaci\u00f3n m\u00ednima\nde 3 a\u00f1os. Esta \u00faltima observaci\u00f3n no corresponde. recuerdo a la convocante que una vez que la DNVS, autoriza la venta del medicamento con la emisi\u00f3n de Registros Sanitario y Actas de precios, esta habilitada para vender en todas las farmacias, Sanatorios, Hospitales y participar en licitaciones. Solicitamos respetuosamente, que este punto sea Excluido, puesto que atenta contra la libre competencia. ", "author": {"name": "Bioethic Pharma S.A.", "id": "PY-RUC-80058902-5"}, "answer": "Favor considerar la ultima versi\u00f3n del PbyC.", "dateAnswered": "2022-11-18T14:48:14-04:00"}, {"id": "76", "date": "2022-10-22T20:57:34-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "Para los puntos 1 y 2.\nSolicitan: Resoluci\u00f3n de Apertura vigente, y que el caso En caso de que se encuentre vencida, se deber\u00e1 acompa\u00f1ar constancia emitida por la DINAVISA de que el mismo se encuentra en tr\u00e1mite de renovaci\u00f3n y que es apta para la comercializaci\u00f3n. En este caso el oferente deber\u00e1 acompa\u00f1ar una declaraci\u00f3n jurada en la que se compromete a presentar al momento de la entrega en el parque sanitario asignado, en caso de ser adjudicado. \nConsiderando que la Renovaci\u00f3n de Apertura depende exclusivamente de la capacidad de respuesta de DINAVISA, la empresa no puede comprometerse por la responsabilidad de otra instituciones, siendo que la misma gestiona en tiempo y forma. Favor rever el tema de la DDJJ.  ", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor ajustarse y considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:25:15-04:00"}, {"id": "64", "date": "2022-10-22T19:44:28-04:00", "title": "Punto 19 - Requisitos para demostrar experiencia tecnica_ Pag. 24/46", "description": "Aclarar si el CLV es emitido por FDA o EMA no es necesario presentar los estudios mencionados en el Punto 11???", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:15:57-04:00"}, {"id": "25", "date": "2022-10-21T15:32:26-04:00", "title": " REQUISITOS PARA EVALUAR LA CAPACIDAD T\u00c9CNICA: ", "description": "El Pliego de Bases y Condiciones en el apartado Requisitos documentales para evaluar la capacidad t\u00e9cnica prev\u00e9 en su punto 4 cuanto sigue: \u0085Fotocopia autenticada del Certificado de Registro Sanitario vigente, expedido por la Direcci\u00f3n de Vigilancia Sanitaria del MSPBYS, o certificado actualizado (vigencia no mayor a 6 meses) de que encuentra en tr\u00e1mites de renovaci\u00f3n (sic). Teniendo en cuenta que el requisito descrito m\u00e1s arrida en el cual se  indica que el certificado no deber\u00e1 ser mayor a 6 meses, se solicita a la Convocante estudie la posibilidad de modificar el citado requerimiento, considerando que la propia  Autoridad Regulatoria de la materia (Direcci\u00f3n Nacional de Vigilancia Sanitaria), le otorga a la citada documentaci\u00f3n una validez de 1 (un) a\u00f1o,  por lo que reconocerle una validez inferior, ir\u00eda en contradicci\u00f3n a lo indicado por esta.  ", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:25:50-04:00"}, {"id": "41", "date": "2022-10-21T17:01:39-04:00", "title": "Sistema de abastecimiento simultaneo", "description": "Solicitamos que el Sistema de Adjudicaci\u00f3n sea de Abastecimiento Simult\u00e1neo, con ello la convocante evitar\u00eda el riesgo de poder quedar desabastecida. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:32:52-04:00"}, {"id": "98", "date": "2022-11-16T17:48:13-04:00", "title": "Capacidad T\u00e9cnica", "description": "Reiteramos la solicitud de establecer la posibilidad de presentar Certificado de Buenas Practicas y/o Certificado del producto farmac\u00e9utico, considerando que conforme al Decreto N\u00ba 6611/16, estos documentos son los requeridos por la autoridad reguladora para la obtenci\u00f3n del registro sanitario y mal podr\u00eda la Convocante limitar de forma innecesaria el PBC con requisitos ni siquiera requeridos por la DNVS. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor ajustarse y considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T17:43:07-04:00"}, {"id": "44", "date": "2022-10-21T17:14:57-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica. Punto 10", "description": "En dicho punto, el PBC establece: \"Para productos biosimilar presentar\u00e1 certificados de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n vigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA,FDA, Health Canada, ANVISA o ANMAT.\" Al respecto, solicitamos a la Convocante establecer la posibilidad de presentar Certificado de Buenas Practicas y/o Certificado del producto farmac\u00e9utico, considerando que conforme al Decreto N\u00ba 6611/16, la presentaci\u00f3n de uno de estos documentos es suficiente aval para la obtenci\u00f3n del registro sanitario por parte de la autoridad reguladora. Esto a fin de no limitar la participaci\u00f3n de potenciales oferentes. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:40:31-04:00"}, {"id": "51", "date": "2022-10-21T17:38:40-04:00", "title": "Punto 19. Requsiitos documentales", "description": "En dicho punto establece: \"Los productos biol\u00f3gicos innovadores presentar\u00e1n copia autenticada de Certificado de Libre Venta, emitido por una entidad regulatoria de referencia, FDA o EMA (No requieren presentar estudios mencionados).\" Al respecto, recordamos que todos los productos deben contar con los respaldos en cuanto a documentaciones t\u00e9cnicas conforme lo requiere la propia autoridad reguladora. \n Por tanto, solicitamos establecer los requisitos aplicables para productos innovadores a fin de garantizar la participaci\u00f3n en igualdad de condiciones. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:46:27-04:00"}, {"id": "80", "date": "2022-10-23T09:40:53-04:00", "title": "PBC \u0096 Requisito documental para evaluar capacidad t\u00e9cnica- P\u00e1gs. 24/46. Punto 16", "description": "\u00bfEs posible presentar reportes de Informes Peri\u00f3dicos de Seguridad de otros pa\u00edses en los cuales se tenga una experiencia m\u00e1s prolongada de uso del medicamento? En caso afirmativo, cu\u00e1les? Podr\u00edan utilizarse de lugares donde el producto fue aprobado por las autoridades competentes?", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:43:49-04:00"}, {"id": "34", "date": "2022-10-21T16:21:39-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "Pagina 24/46 \u0096 punto 16 del PBC menciona: Deber\u00e1n presentar como m\u00ednimo cuatro reportes locales del Informe Peri\u00f3dico de Seguridad (PSUR), que hayan sido entregados a DINAVISA, durante la comercializaci\u00f3n del producto: En el Plan de Farmacovigilancia del producto, se deber\u00e1 considerar, de acuerdo a la Gu\u00eda correspondiente los siguientes puntos: \n-Efectos adversos raros y especialmente peligrosos. \n-Actividades para continuar con un control de inmunogenicidad. -\n- Tener un procedimiento adecuado de trazabilidad del biosimilar y distinguirlo del producto de referencia. - \nSolicitamos a la Convocante aclarar este punto en caso que aplique tambi\u00e9n a los biol\u00f3gicos y no biol\u00f3gicos si ser\u00eda suficiente la presentaci\u00f3n de una declaraci\u00f3n jurada en el cual se informe que el producto en cuesti\u00f3n no ha reportado efectos adversos a la fecha, adem\u00e1s de adjuntar los procedimientos operativos est\u00e1ndar del sistema de Farmacovigilancia.\n", "author": {"name": "TASSOS SA", "id": "PY-RUC-80078413-8"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:27:47-04:00"}, {"id": "59", "date": "2022-10-22T09:53:43-04:00", "title": "EETT ITEM N\u00ba 6 Gemcitabina Inyectble", "description": "Solicitamos a la Convocante aclarar la concentraci\u00f3n solicitada en el PBC. La concentraci\u00f3n requerida seria de 1G? Esto a modo de evitar confusiones a la hora de presentar las ofertas en el presente llamado.", "author": {"name": "EUROQUIMICA S.A.", "id": "PY-RUC-80061211-6"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:48:19-04:00"}, {"id": "72", "date": "2022-10-22T20:01:53-04:00", "title": "Sistema de Adjudicacion", "description": "Solicitamos a la convocante establecer el metodo de Abastesimiento Simultaneo a fin de asegurar la provision en timpo y forma de los productos en salvaguarda del tratamiento oportuno de los pacientes", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:23:30-04:00"}, {"id": "40", "date": "2022-10-21T16:56:07-04:00", "title": "ITEM 13 - PRECIO REFERENCIAL", "description": "Solicitamos aclaraci\u00f3n si en el ITEM 13 - FUlvestrant el precio referencial de Gs. 7.732.000 seria por CAJA conteniendo 2 jeringas pre rellenadas / CAJA conteniendo frasco ampolla de vidrio de 5 ml c/u acompa\u00f1ado de kit de administraci\u00f3n  jeringas prellenadas  o seria POR UNIDAD lo solicitado?", "author": {"name": "TASSOS SA", "id": "PY-RUC-80078413-8"}, "answer": "Favor ajustarse a los t\u00e9rminos iniciales y considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:32:40-04:00"}, {"id": "65", "date": "2022-10-22T19:48:35-04:00", "title": "Criterios ambientales: Pag. 4/46", "description": "Solicitan: \nEl oferente adjudicado deber\u00e1 asegurar que todos los residuos generados por sus actividades sean adecuadamente\ngestionados (identificados, segregados y destinados) y buscar su reducci\u00f3n o eliminaci\u00f3n en la fuente, por medio de\npr\u00e1cticas como la modificaci\u00f3n de los procesos de producci\u00f3n, manutenci\u00f3n y de las instalaciones utilizadas,\nadem\u00e1s de la sustituci\u00f3n, conservaci\u00f3n, reciclaje o reutilizaci\u00f3n de materiales.\n\nConsulta: \u00bfC\u00f3mo se demostrar\u00eda este punto? \u00bfAplica para importadoras?\n", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor considerar los t\u00e9rminos generales del PbyC.", "dateAnswered": "2022-11-18T16:20:23-04:00"}, {"id": "90", "date": "2022-10-24T07:50:37-04:00", "title": "Plan de Entregas", "description": "El PBC solicita Cantidades m\u00ednimas solicitadas Hasta 20% de la cantidad m\u00ednima adjudicada: La primera Orden de Compra, ser\u00e1 emitida dentro de los 15 (quince) d\u00edas corridos posteriores a la firma del contrato donde el proveedor tendr\u00e1 hasta los 10 (diez) d\u00edas corridos para la entrega contados a partir de la recepci\u00f3n de la orden de compra. Solicitamos a la Convocante ampliar el plazo de entrega a por los 20 (veinte) d\u00edas calendarios para la entrega de los productos, teniendo en cuenta el tiempo de fabricaci\u00f3n y adecuaci\u00f3n de los mismos conforme al PBC.", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T16:45:04-04:00"}, {"id": "84", "date": "2022-10-23T10:22:36-04:00", "title": "Item 20 - Docetaxel Trihidrato", "description": "Solicitamos a la convocante cambiar el item 10  simplemente DOCETAXEL, puesto que en el mercado tambi\u00e9n se comercializa el Docetaxel Anhidro, a fin de dar mayor participaci\u00f3n a potenciales oferentes, considerando que la eficacia farmacol\u00f3gica no varia y es la misma contra la presentaci\u00f3n del Thidrato, no exisite ninguna diferencia al respecto, eso ya se encuentra demostrado en el uso normal del Docetaxel anidro y que es es consumido en el mercado privado y publico (cuando estos quedan desavastecidos).", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Favor ajustarse a los t\u00e9rminos iniciales establecidos en el PbyC.", "dateAnswered": "2022-11-18T17:33:29-04:00"}, {"id": "46", "date": "2022-10-21T17:23:08-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica. Punto 11", "description": "En dicho punto la Convocante establece: 11. Los productos biosimilares deber\u00e1n presentar la caracterizaci\u00f3n fisicoqu\u00edmica igual al producto biol\u00f3gico innovador de referencia. El producto biosimilar deber\u00e1 incluir sus estudios cl\u00ednicos, propios, multic\u00e9ntricos, randomizados, en la indicaci\u00f3n m\u00e1s referente al producto. El producto biosimilar deber\u00e1 presentar estudios\nde farmacocin\u00e9tica y farmacodinamia comparables al biol\u00f3gico innovador. Al respecto, se solicita aclarar que criterios y datos espec\u00edficos evaluara la Convocante sobre estos estudios requeridos, a fin de garantizar la presentaci\u00f3n de las documentaciones conforme a los criterios que ser\u00e1n evaluados para cada caso. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "La Convocante aclara que solicita los estudios precl\u00ednicos que abarcan los estudios farmacocin\u00e9ticos, farmacodin\u00e1micas de comparabilidad con el producto innovador, adem\u00e1s de los estudios cl\u00ednicos, propios completos y cuyas caracter\u00edsticas deben ser multic\u00e9ntricos, randomizados y sobre la indicaci\u00f3n mas referente del producto.", "dateAnswered": "2022-11-18T15:44:40-04:00"}, {"id": "17", "date": "2022-10-21T06:42:11-04:00", "title": "CAPACIDAD TECNICA", "description": "El pliego indica Para productos biosimilar presentar\u00e1 certificados de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n vigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA,FDA, Health Canada, ANVISA o\nANMAT. El producto biosimilar deber\u00e1 contar con Registro Sanitario emitido por DNV, con antelaci\u00f3n m\u00ednima de 3 a\u00f1os. Lo expuesto es absolutamente limitante y atenta contra el principio de igualdad. La ley indica que los productos farmac\u00e9uticos son h\u00e1biles para su distribuci\u00f3n con el otorgamiento del registro sanitario y desde el momento en que la autoridad sanitaria otorga el Registro. Se solicita excluir el requerimiento y eliminar el ilegal periodo de 3 a\u00f1os de antelaci\u00f3n", "author": {"name": "LIBRA PARAGUAY S.A.", "id": "PY-RUC-80023379-4"}, "answer": "Favor considerar las ultimas modificaciones introducidas al PbyC.", "dateAnswered": "2022-11-18T15:19:22-04:00"}, {"id": "85", "date": "2022-10-23T15:15:12-04:00", "title": "CAPACIDAD TECNICA", "description": "10. Para productos biosimilar presentar\u00e1 certificados de registro sanitario y autorizaci\u00f3n de comercializaci\u00f3n vigente otorgado por una de las autoridades de alta vigilancia sanitaria EMA,FDA, Health Canada, ANVISA o ANMAT. El producto biosimilar deber\u00e1 contar con Registro Sanitario emitido por DNV, con antelaci\u00f3n m\u00ednima de 3 a\u00f1os.\nLa  Autorizaci\u00f3n de comercializaci\u00f3n vigente es el Certificado de Libre Venta (CLV), el cual ya fue presentado ante DINAVISA para la obtenci\u00f3n del Registro Sanitario. Se recomienda a la convocante omitir este punto ya que limita la participaci\u00f3n", "author": {"name": "INNOVAPHARMA S.R.L", "id": "PY-RUC-80005431-8"}, "answer": "Favor ajustarse a los t\u00e9rminos actuales del PbyC.", "dateAnswered": "2022-11-18T17:34:29-04:00"}], "lots": [{"id": "1Z/0XL45bpY=", "title": "7 - Acetato de leuprolida inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 7650000000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "7", "id": "1"}]}, {"id": "2zz3wIJ7Cg4=", "title": "22 - Nivolumab Inyectable", "status": "unsuccessful", "statusDetails": "Desierto", "value": {"amount": 105878472000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "22", "id": "1"}]}, {"id": "3/8OTvpYtc4=", "title": "15 - Paclitaxel inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 601800000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "15", "id": "1"}]}, {"id": "6eBm64rju9k=", "title": "12 - Bevacizumab Inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 103925802000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "12", "id": "1"}]}, {"id": "7cR4chPjk4c=", "title": "18 - Fluorouracilo inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 1414440000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "18", "id": "1"}]}, {"id": "7LXvqqIHzHA=", "title": "3 - Trastuzumab Inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 38632001760, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "3", "id": "1"}]}, {"id": "9RZ39kMSGQM=", "title": "20 - Docetaxel Trihidrato inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 18010128000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "20", "id": "1"}]}, {"id": "AD8fI3jvQvE=", "title": "10 - Lenvatinib Capsula", "status": "active", "statusDetails": "Activo", "value": {"amount": 27000000000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "10", "id": "1"}]}, {"id": "BJt36pqNhsw=", "title": "16 - Paclitaxel inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 4321324800, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "16", "id": "1"}]}, {"id": "BOfET4i1UFE=", "title": "2 - Pembrolizumab inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 125830872000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "2", "id": "1"}]}, {"id": "hrjJ/9yer3g=", "title": "19 - Metotrexato inyectable", "status": "unsuccessful", "statusDetails": "Desierto", "value": {"amount": 301900800, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "19", "id": "1"}]}, {"id": "JOSkHu+CI2Q=", "title": "1 - Dacarbazina inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 455475600, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "1", "id": "1"}]}, {"id": "LFr9HKqUdw8=", "title": "4 - Palbociclib Capsula", "status": "active", "statusDetails": "Activo", "value": {"amount": 5368018320, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "4", "id": "1"}]}, {"id": "maDTYf7dPqE=", "title": "9 - Lenvatinib Capsula", "status": "active", "statusDetails": "Activo", "value": {"amount": 11900000000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "9", "id": "1"}]}, {"id": "n98kfm6XFAY=", "title": "5 - Enzalutamida Capsula", "status": "active", "statusDetails": "Activo", "value": {"amount": 36401518080, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "5", "id": "1"}]}, {"id": "NQeJMv2fzT0=", "title": "8 - Pemetrexed Inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 16800000000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "8", "id": "1"}]}, {"id": "nrCo9KsVzuk=", "title": "6 - Gemcitabina Inyectble", "status": "active", "statusDetails": "Activo", "value": {"amount": 948600000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "6", "id": "1"}]}, {"id": "pREiwHJMHiY=", "title": "11 - Bevacizumab Inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 25386666000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "11", "id": "1"}]}, {"id": "RNQnr7wtWRI=", "title": "13 - Fulvestrant Inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 22422800000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "13", "id": "1"}]}, {"id": "UFF0sa7VZSM=", "title": "21 - Abiraterona Acetato Comprimido", "status": "active", "statusDetails": "Activo", "value": {"amount": 1994672000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "21", "id": "1"}]}, {"id": "VcLqVBo5FGc=", "title": "17 - Irinotecan Inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 1228050960, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "17", "id": "1"}]}, {"id": "W9Or6qCJIFU=", "title": "14 - Cisplatino Inyectable", "status": "unsuccessful", "statusDetails": "Desierto", "value": {"amount": 1079644944, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "14", "id": "1"}]}], "items": [{"id": "0gp3KSHgQj4ZNSsfEK84Qw==", "description": "Cisplatino Inyectable", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51111506-001", "description": "Cisplatino Inyectable", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51111506-001"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51111506", "description": "Cisplatino", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51111506"}], "quantity": 9744, "minQuantity": 4872, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 110801, "currency": "PYG"}}, "relatedLot": "W9Or6qCJIFU=", "attributes": [{"name": "Orden", "value": "14", "id": "2"}]}, {"id": "4mpkosPPQo0WfhEpQC76Ig==", "description": "Pembrolizumab inyectable", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51111713-9994", "description": "Pembrolizumab inyectable", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51111713-9994"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51111713", "description": "Anticuerpo Monoclonal Humanizado", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51111713"}], "quantity": 3600, "minQuantity": 1800, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 34953020, "currency": "PYG"}}, "relatedLot": "BOfET4i1UFE=", "attributes": [{"name": "Orden", "value": "2", "id": "2"}]}, {"id": "bcU5W9YXePk7tGCtsNK9bA==", "description": "Lenvatinib Capsula", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51111713-9982", "description": "Lenvatinib Capsula", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51111713-9982"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51111713", "description": "Anticuerpo Monoclonal Humanizado", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51111713"}], "quantity": 1000, "minQuantity": 500, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 27000000, "currency": "PYG"}}, "relatedLot": "AD8fI3jvQvE=", "attributes": [{"name": 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