{"id":40706,"date":"2026-07-21T09:43:33","date_gmt":"2026-07-21T12:43:33","guid":{"rendered":"https:\/\/victoriaaldia.com\/?p=40706"},"modified":"2026-07-21T09:45:26","modified_gmt":"2026-07-21T12:45:26","slug":"las-empresas-alcanzadas-entre-las-firmas-incluidas-en-la-disposicion-figuran-pmx-s-a-importadora-y-exportadora-magallanes-s-r-l-vasculart-s-a-continental-business-s-a-oftakame-s-r-l-hyaltec","status":"publish","type":"post","link":"https:\/\/victoriaaldia.com\/?p=40706","title":{"rendered":"ANMAT dio de baja habilitaciones de 16 empresas y cancel\u00f3 el registro de productos m\u00e9dicos"},"content":{"rendered":"<p>ANMAT cancel\u00f3 habilitaciones y registros de productos m\u00e9dicos de 16 empresas por incumplimientos administrativos relacionados con la falta de un Director T\u00e9cnico habilitado.<\/p>\n<p>La Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica (ANMAT) dispuso la baja de los certificados de habilitaci\u00f3n de 16 empresas fabricantes e importadoras de productos m\u00e9dicos y, como consecuencia, cancel\u00f3 el registro de numerosos productos que esas firmas ten\u00edan autorizados para comercializar en el pa\u00eds.<\/p>\n<p>La medida fue oficializada mediante la Disposici\u00f3n 4398\/2026, luego de que el organismo verificara que las empresas intimadas no designaron un nuevo Director T\u00e9cnico, un requisito obligatorio para mantener la autorizaci\u00f3n de funcionamiento prevista por la legislaci\u00f3n vigente.<\/p>\n<p>Seg\u00fan explic\u00f3 la ANMAT, las firmas fueron notificadas para regularizar la situaci\u00f3n, pero al no hacerlo se resolvi\u00f3 cancelar tanto los certificados de inscripci\u00f3n de los establecimientos como los registros de los productos m\u00e9dicos que figuraban a su nombre.<\/p>\n<p>&nbsp;<\/p>\n<p>Qu\u00e9 implica la medida<\/p>\n<p>La disposici\u00f3n aclara que la decisi\u00f3n no responde a problemas de calidad, seguridad o eficacia de los productos, sino al incumplimiento de una exigencia administrativa prevista en la Ley 16.463.<\/p>\n<p>&nbsp;<\/p>\n<p>La normativa establece que toda empresa dedicada a fabricar, importar o comercializar productos m\u00e9dicos debe contar con un Director T\u00e9cnico, profesional responsable de garantizar el cumplimiento de las normas sanitarias y regulatorias.<\/p>\n<p>&nbsp;<\/p>\n<p>Al perder esa condici\u00f3n, la ANMAT consider\u00f3 que las empresas dejaron de reunir los requisitos bajo los cuales hab\u00edan obtenido su autorizaci\u00f3n para operar y, por ese motivo, resolvi\u00f3 cancelar las habilitaciones y los registros correspondientes.<\/p>\n<p>Seg\u00fan explic\u00f3 la ANMAT, las firmas fueron notificadas para regularizar la situaci\u00f3n, pero al no hacerlo se resolvi\u00f3 cancelar tanto los certificados de inscripci\u00f3n de los establecimientos como los registros de los productos m\u00e9dicos que figuraban a su nombre.<\/p>\n<p>&nbsp;<\/p>\n<p>Qu\u00e9 implica la medida<\/p>\n<p>La disposici\u00f3n aclara que la decisi\u00f3n no responde a problemas de calidad, seguridad o eficacia de los productos, sino al incumplimiento de una exigencia administrativa prevista en la Ley 16.463.<\/p>\n<p>&nbsp;<\/p>\n<p>La normativa establece que toda empresa dedicada a fabricar, importar o comercializar productos m\u00e9dicos debe contar con un Director T\u00e9cnico, profesional responsable de garantizar el cumplimiento de las normas sanitarias y regulatorias.<\/p>\n<p>&nbsp;<\/p>\n<p>Al perder esa condici\u00f3n, la ANMAT consider\u00f3 que las empresas dejaron de reunir los requisitos bajo los cuales hab\u00edan obtenido su autorizaci\u00f3n para operar y, por ese motivo, resolvi\u00f3 cancelar las habilitaciones y los registros correspondientes.<\/p>\n<p>Las empresas alcanzadas<\/p>\n<p>Entre las firmas incluidas en la disposici\u00f3n figuran PMX S.A., Importadora y Exportadora Magallanes S.R.L., Vasculart S.A., Continental Business S.A., Oftakame S.R.L., Hyaltec Argentina S.A., Victhor Implantes S.R.L., Alphatec Buenos Aires S.R.L., Away Custom Brokers S.R.L., Suministros M\u00e9dicos La Femme Argentina S.A., Distribuidora Kepler S.R.L., Prodentos S.A., Apositos Argentinos, Siempre Linda S.R.L., Guillermo Gustavo Soria y Magadan Walter Daniel Anselmo.<\/p>\n<p>&nbsp;<\/p>\n<p>Asimismo, la resoluci\u00f3n cancel\u00f3 los certificados de registro de numerosos productos m\u00e9dicos pertenecientes a parte de esas empresas, entre ellas PMX S.A., Continental Business S.A., Magadan Walter Daniel Anselmo, Victhor Implantes S.R.L., Away Custom Brokers S.R.L., Oftakame S.R.L., Vasculart S.A., Alphatec Buenos Aires S.R.L. y Suministros M\u00e9dicos La Femme Argentina S.A.<\/p>\n<p>&nbsp;<\/p>\n<p>Las empresas podr\u00e1n apelar<\/p>\n<p>La disposici\u00f3n establece que las firmas alcanzadas podr\u00e1n presentar los recursos administrativos previstos por la normativa o acudir a la Justicia para cuestionar la decisi\u00f3n.<\/p>\n<p>&nbsp;<\/p>\n<p>Mientras tanto, la baja de los certificados y la cancelaci\u00f3n de los registros permanecer\u00e1n vigentes conforme a lo resuelto por la autoridad sanitaria nacional. Fuente: El Once<\/p>\n<p><a href=\"https:\/\/victoriaaldia.com\/?attachment_id=9276\" rel=\"attachment wp-att-9276\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-9276\" src=\"http:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/coopar.png\" alt=\"\" width=\"720\" height=\"90\" srcset=\"https:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/coopar.png 720w, https:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/coopar-300x38.png 300w\" sizes=\"auto, (max-width: 720px) 100vw, 720px\" \/><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ANMAT cancel\u00f3 habilitaciones y registros de productos m\u00e9dicos de 16 empresas por incumplimientos administrativos relacionados con la falta de un&hellip;<\/p>\n","protected":false},"author":3,"featured_media":40707,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"nogoya_volanta":"","nogoya_breaking":false,"nogoya_exclusive":false,"footnotes":""},"categories":[4,3,17],"tags":[],"class_list":["post-40706","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nacionales","category-noticias","category-sociedad"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - 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