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Solicitamos la exclusi\u00f3n de dicho requisito ya que la informaci\u00f3n solicitada se encuentra contemplada en el prospecto que acompa\u00f1a al medicamento.", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:22:10-04:00"}, {"id": "14", "date": "2023-04-27T17:12:48-04:00", "title": "Informe Peri\u00f3dico de Seguridad (PSUR)", "description": "Solicitamos se excluya dicha documento, pues al tratarse de un Registro Nuevo o con no tanta antiguedad, es imposible poder contar con 4 informes como lo pide el pliego.\n ", "author": {"name": "LIBRA PARAGUAY S.A.", "id": "PY-RUC-80023379-4"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que de acuerdo a la resoluci\u00f3n nro. 259/2022 de la DINAVISA, la autoridad sanitaria nacional debe evaluar los programas internacionales de Farmacovigilancia, por lo que los datos obtenidos de los sistemas de Farmacovigilancia no ser\u00e1n reconocidos ni tendr\u00e1n car\u00e1cter global y/o definitorio en tanto no hayan sido fehacientemente evaluados por la misma.\nComo se describe en el informe de la Organizaci\u00f3n Mundial de la Salud (OMS), Alianza mundial para la seguridad del paciente, entre los principales requisitos de los programas para mejorar la seguridad de los pacientes figuran la calidad y la capacidad de reunir la informaci\u00f3n m\u00e1s completa sobre reacciones adversas y errores de medicaci\u00f3n, de modo que esos programas constituyan fuentes de conocimiento y sirvan de base para futuras actividades de prevenci\u00f3n, por lo que este requisito se hace t\u00e9cnicamente indispensable y debe cumplir con la normativa vigente.\n", "dateAnswered": "2023-07-21T12:18:36-04:00"}, {"id": "20", "date": "2023-04-27T17:49:55-04:00", "title": "Intercambiables.", "description": "Los puntos indicados requieren  que los productos biosimilares incluyan sus estudios cl\u00ednicos, propios y concluidos con una poblaci\u00f3n estad\u00edsticamente significativa que demuestre que son intercambiables, cumpliendo las Gu\u00edas de FDA de mayo/2019 Consideraciones en la demostraci\u00f3n de Intercambiabilidad con un producto de referencia y que dichos estudios est\u00e9n dise\u00f1ados para demostrar la sustituci\u00f3n del producto biosimilar con el original seg\u00fan esas normas. Solicitamos que la Convocante elimine este requisito por ser innecesario para productos biosimilares que cuentan con la aprobaci\u00f3n de la FDA como tales. Si la FDA aprob\u00f3 un medicamento biosimilar es porque se demostr\u00f3 cient\u00edficamente que  cuenta con los estudios cl\u00ednicos que d\u00e9 muestras su seguridad, eficacia comparabilidad con el producto de referencia. Solicitar estudios adicionales que demuestren intercambiabilidad, en los casos en que se cuente con aprobaci\u00f3n de la FDA como biosimilares, no aporta ning\u00fan valor a\u00f1adido en cuanto a seguridad.\nYa que seg\u00fan organismos regulatorios de alta vigilancia como la EMA confirma que los productos biosimilares son intercambiables con su medicamento de referencia o con un biosimilar equivalente.\n", "author": {"name": "FARMACEUTICA PARAGUAYA S.A.", "id": "PY-RUC-80006276-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que la actividad de la comparaci\u00f3n de biosimilares con sus productos de referencia, se encuentra reservada exclusivamente para el cuerpo t\u00e9cnico, es decir los m\u00e9dicos tratantes, por lo se resalta el criterio de \u00e9stos en la evaluaci\u00f3n exhaustiva de la informaci\u00f3n t\u00e9cnica disponible as\u00ed como la experiencia de uso (informaci\u00f3n de seguridad) del producto.\nCon relaci\u00f3n a la caracterizaci\u00f3n f\u00edsico-qu\u00edmica, de acuerdo a los lineamientos de la EMA solo se permite un peque\u00f1o margen de variabilidad cuando las pruebas cient\u00edficas demuestran que no afecta a la seguridad ni a la eficacia del biosimilar, por lo que es necesario que nuestro cuerpo m\u00e9dico pueda comprobarlo. El rango de variabilidad permitido para un biosimilar es el mismo que el permitido entre lotes del medicamento de referencia. Esto se consigue mediante un proceso de fabricaci\u00f3n consistente, que garantice que todos los lotes del medicamento tienen calidad probada.\nCon relaci\u00f3n a los estudios cl\u00ednicos, propios y concluidos con una poblaci\u00f3n estad\u00edsticamente significativa que demuestre que son intercambiables, cumpliendo las Gu\u00edas de FDA de mayo/2019, como es caracter\u00edstico que los biosimilares experimenten varios cambios en su proceso de fabricaci\u00f3n, que con frecuencia da lugar a peque\u00f1as diferencias en relaci\u00f3n con la versi\u00f3n autorizada originalmente o la versi\u00f3n utilizada en los ensayos cl\u00ednicos presentados para su autorizaci\u00f3n, es un requisito t\u00e9cnico indispensable la presentaci\u00f3n de los estudios cl\u00ednicos m\u00e1s actualizados.\nEste requisito ha sido solicitado de forma consistente por la instituci\u00f3n para esta categor\u00eda de productos oncol\u00f3gicos, y aclaramos que en el ejemplo mencionado no se solicitaban estos bienes.\n", "dateAnswered": "2023-07-21T12:19:45-04:00"}, {"id": "17", "date": "2023-04-27T17:29:06-04:00", "title": "7- Para Anticuerpos Monoclonales  Punta B", "description": "El punto indicado requiere que el producto biosimilar debe presentar la caracterizaci\u00f3n fisicoqu\u00edmica igual al producto biol\u00f3gico innovador de referencia. El biosimilar contiene una versi\u00f3n del principio activo del producto de referencia. La equivalencia con este debe establecerse mediante un exhaustivo ejercicio de comparabilidad. El objetivo de ese ejercicio es demostrar que las leves diferencias fisicoqu\u00edmicas existentes entre ambos productos no inciden significativamente en el perfil beneficio/riesgo, lo cual permite sustentar que el principio activo de ambos medicamentos es en esencia el mismo. Una vez acreditada la equivalencia y autorizado, el biosimilar es un medicamento biol\u00f3gico m\u00e1s. La variabilidad fisicoqu\u00edmica sin trascendencia terap\u00e9utica es inherente a productos de naturaleza biol\u00f3gica, e identificable en ocasiones entre lotes de determinados medicamentos biol\u00f3gicos sometidos a cambios en el proceso productivo. Lo cual puede exigir incluso la ejecuci\u00f3n de un ejercicio de comparabilidad a la medida entre dos o m\u00e1s lotes de un mismo medicamento biol\u00f3gico, original o biosimilar, con el fin de comprobar su equivalencia.\nPor lo anterior, este requisito resulta de cumplimiento imposible para los productos biosimilares, siendo una restricci\u00f3n injustificada que impide la participaci\u00f3n de una mayor cantidad de oferentes y de permitir la libre competencia, conforme a los delineamientos de la normativa aplicable. Por dicho motivo, solicitamos a la Convocante que el requisito mencionado sea eliminado. Caso contrario, solicitamos se aclare, que las caracter\u00edsticas \nLos puntos indicados requieren que que los productos biosimilares incluyan sus estudios cl\u00ednicos, propios y concluidos con una poblaci\u00f3n estad\u00edsticamente significativa que demuestre que son intercambiables, cumpliendo las Gu\u00edas de FDA de mayo/2019 Consideraciones en la demostraci\u00f3n de Intercambiabilidad con un producto de referencia y que dichos estudios est\u00e9n dise\u00f1ados para demostrar la sustituci\u00f3n del producto biosimilar con el original seg\u00fan esas normas. Solicitamos que la Convocante elimine este requisito por ser innecesario para productos biosimilares que cuentan con la aprobaci\u00f3n de la FDA como tales. Si la FDA aprob\u00f3 un medicamento biosimilar es porque se demostr\u00f3 cient\u00edficamente que  cuenta con los estudios cl\u00ednicos que d\u00e9 muestras su seguridad, eficacia comparabilidad con el producto de referencia. Solicitar estudios adicionales que demuestren intercambiabilidad, en los casos en que se cuente con aprobaci\u00f3n de la FDA como biosimilares, no aporta ning\u00fan valor a\u00f1adido en cuanto a seguridad.\nYa que seg\u00fan organismos regulatorios de alta vigilancia como la EMA confirma que los productos biosimilares son intercambiables con su medicamento de referencia o con un biosimilar equivalente.\n Su inclusi\u00f3n significa solo un obst\u00e1culo para que se puedan ofertar productos biosimilares intercambiables aprobados por la FDA que redundar\u00edan en ofertas m\u00e1s convenientes para el IPS respecto de los originales. Asimismo, cabe mencionar que en procesos de contrataci\u00f3n previa llevados a cabo por IPS, no se incluy\u00f3 este requisito adicional, a\u00fan trat\u00e1ndose de la adquisici\u00f3n de medicamentos para el tratamiento de enfermedades graves de car\u00e1cter oncol\u00f3gico, citando como ejemplo la CVE 24/21 Adquisici\u00f3n urgente de medicamentos biol\u00f3gicos, biotecnol\u00f3gicos, oncol\u00f3gicos e inmunodepresores para el IPS (ID 399181). Considerando lo anterior, solicitamos a la Convocante que elimine el requisito mencionado o que, al menos, aclare que si los biosimilares est\u00e1n aprobados por la FDA como intercambiables, no es necesario agregar los estudios solicitados\n", "author": {"name": "FARMACEUTICA PARAGUAYA S.A.", "id": "PY-RUC-80006276-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:19:14-04:00"}, {"id": "31", "date": "2023-04-27T19:24:42-04:00", "title": "Capacidad Tecnica", "description": "En el Plan de farmacovigilancia del producto, se deber\u00e1 considerar, de acuerdo a la Gu\u00eda correspondiente los siguientes puntos: * 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.", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que la inmunogenicidad puede estar influida por las caracter\u00edsticas de los productos (por ejemplo, pueden producirse cambios en la estructura de las prote\u00ednas si se transportan o almacenan de forma inadecuada, o las prote\u00ednas podr\u00edan formar agregados), pero tambi\u00e9n por factores relacionados con el tratamiento (por ejemplo, el riesgo puede variar con la administraci\u00f3n intravenosa frente a la subcut\u00e1nea o con un tratamiento continuo frente a uno intermitente), as\u00ed como por factores relacionados con los pacientes y las enfermedades (por ejemplo, edad, condiciones gen\u00e9ticas o inmunitarias o tratamientos concomitantes)\nPor lo que la inmunogenicidad siempre es objeto de seguimiento una vez comercializada el medicamento. Esto es especialmente importante para saber si aparecen reacciones inmunitarias infrecuentes que solo es posible detectar tras un largo periodo de seguimiento de un gran n\u00famero de pacientes.\n", "dateAnswered": "2023-07-21T12:21:48-04:00"}, {"id": "26", "date": "2023-04-27T19:18:03-04:00", "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": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:20:56-04:00"}, {"id": "40", "date": "2023-04-27T19:30:00-04:00", "title": "Capacidad Tecnica", "description": "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": "Se aclara que la autorizaci\u00f3n de comercializaci\u00f3n vigente hace referencia al Certificado del Producto Farmaceutico (CPP) de acuerdo al pa\u00eds que lo emite.", "dateAnswered": "2023-07-21T12:23:39-04:00"}, {"id": "7", "date": "2023-04-27T14:14:58-04:00", "title": "REPORTES LOCALES (PSUR)", "description": "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.\nSolicitamos a la Convocante la presentaci\u00f3n de Informes Peri\u00f3dicos de Seguridad (PSUR) emitidos por el Fabricante o sus representadas ante la Autoridad Sanitaria.  \n", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que el oferente de acuerdo a la resoluci\u00f3n nro. 259/2022 de la DINAVISA, la autoridad sanitaria nacional debe evaluar los programas internacionales de Farmacovigilancia, por lo que los datos obtenidos de los sistemas de Farmacovigilancia no ser\u00e1n reconocidos ni tendr\u00e1n car\u00e1cter global y/o definitorio en tanto no hayan sido fehacientemente evaluados por la misma.\nComo se describe en el informe de la Organizaci\u00f3n Mundial de la Salud (OMS), Alianza mundial para la seguridad del paciente, entre los principales requisitos de los programas para mejorar la seguridad de los pacientes figuran la calidad y la capacidad de reunir la informaci\u00f3n m\u00e1s completa sobre reacciones adversas y errores de medicaci\u00f3n, de modo que esos programas constituyan fuentes de conocimiento y sirvan de base para futuras actividades de prevenci\u00f3n, por lo que este requisito se hace t\u00e9cnicamente indispensable y debe cumplir con la normativa vigente.\n", "dateAnswered": "2023-07-21T12:17:16-04:00"}, {"id": "35", "date": "2023-04-27T19:27:19-04:00", "title": "Capacidad Tecnica", "description": "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, solicitamos aclarar cuanto sigue: 1. Solicitamos aclarar a que gu\u00eda hace referencia la Convocante al mencionar lo detallado. 2. 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 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. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que de acuerdo a la resoluci\u00f3n nro. 259/2022 de la DINAVISA, la autoridad sanitaria nacional debe evaluar los programas internacionales de Farmacovigilancia, por lo que los datos obtenidos de los sistemas de Farmacovigilancia no ser\u00e1n reconocidos ni tendr\u00e1n car\u00e1cter global y/o definitorio en tanto no hayan sido fehacientemente evaluados por la misma.\nComo se describe en el informe de la Organizaci\u00f3n Mundial de la Salud (OMS), Alianza mundial para la seguridad del paciente, entre los principales requisitos de los programas para mejorar la seguridad de los pacientes figuran la calidad y la capacidad de reunir la informaci\u00f3n m\u00e1s completa sobre reacciones adversas y errores de medicaci\u00f3n, de modo que esos programas constituyan fuentes de conocimiento y sirvan de base para futuras actividades de prevenci\u00f3n, por lo que este requisito se hace t\u00e9cnicamente indispensable y debe cumplir con la normativa vigente.\nEs importante aclarar que las necesidades en materia de salud y el uso de medicamentos var\u00edan mucho entre pa\u00edses, debido a razones econ\u00f3micas, \u00e9tnicas y culturales, as\u00ed como por la carga de morbilidad, la dieta y el nivel de desarrollo del pa\u00eds; en consecuencia, las decisiones concernientes a la efectividad y la seguridad de los f\u00e1rmacos han de considerarse en el contexto espec\u00edfico de cada pa\u00eds. En tal sentido, la experiencia en el mercado constituye un elemento clave para comprobar la efectividad del producto en la poblaci\u00f3n y deben ser una prioridad de la salud p\u00fablica.\n", "dateAnswered": "2023-07-21T12:22:41-04:00"}, {"id": "28", "date": "2023-04-27T19:20:19-04:00", "title": "REQUISITO DOCUMENTAL PARA EVALUAR LA CAPACIDAD TECNICA", "description": "En el punto N\u00ba 7 apartado a) para los Para Anticuerpos Monoclonales como: Bevacizumab y Rituximab. La Convocante solicita lo siguiente: Para productos biosimilares 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 Canad\u00e1, 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 respecto solicitamos a la convocante excluir el requerimiento de que el registro sanitario deber\u00e1 contar con una antig\u00fcedad m\u00ednima de 3 a\u00f1os desde su emisi\u00f3n, teniendo en cuenta que una vez emitido el registro sanitario y acta de precios por la Autoridad Sanitaria Reguladora DNVS, el mismo se encuentra habilitado para la comercializaci\u00f3n. Ya que la DNVS emite dichos registros sanitarios una vez analizada toda la documentaci\u00f3n t\u00e9cnica y legal presentada por el solicitante y que demuestran la calidad, seguridad y eficacia del producto registrado. Por lo tanto, dicho requerimiento no hace m\u00e1s que limitar innecesariamente la participaci\u00f3n de potenciales oferentes cuyos registros han sido emitidos recientemente, pese a contar con la aprobaci\u00f3n y el aval de la Autoridad Sanitaria Reguladora Local, transgrediendo as\u00ed el principio que igualdad y libre competencia de la Ley N\u00ba 2051/03. Por otro lado, solicitamos que en el listado de Agencias reguladoras de referencia sean incluidas las Agencias Reguladoras de Referencia Regional Nivel IV reconocidas por la Organizaci\u00f3n Panamericana de la Salud (OPS) tal como lo establece el Decreto N\u00ba 6611/16 y no solo limitar a alguna de ellas.\n", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:21:18-04:00"}, {"id": "12", "date": "2023-04-27T17:03:26-04:00", "title": "ANTIG\u00dcEDAD DEL REGISTRO", "description": "El punto indicado requiere que el producto biosimilar cuente con un certificado de registro de producto emitido por DINAVISA con una antelaci\u00f3n m\u00ednima de 3 a\u00f1os. Solicitamos que se elimine este requisito porque no tiene m\u00e1s efecto que restringir la participaci\u00f3n de m\u00e1s proveedores y, en consecuencia, impedir una competencia que redunde en condiciones m\u00e1s favorables de adquisici\u00f3n para IPS. El requisito incluido permite solamente que determinados proveedores de los productos biol\u00f3gicos puedan participar, eliminando en la pr\u00e1ctica la posibilidad de que otros proveedores de biosimilares puedan ofertar sus productos en igualdad de condiciones, siguiendo el principio de igualdad y libre competencia consagrado en la Ley 2051/03. ala antig\u00fcedad de comercializaci\u00f3n en Paraguay, no existen fundamentos t\u00e9cnicos o cient\u00edficos para exigir una antelaci\u00f3n en la obtenci\u00f3n del registro del producto, ocasionando \u00fanicamente que la adjudicaci\u00f3n recaiga en determinados proveedores. Reiteramos que, desde el momento en que la DINAVISA autoriza el registro de un producto, este puede ser comercializado con total seguridad y en las mismas condiciones que otros productos que llevan m\u00e1s tiempo en el mercado paraguayo. Incluir requisitos de antig\u00fcedad en la comercializaci\u00f3n implica una discriminaci\u00f3n de otros productos aprobados por la autoridad sanitaria y que presentan igual o m\u00e1s garant\u00edas de seguridad para su uso. La antig\u00fcedad del registro solicitado no supone ning\u00fan tipo de par\u00e1metro t\u00e9cnico para reforzar la calidad, seguridad y eficacia del producto. No encontramos ning\u00fan fundamento cient\u00edfico o t\u00e9cnico que avale este requisito de antig\u00fcedad del registro y que pueda justificar la restricci\u00f3n de participaci\u00f3n a m\u00e1s oferentes. Tampoco hay motivos para que un producto biosimilar, autorizado por la FDA o la EMA, a cuyo efecto pas\u00f3 los controles m\u00e1s rigurosos que existen deba tener una antig\u00fcedad determinada de registro. A efectos de permitir una mayor participaci\u00f3n, solicitamos se elimine el requisito mencionado, fundado en el art\u00edculo 20 de la Ley 2051/03, as\u00ed como en virtud del principio de libre competencia consagrado en la misma", "author": {"name": "FARMACEUTICA PARAGUAYA S.A.", "id": "PY-RUC-80006276-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que la intenci\u00f3n de establecer este requisito radica en la necesidad de comprobar el efecto del producto en la poblaci\u00f3n paraguaya, con el fin de evitar la proliferaci\u00f3n de efectos adversos que impacten negativamente en la salud de los asegurados, aumentando el nivel de internaciones y generando de esta manera un desbalance presupuestario. Cada poblaci\u00f3n conlleva elementos espec\u00edficos que impactan directamente en la relaci\u00f3n riesgo/beneficio del producto, como ser la gen\u00e9tica, la cultura, la dieta, entre otros, de la poblaci\u00f3n estad\u00edsticamente significativa.\n", "dateAnswered": "2023-07-21T12:18:16-04:00"}, {"id": "23", "date": "2023-04-27T18:48:23-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "En el punto punto 7- Para Anticuerpos Monoclonales como: Bevacizumab y Rituximab., se establece:\nd. El producto biol\u00f3gico (innovador o biosimilar), deber\u00e1 incluir una gu\u00eda de manejo y preparaci\u00f3n del producto y su aplicaci\u00f3n al paciente, elaborado y firmado por el Director t\u00e9cnico, con certificaci\u00f3n de firma.\nSolicitamos a la Convocante eliminar este requisito que es limitante, ya que estos productos son de uso habitual y son conocidos por los profesionales de la Instituci\u00f3n.\n", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "Se aclara que este requisito no representa una dificultad t\u00e9cnica para el oferente ya que debe ser generado por el mismo, sin embargo, resulta sumamente \u00fatil para garantizar la correcta administraci\u00f3n del producto y educaci\u00f3n del personal de blanco y pacientes. Por lo que el oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2023-07-21T12:20:24-04:00"}, {"id": "13", "date": "2023-04-27T17:08:51-04:00", "title": "Antiguedad del Registro", "description": "Por el principio de Igualdad y Libre Compentencia establecidos en la Ley de Contrataicones, solicitamos se excluya el requisito de antiguedad de 3 a\u00f1os del Registro Sanitario, siendo que una vez DINAVISA otorgue dicho documento ya es autorizaci\u00f3n suficiente para la comercializaci\u00f3n en toda la Rep\u00fablica.", "author": {"name": "LIBRA PARAGUAY S.A.", "id": "PY-RUC-80023379-4"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que la intenci\u00f3n de establecer este requisito radica en la necesidad de comprobar el efecto del producto en la poblaci\u00f3n paraguaya, con el fin de evitar la proliferaci\u00f3n de efectos adversos que impacten negativamente en la salud de los asegurados, aumentando el nivel de internaciones y generando de esta manera un desbalance presupuestario. Cada poblaci\u00f3n conlleva elementos espec\u00edficos que impactan directamente en la relaci\u00f3n riesgo/beneficio del producto, como ser la gen\u00e9tica, la cultura, la dieta, entre otros, de la poblaci\u00f3n estad\u00edsticamente significativa.\n", "dateAnswered": "2023-07-21T12:18:26-04:00"}, {"id": "43", "date": "2023-04-27T19:32:18-04:00", "title": "Capacidad Tecnica", "description": "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": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n", "dateAnswered": "2023-07-21T12:24:13-04:00"}, {"id": "24", "date": "2023-04-27T18:49:30-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "En el punto punto 7- Para Anticuerpos Monoclonales como: Bevacizumab y Rituximab., se establece:\ne. Los productos biosimilares deber\u00e1n contar con experiencia de uso y comercializaci\u00f3n en Paraguay de por lo menos 2 a\u00f1os\nSolicitamos a la Convocante eliminar este requisito, considerando que una vez que la Direcci\u00f3n Nacional de Vigilancia Sanitaria emite el Certificado de Registro Sanitario ya habilita la comercializaci\u00f3n del medicamento, sin necesidad alguna de esperar un plazo para su comercializaci\u00f3n. Mantener este requisito ser\u00eda una  transgresi\u00f3n a los principios de igualdad, libre competencia y eficiencia y econom\u00eda.\n", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:20:34-04:00"}, {"id": "30", "date": "2023-04-27T19:23:37-04:00", "title": "REQUISITO DOCUMENTAL PARA EVALUAR LA CAPACIDAD TECNICA", "description": "En el punto N\u00ba 7 apartado b) La convocante solicita: Los productos biosimilares deber\u00e1n incluir sus estudios cl\u00ednicos, propios y concluidos con una poblaci\u00f3n estad\u00edsticamente significativa que demuestre que son intercambiables, cumpliendo las Gu\u00edas de FDA de mayo/2019.\nAl respecto pedimos a la Convocante la exclusi\u00f3n de dicha limitaci\u00f3n, teniendo en cuenta que el Decreto N\u00ba 6611/16 de Productos Biol\u00f3gicos, en su art. 8, inc b) claramente establece: Los estudios precl\u00ednicos y cl\u00ednicos comparativos necesarios para la demostraci\u00f3n de biosimilaridad en cuanto a seguridad, eficacia e inmunogenicidad, seguir\u00e1n los requisitos espec\u00edficos diferentes caso a caso para cada medicamento biol\u00f3gico solicitante, DE ACUERDO A LOS LINEAMIENTOS INTERNACIONALES de la OMS o ICH\u0085). Por lo tanto, solicitar que los estudios sean de acuerdo a las gu\u00edas de la FDA solamente resultan totalmente improcedentes y hasta limitantes, como ejemplo citamos una convocatoria anterior en donde dicha limitaci\u00f3n no formaba parte del PBC. (LPN 74/22 / ID 414214.) de la misma convocante.\n", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:21:37-04:00"}, {"id": "18", "date": "2023-04-27T17:34:54-04:00", "title": "e. experiencia de uso y comercializaci\u00f3n en Paraguay de por lo menos 2 a\u00f1os", "description": "El punto se\u00f1alado requiere que los productos biosimilares cuenten con experiencia de uso y comercializaci\u00f3n en Paraguay de por lo menos 2 a\u00f1os. Solicitamos a la Convocante la eliminaci\u00f3n de este requisito de antig\u00fcedad de comercializaci\u00f3n, ya que no existe ning\u00fan fundamento t\u00e9cnico o cient\u00edfico que pueda avalar dicha exigencia, la cual supone una restricci\u00f3n injustificada para que posibles oferentes puedan participar de la licitaci\u00f3n. Esta solicitud lo realizamos a fin de no limitar innecesariamente la concurrencia de potenciales oferentes que cuenten con los productos solicitados, privando a la Convocante de la posibilidad de acceder a mejores precios. Adem\u00e1s de mantenerse el requisito en tales condiciones se estar\u00e1 transgrediendo abiertamente los principios que rigen las compras p\u00fablicas: IGUALDAD Y LIBRE COMPETENCIA Y EFICIENCIA Y ECONOMIA", "author": {"name": "FARMACEUTICA PARAGUAYA S.A.", "id": "PY-RUC-80006276-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:19:23-04:00"}, {"id": "44", "date": "2023-04-27T19:33:50-04:00", "title": "Capacidad Tecnica", "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 – 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": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que de acuerdo a la resoluci\u00f3n nro. 259/2022 de la DINAVISA, la autoridad sanitaria nacional debe evaluar los programas internacionales de Farmacovigilancia, por lo que los datos obtenidos de los sistemas de Farmacovigilancia no ser\u00e1n reconocidos ni tendr\u00e1n car\u00e1cter global y/o definitorio en tanto no hayan sido fehacientemente evaluados por la misma.\nComo se describe en el informe de la Organizaci\u00f3n Mundial de la Salud (OMS), Alianza mundial para la seguridad del paciente, entre los principales requisitos de los programas para mejorar la seguridad de los pacientes figuran la calidad y la capacidad de reunir la informaci\u00f3n m\u00e1s completa sobre reacciones adversas y errores de medicaci\u00f3n, de modo que esos programas constituyan fuentes de conocimiento y sirvan de base para futuras actividades de prevenci\u00f3n, por lo que este requisito se hace t\u00e9cnicamente indispensable y debe cumplir con la normativa vigente.\n", "dateAnswered": "2023-07-21T12:24:23-04:00"}, {"id": "48", "date": "2023-04-28T09:59:37-04:00", "title": "Capacidad Tecnica", "description": "En el PBC se establece: Los productos biosimilares deber\u00e1n presentar la caracterizaci\u00f3n fisicoqu\u00edmica igual al producto biol\u00f3gico innovador de referencia. Los productos biosimilares deber\u00e1n incluir sus estudios cl\u00ednicos, propios y concluidos con una poblaci\u00f3n estad\u00edsticamente significativa que demuestre que son intercambiables, cumpliendo las Gu\u00edas de FDA de mayo/2019 Consideraciones en la demostraci\u00f3n de Intercambiabilidad y en todas las mismas indicaciones de uso que el producto de referencia. Al respecto, solicitamos aclarar en que se basa la Convocante al requerir una gu\u00eda en especifico, recordamos a la misma que como su nombre lo dice son gu\u00edas y no son de uso obligatorio, pudiendo cada fabricante realizarla de acuerdo a sus parametros y considerando estas guias, por lo que solicitamos eliminar este requisito, resultando el mismo limitante, atentando contra el principio de igualdad y libre compentencia. ", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que la actividad de la comparaci\u00f3n de biosimilares con sus productos de referencia, se encuentra reservada exclusivamente para el cuerpo t\u00e9cnico, es decir los m\u00e9dicos tratantes, por lo se resalta el criterio de \u00e9stos en la evaluaci\u00f3n exhaustiva de la informaci\u00f3n t\u00e9cnica disponible as\u00ed como la experiencia de uso (informaci\u00f3n de seguridad) del producto.\nCon relaci\u00f3n a la caracterizaci\u00f3n f\u00edsico-qu\u00edmica, de acuerdo a los lineamientos de la EMA solo se permite un peque\u00f1o margen de variabilidad cuando las pruebas cient\u00edficas demuestran que no afecta a la seguridad ni a la eficacia del biosimilar, por lo que es necesario que nuestro cuerpo m\u00e9dico pueda comprobarlo. El rango de variabilidad permitido para un biosimilar es el mismo que el permitido entre lotes del medicamento de referencia. Esto se consigue mediante un proceso de fabricaci\u00f3n consistente, que garantice que todos los lotes del medicamento tienen calidad probada.\nCon relaci\u00f3n a los estudios cl\u00ednicos, propios y concluidos con una poblaci\u00f3n estad\u00edsticamente significativa que demuestre que son intercambiables, cumpliendo las Gu\u00edas de FDA de mayo/2019, como es caracter\u00edstico que los biosimilares experimenten varios cambios en su proceso de fabricaci\u00f3n, que con frecuencia da lugar a peque\u00f1as diferencias en relaci\u00f3n con la versi\u00f3n autorizada originalmente o la versi\u00f3n utilizada en los ensayos cl\u00ednicos presentados para su autorizaci\u00f3n, es un requisito t\u00e9cnico indispensable la presentaci\u00f3n de los estudios cl\u00ednicos m\u00e1s actualizados.\nEste requisito ha sido solicitado de forma consistente por la instituci\u00f3n para esta categor\u00eda de productos oncol\u00f3gicos, y aclaramos que en el ejemplo mencionado no se solicitaban estos bienes.\nLa instituci\u00f3n se basa en el criterio de su experimentado cuerpo m\u00e9dico para establecer los requisitos de capacidad t\u00e9cnica, los cuales son cr\u00edticos para salvaguardar la vida y la salud de los pacientes beneficiarios de la instituci\u00f3n. \nSubrayamos la responsabilidad legal exclusiva del cuerpo m\u00e9dico, no de la autoridad regulatoria (DINAVISA), tratante respecto a la prescripci\u00f3n de tratamientos y la necesidad imperioso de que \u00e9stos dispongan de la informaci\u00f3n t\u00e9cnica m\u00e9dica necesaria para la identificaci\u00f3n y la aplicaci\u00f3n de tratamientos m\u00e9dicos, los cuales revisten mayor criticidad en esta instancia trat\u00e1ndose de pacientes oncol\u00f3gicos. Recordamos a los recurrentes que la DINAVISA reviste el car\u00e1cter de autoridad regulatoria para la exigencia de requisitos M\u00cdNIMOS para la obtenci\u00f3n de autorizaciones de comercializaci\u00f3n de f\u00e1rmacos. La legislaci\u00f3n regulatoria y administrativa vigente NO precluye la solicitud de requisitos adicionales para la toma de decisiones terap\u00e9uticas de parte del m\u00e9dico tratante.\n", "dateAnswered": "2023-07-21T12:25:14-04:00"}, {"id": "38", "date": "2023-04-27T19:29:01-04:00", "title": "Capacidad Tecnica", "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": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:23:14-04:00"}, {"id": "36", "date": "2023-04-27T19:27:26-04:00", "title": "REQUISITOS PARA EVALUAR LA CAPACIDAD T\u00c9CNICA ", "description": "Solicitamos a la convocante aclarar bajo que fundamento regulatorio, t\u00e9cnico o cient\u00edfico solicita que un potencial oferente presente AUTORIZACION DE COMERCIALIZACION (CLV) emitida por autoridades sanitarias de alta vigilancia, siendo que la misma norma \u0096 Decreto 6611/16 en su Art. 6 inciso b prev\u00e9 en listado de documentos que deben ser presentados para registrar un medicamento biol\u00f3gico entre los cuales se cita textualmente Copia autenticada del CERTIFICADO DE LIBRE VENTA o documentaci\u00f3n que acredite la comercializaci\u00f3n del medicamento EMITIDO POR LA AUTORIDAD SANITARIA DEL PA\u00cdS DE ORIGEN o procedencia (seg\u00fan corresponda).\nQue las condiciones actuales del PBC para con los medicamentos biosimilares suponen una restricci\u00f3n injustificada para que posibles oferentes puedan participar de la licitaci\u00f3n vulnerando totalmente el principio de igualdad consagrado en las contrataciones p\u00fablicas.\n", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que la Convocante tiene potestades para evaluar las necesidades p\u00fablicas a satisfacer y establecer los requisitos t\u00e9cnicos necesarios que considere indispensables para el efecto. La normativa confiere la facultad exclusiva a la entidad convocante en realizar la redacci\u00f3n de los PBC con especial atenci\u00f3n a satisfacer la necesidad que diera origen al llamado (arts. 7 inc. g y 33 del Dto. N\u00b0 2992/19).\nLos medicamentos objeto de la licitaci\u00f3n son vitales para la vida de los pacientes, por lo que su adquisici\u00f3n debe enmarcarse dentro de un riguroso control de calidad a fin de buscar la oferta m\u00e1s conveniente que permita alcanzar los resultados terap\u00e9uticos esperados por el IPS para sus pacientes, respetando el criterio m\u00e9dico del cuerpo t\u00e9cnico y salvaguardando el inter\u00e9s superior de sus pacientes.\n", "dateAnswered": "2023-07-21T12:22:49-04:00"}, {"id": "8", "date": "2023-04-27T14:15:51-04:00", "title": "EXPERIENCIA DE USO BIOSIMILARES", "description": "Los productos biosimilares deber\u00e1n contar con experiencia de uso y comercializaci\u00f3n en Paraguay de por lo menos 2 a\u00f1os. \nEXCLUIR el requisito que exige el uso de 2 a\u00f1os en Paraguay, pues atenta contra la reglamentaci\u00f3n vigente aprobada por Decreto 6611/2016 la CN y dem\u00e1s concordantes limitando innecesariamente a ejercer la actividad comercial en el rubro despu\u00e9s de haber cumplido con todos los requisitos t\u00e9cnicos y legales para demostrar por medio de una exhaustiva evaluaci\u00f3n realizada por avezados profesionales de la DNVS que el producto cuenta con la seguridad y eficacia requeridos y puede comercializado y por ende utilizado por los profesionales m\u00e9dicos.-\nFundamentamos la solicitud en el art\u00edculo 22 del reglamento que dicta \u0085De cumplir el Titular del Registro con todos los requisitos  de este Decreto y habiendo la DNVS otorgado autorizaci\u00f3n de comercializaci\u00f3n a trav\u00e9s del correspondiente registro sanitario, podr\u00e1 comercializar los productos biol\u00f3gicos afectados a este Decreto 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 utilizados en todos los procesos de la adquisici\u00f3n como garant\u00eda de calidad, seguridad y eficacia de los medicamentos biol\u00f3gicos\n", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que no existe contradicci\u00f3n con lo dispuesto en el decreto 6611/2016 y dicha interpretaci\u00f3n carece de sustento jur\u00eddico. Lo estipulado en el referido decreto son los requisitos m\u00ednimos para la obtenci\u00f3n de la autorizaci\u00f3n de comercializaci\u00f3n. Es decir, son los requisitos b\u00e1sicos para que el f\u00e1rmaco se pueda disponibilizar en el territorio nacional. El decreto no obliga a las Convocantes a considerar las documentaciones mencionadas como suficientes para los procesos de adquisici\u00f3n, siendo estas capacidades exclusivas de cada entidad convocante o entidad adquirente, siendo p\u00fablica o privada.\nResulta sumamente peligroso buscar afirmar que la autoridad sanitaria obliga a la adquisici\u00f3n de determinados f\u00e1rmacos o que la autoridad sanitaria puede ponerse sobre el criterio t\u00e9cnico m\u00e9dico de los profesionales intervinientes en el tratamiento terap\u00e9utico. De hecho, la autoridad sanitaria que confirmado y ratificado que las decisiones de uso, sea prescripci\u00f3n y/o intercambiabilidad, es de potestad EXCLUSIVA del m\u00e9dico tratante. En este caso, el cuerpo m\u00e9dico tratante se manifiesta a trav\u00e9s del servicio oncol\u00f3gico del IPS y se consolidan dichos criterios en el pliego de bases y condiciones. \nEl criterio m\u00e9dico responde \u00fanica y exclusivamente para salvaguardar la vida y la salud de los pacientes, siendo \u00e9stos preceptos garantizados constitucionalmente a los cuales esta instituci\u00f3n se ve abocada desde su creaci\u00f3n y su prop\u00f3sito de seguro social.\nEs importante aclarar que las necesidades en materia de salud y el uso de medicamentos var\u00edan mucho entre pa\u00edses, debido a razones econ\u00f3micas, \u00e9tnicas y culturales, as\u00ed como por la carga de morbilidad, la dieta y el nivel de desarrollo del pa\u00eds; en consecuencia, las decisiones concernientes a la efectividad y la seguridad de los f\u00e1rmacos han de considerarse en el contexto espec\u00edfico de cada pa\u00eds. En tal sentido, la experiencia en el mercado constituye un elemento clave para comprobar la efectividad del producto en la poblaci\u00f3n y deben ser una prioridad de la salud p\u00fablica.\n", "dateAnswered": "2023-07-21T12:17:35-04:00"}, {"id": "22", "date": "2023-04-27T18:47:12-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "En el punto 7- Para Anticuerpos Monoclonales como: Bevacizumab y Rituximab., se establece:\nb. Los productos biosimilares deber\u00e1n presentar la caracterizaci\u00f3n fisicoqu\u00edmica igual al producto biol\u00f3gico innovador de referencia. Los productos biosimilares deber\u00e1n incluir sus estudios cl\u00ednicos, propios y concluidos con una poblaci\u00f3n estad\u00edsticamente significativa que demuestre que son intercambiables, cumpliendo las Gu\u00edas de FDA de mayo/2019 Consideraciones en la demostraci\u00f3n de Intercambiabilidad y en todas las mismas indicaciones de uso que el producto de referencia. . Dichos estudios deber\u00e1n estar dise\u00f1ados para demostrar la sustituci\u00f3n del producto biosimilar con el original seg\u00fan estas normas. El biosimilar deber\u00e1 tener estudios en todas las mismas indicaciones de uso que el producto de referencia. El producto biosimilar deber\u00e1 presentar estudios de farmacocin\u00e9tica y farmacodinamia comparables al biol\u00f3gico innovador.\nc. 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:\nEn el Plan de Farmacovigilancia del producto, se deber\u00e1 considerar, de acuerdo a la Gu\u00eda correspondiente los siguientes 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.\nSolicitamos a la Convocante eliminar estos requisitos que limitan la participaci\u00f3n de potenciales oferentes.\n", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:20:14-04:00"}, {"id": "46", "date": "2023-04-28T08:36:50-04:00", "title": "REQUISITOS PARA EVALUAR LA CAPACIDAD T\u00c9CNICA ", "description": "El PBC solicita lo siguiente Para productos biosimilares 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 Canad\u00e1, 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 la exclusi\u00f3n de dicho requisito, ya que los registros son emitidos previo an\u00e1lisis de documentaci\u00f3n t\u00e9cnica y legal por parte de la Autoridad Sanitaria Reguladora DNVS, lo cual se corresponde en la principal aprobaci\u00f3n para su comercializaci\u00f3n, sin hacer menci\u00f3n a antig\u00fcedad alguna. De la manera en c\u00f3mo se presenta el actual PBC, lo \u00fanico que hace es limitar la participaci\u00f3n de los potenciales oferentes que han obtenido recientemente sus Certificados de Registro Sanitario.", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:24:51-04:00"}, {"id": "2", "date": "2023-04-27T14:08:03-04:00", "title": "ABASTECIMIENTO SIMULT\u00c1NEO", "description": "Solicitamos la aplicaci\u00f3n de la modalidad de Abastecimiento simult\u00e1neo para las entregas 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 que acuden al Servicio.", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:16:31-04:00"}, {"id": "21", "date": "2023-04-27T18:45:59-04:00", "title": "1.\tSistema de Abastecimiento", "description": "Solicitamos a la convocante cambiar el Sistema de Adjudicaci\u00f3n a Abastecimiento Simult\u00e1neo, de forma a dar participaci\u00f3n a m\u00e1s oferentes y a la vez asegurar la provisi\u00f3n continua y que la Instituci\u00f3n no quede desabastecida en ning\u00fan momento.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:19:55-04:00"}, {"id": "47", "date": "2023-04-28T09:05:38-04:00", "title": "PORCENTAJE DE MULTA", "description": "Solicitamos a la Convocante modificar y disminuir el porcentaje de multa establecido que es de 0,10%, y que se observa, que el porcentaje de tasa de inter\u00e9s por mora por parte de la Contratante es de 0,01%, por tanto solicitamos que el porcentaje de multa sea igual al porcentaje de inter\u00e9s por mora por falta de pago por parte de la Convocante.", "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": "2023-07-21T12:25:00-04:00"}, {"id": "25", "date": "2023-04-27T18:50:35-04:00", "title": "Requisito documental para evaluar la capacidad t\u00e9cnica", "description": "En el punto punto 7- Para Anticuerpos Monoclonales como: Bevacizumab y Rituximab., se establece:\nPara los estudios cl\u00ednicos, podr\u00e1n estar respaldados por una declaraci\u00f3n formalizada por el fabricante del producto ante Escribano o Notario P\u00fablico, autenticada y para la firma del contrato deber\u00e1 estar debidamente legalizada por el Ministerio de Relaciones Exteriores del Paraguay o apostillada, en la que se individualicen espec\u00edficamente los estudios que se presentan y se reconozca su autenticidad,\nSolicitamos a la Convocante que se excluya este requisito, que limita la participaci\u00f3n de potenciales oferentes considerando que los tr\u00e1mites mencionados en este p\u00e1rrafo llevan mucho tiempo y no se podr\u00e1n concluir para las fechas requeridas, adem\u00e1s de transgredir los principios de igualdad, libre competencia y eficiencia y econom\u00eda. El Comit\u00e9 Evaluador o del Consejo de Administraci\u00f3n podr\u00e1n solicitar a la Direcci\u00f3n Nacional de Vigilancia Sanitaria del Ministerio de Salud P\u00fablica y Bienestar Social toda la documentaci\u00f3n que requiera para aclarar cualquier duda.", "author": {"name": "DISTRIBUIDORA LA POLICLINICA S. A.", "id": "PY-RUC-80025906-8"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:20:46-04:00"}, {"id": "1", "date": "2023-04-27T12:28:53-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Solicitamos amablemente a la convocante modificar el sistema de abastecimiento por cantidad a abastecimiento simultaneo, de este modo se dar\u00e1 mayor participaci\u00f3n a futuros oferentes y evitar\u00eda un posible desabastecimiento de producto.", "author": {"name": "FARMACEUTICA PARAGUAYA S.A.", "id": "PY-RUC-80006276-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:16:20-04:00"}, {"id": "34", "date": "2023-04-27T19:26:51-04:00", "title": "REQUISITOS PARA EVALUAR LA CAPACIDAD T\u00c9CNICA.", "description": "La convocante solicita en el punto e. Los productos biosimilares deber\u00e1n contar con experiencia de uso y comercializaci\u00f3n en Paraguay de por lo menos 2 a\u00f1os. Al respecto pedimos a la Convocante excluir dicho requisito ya que una vez que la DNVS otorga la autorizaci\u00f3n de comercializaci\u00f3n, a trav\u00e9s del correspondiente registro sanitario, el detentor del mismo puede comercializar los mismos dentro del territorio de la Rep\u00fablica del Paraguay, por s\u00ed mismo o por representaci\u00f3n concedida, sin mencionar antig\u00fcedad alguna, ya que dicho registro sanitario es emitido previo an\u00e1lisis de las documentaciones legales, administrativas y t\u00e9cnicas-cient\u00edficas presentadas por el solicitante, en donde las mismas han demostrado que el producto cuenta con las garant\u00edas de calidad, seguridad y eficacia.", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:22:20-04:00"}, {"id": "3", "date": "2023-04-27T14:11:10-04:00", "title": "EXPERIENCIA REQUERIDA", "description": "En el apartado Requisitos para validar la Experiencia, se menciona cuanto sigue: 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: 2019 2020-2021. Para el caso de 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.\n\u00bfCu\u00e1l es el sentido de establecer una barrera de entrada de este tipo, cuando los productos elaborados, distribuidos y comercializados por el fabricante ya cuentan con autorizaci\u00f3n de las autoridades sanitarias y regulatorias? \u00bfCu\u00e1l es el sentido de que un comercio pueda ser v\u00e1lidamente vendido a la poblaci\u00f3n en general en las farmacias, pero no pueda ser adquirido por el Estado? \n\u00bfQu\u00e9 garant\u00eda brinda la antig\u00fcedad del fabricante? El cumplimiento se encuentra cubierto por los antecedentes del oferente y las p\u00f3lizas exigidas en el PBC. Llevando el ejemplo al absurdo, \u00bfpor qu\u00e9 no exigir experiencia de 3 a\u00f1os de todos los proveedores del fabricante? \nSolicitamos a la Convocante que EXCLUYA de los requisitos la experiencia del fabricante; limit\u00e1ndose solo al oferente.\nEsta solicitud lo realizamos a fin de no limitar innecesariamente la concurrencia de potenciales oferentes que cuenten con los productos solicitados, privando a la Convocante de la posibilidad de acceder a mejores precios. Adem\u00e1s de mantenerse el requisito en tales condiciones se estar\u00e1 transgrediendo abiertamente los principios que rigen las compras p\u00fablicas: IGUALDAD Y LIBRE COMPETENCIA Y EFICIENCIA Y ECONOMIA. \n", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Se aclara que el requisito no resulta en absoluto limitante o excluyente, sino que por el contrario 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.-\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: \nPara 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. \nPor lo que el oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.\n", "dateAnswered": "2023-07-21T12:16:40-04:00"}, {"id": "45", "date": "2023-04-28T07:56:35-04:00", "title": "REQUISITOS PARA EVALUAR LA CAPACIDAD T\u00c9CNICA ", "description": "Solicitamos a la Convocante que el requisito de presentaci\u00f3n de informes de Farmacovigilancia sea excluido. Esto debido a que se corresponde en un requisito innecesario, ya que la evaluaci\u00f3n del mismo se realiza con criterios subjetivos, generando contratiempos tanto en la realizaci\u00f3n del llamado, como en la evaluaci\u00f3n del mismo hasta la etapa de adjudicaci\u00f3n. Tomando como referencia un llamado que actualmente se encuentra abierto, en donde dicho requisito fue excluido por parte de la Convocante, la licitaci\u00f3n referida es la LPN N\u00ba 144-22 ID 419.027.", "author": {"name": "PROSALUD FARMA S.A.", "id": "PY-RUC-80033584-8"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que de acuerdo a la resoluci\u00f3n nro. 259/2022 de la DINAVISA, la autoridad sanitaria nacional debe evaluar los programas internacionales de Farmacovigilancia, por lo que los datos obtenidos de los sistemas de Farmacovigilancia no ser\u00e1n reconocidos ni tendr\u00e1n car\u00e1cter global y/o definitorio en tanto no hayan sido fehacientemente evaluados por la misma.\nComo se describe en el informe de la Organizaci\u00f3n Mundial de la Salud (OMS), Alianza mundial para la seguridad del paciente, entre los principales requisitos de los programas para mejorar la seguridad de los pacientes figuran la calidad y la capacidad de reunir la informaci\u00f3n m\u00e1s completa sobre reacciones adversas y errores de medicaci\u00f3n, de modo que esos programas constituyan fuentes de conocimiento y sirvan de base para futuras actividades de prevenci\u00f3n, por lo que este requisito se hace t\u00e9cnicamente indispensable y debe cumplir con la normativa vigente.\n", "dateAnswered": "2023-07-21T12:24:40-04:00"}, {"id": "16", "date": "2023-04-27T17:24:09-04:00", "title": "Abastecimiento Simult\u00e1neo", "description": "Solicitamos amablemente a la convocante modificar el sistema de abastecimiento por cantidad a abastecimiento simultaneo, 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 a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:19:04-04:00"}, {"id": "32", "date": "2023-04-27T19:24:42-04:00", "title": "REQUISITOS PARA EVALUAR LA CAPACIDAD T\u00c9CNICA PARA PRODUCTOS BIOSIMILARES.", "description": "Solicitamos a la convocante aclarar bajo que fundamento regulatorio, t\u00e9cnico o cient\u00edfico solicita que un potencial oferente presente Registro Sanitario otorgado solo por algunas autoridades sanitarias de alta vigilancia, excluyendo otras que claramente son admisibles conforme al Decreto 6611/16, tales como: ISPCH de CHILE, INVIMA de COLOMBIA, COFEPRIS de MEXICO, CECMED de CUBA, entre otros. Por lo cual solicitamos que este apartado sea reformulado de la siguiente manera:\nA los efectos del presente decreto, ser\u00e1n consideradas como Agencias Reguladoras de Referencia las siguientes:\na)\tAgencias Reguladoras de Alta Vigilancia de los pa\u00edses indicados en el Art. 11 de la Ley N\u00ba 3283/2007 De protecci\u00f3n de la informaci\u00f3n p\u00fablica no divulgada y datos de prueba para los registros farmac\u00e9uticos\nb)\tA las dem\u00e1s Agencias Reguladoras de los pa\u00edses indicados en el Art. 11 de la mencionada Ley N\u00ba 3283/2007.\nc)\tAgencias Reguladoras de la EMA (European Medicines Agency).\nd)\tAgencias Reguladoras de referencia Regional (Nivel 4) reconocidas por la Organizaci\u00f3n Panamericana de Salud (OPS).", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:22:00-04:00"}, {"id": "41", "date": "2023-04-27T19:31:02-04:00", "title": "Capacidad Tecnica", "description": "En el P.B.C. se establece: Los productos biosimilares deber\u00e1n contar con experiencia de uso y comercializaci\u00f3n en Paraguay de por lo menos 2 a\u00f1os. Solicitamos a la Convocante excluir este requisito porque limita la participaci\u00f3n de oferentes.", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:23:49-04:00"}, {"id": "39", "date": "2023-04-27T19:29:34-04:00", "title": "Capacidad Tecnica", "description": "En 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": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que el Certificado de Buenas Pr\u00e1cticas, m\u00e1s conocidas como Good Manufacturing Practices (GMP), son un conjunto de normas que la Organizaci\u00f3n Mundial de la Salud (OMS) recomienda aplicar en los laboratorios farmac\u00e9uticos para garantizar que los medicamentos se fabrican en forma uniforme y controlada, por lo que este documento est\u00e1 m\u00e1s relacionado con el sitio de fabricaci\u00f3n y es solicitado en otro apartado.\nEl Certificado del producto farmac\u00e9utico es el documento que certifica la calidad en si del f\u00e1rmaco, as\u00ed como que tenga el registro vigente y est\u00e9 autorizado para la venta o distribuci\u00f3n.\nPor lo tanto, un documento no puede reemplazar al otro de manera indistinta.\n", "dateAnswered": "2023-07-21T12:23:28-04:00"}, {"id": "19", "date": "2023-04-27T17:45:18-04:00", "title": "Registro sanitario 3 a\u00f1os de antiguedad", "description": "El punto indicado requiere que el producto biosimilar cuente con un certificado de registro de producto emitido por DINAVISA con una antelaci\u00f3n m\u00ednima de 3 a\u00f1os. Solicitamos que se elimine este requisito porque no tiene m\u00e1s efecto que restringir la participaci\u00f3n de m\u00e1s proveedores y, en consecuencia, impedir una competencia que redunde en condiciones m\u00e1s favorables de adquisici\u00f3n para IPS. El requisito incluido permite solamente que determinados proveedores de los productos biol\u00f3gicos puedan participar, eliminando en la pr\u00e1ctica la posibilidad de que otros proveedores de biosimilares puedan ofertar sus productos en igualdad de condiciones, siguiendo el principio de igualdad y libre competencia consagrado en la Ley 2051/03", "author": {"name": "FARMACEUTICA PARAGUAYA S.A.", "id": "PY-RUC-80006276-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que la intenci\u00f3n de establecer este requisito radica en la necesidad de comprobar el efecto del producto en la poblaci\u00f3n paraguaya, con el fin de evitar la proliferaci\u00f3n de efectos adversos que impacten negativamente en la salud de los asegurados, aumentando el nivel de internaciones y generando de esta manera un desbalance presupuestario. Cada poblaci\u00f3n conlleva elementos espec\u00edficos que impactan directamente en la relaci\u00f3n riesgo/beneficio del producto, como ser la gen\u00e9tica, la cultura, la dieta, entre otros, de la poblaci\u00f3n estad\u00edsticamente significativa.\n", "dateAnswered": "2023-07-21T12:19:32-04:00"}, {"id": "42", "date": "2023-04-27T19:31:12-04:00", "title": "ACLARATORIA A REPAROS:", "description": "Que de la lectura integra de los documentos publicados en el presente llamado, nos hemos percatado de que las muchas limitaciones introducidas en el PBC para que un biosimilar pueda resultar adjudicado, se encuentra fundamentado en que la legislaci\u00f3n vigente no permite identificar una COPIA de un biosimilar, al respecto cumplimos en aclarar que el Decreto 6611/16 del MSPYBS regula el registro y la comercializaci\u00f3n de productos innovadores y biosimilares, siempre y cuando estos hayan pasado por el proceso de revisi\u00f3n y evaluaci\u00f3n de todos los documentos requeridos en el decreto, por lo tanto la DINAVISA a trav\u00e9s del decreto 6611/16, NIEGA TOTALMENTE la posibilidad de que pueda ser registrado y comercializado un producto que no cuenta con las garant\u00edas de calidad, seguridad y eficacia, enti\u00e9ndase COPIAS.\nPor lo cual requerimos al IPS que se interiorice en los requisitos establecidos en el Decreto 6611/16 y reformule totalmente los requerimientos hoy establecidos en el PBC conforme a la legislaci\u00f3n vigente y conforme a lo establecido en el PBC de una convocatoria en curso el cual, si se encuentra conforme la reglamentaci\u00f3n vigente, detallamos link:\nhttps://www.contrataciones.gov.py/licitaciones/convocatoria/419027-lpn-sbe-144-22-adquisicion-medicamentos-monoclonales-asegurados-ips-ad-referendum-20-1.html  \n\n", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones\nSe aclara que la instituci\u00f3n se basa en el criterio de su experimentado cuerpo m\u00e9dico para establecer los requisitos de capacidad t\u00e9cnica, los cuales son cr\u00edticos para salvaguardar la vida y la salud de los pacientes beneficiarios de la instituci\u00f3n. Subrayamos la responsabilidad legal exclusiva del cuerpo m\u00e9dico, no de la autoridad regulatoria (DINAVISA), tratante respecto a la prescripci\u00f3n de tratamientos y la necesidad  imperioso de que \u00e9stos dispongan de la informaci\u00f3n t\u00e9cnica m\u00e9dica necesaria para la identificaci\u00f3n y la aplicaci\u00f3n de tratamientos m\u00e9dicos, los cuales revisten mayor criticidad en esta instancia trat\u00e1ndose de pacientes oncol\u00f3gicos. Recordamos a los recurrentes que la DINAVISA reviste el car\u00e1cter de autoridad regulatoria para la exigencia de requisitos M\u00cdNIMOS para la obtenci\u00f3n de autorizaciones de comercializaci\u00f3n de f\u00e1rmacos. La legislaci\u00f3n regulatoria y administrativa vigente NO precluye la solicitud de requisitos adicionales para la toma de decisiones terap\u00e9uticas de parte del m\u00e9dico tratante.\n", "dateAnswered": "2023-07-21T12:24:03-04:00"}, {"id": "29", "date": "2023-04-27T19:21:59-04:00", "title": "REQUISITO DOCUMENTAL PARA EVALUAR LA CAPACIDAD TECNICA", "description": "En el punto N\u00ba 7 apartado c) 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. \nAl respecto de este requisito solicitamos a la Convocante que el mismo sea excluido, ya que existen sobrados antecedentes de que el requisito de farmacovigilancia ha sido utilizado en forma discrecional y subjetivo dependiendo del profesional que formaba parte del comit\u00e9 evaluador, creando situaciones de desigualdad los cuales generaban constantes recursos de protestas lo que a su vez constitu\u00eda un retraso en los procesos licitatorios y la adquisici\u00f3n de los medicamentos. Por otro lado, el requisito de farmacovigilancia no se constituye en un elemento t\u00e9cnicamente indispensable para adquirir los medicamentos hoy solicitados, ya que como ejemplo traemos a la vista un llamado en curso (LPN N\u00ba 144/22 con ID 419.027), donde se busca adquirir medicamentos de la misma naturaleza (monoclonales) en la cual el requisito de Farmacovigilancia NO EXISTE.\n", "author": {"name": "BIOTENG S.A.", "id": "PY-RUC-80035226-2"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:21:27-04:00"}, {"id": "5", "date": "2023-04-27T14:13:18-04:00", "title": "ANTIG\u00dcEDAD DEL REGISTRO", "description": "El producto biosimilar deber\u00e1 contar con Registro Sanitario emitido por DNVS, con antelaci\u00f3n m\u00ednima de 3 a\u00f1os\n\u00bfQu\u00e9 garant\u00eda brinda la antig\u00fcedad del fabricante? El cumplimiento se encuentra cubierto por los antecedentes del oferente y las p\u00f3lizas exigidas en el PBC. Llevando el ejemplo al absurdo, \u00bfpor qu\u00e9 no exigir experiencia de 3 a\u00f1os de todos los proveedores del fabricante? \nSolicitamos a la Convocante que EXCLUYA de los requisitos antig\u00fcedad del registro.\nEsta solicitud lo realizamos a fin de no limitar innecesariamente la concurrencia de potenciales oferentes que cuenten con los productos solicitados, privando a la Convocante de la posibilidad de acceder a mejores precios. Adem\u00e1s de mantenerse el requisito en tales condiciones se estar\u00e1 transgrediendo abiertamente los principios que rigen las compras p\u00fablicas: IGUALDAD Y LIBRE COMPETENCIA Y EFICIENCIA Y ECONOMIA. \n", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:17:03-04:00"}, {"id": "4", "date": "2023-04-27T14:12:39-04:00", "title": "REGISTRO Y AUTORIZACI\u00d3N DE COMERCIALIZACION", "description": "3.\tPara productos biosimilares 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 Canad\u00e1, ANVISA o ANMAT. \nSe solicita a la Convocante ampliar el criterio de Autoridades Reguladoras aprobadas por la OPS para la presentaci\u00f3n de Certificado de Registro Sanitario y Autorizaci\u00f3n de comercializaci\u00f3n incluyendo a todos los declarados conforme al Decreto N\u00b0 6611/16 art\u00edculo 4\u00b0. Siendo esta una aplicaci\u00f3n correcta de la reglamentaci\u00f3n vigente en materia de comercializaci\u00f3n de productos biol\u00f3gicos, biosimilares y monoclonales.\nQuedando como sigue: Para productos biosimilares se deber\u00e1 presentar Certificado de registro sanitario y/o Autorizaci\u00f3n de comercializaci\u00f3n vigente otorgado por una de las Agencias Reguladoras de Referencia establecidas en el art\u00edculo 4\u00b0 del Decreto N\u00b0 6611/2016 que Reglamenta el Registro de Medicamentos Biol\u00f3gicos\n", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nLa Convocante tiene potestades para evaluar las necesidades p\u00fablicas a satisfacer y establecer los requisitos t\u00e9cnicos necesarios que considere indispensables para el efecto. La normativa confiere la facultad exclusiva a la entidad convocante en realizar la redacci\u00f3n de los PBC con especial atenci\u00f3n a satisfacer la necesidad que diera origen al llamado (arts. 7 inc. g y 33 del Dto. N\u00b0 2992/19).\nLos medicamentos objeto de la licitaci\u00f3n son vitales para la vida de los pacientes, por lo que su adquisici\u00f3n debe enmarcarse dentro de un riguroso control de calidad a fin de buscar la oferta m\u00e1s conveniente que permita alcanzar los resultados terap\u00e9uticos esperados por el IPS para sus pacientes, respetando el criterio m\u00e9dico del cuerpo t\u00e9cnico y salvaguardando el inter\u00e9s superior de sus pacientes.\n\n", "dateAnswered": "2023-07-21T12:16:55-04:00"}, {"id": "37", "date": "2023-04-27T19:28:13-04:00", "title": "Capacidad Tecnica", "description": "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": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:23:02-04:00"}, {"id": "27", "date": "2023-04-27T19:19:21-04:00", "title": "Capacidad Tecnica - Punto 7. inciso a)", "description": "Para productos biosimilares deber\u00e1 presentara 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 deberan contar con registro emitido por DNVS 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. Adem\u00e1s de mantenerse el requisito en tales condiciones se esta transgrediendo abiertamente los principios que rigen las compras p\u00fablicas.", "author": {"name": "QUIMFA S.A.", "id": "PY-RUC-80074991-0"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.", "dateAnswered": "2023-07-21T12:21:07-04:00"}, {"id": "15", "date": "2023-04-27T17:18:09-04:00", "title": "Experiencia de uso y comercializaci\u00f3n ", "description": "Por el principio de igualdad y libre competencia establecidos en la Ley de Contrataciones, solicitamos eliminar el requisito de la experiencia de uso y comercializaci\u00f3n  en Paraguay de por lo menos 2 a\u00f1os, pues al obtener el Certificado de Registro Sanitario expedido por Dinavisa, es autorizaci\u00f3n suficiente para su comercializaci\u00f3n sin necesidad de una antiguedad ni experiencia de uso.", "author": {"name": "LIBRA PARAGUAY S.A.", "id": "PY-RUC-80023379-4"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que no existe contradicci\u00f3n con lo dispuesto en el decreto 6611/2016 y dicha interpretaci\u00f3n carece de sustento jur\u00eddico. Lo estipulado en el referido decreto son los requisitos m\u00ednimos para la obtenci\u00f3n de la autorizaci\u00f3n de comercializaci\u00f3n. Es decir, son los requisitos b\u00e1sicos para que el f\u00e1rmaco se pueda disponibilizar en el territorio nacional. El decreto no obliga a las Convocantes a considerar las documentaciones mencionadas como suficientes para los procesos de adquisici\u00f3n, siendo estas capacidades exclusivas de cada entidad convocante o entidad adquirente, siendo p\u00fablica o privada.\n\nResulta sumamente peligroso buscar afirmar que la autoridad sanitaria obliga a la adquisici\u00f3n de determinados f\u00e1rmacos o que la autoridad sanitaria puede ponerse sobre el criterio t\u00e9cnico m\u00e9dico de los profesionales intervinientes en el tratamiento terap\u00e9utico. De hecho, la autoridad sanitaria que confirmado y ratificado que las decisiones de uso, sea prescripci\u00f3n y/o intercambiabilidad, es de potestad EXCLUSIVA del m\u00e9dico tratante. En este caso, el cuerpo m\u00e9dico tratante se manifiesta a trav\u00e9s del servicio oncol\u00f3gico del IPS y se consolidan dichos criterios en el pliego de bases y condiciones. El criterio m\u00e9dico responde \u00fanica y exclusivamente para salvaguardar la vida y la salud de los pacientes, siendo \u00e9stos preceptos garantizados constitucionalmente a los cuales esta instituci\u00f3n se ve abocada desde su creaci\u00f3n y su prop\u00f3sito de seguro social.\nEs importante aclarar que las necesidades en materia de salud y el uso de medicamentos var\u00edan mucho entre pa\u00edses, debido a razones econ\u00f3micas, \u00e9tnicas y culturales, as\u00ed como por la carga de morbilidad, la dieta y el nivel de desarrollo del pa\u00eds; en consecuencia, las decisiones concernientes a la efectividad y la seguridad de los f\u00e1rmacos han de considerarse en el contexto espec\u00edfico de cada pa\u00eds. En tal sentido, la experiencia en el mercado constituye un elemento clave para comprobar la efectividad del producto en la poblaci\u00f3n y deben ser una prioridad de la salud p\u00fablica.\n", "dateAnswered": "2023-07-21T12:18:52-04:00"}, {"id": "6", "date": "2023-04-27T14:14:03-04:00", "title": "EE.TT. VIAL VS FRASCO AMPOLLA", "description": "Solicitamos aclaraci\u00f3n sobre la diferencia que existe entre Frasco ampolla y vial declaradas en las Especificaciones t\u00e9cnicas en el cuadro de presentaci\u00f3n y presentaci\u00f3n a entregar. En caso de que sean t\u00e9rminos sin\u00f3nimos solicitamos la unificaci\u00f3n. ", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "Se aclara que son sin\u00f3nimos, por lo tanto el oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2023-07-21T12:17:10-04:00"}, {"id": "11", "date": "2023-04-27T16:31:48-04:00", "title": "PLAZO DE ENTREGAS", "description": "10.\tSolicitamos a la Convocante la modificaci\u00f3n del plazo de entregas del saldo del 80% de la cantidad m\u00ednima y la cantidad m\u00e1xima a 30 d\u00edas calendario desde la recepci\u00f3n de la orden de compra.\nEsto obedece a que los productos son importados que deben cumplir con varios tr\u00e1mites de despacho hasta llegar a nuestro pa\u00eds. Esto se tarda aproximadamente 20 d\u00edas h\u00e1biles.-\n", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "El oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2023-07-21T12:18:03-04:00"}, {"id": "10", "date": "2023-04-27T15:52:29-04:00", "title": "PRESENTACION DE ESTUDIOS CL\u00cdNICOS", "description": "Donde dice:  \u0085 para los estudios cl\u00ednicos, podr\u00e1n estar respaldados por una declaraci\u00f3n formalizada por el fabricante del producto ante Escribano o Notario P\u00fablico, autenticada y para la firma del contrato deber\u00e1 estar debidamente legalizada por el Ministerio de Relaciones Exteriores del Paraguay o apostillada, en la que se individualicen espec\u00edficamente los estudios que se presentan y se reconozca su autenticidad\n\nSe solicita a la Convocante aclaraci\u00f3n sobre la presentaci\u00f3n de declaraci\u00f3n formalizada por el Fabricante ante Escribano y su posterior apostilla en caso de firmar contrato.\nAsimismo, EXCLUIR esta exigencia teniendo en cuenta que el IPS tiene la potestad de solicitar los mismos documentos a la DNVS para corroborar su autenticidad. \n", "author": {"name": "EL ALAMO SA", "id": "PY-RUC-80015788-5"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en el Pliego Electr\u00f3nico \u00daltima Versi\u00f3n.\nSe aclara que el se solicita al oferente que el fabricante emita una declaraci\u00f3n jurada donde individualice los estudios cl\u00ednicos a presentarse con la oferta y reconozcan de forma expresa su autenticidad con el fin de avalar la legitimidad de los mismos. De acuerdo a la legislaci\u00f3n vigente para el reconocimiento de documentos extranjeros, se solicita que la nota sea refrendada por un notario p\u00fablico y/o apostillada.\nComo es caracter\u00edstico que los biosimilares experimenten varios cambios en su proceso de fabricaci\u00f3n, que con frecuencia da lugar a peque\u00f1as diferencias en relaci\u00f3n con la versi\u00f3n autorizada originalmente o la versi\u00f3n utilizada en los ensayos cl\u00ednicos presentados para su autorizaci\u00f3n, es un requisito t\u00e9cnico indispensable la presentaci\u00f3n de los estudios cl\u00ednicos m\u00e1s actualizados.\nLa comparabilidad es un principio cient\u00edfico consolidado de la ciencia reguladora, por lo que nuestro equipo m\u00e9dico exige exhaustivos estudios comparativos de calidad que demuestren que las propiedades fisicoqu\u00edmicas y la actividad biol\u00f3gica son muy similares al innovador.\n", "dateAnswered": "2023-07-21T12:17:52-04:00"}], "lots": [{"id": "67k1bI1CDco=", "title": "1 - Bevacizumab Inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 17633331800, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "1", "id": "1"}]}, {"id": "2DoqKj7+qSI=", "title": "3 - Rituximab inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 36013388160, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "3", "id": "1"}]}, {"id": "A9j92NB7QWc=", "title": "2 - Bevacizumab Inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 77317920000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "2", "id": "1"}]}, {"id": "z5oYGglmzoQ=", "title": "4 - Rituximab inyectable", "status": "active", "statusDetails": "Activo", "value": {"amount": 6923000000, "currency": "PYG"}, "openContractType": " Por cantidad", "simultaneousSupply": true, "attributes": [{"name": "Orden", "value": "4", "id": "1"}]}], "items": [{"id": "mUuVVwgE6JiptNStiwHlLQ==", "description": "Rituximab inyectable", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51111716-001", "description": "Rituximab inyectable", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51111716-001"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51111716", "description": "Rituximab", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51111716"}], "quantity": 3144, "minQuantity": 1572, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 11454640, "currency": "PYG"}}, "relatedLot": "2DoqKj7+qSI=", "attributes": [{"name": "Orden", "value": "3", "id": "2"}]}, {"id": "Dw8uqOl9N8MKPCm+A9//pA==", "description": "Bevacizumab Inyectable", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51111717-002", "description": "Bevacizumab Inyectable", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51111717-002"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51111717", "description": "Trastuzumab", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51111717"}], "quantity": 4600, "minQuantity": 2300, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 3833333, "currency": "PYG"}}, "relatedLot": "67k1bI1CDco=", "attributes": [{"name": "Orden", "value": "1", "id": "2"}]}, {"id": "2BL6bK+b9rnmUJ3FwQ3EBg==", "description": "Bevacizumab Inyectable", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51111717-002", "description": "Bevacizumab Inyectable", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51111717-002"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51111717", "description": "Trastuzumab", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51111717"}], "quantity": 4800, "minQuantity": 2400, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 16107900, "currency": "PYG"}}, "relatedLot": "A9j92NB7QWc=", "attributes": [{"name": "Orden", "value": "2", "id": "2"}]}, {"id": "IhBDLH76GYLy0HKxgS5iOA==", "description": "Rituximab inyectable", "classification": {"scheme": "catalogoNivel5DNCP", "id": "51111716-001", "description": "Rituximab inyectable", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/51111716-001"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "51111716", "description": "Rituximab", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/51111716"}], "quantity": 3010, "minQuantity": 1505, "unit": {"name": "Unidad", "id": "UNI", "value": {"amount": 2300000, "currency": "PYG"}}, "relatedLot": "z5oYGglmzoQ=", "attributes": [{"name": "Orden", "value": "4", "id": "2"}]}], "tenderers": [{"name": "DISTRIBUIDORA LA POLICLINICA S. 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