Decisión n.o 2/JP/2018, de 17 de julio de 2018, del Comité Mixto creado en el marco del Acuerdo sobre reconocimiento mutuo entre la Comunidad Europea y Japón [2018/1104]
Section | Decision |
Issuing Organization | Comité Mixto |
8.8.2018 ES Diario Oficial de la Unión Europea L 201/4
Visto el Acuerdo sobre reconocimiento mutuo entre la Comunidad Europea y Japón (en lo sucesivo, «Acuerdo»), y en particular su artículo 8, apartado 3,
Considerando que el Comité Mixto debe confirmar el ámbito operativo de los productos del anexo sectorial sobre prácticas correctas de fabricación de medicamentos (en lo sucesivo, «anexo sectorial»), establecido por el Subcomité para el anexo sectorial en su 6.a reunión,
DECIDE:
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El nuevo ámbito operativo de las categorías de medicamentos sujetas al anexo sectorial del Acuerdo, hecho en Bruselas el 4 de abril de 2001, incluye ahora las siguientes categorías: 1) fármacos químicos;
2) medicamentos homeopáticos (siempre que se los considere medicamentos y estén sujetos a los requisitos relativos a las prácticas correctas de fabricación en Japón);
3) vitaminas, minerales y fitofármacos (si ambas Partes los consideran medicamentos);
4) fármacos biológicos (1), incluidos los inmunológicos y las vacunas, pertenecientes a las siguientes categorías:
4.1) medicamentos producidos mediante cultivo celular utilizando microorganismos o estirpes celulares establecidas naturales;
4.2) medicamentos producidos mediante cultivo celular utilizando microorganismos o estirpes celulares establecidas recombinantes; y
4.3) medicamentos derivados de plantas no transgénicas y animales no transgénicos;
5)...
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