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En plaza m\u00e1s existen varias marcas de la presentaci\u00f3n de 440 MG, lo que posibilitar\u00e1 la participaci\u00f3n de mayor cantidad de oferentes, cumpliendo la Convocante con los principios de igualdad y libre competencia; econom\u00eda, eficacia y eficiencia y la mejor relaci\u00f3n costo beneficio en la adquisici\u00f3n.", "author": {"name": "LIBRA PARAGUAY S.A.", "id": "PY-RUC-80023379-4"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:27:58-04:00"}, {"id": "8", "date": "2023-10-14T19:58:19-04:00", "title": "EXPERIENCIA REQUERIDA ", "description": "El Pliego de Bases y Condiciones establece que \u0085 Para el caso de MEDICAMENTOS IMPORTADOS y que el oferente no sea el fabricante y/o el titular del registro sanitario de los medicamentos, dicha experiencia deber\u00e1 estar igualmente acreditada por el oferente, por el titular del registro sanitario y el fabricante del producto que se oferta. En lo que respecta a la experiencia de este \u00faltimo (el fabricante extranjero), dicha experiencia podr\u00e1 ser igualmente acreditada con una declaraci\u00f3n jurada en la cual se indique claramente que el mismo cumple con dichos porcentajes.. Dado que es el oferente local quien asume de forma exclusiva las obligaciones con el Estado y es el titular del registro sanitario, garantizando con su experiencia la debida solvencia y capacidad t\u00e9cnica y econ\u00f3mica para afrontar los riesgos propios que implican un contrato de considerable envergadura con el Estado, consideramos que extender dicha exigencia a su vez a los fabricantes de los productos resulta desproporcionado e irracional con la finalidad del presente proceso siendo que la cadena de autorizaciones puede ser comprobada con la documentaci\u00f3n correspondiente. ", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Se aclara que lo solicitado no es irracional ni desproporcionada, ya que es necesario contar con experiencia acreditada sobre el uso de este tipo de medicamentos que otorgue seguridad sobre el uso y experiencia de eficacia de los medicamentos ya que son producto de clones, por lo que el oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-03-04T15:27:04-04:00"}, {"id": "7", "date": "2023-10-13T17:42:13-04:00", "title": "Abastecimiento Simultaneo", "description": "Solicitamos a la Convocante incluir el sistema de abastecimiento simult\u00e1neo y que el mismo quede de la siguiente manera: 1- En caso de presentarse un solo oferente en un \u00edtem, se le adjudicara el 100% del monto del \u00edtem correspondiente. 2- De 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. 3. De 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.  Esto posibilitar\u00eda la participaci\u00f3n de un mayor n\u00famero de oferentes as\u00ed como precios m\u00e1s competitivos para la Convocante.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:26:31-04:00"}, {"id": "12", "date": "2023-10-16T09:11:08-04:00", "title": "Sistema de Abastecimiento - Item 10", "description": "Solicitamos amablemente a la convocante modificar el sistema de abastecimiento por cantidad a abastecimiento simultaneo para el \u00edtem 10. De este modo se dar\u00e1 mayor participaci\u00f3n a futuros oferentes y evitar\u00eda un posible desabastecimiento de producto.", "author": {"name": "LIBRA PARAGUAY S.A.", "id": "PY-RUC-80023379-4"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:28:20-04:00"}, {"id": "14", "date": "2023-10-16T09:28:28-04:00", "title": "Abastecimiento Simultaneo ", "description": "Dada la naturaleza y con el objetivo de reducir los problemas de abastecimiento, se solicita a la convocante establecer el sistema de adjudicaci\u00f3n por Abastecimiento simult\u00e1neo. ", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:28:54-04:00"}, {"id": "5", "date": "2023-10-12T18:17:27-04:00", "title": "MUESTRAS.", "description": "Solicitamos a la convocante  que las muestras de los \u00edtems ofertados, en caso de ser adjudicados, sean consideradas como parte de la primera entrega, considerando el elevado costo de los mismos.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "Se aclara que no se podr\u00e1n aceptar como parte de la primera entrega ya que existe un plazo para realizar la primera entrega y la muestra queda en resguardo hasta que finiquite los plazos establecidos en el Pliego de Bases y Condiciones para la devoluci\u00f3n de las muestras siempre que no exista protesta, por lo tanto el oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-03-04T15:25:55-04:00"}, {"id": "28", "date": "2024-03-06T10:04:08-04:00", "title": "Experiencia Requerida", "description": "En lo que respecta a la Experiencia Requerida, consultamos a la convocante si no ser\u00eda factible limitar la misma a los \u00faltimos 2 (dos) a\u00f1os, o sea, el 2022 y 2023. Esto considerando que de esta forma la convocante podr\u00e1 tener conocimiento de la efectiva capacidad de provisi\u00f3n que tiene el potencial oferente ya que, de otro modo, al incluir a\u00f1os anteriores a ellos la experiencia de provisi\u00f3n m\u00e1s reciente se est\u00e1 diluyendo con experiencia hist\u00f3rica que nada acredita en relaci\u00f3n a capacidades actuales. ", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-04-03T10:11:00-04:00"}, {"id": "15", "date": "2023-10-16T09:38:26-04:00", "title": "\u00cdTEMS 1  ADALIMUMAB", "description": "Solicitamos a la convocante modificar lo requerido en el item 1 ADALIMUMAB INYECTABLE 40 mg/0,4 cc incluyendo o aceptando la presentacion de ADALIMUMAB inyectable 40 mg/0,8 ml considerando que en el llamado anterior se contemplo la presentaci\u00f3n solicitada 40 mg/0,8 ml en un item diferente esto considerando ambas presentaciones cumplen con la concentraci\u00f3n requerida 40mg independientemente de si el producto aplicado al paciente es de 0,4 ml. o de 0,8 ml., el paciente recibir\u00e1 la dosis misma dosis necesaria. Y considerando que en el mercado solo un oferente puede cumplir con el item requerido ADALIMUMAB INYECTABLE 40 mg/0,4 cc por que a fin de no limitar la participaci\u00f3n de potenciales oferentes solicitamos la modificaci\u00f3n ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:29:14-04:00"}, {"id": "3", "date": "2023-10-12T14:11:01-04:00", "title": "Abastecimiento Simultaneo - item 5", "description": "Se\u00f1ores convocantes: Con relaci\u00f3n al \u00edtem 5, solicitamos que la misma evalu\u00e9 la posibilidad de pasar a : ABASTECIMIENTO SIMULT\u00c0NEO, para mayor participaci\u00f3n de participantes, asegurando la entrega de medicamentos en tiempo y forma. ", "author": {"name": "Bioethic Pharma S.A.", "id": "PY-RUC-80058902-5"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:25:18-04:00"}, {"id": "26", "date": "2024-03-06T10:00:08-04:00", "title": "Requisitos documentales para la evaluación de la experiencia ", "description": "En este apartado, el PBC solicita cuanto sigue: Presentación como mínimo de 3 (tres) Certificados o Actas de Recepción Final de laProvision de Medicamentos donde conste eldesempeño satisfactorio del oferente, expedidos por Instituciones Públicas o Privadas dentro de los últimos 03 (tres) años (2020 20201 2022). (Dicho documento deberá estar debidamente sellado y firmado por el responsable que lo emitió).. Sobre el punto, entendemos que el PBC debe ser modificado y corregir el claro error consistente en requerir documentos del a\u00f1o 20201 y, de igual modo, incluir el a\u00f1o 2023 atendiendo a que es el a\u00f1o inmediatamente anterior al presente.", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-04-03T10:10:18-04:00"}, {"id": "33", "date": "2024-03-06T11:34:48-04:00", "title": "Experiencia requerida ", "description": "En el punto correspondiente a Experiencia Requerida, el PBC establece cuanto sigue: Demostrar la experiencia en PROVISION DE MEDICAMENTOS, con facturaciones de venta y/o contratos ejecutados por un monto equivalente al 25 % como mínimo del monto máximo ofertado en la presente licitación, en promedio en los años: 2020- 2021-2022. \n\nAl respecto, consideramos prudente modificar el requerimiento e incluir entre los a\u00f1os a ser tenidos en cuenta al a\u00f1o 2023. Esto considerando a que incluyendo dicho a\u00f1o en la experiencia, la convocante podr\u00e1 evaluar la situaci\u00f3n mas actual del potencial oferente ya que de nada sirve que el mismo cuente con experiencia de a\u00f1os anteriores y no del a\u00f1o inmediatamente anterior al presente. ", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-04-03T11:05:43-04:00"}, {"id": "31", "date": "2024-03-06T11:05:16-04:00", "title": "\u00cdTEM 4 INFLIXIMAB 100 MG. INY. ", "description": "En vista que el producto ADALIMUMAB fue excluido de la lista de \u00edtems solicitados en este llamado, consultamos a la Convocante si no ser\u00eda conveniente aumentar la cantidad solicitada en el \u00edtem 4 INFLIXIMAB 100 mg., ya que \u00e9ste \u00faltimo es utilizado para la misma patolog\u00eda que el ADALIMUMAB, la artritis reumatoidea, a efectos de cubrir fehacientemente las necesidades de los asegurados.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-04-03T10:12:27-04:00"}, {"id": "23", "date": "2023-10-16T09:57:04-04:00", "title": "Item 9 Tocilizumab 162mg", "description": "Solicitamos a la convocante modificar la presentacion de entrega y aceptar la presentaci\u00f3n, modificando de la siguiente manera Caja conteniendo 4 jeringas prellenadas x 0.9 ml/ vial  para cumplir con uno de los principios de la Ley de Contrataciones respecto a la igualdad de competencia", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Se aclara que lo solicitado se encuentra acorde a las Especificaciones T\u00e9cnicas del vadem\u00e9cum institucional en base a las necesidades de medicaci\u00f3n para los asegurados, por lo que el oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.\n", "dateAnswered": "2024-03-04T15:32:20-04:00"}, {"id": "32", "date": "2024-03-06T11:06:14-04:00", "title": "Experiencia requerida", "description": "Se solicita a la convocante tener en cuenta la experiencia generada en el 2023 teniendo en cuenta las nuevas fechas de apertura.", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-04-03T11:05:22-04:00"}, {"id": "25", "date": "2024-03-06T09:59:45-04:00", "title": "Experiencia requerida ", "description": "En el punto correspondiente a Experiencia Requerida, el PBC establece cuanto sigue: Demostrar la experiencia en PROVISION DE MEDICAMENTOS, con facturaciones de venta y/o contratos ejecutados por un monto equivalente al 25 % como mínimo del monto máximo ofertado en la presente licitación, en promedio en los años: 2020- 2021-2022. \n\nAl respecto, consideramos prudente modificar el requerimiento e incluir entre los a\u00f1os a ser tenidos en cuenta al a\u00f1o 2023. Esto considerando a que incluyendo dicho a\u00f1o en la experiencia, la convocante podr\u00e1 evaluar la situaci\u00f3n mas actual del potencial oferente ya que de nada sirve que el mismo cuente con experiencia de a\u00f1os anteriores y no del a\u00f1o inmediatamente anterior al presente. \n", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "El oferente deber\u00e1 remitirse al Pliego Ultima Versi\u00f3n.", "dateAnswered": "2024-04-03T10:10:01-04:00"}, {"id": "29", "date": "2024-03-06T10:04:42-04:00", "title": "Experiencia Requerida", "description": "En el apartado de Experiencia Requerida, p\u00e1gina 17, el PBC solicita la acreditaci\u00f3n de experiencia en la PROVISION DE MEDICAMENTOS mediante la facturaci\u00f3n de venta y/o contratos ejecutados por un monto equivalente al 25 % como mínimo del monto máximo ofertado en la presente licitaci\u00f3n, tanto para el caso de ofertar medicamentos de origen nacional como importados, haciendo una salvedad para el caso de que los productos sean importados. Ahora bien, l\u00edneas seguidas se observa que se ha insertado la siguiente aclaraci\u00f3n Los productos innovadores (Originales) deben presentar únicamente copia autenticada de Certificado de Libre Venta/CPP, emitido por una entidad regulatoria de referencia, FDA o EMA (No requieren presentar documentos adicionales).. Al respecto de esto, entendemos que esta aclaraci\u00f3n debe ser eliminada y/o reformulada y/o reubicada en el PBC ya que, de la manera en la cual est\u00e1 redactada y en el apartado en el cual se encuentra inserto (Experiencia Requerida), parecer\u00eda dar a entender que para el caso de ofertar productos innovadores (originales) al oferente se le est\u00e1 eximiendo del cumplimiento de todos los dem\u00e1s requerimientos de experiencia, o sea, de la facturaci\u00f3n m\u00ednima exigida, lo cual ser\u00eda un total desprop\u00f3sito y atentar\u00eda contra el principio de igualdad que debe regir en las compras p\u00fablicas, en detrimento de otros oferentes a los cuales SI se les exige dichos requerimientos. \nCabe se\u00f1alar que, el p\u00e1rrafo en cuesti\u00f3n tendr\u00eda sentido (as\u00ed como la exenci\u00f3n de la presentaci\u00f3n de documentos) si es que el mismo se encontrase inserto en el apartado correspondiente a Capacidad T\u00e9cnica ya que en ellos es requerido una gran cantidad de documentaci\u00f3n para los productos biosimilares y, l\u00f3gicamente, al original no se le puede exigir lo mismo. Pero, en lo que respecta a Experiencia Requerida, lo que se est\u00e1 evaluando con dichos requerimientos es la CAPACIDAD DEL OFERENTE de proveer los bienes, raz\u00f3n por la cual, si bien, el producto en cuesti\u00f3n podr\u00eda contar con antig\u00fcedad y volumen de ventas en el mercado, ello no obsta a que el oferente (nacional) de igual modo debe demostrar su capacidad de provisi\u00f3n y, la forma de hacerlo es mediante la facturaci\u00f3n en cuesti\u00f3n.", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "Se aclara que el requisito busca flexibilizar la participaci\u00f3n de aquellas empresas que no siendo fabricantes oferten productos innovadores, quienes a los efectos de la demostraci\u00f3n de la facturaci\u00f3n del fabricante deber\u00e1n solamente presentar la copia autenticada de Certificado de Libre Venta/CPP, emitido por una entidad regulatoria de referencia, FDA o EMA, evitando con ello el tr\u00e1nsito de documentaci\u00f3n con las legalizaciones y apostillados en cuesti\u00f3n.-\n\nAs\u00ed tambi\u00e9n se aclara que tanto el Oferente, como el titular del registro (de productos innovadores Original) deben de acreditar su experiencia, tal como se requiere en el Punto Experiencia requerida: Para productos Nacionales e Importados, quedando por sentado entonces las mismas exigencias y por ende la igualdad de condiciones en cuanto a los requisitos exigidos para demostrar la experiencia, por lo que el Oferente deber\u00e1 remitirse al Pliego \u00faltima versi\u00f3n.\n", "dateAnswered": "2024-04-03T10:11:46-04:00"}, {"id": "2", "date": "2023-10-12T13:19:04-04:00", "title": "ABASTECIMIENTO SIMULT\u00c1NEO ", "description": "Solicitamos la aplicaci\u00f3n de la modalidad de Abastecimiento simult\u00e1neo para todos los \u00edtems otorgando de esta forma la posibilidad de que la Convocante pueda contar con los productos adjudicados en tiempo y forma asegurando la continuidad de los tratamientos sin interrupci\u00f3n a los pacientes.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:25:00-04:00"}, {"id": "16", "date": "2023-10-16T09:38:53-04:00", "title": "Item 1 Adalimumab inyectable", "description": "Solicitamos que la concentraci\u00f3n no est\u00e9 limitada a 40mg/0.4cc, atendiendo a que en el mercado existen otras presentaciones como ser la concentraci\u00f3n 40mg/0.8cc. Por lo tanto para cumplir con el principio de la Ley de Contrataciones respecto a la libre competencia, solicitamos tambi\u00e9n poder cotizar el producto con concentraci\u00f3n 40mg/0.8cc.", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:29:30-04:00"}, {"id": "35", "date": "2024-03-06T13:14:08-04:00", "title": "\u00cdTEM 4 INFLIXIMAB 100 MG. INY. ", "description": "En vista que el producto ADALIMUMAB fue excluido de la lista de \u00edtems solicitados en este llamado, consultamos a la Convocante si no ser\u00eda conveniente aumentar la cantidad solicitada en el \u00edtem 4 INFLIXIMAB 100 mg., ya que \u00e9ste \u00faltimo es utilizado para la misma patolog\u00eda que el ADALIMUMAB, la artritis reumatoidea, a efectos de cubrir fehacientemente las necesidades de los asegurados.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-04-03T11:06:15-04:00"}, {"id": "27", "date": "2024-03-06T10:02:10-04:00", "title": "Capacidad T\u00e9cnica", "description": "El PBC, en el punto Capacidad T\u00e9cnica, punto 7- 1. Documentaciones según lo ofertado: Para Anticuerpos Monoclonales como ADO-TRASTUZUMAB, DARATUMUMAB 100, DARATURUMAB 400, INFLIXIMAB, OCRELIZUMAB, PALIVIZUMAB, PEMBROLIZUMAB, TOCILIZUMAB., 1-Para productos Biol\u00f3gicos biosimilares:\u0085, solicita cuanto sigue: El producto biosimilar deber\u00e1 presentar estudios  de farmacocin\u00e9tica y farmacodinamia comparables al biol\u00f3gico innovador.. \n\nAl respecto de este requerimiento, solicitamos la eliminaci\u00f3n del mismo atendiendo a que dichos estudios en la generalidad son documentos de car\u00e1cter confidencial por parte de los fabricantes y la divulgaci\u00f3n de los mismos se encuentra protegida por contratos de confidencialidad ya que en ellos se encuentra informaci\u00f3n sumamente sensible de car\u00e1cter t\u00e9cnico/cient\u00edfico.\n\nCabe se\u00f1alar de igual modo que, si es que el producto ya cuenta para su comercializaci\u00f3n con el \u0085registro o certificado de producto farmac\u00e9utico vigente otorgado ante alguna de las Agencias Reguladoras de los pa\u00edses citadas en el artículo 4\u00b0 incisos a, c y d del Decreto 6611/2016., la calidad y eficacia del mismo ya se encuentra respaldada con ello, torn\u00e1ndose innecesaria la presentaci\u00f3n de la documentaci\u00f3n que solicitamos sea excluida. ", "author": {"name": "V Y T FARMA SA", "id": "PY-RUC-80022776-0"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones. ", "dateAnswered": "2024-04-03T10:10:41-04:00"}, {"id": "19", "date": "2023-10-16T09:43:53-04:00", "title": "Experiencias", "description": "En relaci\u00f3n al punto Experiencia Requerida que dice \" Demostrar la experiencia en PROVISI\u00d3N DE MEDICAMENTOS, con facturaciones de venta y/o contratos ejecutados por un monto equivalente al 25 % como m\u00ednimo del monto m\u00e1ximo ofertado en la presente licitaci\u00f3n, en promedio en los a\u00f1os: 2020- 2021-2022 (...) Para el caso de MEDICAMENTOS IMPORTADOS y que el oferente no sea el fabricante y/o el titular del registro sanitario de los medicamentos, dicha experiencia deber\u00e1 estar igualmente acreditada por el oferente, por el titular del registro sanitario y el fabricante del producto que se oferta. En lo que respecta a la experiencia de este \u00faltimo (el fabricante extranjero), dicha experiencia podr\u00e1 ser igualmente acreditada con una declaraci\u00f3n jurada en la cual se indique claramente que el mismo cumple con dichos porcentajes.\" entendemos que si somos OFERENTES y TITULARES DEL REGISTRO SANITARIO del producto importado, s\u00f3lo debemos presentar  facturaciones de venta y/o contratos ejecutados por nosotros (OFERENTES Y TITULARES DEL REGISTRO SANITARIO DEL MEDICAMENTO OFERTADO) por un monto equivalente al 25 % como m\u00ednimo del monto m\u00e1ximo ofertado en la licitaci\u00f3n y ninguna facturaci\u00f3n de venta y/o contratos ejecutados o declaraci\u00f3n jurada del fabricante. Es correcto el entendimiento?  \n\nEntendemos tambi\u00e9n que si somos OFERENTES, pero NO TITULARES DEL REGISTRO SANITARIO, entonces debemos presentar  tambi\u00e9n:\n1.\tFacturaciones de venta y/o contratos ejecutados por un monto equivalente al 25 % como m\u00ednimo del monto m\u00e1ximo ofertado en la licitaci\u00f3n del Titular del Registro Sanitario. \n2.\tDeclaraci\u00f3n Jurada del fabricante (del medicamento) que declare bajo fe de juramento que posee Facturaciones de venta y/o contratos ejecutados por un monto equivalente al 25 % como m\u00ednimo del monto m\u00e1ximo ofertado en la licitaci\u00f3n del Titular del Registro Sanitario.\nEs correcto el entendimiento? o en este \u00faltimo caso la declaraci\u00f3n jurada en relaci\u00f3n a la experiencia del fabricante del medicamento importado debe ser extendida por el OFERENTE? \n", "author": {"name": "Bioethic Pharma S.A.", "id": "PY-RUC-80058902-5"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-03-04T15:30:26-04:00"}, {"id": "13", "date": "2023-10-16T09:21:06-04:00", "title": "Item 1 - Adalimumab", "description": "Solicitamos que la concentraci\u00f3n no est\u00e9 limitada a 40mg/0.4cc, atendiendo a que en el mercado existe mayoritariamente la presentacion 40mg/0.8cc y la solicitada tiene un solo proveedor. Por lo tanto para cumplir con el principio de la Ley de Contrataciones respecto a la libre competencia, solicitamos tambi\u00e9n poder cotizar el producto con presentaci\u00f3n 40mg/0.8cc.", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:28:38-04:00"}, {"id": "10", "date": "2023-10-16T08:32:41-04:00", "title": "ABASTECIMIENTO SIMULT\u00c1NEO ITEM 5: INFLIXIMAB", "description": "Solicitamos amablemente a la convocante modificar el sistema de abastecimiento por cantidad a abastecimiento simultaneo para el \u00edtem 5: Infliximab, de este modo se dar\u00e1 mayor participaci\u00f3n a futuros oferentes y evitar\u00eda un posible desabastecimiento de producto.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:27:42-04:00"}, {"id": "30", "date": "2024-03-06T10:10:00-04:00", "title": "CAPACIDAD T\u00c9CNICA", "description": "En el punto  5 - Copia autenticada del acta de fijaci\u00f3n de precios indican que desde ser emitida con anterioridad a la fecha de inicio de la subasta. Favor aclarar si debe ser antes de la fecha de carga de subasta o antes del inicio de la etapa competitiva.", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n", "dateAnswered": "2024-04-03T10:12:08-04:00"}, {"id": "20", "date": "2023-10-16T09:44:27-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "Para los estudios solicitados en el caso de que sea un biosimilar, recordamos a la convocante que el Decreto N\u00b0 6611 de medicamentos biol\u00f3gicos en su articulo 22) textualmente aclara: De cumplir el Titular del registro sanitario con todos los requisitos de este Decreto y HABIENDO la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DNVS) OTORGADO autorizaci\u00f3n de comercializaci\u00f3n, a trav\u00e9s del correspondiente registro sanitario, PODR\u00c1 COMERCIALIZAR LOS PRODUCTOS BIOLOGICOS AFECTADOS A ESTE DECRETO dentro del territorio de la Rep\u00fablica del Paraguay, por si mismo o por representaci\u00f3n concedida, siendo las documentaciones mencionadas en el presente decreto, suficientes para ser utilizados en todos los procesos de adquisici\u00f3n como garant\u00eda de calidad, seguridad y eficacia de los medicamentos biol\u00f3gicos. Por lo tanto del an\u00e1lisis de dicho art\u00edculo se concluye que la obtenci\u00f3n del registro sanitario es suficiente garant\u00eda para la comercializaci\u00f3n del producto. Se solicita excluir dichos estudios solicitados que limitan arbitrariamente la participaci\u00f3n.", "author": {"name": "LABORATORIO DE PRODUCTOS \u00c9TICOS COMERCIAL E INDUSTRIAL S.A.", "id": "PY-RUC-80000146-0"}, "answer": "Se aclara que lo solicitado en el PBC,  asegura al IPS que el producto ofertado mantenga la calidad y eficacia dada la naturaleza del producto ofertado en el presente llamado, asegurar que durante la vigencia del contrato y la utilizaci\u00f3n del producto por parte de los asegurados  que durante este periodo no presente desv\u00edo de calidad, considerando que para el IPS el oferente de estos productos solo presenta una declaraci\u00f3n jurada sobre la calidad y la eficacia del producto a la hora de entrega y considerando que el mismo no est\u00e1 sujeto a an\u00e1lisis de control de calidad como son los productos de s\u00edntesis y los biol\u00f3gicos que son adquiridos por el IPS, por lo tanto el oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:30:55-04:00"}, {"id": "22", "date": "2023-10-16T09:56:38-04:00", "title": "Item 9 Tocilizumab 162mg", "description": "Solicitamos a la convocante modificar lo requerido en el item 9  Tocilizumab 162mg, a Tocilizumab 162- 200mg a fin de no limitar innecesariamente la participaci\u00f3n de potenciales oferentes, para cumplir con uno de los principios de la Ley de Contrataciones respecto a la igualdad de competencia", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Se aclara que lo solicitado se encuentra acorde a las Especificaciones T\u00e9cnicas del vadem\u00e9cum institucional en base a las necesidades de medicaci\u00f3n para los asegurados, por lo que el oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-03-04T15:31:58-04:00"}, {"id": "21", "date": "2023-10-16T09:56:12-04:00", "title": "Item 9 Tocilizumab 162mg", "description": "Solicitamos a la convocante modificar lo requerido en el item 9 Tocilizumab 162mg, considerando que de esta forma solo existe un potencial oferente con esta presentaci\u00f3n por lo que solicitamos modificar la concentraci\u00f3n requerida o aceptar la presentacion de Tocilizumab 200mg a fin de no limitar innecesariamente la participaci\u00f3n de potenciales oferentes, para cumplir con uno de los principios de la Ley de Contrataciones respecto a la igualdad de competencia", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "Se aclara que lo solicitado se encuentra acorde a las Especificaciones T\u00e9cnicas del vadem\u00e9cum institucional en base a las necesidades de medicaci\u00f3n para los asegurados, por lo que el oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.\n", "dateAnswered": "2024-03-04T15:31:17-04:00"}, {"id": "34", "date": "2024-03-06T11:40:09-04:00", "title": "Experiencia Requerida", "description": "En el apartado de Experiencia Requerida, p\u00e1gina 17, el PBC solicita la acreditaci\u00f3n de experiencia en la PROVISION DE MEDICAMENTOS mediante la facturaci\u00f3n de venta y/o contratos ejecutados por un monto equivalente al 25 % como mínimo del monto máximo ofertado en la presente licitaci\u00f3n, tanto para el caso de ofertar medicamentos de origen nacional como importados, haciendo una salvedad para el caso de que los productos sean importados. Ahora bien, l\u00edneas seguidas se observa que se ha insertado la siguiente aclaraci\u00f3n Los productos innovadores (Originales) deben presentar únicamente copia autenticada de Certificado de Libre Venta/CPP, emitido por una entidad regulatoria de referencia, FDA o EMA (No requieren presentar documentos adicionales).. Al respecto de esto, entendemos que esta aclaraci\u00f3n debe ser eliminada y/o reformulada y/o reubicada en el PBC ya que, de la manera en la cual est\u00e1 redactada y en el apartado en el cual se encuentra inserto (Experiencia Requerida), parecer\u00eda dar a entender que para el caso de ofertar productos innovadores (originales) al oferente se le est\u00e1 eximiendo del cumplimiento de todos los dem\u00e1s requerimientos de experiencia, o sea, de la facturaci\u00f3n m\u00ednima exigida, lo cual ser\u00eda un total desprop\u00f3sito y atentar\u00eda contra el principio de igualdad que debe regir en las compras p\u00fablicas, en detrimento de otros oferentes a los cuales SI se les exige dichos requerimientos. \nCabe se\u00f1alar que, el p\u00e1rrafo en cuesti\u00f3n tendr\u00eda sentido (as\u00ed como la exenci\u00f3n de la presentaci\u00f3n de documentos) si es que el mismo se encontrase inserto en el apartado correspondiente a Capacidad T\u00e9cnica ya que en ellos es requerido una gran cantidad de documentaci\u00f3n para los productos biosimilares y, l\u00f3gicamente, al original no se le puede exigir lo mismo. Pero, en lo que respecta a Experiencia Requerida, lo que se est\u00e1 evaluando con dichos requerimientos es la CAPACIDAD DEL OFERENTE de proveer los bienes, raz\u00f3n por la cual, si bien, el producto en cuesti\u00f3n podr\u00eda contar con antig\u00fcedad y volumen de ventas en el mercado, ello no obsta a que el oferente (nacional) de igual modo debe demostrar su capacidad de provisi\u00f3n y, la forma de hacerlo es mediante la facturaci\u00f3n en cuesti\u00f3n.", "author": {"name": "PRODUCTOS MEDICINALES PARAGUAYOS S.A. (PROMEPAR S.A.) ", "id": "PY-RUC-80022558-9"}, "answer": "Se aclara que el requisito busca flexibilizar la participaci\u00f3n de aquellas empresas que no siendo fabricantes oferten productos innovadores, quienes a los efectos de la demostraci\u00f3n de la facturaci\u00f3n del fabricante deber\u00e1n solamente presentar la copia autenticada de Certificado de Libre Venta/CPP, emitido por una entidad regulatoria de referencia, FDA o EMA, evitando con ello el tr\u00e1nsito de documentaci\u00f3n con las legalizaciones y apostillados en cuesti\u00f3n.-\n\nAs\u00ed tambi\u00e9n se aclara que tanto el Oferente, como el titular del registro (de productos innovadores Original) deben de acreditar su experiencia, tal como se requiere en el Punto Experiencia requerida: Para productos Nacionales e Importados, quedando por sentado entonces las mismas exigencias y por ende la igualdad de condiciones en cuanto a los requisitos exigidos para demostrar la experiencia, por lo que el oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.\n", "dateAnswered": "2024-04-03T11:06:02-04:00"}, {"id": "9", "date": "2023-10-14T20:03:35-04:00", "title": "VENCIMIENTO", "description": "El Pliego de Bases y Condiciones en el punto plan de entregas de los bienes, solicita cuanto sigue : CRONOGRAMA DE ENTREGA: CANTIDAD MINIMA- 20%: Hasta 8 (ocho) d\u00edas calendarios. - 80%: Hasta 15 (quince) d\u00edas calendarios. Con entregas que podr\u00e1n ser fraccionadas hasta dos (2) veces, siempre dentro del mencionado plazo. Las \u00d3rdenes de Entrega podr\u00e1n ser fraccionadas de acuerdo a la necesidad del IPS y el espacio disponible en DASM. CANTIDAD M\u00c1XIMA: Con Orden de Entrega de la Direcci\u00f3n de Log\u00edstica de Suministros de Salud, una vez emitida la totalidad de las Cantidades M\u00ednimas. El plazo de entrega ser\u00e1 de hasta 20 (veinte) d\u00edas calendarios. Las \u00d3rdenes de Entrega podr\u00e1n ser fraccionadas de acuerdo a la necesidad del IPS y el espacio disponible en DASM. Considerando que: estos productos deben ser importados y que por la naturaleza de los mismos su vencimiento te\u00f3rico no superan los 18 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, por la escasa disponibilidad de espacio en las aeronaves, 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: - 20%: Hasta 8 (ocho) d\u00edas calendarios. - 80%: Hasta 20 (veinte) d\u00edas calendarios. Con entregas que podr\u00e1n ser fraccionadas hasta dos (2) veces, siempre dentro del mencionado plazo. Las \u00d3rdenes de Entrega podr\u00e1n ser fraccionadas de acuerdo a la necesidad del IPS y el espacio disponible en DASM. CANTIDAD M\u00c1XIMA: Con Orden de Entrega de la Direcci\u00f3n de Log\u00edstica de Suministros de Salud, una vez emitida la totalidad de las Cantidades M\u00ednimas. El plazo de entrega ser\u00e1 de hasta 30 (treinta) d\u00edas calendarios. Las \u00d3rdenes de Entrega podr\u00e1n ser fraccionadas de acuerdo a la necesidad del IPS y el espacio disponible en DASM", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-03-04T15:27:25-04:00"}, {"id": "6", "date": "2023-10-13T16:03:01-04:00", "title": "Item 10: TRASTUZUMAB 600 MG", "description": "Solicitamos a la Convocante modificar las Especificaciones T\u00e9cnicas del \u00edtem 10 TRASTUZUMAB 600 MG. a TRASTUZUMAB 440 MG. La presentaci\u00f3n de 440 MG. es de aplicaci\u00f3n endovenosa, la indicaci\u00f3n de uso es m\u00e1s amplia, pudiendo ser prescripta para c\u00e1ncer pulmonar, g\u00e1strico, de colon, mamas, endometrio y su precio es m\u00e1s conveniente para la Instituci\u00f3n. Adem\u00e1s, en plaza existen varias marcas de la presentaci\u00f3n de 440 MG, lo que posibilitar\u00e1 la participaci\u00f3n de mayor cantidad de oferentes, cumpliendo la Convocante con los principios de igualdad y libre competencia; econom\u00eda, eficacia y eficiencia y la mejor relaci\u00f3n costo beneficio en la adquisici\u00f3n.", "author": {"name": "LIBRA PARAGUAY S.A.", "id": "PY-RUC-80023379-4"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:26:16-04:00"}, {"id": "18", "date": "2023-10-16T09:39:38-04:00", "title": "Item 10 \u0096 Trastuzumab", "description": "Para el item 10 trastuzumab solicitamos a la convocar verificar y modificar la concentraci\u00f3n requerida a la presentaci\u00f3n mayor\u00eda disponible en el mercado, considerando que la presentaci\u00f3n requerida a la fecha solo una empresa pueda participar, sin olvidar que la concentraci\u00f3n requerida 600mg est\u00e1 limitada la indicaci\u00f3n por la que no puede aplicarse a todas las patolog\u00edas oncologica aprobadas comparando con la concentraci\u00f3n de Trastuzumab 440mg solicitamos modificar a la presentaci\u00f3n de trastuzumab 440 mg a fin de no limitar innecesariamente la participaci\u00f3n y evitar el direccionamiento a una sola empresa", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:30:04-04:00"}, {"id": "17", "date": "2023-10-16T09:39:18-04:00", "title": "Item 10 \u0096 Trastuzumab", "description": "Para cumplir con uno de los principios de la Ley de Contrataciones respecto a la igualdad de competencia, solicitamos cambiar la concentraci\u00f3n del Trastuzumab de 600mg a 440mg, producto ofrecido por varias empresas en el mercado.", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:29:46-04:00"}, {"id": "4", "date": "2023-10-12T18:16:05-04:00", "title": "Item 10: TRASTUZUMAB 600 mg.", "description": "Solicitamos a la Convocante modificar las Especificaciones T\u00e9cnicas del \u00edtem 10 TRASTUZUMAB 600 mg. a TRASTUZUMAB 440 mg. La presentaci\u00f3n de 440 mg. es de aplicaci\u00f3n endovenosa, la indicaci\u00f3n de uso es m\u00e1s amplia, pudiendo ser prescripta para c\u00e1ncer pulmonar, g\u00e1strico, de colon, mamas, endometrio y su precio es m\u00e1s conveniente para la Instituci\u00f3n. Adem\u00e1s, en plaza existen varias marcas de la presentaci\u00f3n de 440 mg., lo que posibilitar\u00e1 la participaci\u00f3n de mayor cantidad de oferentes, cumpliendo la Convocante con los principios de igualdad y libre competencia;  econom\u00eda, eficacia y eficiencia y la mejor relaci\u00f3n costo beneficio en la adquisici\u00f3n.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:25:33-04:00"}, {"id": "24", "date": "2023-10-16T09:58:02-04:00", "title": "Item 10 \u0096 Trastuzumab 600", "description": "Solicitamos a la convocante  modificar la concentraci\u00f3n requerida para el item Trastuzumab 600 considerando las presentaciones disponibles en el mercado  Como se contempla en  el Vadem\u00e9cum de Medicamentos, se observa que la presentaci\u00f3n con mayor n\u00famero de potenciales oferentes corresponde a la presentaci\u00f3n de 440 mg, por lo cual, para preservar los principios de IGUALDAD, LIBRE COMPETENCIA, TRANSPARENCIA Y PUBLICIDAD, la especificaci\u00f3n del producto en cuesti\u00f3n se exprese en rangos, pudiendo ofertarse indistintamente, desde 440 hasta 600 mg, de modo a permitir la participaci\u00f3n de oferentes que puedan presentar propuestas de acuerdo con la naturaleza espec\u00edfica del contrato. O en su caso, una alternativa establecida por la Convocante, que permita una mayor concurrencia, sin que la especificaci\u00f3n resulte limitativa a un \u00fanico participante.", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-03-04T15:32:40-04:00"}, {"id": "1", "date": "2023-10-12T13:17:22-04:00", "title": "ITEM 1 ADALIMUMAB 40 mg./0,4 ml", "description": "Considerando que en el mercado tambi\u00e9n  existe la concentraci\u00f3n de 40 mg/0,8 cc., con la misma eficacia que la de 40 mg/0,4 cc, solicitamos que se permita la posibilidad de  cotizar en este \u00edtem indistintamente el producto con concentraci\u00f3n de 40 mg/0,4 cc o la de 40 mg/0,8 cc., para cumplir con el principio de la Ley de Contrataciones respecto a igualdad, libre competencia y eficiencia y econom\u00eda.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "El oferente deber\u00e1 remitirse al Pliego Ultima Versi\u00f3n. ", "dateAnswered": "2024-03-04T15:24:44-04:00"}], "lots": [{"id": "+xvWVqbBWKc=", "title": "6 - PALIVIZUMAB SOLUCI\u00d3N INYECTABLE", "status": "active", "statusDetails": "Activo", "value": {"amount": 13600956250, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "6", "id": "1"}]}, {"id": "IjPEl3yHhVM=", "title": "2 - DARATUMUMAB INYECTABLE", "status": "active", "statusDetails": "Activo", "value": {"amount": 1882452000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "2", "id": "1"}]}, {"id": "jGgVmz4XJEA=", "title": "7 - PEMBROLIZUMAB INYECTABLE", "status": "active", "statusDetails": "Activo", "value": {"amount": 153251501200, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "7", "id": "1"}]}, {"id": "ESc74YNs2AE=", "title": "4 - INFLIXIMAB INYECTABLE", 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