Spain: Nueva nota informativa de la Agencia Española del Medicamento y Productos Sanitarios respecto a productos sanitarios en caso de Brexit duro

Last Updated: 29 April 2019
Article by Gemma Colomer

Ante la posible salida del Reino Unido de la Unión Europea el próximo viernes 12 de abril de 2019, la Agencia Española del Medicamentos y Productos Sanitarios (AEMPS) ha publicado una nueva nota informativa, esta vez respecto a las implicaciones de un Brexit sin acuerdo en el ámbito de los productos sanitarios. De entrada, cabe destacar que tal nota debe necesariamente complementarse con las directrices del gobierno británico en cuanto a las consecuencias de un Brexit sin acuerdo para productos sanitarios, que ya sintetizamos en Newsletter el 1 de febrero de este mismo año.

Así mismo, cabe señalar que la AEMPS ya publicó nota informativa respecto al Brexit, en la cual, de forma general, exponía algunas de las consecuencias que tendría un Brexit sin acuerdo. Así, entre otras, cabe destacar las siguientes:

  • En relación a medicamentos, la necesidad de que las compañías farmacéuticas cambien determinadas operaciones que venían realizándose desde el Reino Unido a un Estado Miembro de la UE-27.
  • Respecto a productos sanitarios, la pérdida de validez de los certificados expedidos por los Organismos notificados del Reino Unido.
  • En el caso de productos cosméticos, la obligación de que la persona responsable esté establecida en la UE-27, no siendo posible su establecimiento en Reino Unido.

Ahora, en fecha 4 de abril de 2019 la AEMPS ha publicado una nueva Nota Informativa en la que detalla y amplía la situación que acontecerá en el caso de los productos sanitarios si se da un Brexit sin acuerdo, así como una serie de recomendaciones a seguir en ese caso. Esta Nota Informativa puede sintetizarse en los siguientes apuntes:

  • Respecto a los productos sanitarios cuya fecha de puesta en el mercado en la UE-27 sea anterior al Brexit, podrán comercializarse en España con el mismo etiquetado y documentos acreditativos de conformidad actuales, de forma que las empresas deberán disponer de documentos que acrediten que los productos han sido fabricados y puestos en el mercado antes de la fecha del Brexit. Se entenderá por puesta en el mercado cualquier transacción comercial a una entidad de la UE una vez fabricados completamente los productos, sin necesidad de distribución física.
  • En cuanto a los representantes autorizados, los fabricantes, tanto del Reino Unido como de terceros países, que tengan su representante autorizado en Reino Unido, deberán designar nuevo representante en la UE-27.
  • Además, los productos sanitarios procedentes de Reino Unido pasarán a ser considerados como importaciones, con lo que podrán someterse a controles en la frontera, y sus distribuidores, pasarán a ser considerados importadores, por lo que deberán solicitar a la AEMPS la correspondiente licencia de importación.
  • Respecto a los Organismos notificados y sus certificados, los fabricantes deberán transferir sus certificados, antes de la fecha del Brexit, a un organismo notificado en la UE-27 o solicitar un nuevo certificado. En estos casos, para los productos puestos en el mercado UE-27 después de la fecha del Brexit pero fabricados antes, deberá modificarse su declaración de conformidad y certificado del Organismo notificado. Si además han sido fabricados después de la fecha del Brexit, también deberán ser identificados con el nuevo número de Organismo notificado.

Por último, y a modo de resumen, la AEMPS destaca una serie de recomendaciones, que pasan a exponerse a continuación:

  • Las empresas distribuidoras que van a importar productos procedentes del Reino Unido deberán de solicitar previamente una licencia de importación a la AEMPS.
  • Las empresas españolas designadas como Representantes autorizados por parte de un fabricante de productos sanitarios de clase I o a medida del Reino Unido o de un tercer país, deberán de comunicar sus datos y los productos al Registro de Responsables de la AEMPS.
  • Las empresas que comercialicen productos sanitarios en España que como consecuencia del Brexit hayan sufrido una modificación en sus certificados de marcado CE o en sus etiquetados y/o instrucciones de uso, deberán actualizar sus comunicaciones de comercialización realizadas a la AEMPS a través de CCPS.

En cuanto a los productos, los fabricantes españoles que fabriquen productos que estén certificados por un Organismo notificado del Reino Unido deberán solicitar un nuevo certificado o la transferencia a un Organismo notificado de la UE-27 antes de la fecha del Brexit y deberán de modificar los documentos acreditativos de la conformidad y los etiquetados de los productos.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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