{"id":49729,"date":"2023-06-22T00:00:00","date_gmt":"2023-06-21T22:00:00","guid":{"rendered":"https:\/\/biorius.com\/cosmetic-news\/persona-responsable-en-ee-uu\/"},"modified":"2024-05-08T11:48:07","modified_gmt":"2024-05-08T09:48:07","slug":"persona-responsable-en-ee-uu","status":"publish","type":"post","link":"https:\/\/biorius.com\/es\/cosmetic-news\/persona-responsable-en-ee-uu\/","title":{"rendered":"Persona responsable en EE.UU."},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">Carta Informativa Internacional BIORIUS 006: <strong>Aclaraci\u00f3n sobre la definici\u00f3n de Persona Responsable en EE.UU.<\/strong><\/h2>\n\n<p>Persona responsable en EE.UU.: en nuestro <a href=\"https:\/\/biorius.com\/regulatory\/mocra\/\">art\u00edculo anterior <\/a>sobre la Modernizaci\u00f3n de la Ley de Regulaci\u00f3n de Cosm\u00e9ticos, te informamos de que debe designarse una persona responsable para cada producto cosm\u00e9tico comercializado.<\/p>\n\n<p>La Persona Responsable debe:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Garantizar que el producto es seguro<\/li>\n\n\n\n<li>Ocuparse de los casos de cosmetovigilancia, incluyendo :<ul><li>Recepci\u00f3n de reacciones adversas y reacciones adversas graves<\/li><\/ul><ul><li>Notificaci\u00f3n de reacciones adversas graves a la FDA<\/li><\/ul><ul><li>Permitir a las autoridades competentes acceder a los informes de cosmetovigilancia<\/li><\/ul><ul><li>Permitir a las autoridades competentes el acceso a la informaci\u00f3n sobre fragancias y aromas en caso de Reacci\u00f3n Adversa Grave<\/li><\/ul>\n<ul class=\"wp-block-list\">\n<li>Incluir en la etiqueta una persona de contacto, direcci\u00f3n, etc. para recibir las reclamaciones de los consumidores<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Notificar productos cosm\u00e9ticos y:<ul><li>Realizar la renovaci\u00f3n anual de esta notificaci\u00f3n<\/li><\/ul>\n<ul class=\"wp-block-list\">\n<li>Realizar una actualizaci\u00f3n de la notificaci\u00f3n en caso de modificaciones<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Garantizar que los al\u00e9rgenos aparezcan correctamente en la etiqueta (lista que publicar\u00e1 la FDA)<\/li>\n\n\n\n<li>En caso de inspecci\u00f3n, aportar a las autoridades pruebas relativas a la seguridad de los productos en un plazo y de una manera razonables<\/li>\n\n\n\n<li>Retirada de productos a petici\u00f3n de las autoridades<\/li>\n<\/ul>\n\n<p>A principios de junio, la FDA dio m\u00e1s informaci\u00f3n sobre la localizaci\u00f3n de la persona responsable:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>La persona responsable es la entidad que comercializa los productos. No es necesario que la persona responsable se encuentre en territorio estadounidense.<\/li>\n\n\n\n<li>El contacto para la notificaci\u00f3n de reacciones adversas figura en la etiqueta del producto. Este contacto debe tener una direcci\u00f3n completa, un n\u00famero de tel\u00e9fono o un correo electr\u00f3nico de contacto en EEUU.<\/li>\n<\/ul>\n\n<p>En caso de que la persona responsable no se encuentre en territorio estadounidense, debe designarse un agente estadounidense.<\/p>\n\n<p>El Agente estadounidense debe mencionarse en el registro del establecimiento. Tiene que residir en EE.UU. y estar disponible las 24 horas del d\u00eda para preguntas, cuestiones sanitarias y controles o inspecciones. El agente no ser\u00e1 responsable de los productos ni de las cuestiones sanitarias. Sin embargo, facilita las comunicaciones con las autoridades competentes.<\/p>\n\n<p>Esperamos que te sea de ayuda y quedamos a tu disposici\u00f3n para cualquier duda relacionada con este tema. Si tienes alguna pregunta, no dudes en ponerte en contacto con tu CRM<strong>(<\/strong> <strong>Gestor de<\/strong> <strong>Relaciones con<\/strong><strong>los Clientes<\/strong>) o directamente con nosotros: <a href=\"mailto:%20info@biorius.com\">info@biorius.com<\/a>. Te mantendremos informado sobre futuros avances en este tema.<\/p>\n\n<p><\/p>\n\n<p>Gracias a <a href=\"https:\/\/www.linkedin.com\/in\/pierre-verachten-a6087aa4\/\">Pierre Verachten<\/a> por escribir este art\u00edculo.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Carta Informativa Internacional BIORIUS 006: Aclaraci\u00f3n sobre la definici\u00f3n de Persona Responsable en EE.UU. Persona responsable en EE.UU.: en nuestro art\u00edculo anterior sobre la Modernizaci\u00f3n&#8230;<\/p>\n","protected":false},"author":2,"featured_media":47181,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","footnotes":""},"categories":[2400,2401],"tags":[2343,2346,2403,2402,2369],"ppma_author":[2340],"class_list":["post-49729","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mocra-es","category-normativa-sobre-cosmeticos-de-ee-uu","tag-cosmetica","tag-cosmeticos","tag-estados-unidos","tag-mocra-es","tag-normativa","author-nicolas-lenaersbiorius-com"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Persona responsable en EE.UU. - Biorius<\/title>\n<meta name=\"description\" content=\"Debe designarse una Persona Responsable en EE.UU. para cada producto cosm\u00e9tico comercializado en EE.UU.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/biorius.com\/es\/cosmetic-news\/persona-responsable-en-ee-uu\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Persona responsable en EE.UU. - 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