Industria

    ANMAT: ¿Los laboratorios impondrán condiciones a los productores de materias primas?

    Updated:2.493 comentariosLectura de 4 min

    La autoridad de aplicación Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) publicó el proyecto de disposiciones generales y abrió un espacio de consulta para la opinión pública sobre las condiciones que deberán tener los productos.

    El proyecto de autorizaciones emitido por ANMAT, aún no definitivo, apunta a definir los términos y condiciones sobre los que se emitirán los correspondientes pedidos de autorizaciones a quienes elaboren ingredientes farmacéuticos activos (IFA), y quienes elaboren productos terminados.

    “Este procedimiento se aplica a la fabricación, importación, comercialización, monitoreo, inspección y dispensación de ingredientes farmacéuticos activos (IFA) y productos industrializados que contienen derivados de plantas de Cannabis; en adelante denominados productos vegetales a base de cannabis y sus derivados destinados al uso y aplicación en la medicina humana”, indica el documento.

    Los encargados de producir los ingredientes farmacéuticos activos (IFA), entendidos como las flores de cannabis, son los titulares de los proyectos autorizados por el Ministerio de Salud, en el marco de la Ley 27.350 para investigación y la reciente 27.699 abocada a la industrialización.

    Muchos de estos proyectos surgieron de sociedades, mayoritariamente estatal, por iniciativa provincial, y de privados en acuerdos con el INTA, CONICET y facultades públicas. Para estos proyectos la ANMAT solicita el pedido de autorización mediante expediente electrónico. Algo que hasta el momento era desconocido para los titulares de estas licencias productoras de IFA.

    Quienes elaboren productos vegetales  a base de cannabis terminados, serán los laboratorios, que deberán cumplir con las exigencias habituales como Buenas Prácticas de Fabricación (BPF) y certificado de habilitación emitido por el Instituto Nacional de Medicamentos (INAME).

    ¿Solo los laboratorios podrán procesar cannabis?

    Pero a estos requisitos conocidos por los laboratorios, la ANMAT agrega requisitos de control de calidad, donde exige información exhaustiva sobre el IFA. Detalles sobre la especie de cannabis utilizada, quimiotipo, origen de la semilla y tratamiento y control post cosecha entre otros, entre otros.

    Estos requisitos por parte de la ANMAT, para los laboratorios sobre los proyectos autorizados por el Ministerio de Salud para producir flores de cannabis como materia prima vegetal de futuros productos elaborados, son los que despertaron la alarma en los actores de esta cadena productiva.

    La Ley 27699 de industrialización del cannabis medicinal y el cáñamo para todos sus usos, aprobada el 5 de mayo de este año, fue destacada por incluir a las economías regionales, pymes, ong´s y cooperativas como prioridad en la cadena productiva.

    Uno de los debates, expuesto durante la discusión en comisiones, era resguardar a este sector de la presión de los grupos farmacéuticos y laboratorios. Lo ciertos es que este proyecto de disposiciones publicado por ANMAT alertó no solo a cooperativas sino también a privados con licencia que ven amenazada su producción a los requerimientos de los laboratorios, avalada por ANMAT, para comprar la producción de materia prima.

    Al momento este proyecto de disposiciones publicado por ANMAT, en simultáneo, con un espacio de consultas, estará abierto hasta el 2 de julio para hacer llegar dudas y comentarios.

    Una posible intervención

    Uno de los actores que podría intervenir en nivelar este choque de fuerzas sería la Agencia Regulatoria de la Industria del Cáñamo y del Cannabis Medicinal (ARICCAME).

    Desde la promulgación de la Ley 27699, el pasado 24 de mayo, el Ejecutivo trabaja en la reglamentación de la misma, con un plazo de 180 días, donde deberá definir el reglamento interno de la ARICCAME. Las misma estará integrada por representantes del Ministerio de Salud, Agricultura, Ciencia y Tecnología y Seguridad.

    Ésta tendrá como función regular la importación, exportación, cultivo, producción industrial, fabricación, comercialización y adquisición de semillas, de la planta de cannabis y de sus productos derivados con fines medicinales o industriales.

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