{"id":42558,"date":"2026-09-23T07:35:58","date_gmt":"2026-09-23T10:35:58","guid":{"rendered":"https:\/\/victoriaaldia.com\/?p=42558"},"modified":"2026-09-23T07:35:58","modified_gmt":"2026-09-23T10:35:58","slug":"anmat-cancelo-25-registros-de-medicamentos-de-15-laboratorios","status":"publish","type":"post","link":"https:\/\/victoriaaldia.com\/?p=42558","title":{"rendered":"ANMAT cancel\u00f3 25 registros de medicamentos de 15 laboratorios"},"content":{"rendered":"<h2 class=\"cont-volanta\"><span class=\"volanta\">Medida publicada en el Bolet\u00edn Oficial<\/span><\/h2>\n<header class=\"cl-24 header-interior interior-top-1\">La ANMAT dispuso la cancelaci\u00f3n de 25 certificados de especialidades medicinales que hab\u00edan vencido entre 2019 y 2025. La medida involucr\u00f3 a 15 empresas farmac\u00e9uticas.<\/header>\n<header><\/header>\n<header>La <b>Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica (Anmat)<\/b> cancel\u00f3 las autorizaciones para elaborar y comercializar <b>medicamentos<\/b> de 15 firmas, tras detectar que 25 certificados de inscripci\u00f3n en el Registro de Especialidades Medicinales (REM) estaban vencidos y no se hab\u00eda iniciado el tr\u00e1mite para renovarlos.<\/p>\n<p>&nbsp;<\/p>\n<p>La decisi\u00f3n fue formalizada mediante la <a href=\"https:\/\/www.boletinoficial.gob.ar\/detalleAviso\/primera\/347843\/20260923\" target=\"_blank\" rel=\"noopener\">disposici\u00f3n 5866\/2026<\/a>, publicada este mi\u00e9rcoles 23 de septiembre en el <b>Bolet\u00edn Oficial<\/b>. El documento fue firmado por el administrador nacional del organismo, <b>Luis Eduardo Fontana<\/b>.<\/p>\n<p>&nbsp;<\/p>\n<div class=\"banner banner-parrafo\">\n<div id=\"banner-ad-interior-art\" data-zone-id=\"123\">\n<div id=\"div-gpt-ad-1721322587843-0\" data-google-query-id=\"\">\n<div id=\"google_ads_iframe_\/1017853\/ELONCE_LISTADOS_1_0__container__\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>Seg\u00fan se explic\u00f3 en los considerandos de la disposici\u00f3n, las actuaciones se iniciaron a partir de un control de certificados no reinscriptos realizado por la <b>Direcci\u00f3n de Gesti\u00f3n de Informaci\u00f3n T\u00e9cnica<\/b>. Durante esa revisi\u00f3n se detect\u00f3 que determinados registros estaban vencidos y que no se hab\u00edan solicitado las renovaciones correspondientes.<\/p>\n<p>&nbsp;<\/p>\n<p>El organismo record\u00f3 que, de acuerdo con la Ley de Medicamentos, la autorizaci\u00f3n para elaborar y comercializar una especialidad medicinal tiene una vigencia de cinco a\u00f1os contados desde la fecha del certificado que la habilita. Adem\u00e1s, los titulares o representantes deben solicitar su reinscripci\u00f3n dentro de los 30 d\u00edas anteriores al vencimiento.<\/p>\n<p><img data-src=\"https:\/\/www.lanacion.com.ar\/resizer\/v2\/las-autorizaciones-para-elaborar-y-vender-4J6X2GIQPNDK5LD3CVNQDMBCXI.jpg?auth=9c09246b7b3e1bd945a390c3d3aca8af24568cca9a10e1150a2d83a7da2bd10c&amp;width=420&amp;height=280&amp;quality=70&amp;smart=true\" \/><\/p>\n<p>La normativa tambi\u00e9n establece que las autorizaciones de elaboraci\u00f3n y venta ser\u00e1n canceladas por el vencimiento de ese plazo o por modificaciones, alteraciones o incumplimientos de las condiciones bajo las cuales fueron otorgadas. Con ese fundamento, la Anmat dispuso la baja de los certificados detallados en el anexo.<\/p>\n<p>&nbsp;<\/p>\n<div class=\"banner banner-parrafo\">\n<div id=\"banner-ad-interior-art-2\" data-zone-id=\"124\"><\/div>\n<\/div>\n<p>El listado comprende registros cuyas fechas de vencimiento se ubican entre marzo de 2019 y mayo de 2025. Identifica los n\u00fameros de certificado, las firmas titulares o representantes y sus fechas de vigencia, sin detallar los nombres comerciales ni los principios activos de los medicamentos.<\/p>\n<p>&nbsp;<\/p>\n<h3>Qu\u00e9 empresas fueron alcanzadas por la medida<\/h3>\n<p>Entre los registros cancelados aparecen certificados correspondientes a <b>CSL Behring S.A., Lafedar S.A., Microsules Argentina S.A., Aspen Argentina S.A. y Lavimar S.A.<\/b> En la primera p\u00e1gina del anexo se detallaron siete certificados, algunos de los cuales estaban vencidos desde 2019.<\/p>\n<p>&nbsp;<\/p>\n<p>Tambi\u00e9n quedaron comprendidos <b>Laboratorio Internacional Argentino S.A., Savant Pharm S.A., Laboratorios Monserrat y Eclair S.A., Takeda Argentina S.A., Megalabs Argentina S.A.U., Eurofar S.R.L., Monte Verde S.A., Tecnonuclear S.A., Terumo BCT Latin America S.A. y Laboratorio Elea Phoenix S.A.<\/b><\/p>\n<p>&nbsp;<\/p>\n<p>Lafedar figura como titular de <b>cinco certificados<\/b> cancelados: 31858, 47816, 51545, 17638 y 21191. Por su parte, Laboratorio Internacional Argentino aparece en otros <b>cinco registros<\/b>: 51557, 51911, 52159, 52172 y 30007.<\/p>\n<p>&nbsp;<\/p>\n<h3>Por qu\u00e9 ANMAT cancel\u00f3 los registros<\/h3>\n<p>En los fundamentos de la Disposici\u00f3n 5866\/2026, ANMAT se\u00f1ala que la autorizaci\u00f3n para elaborar y comercializar una especialidad medicinal tiene una <b>vigencia de cinco a\u00f1os<\/b>, contados desde la fecha del certificado que la autoriza.<\/p>\n<p>&nbsp;<\/p>\n<p>Adem\u00e1s, los titulares o representantes de los productos inscriptos deben solicitar la reinscripci\u00f3n dentro de los <b>30 d\u00edas anteriores a su vencimiento<\/b>.<\/p>\n<p>&nbsp;<\/p>\n<p>La Direcci\u00f3n de Gesti\u00f3n de Informaci\u00f3n T\u00e9cnica realiz\u00f3 el control de los certificados y constat\u00f3 que los incluidos en el anexo se encontraban vencidos <b>sin que se hubiera iniciado el tr\u00e1mite de reinscripci\u00f3n<\/b>. A partir de esa situaci\u00f3n, el organismo dispuso la cancelaci\u00f3n de las inscripciones.<\/p>\n<h3><\/h3>\n<p>El anexo <b>no detalla los nombres comerciales de las especialidades medicinales ni sus principios activos<\/b>. Por lo tanto, la documentaci\u00f3n publicada permite identificar los certificados y las empresas alcanzadas, pero no individualiza all\u00ed los medicamentos por su denominaci\u00f3n comercial.<\/p>\n<p>&nbsp;<\/p>\n<p>La ANMAT tambi\u00e9n dispuso que las firmas involucradas fueran notificadas de la medida. Fuente: El Once<\/p>\n<p><a href=\"https:\/\/victoriaaldia.com\/?attachment_id=9273\" rel=\"attachment wp-att-9273\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-9273\" src=\"http:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/el-progreso.png\" alt=\"\" width=\"720\" height=\"90\" srcset=\"https:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/el-progreso.png 720w, https:\/\/victoriaaldia.com\/wp-content\/uploads\/2023\/11\/el-progreso-300x38.png 300w\" sizes=\"auto, (max-width: 720px) 100vw, 720px\" \/><\/a><\/p>\n<\/header>\n","protected":false},"excerpt":{"rendered":"<p>Medida publicada en el Bolet\u00edn Oficial La ANMAT dispuso la cancelaci\u00f3n de 25 certificados de especialidades medicinales que hab\u00edan vencido&hellip;<\/p>\n","protected":false},"author":3,"featured_media":42559,"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-42558","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 v28.5 - 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