{"id":5466,"date":"2025-08-02T05:32:06","date_gmt":"2025-08-02T10:32:06","guid":{"rendered":"https:\/\/scrconsultings.com\/?p=5466"},"modified":"2026-01-27T13:19:52","modified_gmt":"2026-01-27T18:19:52","slug":"supreme-decree-008-2025-sa-digemid","status":"publish","type":"post","link":"https:\/\/scrconsultings.com\/es\/supreme-decree-008-2025-sa-digemid\/","title":{"rendered":"Cambios normativos al Reglamento de Establecimientos Farmac\u00e9uticos: lo que establece el Decreto Supremo N.\u00ba 008-2025-SA"},"content":{"rendered":"<p dir=\"ltr\"><strong>Elaborado por Carolina N\u00fa\u00f1ez - Consultora Asociada de Aseguramiento de la Calidad e Inteligencia Regulatoria<\/strong><\/p>\n<p dir=\"ltr\" class=\"translation-block\">El pasado viernes 13 de junio de 2025, la Direcci\u00f3n General de Medicamentos, Insumos y Drogas (DIGEMID) convoc\u00f3 a los actores del sector farmac\u00e9utico para exponer los alcances del <strong>Decreto Supremo N.\u00ba 008-2025-SA<\/strong>, norma que modifica art\u00edculos clave del Reglamento de Establecimientos Farmac\u00e9uticos (Decreto Supremo N.\u00ba 014-2011-SA). Esta modificaci\u00f3n tiene por objeto actualizar procedimientos administrativos, fortalecer mecanismos de control y fiscalizaci\u00f3n, y facilitar ciertas obligaciones relacionadas con certificaciones t\u00e9cnicas.<\/p>\n<p dir=\"ltr\">La norma incorpora cambios a los art\u00edculos 23, 94, 110, 123 al 129, 135 (literal d) y 137, incluyendo adem\u00e1s disposiciones complementarias orientadas a establecer plazos y condiciones transitorias para establecimientos con procedimientos en curso.<\/p>\n<p dir=\"ltr\">A continuaci\u00f3n, se detallan los principales aspectos abordados por la autoridad sanitaria:<\/p>\n<p dir=\"ltr\"><strong>Cierres temporales y definitivos: modificaciones al art\u00edculo 23<\/strong><\/p>\n<p dir=\"ltr\" class=\"translation-block\">Se ampl\u00eda el <strong>plazo m\u00e1ximo para el cierre temporal<\/strong> de un establecimiento farmac\u00e9utico de <strong>6 a 12 meses,<\/strong> contados desde la fecha comunicada a la Autoridad de Salud. Vencido este plazo sin reanudaci\u00f3n de actividades, se dispondr\u00e1 el <strong>cierre definitivo autom\u00e1tico.<\/strong><\/p>\n<p dir=\"ltr\">Durante el cierre temporal, si el establecimiento mantiene productos en stock, debe asegurar el cumplimiento de las Buenas Pr\u00e1cticas de Almacenamiento, bajo responsabilidad del Director T\u00e9cnico y del representante legal. Asimismo, se establece que en los casos de cierre temporal por medida de seguridad, la vigencia ser\u00e1 tambi\u00e9n de hasta 12 meses, transcurridos los cuales sin levantamiento de observaciones, se proceder\u00e1 al cierre definitivo.<\/p>\n<p dir=\"ltr\"><strong>Requisitos profesionales en laboratorios de productos sanitarios y gases medicinales (art\u00edculo 94)<\/strong><\/p>\n<p dir=\"ltr\" class=\"translation-block\">Se incorpora un mayor nivel de <strong>flexibilidad t\u00e9cnica<\/strong> para los laboratorios de <strong>productos sanitarios y de gases medicinales.<\/strong> En estos casos:<\/p>\n<ul>\n<li dir=\"ltr\" aria-level=\"1\">\n<p dir=\"ltr\" role=\"presentation\" class=\"translation-block\">El <strong>Director T\u00e9cnico<\/strong> podr\u00e1 asumir directamente las funciones de aseguramiento de la calidad y de producci\u00f3n<\/p>\n<\/li>\n<li dir=\"ltr\" aria-level=\"1\">\n<p dir=\"ltr\" role=\"presentation\" class=\"translation-block\">Siendo la <strong>jefatura de aseguramiento de la calidad<\/strong> la que asuma tambi\u00e9n las funciones de control de calidad.<\/p>\n<\/li>\n<\/ul>\n<p dir=\"ltr\">Asimismo, se detallan los perfiles m\u00ednimos de experiencia, capacitaci\u00f3n y competencias t\u00e9cnicas requeridas para ejercer funciones jefaturales en dichas \u00e1reas, conservando su autonom\u00eda funcional bajo supervisi\u00f3n del Director T\u00e9cnico.<\/p>\n<p dir=\"ltr\"><strong>Certificaci\u00f3n en Buenas Pr\u00e1cticas: vigencia, plazos y simplificaci\u00f3n (art\u00edculos 110, 123 al 129)<\/strong><\/p>\n<p dir=\"ltr\">El Decreto modifica sustancialmente los procedimientos relacionados a la <strong>certificaci\u00f3n de Buenas Pr\u00e1cticas de Farmacovigilancia<\/strong> y de Oficina Farmac\u00e9utica:<\/p>\n<ul>\n<li dir=\"ltr\" aria-level=\"1\">\n<p dir=\"ltr\" role=\"presentation\" class=\"translation-block\">Se establece que la vigencia de ambas certificaciones es ahora <strong>indeterminada,<\/strong> eliminando la renovaci\u00f3n peri\u00f3dica previa (antes cada 3 a\u00f1os).<\/p>\n<\/li>\n<li dir=\"ltr\" aria-level=\"1\">\n<p dir=\"ltr\" role=\"presentation\" class=\"translation-block\">El procedimiento de certificaci\u00f3n debe resolverse en un <strong>plazo m\u00e1ximo de 45 d\u00edas.<\/strong><\/p>\n<\/li>\n<li dir=\"ltr\" aria-level=\"1\">\n<p dir=\"ltr\" role=\"presentation\" class=\"translation-block\">La solicitud de certificaci\u00f3n podr\u00e1 ser presentada mediante <strong>declaraci\u00f3n jurada,<\/strong> sin requisitos adicionales previos.<\/p>\n<\/li>\n<li dir=\"ltr\" aria-level=\"1\">\n<p dir=\"ltr\" role=\"presentation\" class=\"translation-block\">En el caso de establecimientos farmac\u00e9uticos que ya cuenten con certificaci\u00f3n vigente, podr\u00e1n solicitar a la Autoridad Sanitaria la emisi\u00f3n de un nuevo certificado con <strong>vigencia indefinida,<\/strong> sin costo adicional.<\/p>\n<\/li>\n<\/ul>\n<p dir=\"ltr\" class=\"translation-block\">Cabe precisar que la <strong>certificaci\u00f3n en Buenas Pr\u00e1cticas de Farmacovigilancia<\/strong> se mantiene como voluntaria para aquellos establecimientos que <strong>no son titulares de registros sanitarios ni certificados de registro sanitario.<\/strong><\/p>\n<p dir=\"ltr\"><strong>Inspecciones: responsabilidades y consecuencias (art\u00edculos 135 y 137)<\/strong><\/p>\n<p dir=\"ltr\" class=\"translation-block\">Respecto a la inspecci\u00f3n sanitaria, se precisan nuevas disposiciones ante la <strong>inaccesibilidad o interrupci\u00f3n<\/strong> del acto inspectivo:<\/p>\n<ul>\n<li dir=\"ltr\" aria-level=\"1\">\n<p dir=\"ltr\" role=\"presentation\" class=\"translation-block\">Si al momento de la visita el establecimiento se encuentra cerrado, se dejar\u00e1 constancia y nueva fecha. Si permanece cerrado en la segunda oportunidad, se dispondr\u00e1 su <strong>cierre temporal como medida de seguridad.<\/strong><\/p>\n<\/li>\n<li dir=\"ltr\" aria-level=\"1\">\n<p dir=\"ltr\" role=\"presentation\" class=\"translation-block\">Si durante una inspecci\u00f3n esta es <strong>interrumpida o impedida sin causa justificada,<\/strong> tambi\u00e9n se proceder\u00e1 al cierre temporal, el cual podr\u00e1 levantarse \u00fanicamente cuando el establecimiento permita completar la inspecci\u00f3n.<\/p>\n<\/li>\n<li dir=\"ltr\" aria-level=\"1\">\n<p dir=\"ltr\" role=\"presentation\" class=\"translation-block\">Se except\u00faan de estas disposiciones los casos debidamente sustentados por <strong>fuerza mayor o caso fortuito.<\/strong><\/p>\n<\/li>\n<\/ul>\n<p dir=\"ltr\"><strong>Disposici\u00f3n complementaria: adecuaci\u00f3n a la norma<\/strong><\/p>\n<p dir=\"ltr\" class=\"translation-block\">Se ha previsto una disposici\u00f3n transitoria para los establecimientos que, al momento de entrada en vigencia del Decreto, se encuentren con <strong>cierre temporal por medida de seguridad con una antig\u00fcedad mayor a un a\u00f1o.<\/strong> Estos cuentan con <strong>45 d\u00edas calendario<\/strong> para solicitar el levantamiento de observaciones. De no hacerlo, se proceder\u00e1 a su <strong>cierre definitivo.<\/strong><\/p>\n<p dir=\"ltr\"><strong>Consideraciones finales<\/strong><\/p>\n<p dir=\"ltr\" class=\"translation-block\">La promulgaci\u00f3n del Decreto Supremo N.\u00ba 008-2025-SA representa una actualizaci\u00f3n t\u00e9cnica y procedimental significativa para los establecimientos farmac\u00e9uticos del pa\u00eds. Las medidas adoptadas impactan de manera directa en los procesos de cierre, gesti\u00f3n de jefaturas t\u00e9cnicas, fiscalizaci\u00f3n y certificaci\u00f3n, promoviendo tanto el fortalecimiento del sistema como la simplificaci\u00f3n de tr\u00e1mites administrativos.<\/p>\n<p dir=\"ltr\" class=\"translation-block\">El contenido \u00edntegro de los cambios puede revisarse en el texto del Decreto y sus anexos, as\u00ed como en los canales oficiales de la Autoridad Nacional de Productos Farmac\u00e9uticos, Dispositivos M\u00e9dicos y Productos Sanitarios.<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Prepared by Carolina N\u00fa\u00f1ez \u2013 Associate Consultant in Quality Assurance and Regulatory Intelligence On Friday, June 13, 2025, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) convened stakeholders from the pharmaceutical sector to present the scope of Supreme Decree No. 008-2025-SA, which modifies key articles of the Regulation of Pharmaceutical Establishments (Supreme Decree No. [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":5468,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46,80],"tags":[],"class_list":["post-5466","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-pharmaceutical-establishment"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>DS 008-2025-SA: DIGEMID Updates for Peru Pharma Sites<\/title>\n<meta name=\"description\" content=\"Supreme Decree 008-2025-SA updates Peru\u2019s pharmaceutical establishments regulation: closures, inspections, technical staff requirements and simplified good practices certification with indefinite validity.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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