Paragraph 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 F1imposed pursuant to—

(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.

Annotations

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)