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", "dateAnswered": "2024-08-12T14:18:57-04:00"}, {"id": "5c068aa3a3a09826c61a9fa8534954d5-1", "date": "2024-08-15T20:36:57-04:00", "title": "Documentaci\u00f2n solicitada para evaluar capacidad t\u00e9cnica Item N\u00ba 2 Rituximab Inyectable", "description": "El PBC solicita estudios cl\u00ednicos comparativos con la mol\u00e9cula original siguiendo las pautas establecidas por a FDA Y/O EMA Y/O WHO (OMS), al respecto solicitamos sea aceptado los estudios cl\u00ednicos bajo las gu\u00edas/pautas de la ICH. Esto en consideraci\u00f3n que seg\u00fan el Decreto N\u00ba 6611/16, la DINAVISA otorga el registro sanitario de medicamentos biol\u00f3gicos monoclonales luego de haberse presentado los estudios cl\u00ednicos comparativos bajo las gu\u00edas de la OMS (WHO) o bien bajo las gu\u00edas de la ICH. Adem\u00e1s no se debe desconocer que la LEY N\u00ba 7256/24 reconoce a la ICH y a sus miembros como AUTORIDADES REGULADORAS ESTRICTAS (ARES), motivo por el cual no vemos la necesidad de restringir   la participaci\u00f3n de potenciales oferentes incluyendo requisitos que no se encuentran acorde a la normativa legal.", "answer": "Ajustarse al Pliego de Bases y Condiciones. La raz\u00f3n principal para esta exigencia es asegurar que los estudios cl\u00ednicos cumplan con los est\u00e1ndares internacionales m\u00e1s rigurosos y relevantes para la regi\u00f3n.\n\nImportancia de las Gu\u00edas de la FDA, EMA y OMS:\n\n-\tProtecci\u00f3n de la Salud P\u00fablica: Las gu\u00edas de la FDA, EMA y OMS est\u00e1n dise\u00f1adas para proteger la salud p\u00fablica garantizando que los medicamentos sean seguros y efectivos antes de su comercializaci\u00f3n. Estas agencias tienen como prioridad asegurar que los estudios cl\u00ednicos sean rigurosos y que los datos obtenidos sean fiables, proporcionando una evaluaci\u00f3n exhaustiva de los beneficios y riesgos de los medicamentos.\n\n-\tExperiencia y Recursos: La FDA, EMA y OMS cuentan con equipos de expertos altamente capacitados y acceso a extensos recursos cient\u00edficos y bases de datos. Esto les permite desarrollar y actualizar sus gu\u00edas de acuerdo con los \u00faltimos avances cient\u00edficos y las mejores pr\u00e1cticas en la evaluaci\u00f3n de medicamentos.\n\nLas gu\u00edas de la FDA, EMA y OMS proporcionan detalles m\u00e1s espec\u00edficos sobre aspectos cr\u00edticos como la inmunogenicidad, la extrapolaci\u00f3n de datos y la evaluaci\u00f3n de la calidad, que son esenciales para cumplir con los requisitos regulatorios.\n\nEstas gu\u00edas garantizan un alto nivel de calidad y seguridad en los estudios cl\u00ednicos y en los medicamentos aprobados. Su cumplimiento asegura que se cumplen los criterios regulatorios m\u00e1s rigurosos para la evaluaci\u00f3n de medicamentos biol\u00f3gicos. Exigir el cumplimiento de estas gu\u00edas no constituye una restricci\u00f3n injustificada, sino una medida necesaria para proteger la salud p\u00fablica.\n\nEn caso de que las mol\u00e9culas ofrecidas ya cuenten con los estudios requeridos, es fundamental que estos estudios se presenten junto con la oferta, asegurando que fueron realizados con el biosimilar ofertado y no con el producto innovador. Esta medida no solo protege al usuario final desde el punto de vista farmacol\u00f3gico, sino que tambi\u00e9n garantiza la responsabilidad legal del Ministerio, asegurando tanto la provisi\u00f3n como la seguridad de los medicamentos adquiridos\n", "dateAnswered": "2024-08-20T09:32:19-04:00"}, {"id": "2be8afebbf5634549def3a433c28e0a7-1", "date": "2024-08-05T11:20:05-04:00", "title": "Abastecimiento Simultaneo", "description": "Solicitamos a la Convocante establecer todos los \u00edtems con la modalidad de abastecimiento simultaneo. Esto a fin de obtener mejores precios, mayor cantidad de ofertas y garantizar el suministro de los productos por diferentes proveedores para maximizar la provisi\u00f3n al MSP. Evitando tambi\u00e9n de esta manera un desabastecimiento del producto por depender de un \u00fanico proveedor. Esto a fin de garantizar el principio de Econom\u00eda, Eficacia y Eficiencia dispuesto en la normativa aplicable.", "answer": "Debido a la naturaleza de los medicamentos y a que son utilizados para esclerosis m\u00faltiple,  se solicita ajustarse al Pliego.", "dateAnswered": "2024-08-12T14:15:32-04:00"}, {"id": "08d5f97753014ebd6efc5e7c2bc75806-1", "date": "2024-08-16T08:33:11-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica - ITEM 1", "description": "Solicitamos a la convocante excluir el requerimiento de Bioequivalencia para el producto GLATIRAMER ITEM 1 teniendo en cuenta que seg\u00fan la resoluci\u00f3n 092/20 para soluciones inyectables para v\u00eda Intramuscular o subcut\u00e1nea, cuando el producto de prueba sea del mismo tipo de soluci\u00f3n (acuosa u oleosa), contenga la misma concentraci\u00f3n del Principio activo y los mismos excipientes en cantidades similares al producto de referencia, no son requeridos estudios de Bioequivalencia, que de mantenerse las condiciones actuales del PBC se estaria limitando innecesariamente la participaci\u00f3n de potenciales oferentes.", "answer": "Ajustarse al Pliego de Bases. El Ministerio de Salud, en ejercicio de sus atribuciones legales y con el fin supremo de garantizar la salud y el bienestar de la poblaci\u00f3n paraguaya, declara su facultad de establecer requisitos adicionales a los ya establecidos en la normativa vigente para la autorizaci\u00f3n de medicamentos destinados al tratamiento de la esclerosis m\u00faltiple\nEsta decisi\u00f3n se fundamenta en las siguientes bases legales:\n-\tArt\u00edculo 3 de la Ley N\u00ba 836/1980: El MSPBS, como m\u00e1xima autoridad sanitaria del pa\u00eds, posee la competencia exclusiva para regular y controlar todas las actividades relacionadas con la salud y el bienestar social.\n-\tArt\u00edculo 4 del Decreto Ley N\u00b0 2000 y 2001/1936: El MSPBS tiene el mandato de adoptar todas las medidas necesarias para proteger la salud p\u00fablica y garantizar la calidad de los medicamentos.\nConsideramos que la seguridad y eficacia de los tratamientos para la esclerosis m\u00faltiple son prioridades absolutas.\nLos motivos que sustentan esta decisi\u00f3n son:\n-\tNaturaleza de la enfermedad: La esclerosis m\u00faltiple es una enfermedad cr\u00f3nica y compleja que requiere tratamientos altamente espec\u00edficos y seguros.\n-\tVariabilidad en la composici\u00f3n de los medicamentos: A pesar de que dos medicamentos puedan tener el mismo principio activo y excipientes declarados, peque\u00f1as diferencias en la composici\u00f3n o en los procesos de fabricaci\u00f3n pueden afectar significativamente su biodisponibilidad y eficacia.\n-\tImpacto en la salud de los pacientes: La esclerosis m\u00faltiple es una enfermedad cr\u00f3nica que requiere tratamientos altamente efectivos y seguros. Cualquier variaci\u00f3n en la respuesta terap\u00e9utica puede tener un impacto significativo en la calidad de vida de los pacientes.\n-\tProtecci\u00f3n de la salud p\u00fablica: Al exigir estudios de bioequivalencia, el MSPBS garantiza que los pacientes con esclerosis m\u00faltiple reciban tratamientos de la m\u00e1s alta calidad, minimizando los riesgos asociados a variaciones en la composici\u00f3n de los medicamentos.\nEsta medida garantizar\u00e1 que los pacientes con esclerosis m\u00faltiple tengan acceso a tratamientos seguros y efectivos, mejorando as\u00ed su calidad de vida y prolongando su esperanza de vida.\n", "dateAnswered": "2024-08-20T09:35:09-04:00"}, {"id": "dd13a79436b1f5a6dda1a1e867d41845-1", "date": "2024-08-16T08:33:27-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica - ITEM 2", "description": "El PBC solicita estudios cl\u00ednicos comparativos con la molecula original siguiendo las pautas establecidas por a FDA Y/O EMA Y/O WHO (OMS), al respecto solicitamos sea aceptado los estudios clinicos bajo las guias/pautas de la ICH. Esto en consideraci\u00f3n que segun el Decreto N\u00ba 6611/16, la DINAVISA otorga el registro sanitario de medicamentos biologicos monoclonales luego de haberse presentado los estudios clinicos comparativos bajo las guias de la OMS (WHO) o bien bajo las guias de la ICH. Ademas no se debe desconocer que la LEY N\u00ba 7256/24 reconoce a la ICH y a sus miembros como AUTORIDADES REGULADORAS ESTRICTAS (ARES), motivo por el cual no vemos la necesidad de restringir   la participaci\u00f3n de potenciales oferentes incluyendo requisitos que no se encuentran acorde a la normativa legal.", "answer": "Ajustarse al Pliego de Bases y Condiciones. La raz\u00f3n principal para esta exigencia es asegurar que los estudios cl\u00ednicos cumplan con los est\u00e1ndares internacionales m\u00e1s rigurosos y relevantes para la regi\u00f3n.\n\nImportancia de las Gu\u00edas de la FDA, EMA y OMS:\n\n-\tProtecci\u00f3n de la Salud P\u00fablica: Las gu\u00edas de la FDA, EMA y OMS est\u00e1n dise\u00f1adas para proteger la salud p\u00fablica garantizando que los medicamentos sean seguros y efectivos antes de su comercializaci\u00f3n. Estas agencias tienen como prioridad asegurar que los estudios cl\u00ednicos sean rigurosos y que los datos obtenidos sean fiables, proporcionando una evaluaci\u00f3n exhaustiva de los beneficios y riesgos de los medicamentos.\n\n-\tExperiencia y Recursos: La FDA, EMA y OMS cuentan con equipos de expertos altamente capacitados y acceso a extensos recursos cient\u00edficos y bases de datos. Esto les permite desarrollar y actualizar sus gu\u00edas de acuerdo con los \u00faltimos avances cient\u00edficos y las mejores pr\u00e1cticas en la evaluaci\u00f3n de medicamentos.\n\n\nLas gu\u00edas de la FDA, EMA y OMS proporcionan detalles m\u00e1s espec\u00edficos sobre aspectos cr\u00edticos como la inmunogenicidad, la extrapolaci\u00f3n de datos y la evaluaci\u00f3n de la calidad, que son esenciales para cumplir con los requisitos regulatorios.\n\nEstas gu\u00edas garantizan un alto nivel de calidad y seguridad en los estudios cl\u00ednicos y en los medicamentos aprobados. Su cumplimiento asegura que se cumplen los criterios regulatorios m\u00e1s rigurosos para la evaluaci\u00f3n de medicamentos biol\u00f3gicos. Exigir el cumplimiento de estas gu\u00edas no constituye una restricci\u00f3n injustificada, sino una medida necesaria para proteger la salud p\u00fablica.\n\nEn caso de que las mol\u00e9culas ofrecidas ya cuenten con los estudios requeridos, es fundamental que estos estudios se presenten junto con la oferta, asegurando que fueron realizados con el biosimilar ofertado y no con el producto innovador. Esta medida no solo protege al usuario final desde el punto de vista farmacol\u00f3gico, sino que tambi\u00e9n garantiza la responsabilidad legal del Ministerio, asegurando tanto la provisi\u00f3n como la seguridad de los medicamentos adquiridos\n", "dateAnswered": "2024-08-20T09:35:44-04:00"}, {"id": "b1e3af204e299f07c2b7e914a3e66c5d-1", "date": "2024-08-05T15:14:42-04:00", "title": "item 01", "description": "solicitamos respetuosamente a la convocante modificar el sistema de adjudicaci\u00f3n a la modalidad de ABASTECIMIENTO SIMULT\u00c1NEO. Esta modalidad es utilizada con el fin de optimizar el abastecimiento habiendo m\u00e1s de un proveedor para el producto adjudicado logrando beneficios para la convocante y los pacientes, asegurando de esta forma el abastecimiento en tiempo y forma.", "answer": "Debido a la naturaleza de los medicamentos y a que son utilizados para esclerosis m\u00faltiple,  se solicita ajustarse al Pliego.", "dateAnswered": "2024-08-12T14:16:55-04:00"}, {"id": "eb4b4fb3495e73703cb01f04640100e3-1", "date": "2024-08-16T07:12:04-04:00", "title": "Documento para evaluar capacidad t\u00e9cnica Item 1 Glatiramer Inyectable", "description": "Solicitamos a la convocante excluir el requerimiento de Bioequivalencia para el producto GLATIRAMER teniendo en cuenta que seg\u00fan la resoluci\u00f3n 092/20 para soluciones inyectables para v\u00eda Intramuscular o subcut\u00e1nea, cuando el producto de prueba sea del mismo tipo de soluci\u00f3n (acuosa u oleosa), contenga la misma concentraci\u00f3n del Principio activo y los mismos excipientes en cantidades similares al producto de referencia, no son requeridos estudios de Bioequivalencia, que de mantenerse las condiciones actuales del PBC se estar\u00eda limitando innecesariamente la participaci\u00f3n de potenciales oferentes.", "answer": "Ajustarse al Pliego de Bases. El Ministerio de Salud, en ejercicio de sus atribuciones legales y con el fin supremo de garantizar la salud y el bienestar de la poblaci\u00f3n paraguaya, declara su facultad de establecer requisitos adicionales a los ya establecidos en la normativa vigente para la autorizaci\u00f3n de medicamentos destinados al tratamiento de la esclerosis m\u00faltiple\nEsta decisi\u00f3n se fundamenta en las siguientes bases legales:\n-\tArt\u00edculo 3 de la Ley N\u00ba 836/1980: El MSPBS, como m\u00e1xima autoridad sanitaria del pa\u00eds, posee la competencia exclusiva para regular y controlar todas las actividades relacionadas con la salud y el bienestar social.\n-\tArt\u00edculo 4 del Decreto Ley N\u00b0 2000 y 2001/1936: El MSPBS tiene el mandato de adoptar todas las medidas necesarias para proteger la salud p\u00fablica y garantizar la calidad de los medicamentos.\nConsideramos que la seguridad y eficacia de los tratamientos para la esclerosis m\u00faltiple son prioridades absolutas.\nLos motivos que sustentan esta decisi\u00f3n son:\n-\tNaturaleza de la enfermedad: La esclerosis m\u00faltiple es una enfermedad cr\u00f3nica y compleja que requiere tratamientos altamente espec\u00edficos y seguros.\n-\tVariabilidad en la composici\u00f3n de los medicamentos: A pesar de que dos medicamentos puedan tener el mismo principio activo y excipientes declarados, peque\u00f1as diferencias en la composici\u00f3n o en los procesos de fabricaci\u00f3n pueden afectar significativamente su biodisponibilidad y eficacia.\n-\tImpacto en la salud de los pacientes: La esclerosis m\u00faltiple es una enfermedad cr\u00f3nica que requiere tratamientos altamente efectivos y seguros. Cualquier variaci\u00f3n en la respuesta terap\u00e9utica puede tener un impacto significativo en la calidad de vida de los pacientes.\n-\tProtecci\u00f3n de la salud p\u00fablica: Al exigir estudios de bioequivalencia, el MSPBS garantiza que los pacientes con esclerosis m\u00faltiple reciban tratamientos de la m\u00e1s alta calidad, minimizando los riesgos asociados a variaciones en la composici\u00f3n de los medicamentos.\nEsta medida garantizar\u00e1 que los pacientes con esclerosis m\u00faltiple tengan acceso a tratamientos seguros y efectivos, mejorando as\u00ed su calidad de vida y prolongando su esperanza de vida.\n", "dateAnswered": "2024-08-20T09:33:43-04:00"}, {"id": "1a0b4a0975ce776a0f1ec9cf09354161-1", "date": "2024-08-06T09:18:21-04:00", "title": "Requisitos que demuestran la Capacidad t\u00e9cnica", "description": "Para asegurar la calidad de los anticuerpos monoclonales recomendamos amablemente a la convocante incorporar al PBC los siguientes requisitos:\nPara anticuerpos monoclonales:\na) Los productos biol\u00f3gicos, sean innovadores o biosimilares, deber\u00e1n contar con Registro Sanitario vigente con la inscripci\u00f3n MB, en cumplimiento del Decreto 6611/16, expedido por la Direcci\u00f3n de Vigilancia Sanitaria (DINAVISA) del Ministerio de Salud P\u00fablica y Bienestar Social, con antelaci\u00f3n de por lo menos 2 (dos) a\u00f1os.\nb) Los productos biol\u00f3gicos deber\u00e1n presentar la caracterizaci\u00f3n fisicoqu\u00edmica similar al producto biol\u00f3gico innovador de referencia.\nc) Los productos biol\u00f3gicos deber\u00e1n presentar estudios de farmacocin\u00e9tica y farmacodinamia comparables al biol\u00f3gico innovador.\nd) Los productos biol\u00f3gicos deber\u00e1n incluir sus estudios cl\u00ednicos, propios y concluidos con una poblaci\u00f3n estad\u00edsticamente significativa.\ne) El producto biosimilar importado presentar\u00e1 certificados de Registro\nSanitario y Autorizaci\u00f3n de Comercializaci\u00f3n vigentes, otorgados por al menos por 2 de las Autoridades de Alta Vigilancia Sanitaria: EMA, FDA, Health Canad\u00e1, ANVISA, o ANMAT, con antelaci\u00f3n de 3 (tres) a\u00f1os.\nf) En caso de ofertar un producto de origen nacional, se presentar\u00e1\ncertificado de Registro Sanitario emitido por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA).\ng) Los productos biol\u00f3gicos innovadores presentar\u00e1n copia autenticada de Certificado de Libre Venta, emitido por una entidad regulatoria de referencia, FDA o EMA (No requieren presentar estudios mencionados) ni la experiencia a 3 (tres) a\u00f1os.\nh) Copia autenticada del acta de fijaci\u00f3n de precios del producto ofertado,\nexpedida por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) del Ministerio de Salud P\u00fablica y Bienestar Social, en forma legible y emitida con anterioridad a la fecha de apertura o inicio de la etapa competitiva.\ni) Declaraci\u00f3n jurada donde el oferente declara que cuentan con equipos de refrigeraci\u00f3n acorde para almacenar a temperatura constante medicamentos que requieran de temperaturas de 2\u00b0a 8\u00aa (refrigerados) y con generadores propios para suministrar energ\u00eda el\u00e9ctrica en caso de cortes energ\u00e9ticas.\nj) Declaraci\u00f3n jurada donde el oferente declara que posee capacidad de mantener en sus dep\u00f3sitos stock suficiente para la entrega programada seg\u00fan necesidad del Programa de Pacientes con esclerosis m\u00faltiple, conforme a espacio y disponibilidad.\n\nLos documentos podr\u00e1n presentar en copia simple, no obstante, para la firma del contrato deber\u00e1n estar debidamente legalizados por el Ministerio de Relaciones Exteriores del Paraguay o apostillados.\nEn caso de necesidad o duda la convocante a trav\u00e9s del Comit\u00e9 de Evaluaci\u00f3n podr\u00e1 solicitar al oferente o a la Direcci\u00f3n Nacional de Vigilancia Sanitaria del Ministerio de Salud P\u00fablica y\nBienestar Social toda la documentaci\u00f3n presentada por el oferente a la mencionada Direcci\u00f3n de conformidad al Decreto 6611/16 \u201cPOR EL CUAL SE REGLAMENTA EL ARTICULO 24 DE LA LEY 111997 DE PRODUCTOS PARA LA SALUD Y OTROS Y SE ESTABLECEN LOS REQUISITOS PARA EL REGISTRO DE MEDICAMENTOS BIOLOGICOS\u201d; Art. N\u00b0 12. La presentaci\u00f3n de la oferta en el marco del presente llamado implica la autorizaci\u00f3n del oferente para acceder a dicha documentaci\u00f3n.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-08-13T17:44:01-04:00"}, {"id": "c8bf4244de705cc59eadcc2657b56ef8-1", "date": "2024-08-16T07:12:08-04:00", "title": "RITUXIMAB - DOCUMENTO CAPACIDAD TECNICA", "description": "El Pliego de Bases y Condiciones solicita estudios clinicos comparativos con la molecula original siguiendo las pautas establecidas por a FDA Y/O EMA Y/O WHO (OMS), al respecto solicitamos a la convocante que sea aceptado los estudios clinicos bajo las guias/pautas de la ICH. Esto en consideraci\u00f3n que segun el Decreto N\u00ba 6611/16, la DINAVISA otorga el registro sanitario de medicamentos biologicos monoclonales luego de haberse presentado los estudios clinicos comparativos bajo las guias de la OMS (WHO) o bien bajo las guias de la ICH. Ademas no se debe desconocer que la LEY N\u00ba 7256/24 reconoce a la ICH y a sus miembros como AUTORIDADES REGULADORAS ESTRICTAS (ARES), motivo por el cual no vemos la necesidad de restringir   la participaci\u00f3n de potenciales oferentes incluyendo requisitos que no se encuentran acorde a la normativa legal.", "answer": "Ajustarse al Pliego de Bases y Condiciones. La raz\u00f3n principal para esta exigencia es asegurar que los estudios cl\u00ednicos cumplan con los est\u00e1ndares internacionales m\u00e1s rigurosos y relevantes para la regi\u00f3n.\n\nImportancia de las Gu\u00edas de la FDA, EMA y OMS:\n\n-\tProtecci\u00f3n de la Salud P\u00fablica: Las gu\u00edas de la FDA, EMA y OMS est\u00e1n dise\u00f1adas para proteger la salud p\u00fablica garantizando que los medicamentos sean seguros y efectivos antes de su comercializaci\u00f3n. Estas agencias tienen como prioridad asegurar que los estudios cl\u00ednicos sean rigurosos y que los datos obtenidos sean fiables, proporcionando una evaluaci\u00f3n exhaustiva de los beneficios y riesgos de los medicamentos.\n\n-\tExperiencia y Recursos: La FDA, EMA y OMS cuentan con equipos de expertos altamente capacitados y acceso a extensos recursos cient\u00edficos y bases de datos. Esto les permite desarrollar y actualizar sus gu\u00edas de acuerdo con los \u00faltimos avances cient\u00edficos y las mejores pr\u00e1cticas en la evaluaci\u00f3n de medicamentos.\n\n\nLas gu\u00edas de la FDA, EMA y OMS proporcionan detalles m\u00e1s espec\u00edficos sobre aspectos cr\u00edticos como la inmunogenicidad, la extrapolaci\u00f3n de datos y la evaluaci\u00f3n de la calidad, que son esenciales para cumplir con los requisitos regulatorios.\n\nEstas gu\u00edas garantizan un alto nivel de calidad y seguridad en los estudios cl\u00ednicos y en los medicamentos aprobados. Su cumplimiento asegura que se cumplen los criterios regulatorios m\u00e1s rigurosos para la evaluaci\u00f3n de medicamentos biol\u00f3gicos. Exigir el cumplimiento de estas gu\u00edas no constituye una restricci\u00f3n injustificada, sino una medida necesaria para proteger la salud p\u00fablica.\n\nEn caso de que las mol\u00e9culas ofrecidas ya cuenten con los estudios requeridos, es fundamental que estos estudios se presenten junto con la oferta, asegurando que fueron realizados con el biosimilar ofertado y no con el producto innovador. Esta medida no solo protege al usuario final desde el punto de vista farmacol\u00f3gico, sino que tambi\u00e9n garantiza la responsabilidad legal del Ministerio, asegurando tanto la provisi\u00f3n como la seguridad de los medicamentos adquiridos.\n", "dateAnswered": "2024-08-20T09:34:33-04:00"}, {"id": "381e635ef237f7c5ef10c1597c5836eb-1", "date": "2024-08-16T09:49:12-04:00", "title": "VENCIMIENTO DE LOS PRODUCTOS ENTREGADOS", "description": "En la p\u00e1gina 14/48 del P.B.C en VENCIMIENTO dice: \u201cEl vencimiento m\u00ednimo medicamentos no deber\u00e1 ser inferior a 18 (diez y ocho) meses al momento de la entrega en los parques sanitarios, si por la naturaleza del mismo o por necesidad de la Instituci\u00f3n no se puede cumplir con este requisito, la recepci\u00f3n del art\u00edculo deber\u00e1 ser autorizada por la Direcci\u00f3n de Log\u00edstica de la DGGIES y por el Instituto de Medicina Tropical.\nPara aquellos medicamentos cuyo vencimiento sea inferior a 18 meses, adem\u00e1s de la autorizaci\u00f3n de la Direcci\u00f3n de Log\u00edstica de la DGGIES y por el Instituto de Medicina Tropical, se deber\u00e1 presentar P\u00f3liza de Seguro por el 100% del monto del producto con identificaci\u00f3n del n\u00famero de Lote, que ser\u00e1n entregados un original en la Oficina de Contrato y Garant\u00edas de la DGGIES y el duplicado en el Parque Sanitario que corresponda. La validez de dicha p\u00f3liza deber\u00e1 ser por 3 meses posteriores a la fecha del vencimiento del art\u00edculo a entregar.\u201d\nSolicitamos a la Convocante que los lotes con vencimientos menores a 12 (doce) meses sean entregados con Autorizaci\u00f3n de Entrega, Carta de Compromiso de Canje y P\u00f3liza de Seguro por el 100 % del monto del producto a ser entregado.", "answer": "El oferente deber\u00e1 ajustarse a lo solicitado en PBC ya se dio respuesta en la consulta 5.-", "dateAnswered": "2024-08-20T09:38:38-04:00"}, {"id": "bb4d2484ad1491742f92d7603882105f-1", "date": "2024-08-05T16:39:32-04:00", "title": "ITEM 2 PRECIO REFERENCIAL", "description": "Solicitamos a la Convocante la verificaci\u00f3n del precio de referencia del \u00edtem 2, ya que el importe establecido se encuentra muy por debajo de los precios de ese producto vigentes en plaza.", "answer": "Se procedi\u00f3 a la verificaci\u00f3n del precio del \u00edtem 02 realizados en el An\u00e1lisis de Precio de fecha 06 de junio  del 2024, y que lo actuado en dicho an\u00e1lisis se encuentra acorde a lo establecido en la Resoluci\u00f3n DNCP N\u00b0 454/24, como as\u00ed tambi\u00e9n, a lo relacionado en el  Art. 4 de la ley 7021/03, en la cual se establece los Principios de Econom\u00eda, Eficacia y Eficiencia seg\u00fan los cuales las necesidades p\u00fablicas deben ser satisfechas con la oportunidad, calidad y costo que aseguren al Estado Paraguayo las mejores condiciones, sujet\u00e1ndose a disposiciones de racionalidad, austeridad y disciplina presupuestaria. Cabe mencionar por lo expuesto precedentemente, los Precios Referenciales que se encuentran en el An\u00e1lisis de Precio y respaldada en el Dictamen DOC N\u00b0 85/2024, se ratifica y se mantiene igual.", "dateAnswered": "2024-08-13T17:42:37-04:00"}, {"id": "ab9f1a207f35ae9291d83514e463dbd0-1", "date": "2024-08-15T21:07:50-04:00", "title": "CAPACIDAD TECNICA - DOCUMENTOS ITEM 1 GLATIRAMER", "description": "Se solicita a la convocante excluir el requerimiento de Bioequivalencia para el producto GLATIRAMER teniendo en cuenta que seg\u00fan la resoluci\u00f3n 092/20 para soluciones inyectables para v\u00eda Intramuscular o subcut\u00e1nea, cuando el producto de prueba sea del mismo tipo de soluci\u00f3n (acuosa u oleosa), contenga la misma concentraci\u00f3n del Principio activo y los mismos excipientes en cantidades similares al producto de referencia, no son requeridos estudios de Bioequivalencia, que de mantenerse las condiciones actuales del PBC se estar\u00eda limitando innecesariamente la participaci\u00f3n de potenciales oferentes", "answer": "Ajustarse al Pliego de Bases. El Ministerio de Salud, en ejercicio de sus atribuciones legales y con el fin supremo de garantizar la salud y el bienestar de la poblaci\u00f3n paraguaya, declara su facultad de establecer requisitos adicionales a los ya establecidos en la normativa vigente para la autorizaci\u00f3n de medicamentos destinados al tratamiento de la esclerosis m\u00faltiple\nEsta decisi\u00f3n se fundamenta en las siguientes bases legales:\n-\tArt\u00edculo 3 de la Ley N\u00ba 836/1980: El MSPBS, como m\u00e1xima autoridad sanitaria del pa\u00eds, posee la competencia exclusiva para regular y controlar todas las actividades relacionadas con la salud y el bienestar social.\n-\tArt\u00edculo 4 del Decreto Ley N\u00b0 2000 y 2001/1936: El MSPBS tiene el mandato de adoptar todas las medidas necesarias para proteger la salud p\u00fablica y garantizar la calidad de los medicamentos.\nConsideramos que la seguridad y eficacia de los tratamientos para la esclerosis m\u00faltiple son prioridades absolutas.\nLos motivos que sustentan esta decisi\u00f3n son:\n-\tNaturaleza de la enfermedad: La esclerosis m\u00faltiple es una enfermedad cr\u00f3nica y compleja que requiere tratamientos altamente espec\u00edficos y seguros.\n-\tVariabilidad en la composici\u00f3n de los medicamentos: A pesar de que dos medicamentos puedan tener el mismo principio activo y excipientes declarados, peque\u00f1as diferencias en la composici\u00f3n o en los procesos de fabricaci\u00f3n pueden afectar significativamente su biodisponibilidad y eficacia.\n-\tImpacto en la salud de los pacientes: La esclerosis m\u00faltiple es una enfermedad cr\u00f3nica que requiere tratamientos altamente efectivos y seguros. Cualquier variaci\u00f3n en la respuesta terap\u00e9utica puede tener un impacto significativo en la calidad de vida de los pacientes.\n-\tProtecci\u00f3n de la salud p\u00fablica: Al exigir estudios de bioequivalencia, el MSPBS garantiza que los pacientes con esclerosis m\u00faltiple reciban tratamientos de la m\u00e1s alta calidad, minimizando los riesgos asociados a variaciones en la composici\u00f3n de los medicamentos.\nEsta medida garantizar\u00e1 que los pacientes con esclerosis m\u00faltiple tengan acceso a tratamientos seguros y efectivos, mejorando as\u00ed su calidad de vida y prolongando su esperanza de vida.\n", "dateAnswered": "2024-08-20T09:33:12-04:00"}, {"id": "37ea9600d85609ab78f77c76977343a4-1", "date": "2024-08-05T15:15:04-04:00", "title": "item 05", "description": "solicitamos respetuosamente a la convocante modificar el sistema de adjudicaci\u00f3n a la modalidad de ABASTECIMIENTO SIMULT\u00c1NEO. Esta modalidad es utilizada con el fin de optimizar el abastecimiento habiendo m\u00e1s de un proveedor para el producto adjudicado logrando beneficios para la convocante y los pacientes, asegurando de esta forma el abastecimiento en tiempo y forma.", "answer": "Debido a la naturaleza de los medicamentos y a que son utilizados para esclerosis m\u00faltiple,  se solicita ajustarse al Pliego.", "dateAnswered": "2024-08-12T14:17:14-04:00"}, {"id": "912667ec169d3a54b269c133a5f3923e-1", "date": "2024-08-05T12:59:44-04:00", "title": "ABASTECIMIENTO SIMULTANEA", "description": "Solicitamos respetuosamente a la convocante modificar el sistema de adjudicaci\u00f3n a la modalidad de ABASTECIMIENTO SIMULT\u00c1NEO. Esta modalidad es utilizada con el fin de optimizar el abastecimiento habiendo m\u00e1s de un proveedor para el producto adjudicado logrando beneficios para la convocante y los pacientes, asegurando de esta forma el abastecimiento en tiempo y forma.", "answer": "Debido a la naturaleza de los medicamentos y a que son utilizados para esclerosis m\u00faltiple,  se solicita ajustarse al Pliego.", "dateAnswered": "2024-08-12T14:15:48-04:00"}, {"id": "3ffc62e940b477870e80e1998a226fef-1", "date": "2024-08-06T09:57:12-04:00", "title": "Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica", "description": "Solicitamos aclarar si, en caso de ofertar un producto nacional, solo ser\u00e1 necesario el Registro Sanitario emitido por la DINAVISA sin documentos adicionales.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-08-13T17:44:25-04:00"}, {"id": "203e50c7a89885e9e7bd53f5c80636d4-1", "date": "2024-08-05T13:07:15-04:00", "title": "VENCIMIENTO DE LOS PRODUCTOS ENTREGADOS", "description": "En la p\u00e1g. 14 del P.B.C., en Per\u00edodo de validez de la Garant\u00eda de los bienes, segundo p\u00e1rrafo, se establece: Para aquellos medicamentos cuyo vencimiento sea inferior a 18 meses, adem\u00e1s de la autorizaci\u00f3n de la Direcci\u00f3n de Log\u00edstica de la DGGIES y por el Instituto de Medicina Tropical, se deber\u00e1 presentar P\u00f3liza de Seguro por el 100% del monto del producto con identificaci\u00f3n del n\u00famero de Lote, que ser\u00e1n entregados un original en la Oficina de Contrato y Garant\u00edas de la DGGIES y el duplicado en el Parque Sanitario que corresponda. La validez de dicha p\u00f3liza deber\u00e1 ser por 3 meses posteriores a la fecha del vencimiento del art\u00edculo a entregar. Solicitamos a la Convocante que la mencionada p\u00f3liza sea requerida para los productos entregados con menos de 15 (quince) meses de vencimiento.", "answer": "Ajustarse al Pliego de Bases y Condiciones, el vencimiento fue establecido de acuerdo a la necesidad del Programa.", "dateAnswered": "2024-08-12T14:16:06-04:00"}, {"id": "420e40526085c198132b4f319153b92d-1", "date": "2024-07-26T06:52:58-04:00", "title": "REQUISITOS DOCUMENTALES PARA EVALUAR LA CAPACIDAD TECNICA", "description": "Para medicamentos biol\u00f3gicos se solicitan la presentaci\u00f3n de los siguientes documentos: \n1-Para productos importados Biol\u00f3gicos, copia Legalizada y/o apostillada o declaraci\u00f3n jurada del fabricante (debidamente legalizada y/o apostillada) con el link web oficial del Certificado de Buenas Pr\u00e1cticas de Fabricaci\u00f3n vigente, otorgado por alguna de las Agencias regulatorias previstas en el art\u00edculo 11 de la Ley N\u00b0 3283/07, Agencias reguladoras de la EMA (European Medicines Agency), FDA, Agencias Reguladoras de Referencia (Nivel 4) reconocidas\npor la OPS.\n2- Para productos importados Biol\u00f3gicos, copia Legalizada y/o apostillada o declaraci\u00f3n jurada del fabricante (debidamente legalizada y/o apostillada) con el link web oficial del Registro Sanitario, y/o CPP, y/o CLV vigente, otorgado por alguna de las Agencias regulatorias previstas en el art\u00edculo 11 de la Ley N\u00b0 3283/07, Agencias reguladoras de la EMA (European Medicines Agency), FDA, Agencias Reguladoras de Referencia (Nivel 4) reconocidas por la OPS.\nSolicitamos amablemente a la Convocante que aclare si ambos documentos deben ser presentados o uno de ellos indistintamente de la siguiente manera: Certificado de Buenas practicas o  Registro Sanitario o CPP o CLV vigente.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-08-05T18:36:30-04:00"}, {"id": "a0b526982fea9d8dcebd210ab1ed649e-1", "date": "2024-08-05T17:46:44-04:00", "title": "ABASTECIMIENTO SIMULTANEO", "description": "Consultamos a la convocante si ser\u00e1 por abastecimiento simultaneo", "answer": "Debido a la naturaleza de los medicamentos y a que son utilizados para esclerosis m\u00faltiple,  se solicita ajustarse al Pliego.", "dateAnswered": "2024-08-12T14:17:35-04:00"}, {"id": "abbbc920fcfa3a8423a0b571e25ce804-1", "date": "2024-07-17T16:26:52-04:00", "title": "ITEM 1 - GLATIRAMER INYECTABLE - PRECIO REFERENCIAL", "description": "EL precio referencial del ITEM 1 - GLATIRAMER INYECTABLE no se encuentra ajustado a los par\u00e1metros del \u00faltimo proceso convocado por esta entidad, ID 416.959. Solicitamos m\u00ednimamente ajustarlo a dicho par\u00e1metro Gs. 1.600.000.", "answer": "Ajustarse a la \u00faltima versi\u00f3n del PBC.-", "dateAnswered": "2024-08-05T18:36:23-04:00"}, {"id": "0330346de5d0879da3567f3f8501c6b1-1", "date": "2024-08-06T09:18:29-04:00", "title": "Categor\u00eda del llamado", "description": "Hemos notado que los \u00edtems solicitados se encuentran en la categor\u00eda 41000000 \u201cEquipo de Laboratorio, Medida, Observaci\u00f3n y Comprobaci\u00f3n\u201d sin embargo los mismos corresponden a la categor\u00eda 51000000 \u201cMedicamentos y Productos Farmac\u00e9uticos\u201d, solicitamos a la convocante el cambio a la categor\u00eda correcta.", "answer": "La convocante aclara que se han realizado los cambios en el SICP.-", "dateAnswered": "2024-10-04T16:54:41-04:00"}], "lots": [{"id": "1ef348b8-8468-64c4-a97e-71cddaf54afc", "title": "5 - 5 - Fingolimod Capsula", "status": "active", "statusDetails": "activo", "value": {"amount": 677806440, "currency": 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