SCHEDULES

SCHEDULE 6Manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products

PART 1Manufacturer's licences

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—

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.