Limpieza en el Registro
La ANMAT anula 25 habilitaciones de medicamentos
Deja en alerta a los laboratorios infractores.
La Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) dispone la cancelación inmediata de 25 certificados de medicamentos inscriptos en el Registro de Especialidades Medicinales (REM). La medida responde a un control exhaustivo que detectó que estas autorizaciones se encontraban vencidas y que sus titulares no habían iniciado el trámite de reinscripción obligatorio para mantener su vigencia.
La resolución se formaliza a través de la Disposición N° 5866/2026, publicada en el Boletín Oficial y firmada por el titular del organismo, Luis Eduardo Fontana. Según las últimas informaciones, la Dirección de Gestión de Información Técnica identificó que estos productos superaron el plazo legal sin que las empresas impulsaran su renovación, un requisito indispensable para continuar con su comercialización en el país.
El impacto alcanza a una decena de laboratorios, algunos de los cuales vieron cancelados múltiples certificados. Entre las firmas afectadas se encuentran CSL Behring S.A., Lafedar S.A., Microsules Argentina S.A., Aspen Argentina S.A., Lavimar S.A., Laboratorio Internacional Argentino S.A., Savant Pharm S.A., Laboratorios Monserrat y Eclair S.A., Takeda 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.
Ante esta situación, el organismo abre un plazo de entre 20 y 30 días para que las compañías notificadas puedan presentar un recurso de reconsideración. No obstante, la ANMAT recuerda que, según el artículo 7° de la Ley de Medicamentos N° 16.463, la habilitación para elaborar y comercializar una especialidad medicinal tiene una vigencia máxima de cinco años.
La normativa es clara: los titulares deben solicitar la reinscripción dentro de los 30 días previos al vencimiento. El incumplimiento de este cronograma, contemplado en el artículo 8° de la misma ley, faculta al organismo a cancelar las autorizaciones de manera automática, garantizando así que solo circulen en el mercado productos con sus condiciones sanitarias y legales plenamente vigentes.
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