The Human Medicines Regulations 2012 No. 1916

SCHEDULES

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

PART 1 U.K. Manufacturer'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 [F1 imposed pursuant to— U.K.

(a) as regards gametes and embryos, sections 12(3), and 33A to 33D of, and paragraph 1 of Schedule 3A to, the Human Fertilisation and Embryology Act 1990;

(b) as regards blood cells, regulations 8, 9(e) and 14 of the Blood Safety and Quality Regulations 2005; and

(c) as regards other cells and tissues, regulations 13 and 16 of, and paragraph 1 of Schedule 2 to, the Human Tissue (Quality and Safety for Human Application) Regulations 2007].

Textual Amendments

F1 Sch. 6 paras. 11(a)-(c) and words substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 26(5); 2020 c. 1, Sch. 5 para. 1(1)