Reglamento Delegado (UE) 2021/457 de la Comisión, de 13 de enero de 2021, por el que se modifica el Reglamento Delegado (UE) 2016/161 en lo que concierne a una excepción respecto a la obligación de los mayoristas de desactivar el identificador único de los medicamentos exportados al Reino Unido
Section | Serie L |
Issuing Organization | Comisión de las Comunidades Europeas |
17.3.2021 ES Diario Oficial de la Unión Europea L 91/1
(1) El artículo 54 bis, apartado 1, de la Directiva 2001/83/CE establece que los medicamentos sujetos a receta médica deben llevar dispositivos de seguridad.
(2) De conformidad con el artículo 22, letra a), del Reglamento Delegado (UE) 2016/161 de la Comisión (2), los mayoristas deben desactivar el identificador único de los medicamentos que vayan a distribuir fuera de la Unión.
(3) El 1 de febrero de 2020, el Reino Unido se retiró de la Unión Europea y de la Comunidad Europea de la Energía Atómica. De conformidad con los artículos 126 y 127 del Acuerdo sobre la retirada del Reino Unido de Gran Bretaña e Irlanda del Norte de la Unión Europea y de la Comunidad Europea de la Energía Atómica («el Acuerdo de Retirada»), el Derecho de la Unión es aplicable al y en el Reino Unido durante un período transitorio que finaliza el 31 de diciembre de 2020 («el período transitorio»).
(4) De conformidad con el artículo 185 del Acuerdo de Retirada y el artículo 5, apartado 4, del Protocolo sobre Irlanda/Irlanda del Norte, la legislación de la Unión sobre medicamentos es aplicable en Irlanda del Norte después del período transitorio.
(5) Por consiguiente, a falta de una excepción respecto a las normas aplicables, la retirada del Reino Unido de la Unión tendría como consecuencia la obligación de desactivar los identificadores únicos de los medicamentos destinados a ser distribuidos en el Reino Unido.
(6) Varios medicamentos son suministrados a Chipre, Irlanda, Irlanda del Norte o Malta a través de Gran Bretaña. Una vez finalizado el período transitorio, de conformidad con el artículo 54 bis, apartado 1, de la Directiva 2001/83/CE, correspondería a los importadores titulares de una autorización de fabricación en esas zonas colocar un nuevo identificador único en los medicamentos en el momento de su comercialización. Sin embargo, no hay actualmente ningún importador titular de una autorización de fabricación establecido en Chipre, Irlanda...
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