This
adran has no associated
Memorandwm Esboniadol
11. The licence holder must, where an exempt advanced therapy medicinal product contains human cells or tissues, ensure that the traceability system established in accordance with paragraph 8 is complementary to and compatible with the requirements laid down in—U.K.
(a)Articles 8 and 14 of Directive 2004/23/EC as regards human cells and tissues other than blood cells, and
(b)as regards human blood cells, Articles 14 and 24 of Directive 2002/98/EC.