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    de acuerdo al artículo 2 del reglamento de insumos para la salud es el medicamento indicado

    Santiago

    Chicos, ¿alguien sabe la respuesta?

    obtenga de acuerdo al artículo 2 del reglamento de insumos para la salud es el medicamento indicado de este sitio.

    Decreto de 2 de enero de 2014 por el que reforma, adiciona y deroga diversas disposiciones del Reglamento de Insumos para la Salud

    Miércoles 2 de enero de 2008 DIARIO OFICIAL 25

    SECRETARIA DE SALUD

    DECRETO que reforma, adiciona y deroga diversas disposiciones del Reglamento de Insumos para la Salud.

    Al margen un sello con el Escudo Nacional, que dice: Estados Unidos Mexicanos.­ Presidencia de la República.

    FELIPE DE JESÚS CALDERÓN HINOJOSA, Presidente Constitucional de los Estados Unidos Mexicanos, en ejercicio de la facultad que me confiere el artículo 89, fracción I, de la Constitución Política de los Estados Unidos Mexicanos, y con fundamento en los artículos 3, 4. 13 Apartado A, 257, 258, 262, 368,

    372, 376 y 376 bis de la Ley General de Salud, he tenido a bien expedir el siguiente:

    DECRETO QUE REFORMA, ADICIONA Y DEROGA DIVERSAS DISPOSICIONES DEL REGLAMENTO DE INSUMOS PARA LA SALUD

    ARTÍCULO ÚNICO. Se REFORMAN los artículos 2, fracción XIV; 24, fracción II; 31 fracción I y II; la denominación del Capítulo VII del Título Segundo, 73, 131, párrafos primero y tercero; 166 y 170, párrafo primero y fracciones I y II; 177, fracción V y último párrafo; se ADICIONAN los artículos 2, fracción XIV Bis, XV párrafo segundo, 153, párrafo segundo; 167, fracciones V y VI; 190 Bis 1, 190 Bis 2, 190 Bis 3, 190 Bis 4, 190

    Bis 5 y 190 Bis 6, y se DEROGAN los artículos 24, fracción Xl; 31, fracción II; 74, 75, 76, 77, 78, 79 y 80 del

    Reglamento de Insumos para la Salud, para quedar como sigue:

    “ARTÍCULO 2. ... I. a Xlll. .

    XIV. Medicamento Genérico, a la especialidad farmacéutica con el mismo fármaco o sustancia activa y forma farmacéutica, con igual concentración o potencia, que utiliza la misma vía de administración y que mediante las pruebas reglamentarias requeridas, ha comprobado que sus especificaciones farmacopéicas, perfiles de disolución o su biodisponibilidad u otros parámetros, según sea el caso, son equivalentes a las del medicamento de referencia.

    XIV Bis. Medicamento de referencia, al medicamento indicado por la Secretaría como tal, que cuenta con el registro de dicha dependencia, que se encuentra disponible comercialmente y es seleccionado conforme a los criterios establecidos en las Normas.

    XV...

    Para efectos del Comité de Moléculas Nuevas, se clasificarán como moléculas nuevas a aquellas que se encuentren dentro de las siguientes categorías:

    a. Aquel fármaco o medicamento que no tenga registro a nivel mundial y que se pretende registrar en México (nueva entidad molecular).

    b. Aquel fármaco o medicamento que aún existiendo en otros países, con experiencia clínica limitada o información controvertida, no tenga registro en México y pretenda registrarse en nuestro país.

    c. Aquel medicamento que pretenda hacer una combinación que no exista en el mercado nacional de dos o más fármacos.

    d. Aquel fármaco o medicamento existente en el mercado que pretenda comercializarse con otra indicación terapéutica.

    XVI a XVIII. ... ARTÍCULO 24. .

    I. .

    II. La denominación distintiva; en caso de Medicamentos Genéricos su inclusión será optativa;

    III. a X. ... XI. Derogada. XII. ... .

    26 DIARIO OFICIAL Miércoles 2 de enero de 2008

    ARTÍCULO 31. .

    I. Cuando se trate de Medicamentos Genéricos, deberá anotar la Denominación Genérica y si lo desea, podrá indicar la denominación distintiva de su preferencia;

    II. En los demás casos podrá expresar la denominación distintiva o conjuntamente las denominaciones genérica y distintiva;

    .

    Capítulo VII Medicamentos Genéricos

    ARTÍCULO 73. El Consejo de Salubridad General y la Secretaría, mediante publicación en el Diario Oficial de la Federación, determinarán las pruebas de intercambiabilidad, que deberán aplicarse de acuerdo a la normatividad correspondiente.

    ARTÍCULO 74. Derogado. ARTÍCULO 75. Derogado. ARTÍCULO 76. Derogado. ARTÍCULO 77. Derogado. ARTÍCULO 78. Derogado. ARTÍCULO 79. Derogado. ARTÍCULO 80. Derogado.

    ARTÍCULO 131. Para importar medicamentos con fines de comercialización, se deberá contar previamente con el registro sanitario del producto expedido por la Secretaría. En caso de que el importador no sea el titular del registro, deberá contar con el consentimiento del titular.

    .

    Los Establecimientos a que se refiere el presente artículo deberán contar con licencia sanitaria o aviso sanitario, según corresponda, en términos de los artículos 258 y 373 de la Ley.

    . . ARTÍCULO 153. ...

    Los documentos que acompañen a las solicitudes deberán encontrarse redactados en idioma español, y en caso contrario, deberán adjuntar a los mismos su respectiva traducción al español, avalada con la firma del responsable sanitario.

    Los documentos expedidos por autoridades de otros países deberán estar apostillados o legalizados y traducidos por perito traductor.

    ARTÍCULO 166. Las solicitudes de registro sanitario de medicamentos alopáticos serán resueltas por la

    Secretaría, conforme con lo siguiente:

    I. Cuando se trate de medicamentos que incluyan ingredientes activos y con indicaciones terapéuticas ya registradas en los Estados Unidos Mexicanos, la resolución deberá emitirse en un plazo máximo de ciento ochenta días naturales;

    II. Cuando se trate de medicamentos cuyos ingredientes activos no estén registrados en los Estados Unidos Mexicanos, pero se encuentren registrados y se vendan libremente en su país de origen, la resolución deberá emitirse en un plazo máximo de doscientos cuarenta días naturales, y

    fuente : wipolex-res.wipo.int

    Reglamento de insumos para la salud

    0: [object Object]

    Inicio Legislación Legislación Federal Actualizada Federal

    Reglamento de insumos para la salud

    Texto Refundido Texto Original (DOF) Citas 9 Citado por Versiones 5 Análisis 47 RelacionadosVincent

    REGÍSTRATE GRATIS

    Publicado en Diario Oficial de la Federación – Edición del 04 de febrero de 1998

    Norma citada en: 78 sentencias, 56 artículos doctrinales, 50 disposiciones normativas, 184 resoluciones administrativas, 257 noticias

    TÍTULO PRIMERO

    Disposiciones generales

    Artículos 1 a 6 CAPÍTULO ÚNICO Artículos 1 a 6 ARTÍCULO 1o

    El presente ordenamiento tiene por objeto reglamentar el control sanitario de los Insumos y de los remedios herbolarios, así como el de los Establecimientos, actividades y servicios relacionados con los mismos.

    Artículo citado en: 2 sentencias, un artículo doctrinal, 2 disposiciones normativas, 14 resoluciones administrativas

    ARTÍCULO 2o

    Para efectos del presente Reglamento, se entenderá por:

    Acondicionamiento, a las operaciones necesarias por las que un producto a granel debe pasar para llegar a su presentación como producto terminado;

    Biodisponibilidad, a la proporción de fármaco que se absorbe a la circulación general después de la administración de un medicamento y el tiempo que requiere para hacerlo;

    Bis. Certificado Analítico, al documento que avala los resultados obtenidos en un estudio para determinar la composición o naturaleza de una muestra, emitido por el fabricante del producto, de conformidad con las disposiciones de la Ley, el presente Reglamento y demás disposiciones aplicables;

    Fracción II Bis adicionada, Diario Oficial de la Federación del 19 de octubre de 2011

    Condición Sanitaria, a las especificaciones o requisitos sanitarios que deben reunir cada uno de los Insumos, Establecimientos, actividades y servicios y que se establecen en los ordenamientos correspondientes;

    Bis. Denominación Común Internacional, al nombre que identifica una sustancia farmacéutica o principio activo farmacéutico mediante un nombre único que es reconocido a nivel mundial y es de dominio público;

    Fracción III Bis adicionada, Diario Oficial de la Federación del 19 de octubre de 2011

    Denominación Distintiva, al nombre que como marca comercial le asigna el laboratorio o fabricante a sus especialidades farmacéuticas con el fin de distinguirla de otras similares, previa aprobación de la autoridad sanitaria y registro ante las autoridades competentes;

    Denominación Genérica, al nombre del medicamento, determinado a través de un método preestablecido, que identifica al fármaco o sustancia activa reconocido internacionalmente y aceptado por la autoridad sanitaria;

    Envase Primario, a los elementos del sistema de envase que están en contacto directo con el Insumo;

    Envase Secundario, a los componentes que forman parte del empaque en el cual se comercializa el Insumo y no están en contacto directo con él;

    VII Bis 1. Estudios clínicos, a las pruebas realizadas en seres humanos para demostrar la calidad, seguridad y eficacia de los medicamentos;

    Fracción VII Bis 1 adicionada, Diario Oficial de la Federación del 19 de octubre de 2011

    VII Bis 2. Estudios de biocomparabilidad, a las pruebas, ensayos y análisis que sean indispensables para demostrar que un medicamento biotecnológico biocomparable tiene las mismas características de calidad, seguridad y eficacia de un medicamento biotecnológico de referencia;

    Fracción VII Bis 2 adicionada, Diario Oficial de la Federación del 19 de octubre de 2011

    VII Bis 3. Estudios preclínicos, a los estudios in vitro o en animales para demostrar la calidad, seguridad y eficacia del producto y cuyos resultados se puedan extrapolar a los humanos;

    Fracción VII Bis 3 adicionada, Diario Oficial de la Federación del 19 de octubre de 2011

    Etiqueta, al marbete, rótulo, marca o imagen gráfica que se haya escrito, impreso, estarcido, marcado, marcado en relieve o en hueco, grabado, adherido o precintado en cualquier material susceptible de contener el Insumo incluyendo el envase mismo;

    Farmacopea de los Estados Unidos Mexicanos, al documento expedido por la Secretaría que consigna los métodos generales de análisis y los requisitos sobre identidad, pureza y calidad de los fármacos, aditivos, medicamentos y productos biológicos;

    Farmacopea Homeopática de los Estados Unidos Mexicanos, al documento instituido por la Ley y expedido por la Secretaría, que comprende los nombres, procedimientos, métodos y especificaciones para la identificación, preparación o análisis de sustancias y productos homeopáticos;

    Bis. Información técnica, a los ensayos, análisis, estudios preclínicos y clínicos necesarios, en su caso, para demostrar la calidad, seguridad y eficacia requeridos por la Secretaría para la obtención del registro sanitario;

    Fracción X Bis adicionada, Diario Oficial de la Federación del 19 de octubre de 2011

    Insumos, a los Insumos para la salud a que se refiere el artículo 194 bis de la Ley;

    Ley, a la Ley General de Salud;

    Lote, a la cantidad específica de cualquier materia prima o Insumo, que haya sido elaborada en un ciclo de producción, bajo condiciones equivalentes de operación y durante un período determinado;

    XIII Bis 1. Medicamento biotecnológico biocomparable, al medicamento biotecnológico no innovador que demuestre ser biocomparable en términos de seguridad, calidad y eficacia al medicamento biotecnológico de referencia a través de las pruebas que establezca la Ley, este Reglamento y demás disposiciones aplicables;

    fuente : vlex.com.mx

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    fuente : brainly.lat

    ¿Quieres ver la respuesta o más?
    Santiago 14 day ago
    4

    Chicos, ¿alguien sabe la respuesta?

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