El Parlamento aprueba nuevas normas sobre hierbas medicinales
El pasado 20 de noviembre, el Parlamento Europeo votó a favor de una propuesta de la Comisión Europea sobre medicinas de herbolario que crea un procedimiento especial para el registro y comercialización de ciertos de estos medicamentos tradicionales que no requiere detalles ni documentos sobre pruebas y ensayos en su seguridad y eficacia.
El objetivo principal de la directiva es armonizar el marco legislativo de la Comunidad para medicamentos.
A diferencia de las medicinas regulares, este nuevo procedimiento simplificado no requerirá que el fabricante lleve a cabo pruebas y ensayos sobre la seguridad y la eficacia de estos productos. En cambio, se permitirá que los candidatos para la autorización de comercialización presenten pruebas bibliográficas o periciales plausibles sobre el uso medicinal tradicional del producto, así como un estudio bibliográfico con datos sobre la seguridad del producto. Por último, se deberá presentar un informe de expertos.
El Parlamento adoptó varias enmiendas a la propuesta inicial de la Comisión.
Reviste especial importancia la enmienda que crea un nuevo comité independiente (el Comité Sobre Medicamentos de Herboristería) que tendrá la responsabilidad de lo referente a las evaluaciones de medicamentos de este tipo dentro de la Agencia Europea de Evaluación de Medicinas.
El Parlamento también votó a favor de la posibilidad de aprobar medicamentos en los que se combinen productos de herbolario con otros de carácter científico.
Así, los parlamentarios opinan que no hay ninguna razón para excluir del mercado los medicamentos tradicionales que también contengan pequeñas cantidades de vitaminas, minerales y otros ingredientes naturales, excepto aquellos que contengan material biológico.
El Parlamento también fijó en la propuesta el texto que debía utilizarse en la publicidad para los productos tradicionales, añadiendo la siguiente declaración a los productos: "se ha utilizado tradicionalmente y su eficacia se basa en el uso y la experiencia a largo plazo".
Sin embargo el Parlamento...
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