{"id":59115,"date":"2025-03-20T00:06:03","date_gmt":"2025-03-20T06:06:03","guid":{"rendered":"https:\/\/politicosaldesnudo.com.mx\/?p=59115"},"modified":"2025-03-19T22:34:17","modified_gmt":"2025-03-20T04:34:17","slug":"publican-en-dof-modificaciones-a-nom-sobre-fabricacion-de-medicinas","status":"publish","type":"post","link":"https:\/\/politicosaldesnudo.com.mx\/index.php\/2025\/03\/20\/publican-en-dof-modificaciones-a-nom-sobre-fabricacion-de-medicinas\/","title":{"rendered":"Publican en DOF modificaciones a NOM sobre fabricaci\u00f3n de medicinas"},"content":{"rendered":"<p class=\"nota-justify\">En el Diario Oficial de la Federaci\u00f3n (DOF) hoy fue publicada la modificaci\u00f3n de diversos puntos de la Norma Oficial Mexicana NOM-059-SSA1-2015, sobre Buenas pr\u00e1cticas de fabricaci\u00f3n de medicamentos, que data de febrero de 2016. Los cambios y adiciones entran en vigor 180 d\u00edas h\u00e1biles despu\u00e9s de la publicaci\u00f3n en el DOF.<\/p>\n<p class=\"nota-justify\">El documento precisa que el t\u00e9rmino medicamento biotecnol\u00f3gico se refiere a toda sustancia que haya sido producida por biotecnolog\u00eda molecular, tenga efecto terap\u00e9utico, preventivo o rehabilitatorio, se presente en forma farmac\u00e9utica y que se identifique como tal por su actividad farmacol\u00f3gica y propiedades f\u00edsicas, qu\u00edmicas y biol\u00f3gicas.<\/p>\n<p class=\"nota-justify\">Asimismo, indica que los medicamentos biotecnol\u00f3gicos innovadores podr\u00e1n ser referencia para los medicamentos biotecnol\u00f3gicos no innovadores, a los cuales se les denominar\u00e1 biocomparables. \u201cLa forma de identificaci\u00f3n de estos productos ser\u00e1 determinada en el Reglamento de Insumos para la Salud y dem\u00e1s disposiciones aplicables.\u201d<\/p>\n<p class=\"nota-justify\">A\u00f1ade que el Acuerdo de Equivalencias, se refiere a una resoluci\u00f3n que especifica las condiciones mediante las cuales se reconocen unilateralmente o rec\u00edprocamente los reglamentos t\u00e9cnicos extranjeros, las medidas sanitarias o fitosanitarias o los resultados de los procedimientos de evaluaci\u00f3n de la conformidad emitidos por los organismos en el territorio de otro pa\u00eds y que contemplen cuando menos el mismo grado de conformidad para lograr los objetivos leg\u00edtimos perseguidos por las Normas Oficiales Mexicanas.<\/p>\n<p class=\"nota-justify\">Subraya que cada lote de f\u00e1rmacos debe contar con un certificado anal\u00edtico del fabricante con los controles necesarios para asegurar la calidad de los medicamentos, de acuerdo con el registro sanitario o autorizaci\u00f3n de comercializaci\u00f3n.<\/p>\n<p class=\"nota-justify\">\u201cLos an\u00e1lisis correspondientes podr\u00e1n ser realizados en el laboratorio de control de calidad del fabricante o por un laboratorio de control de calidad certificado. En ambos casos deber\u00e1n contar con un certificado de buenas pr\u00e1cticas de fabricaci\u00f3n o documento equivalente emitido por la Secretar\u00eda de Salud o por una Autoridad Regulatoria Nacional.\u201d<\/p>\n<p class=\"nota-justify\">Advierte que cuando el fabricante cuente con un certificado de buenas pr\u00e1cticas de fabricaci\u00f3n o documento equivalente del biof\u00e1rmaco y del medicamento, emitido por la Secretar\u00eda de Salud o por una Autoridad Regulatoria Nacional presentar\u00e1 s\u00f3lo el certificado anal\u00edtico del fabricante.<\/p>\n<p class=\"nota-justify\">En el caso de medicamentos biotecnol\u00f3gicos de importaci\u00f3n, con excepci\u00f3n de vacunas, cada lote de producto terminado deber\u00e1 ser aprobado por el responsable sanitario previo a su liberaci\u00f3n para su comercializaci\u00f3n. \u201cLa liberaci\u00f3n podr\u00e1 ser a trav\u00e9s de revisi\u00f3n documental o mediante an\u00e1lisis de laboratorio.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>En el Diario Oficial de la Federaci\u00f3n (DOF) hoy fue publicada la modificaci\u00f3n de diversos puntos de la Norma Oficial 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