Paragraph 3
The licence holder must ensure, if using human cells or tissues in an exempt advanced therapy medicinal product, that the donation, procurement and testing of those cells or tissues is in accordance with F1requirements imposed pursuant to—
(a)
paragraphs 6 to 9 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards gametes and embryos; and
(b)
paragraphs 9 to 12 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other tissues and cells.
Annotations
Textual amendments
- F1
Sch. 6 para. 3(a)(b) and words substituted for words (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 26(2); 2020 c. 1, Sch. 5 para. 1(1)