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.