Paragraph 4
F1In relation to Great Britain, directions shall require licence holders to adopt such—
systems to report, investigate, register and transmit information about serious adverse events and serious adverse reactions, and
accurate, rapid and verifiable procedures for recalling from distribution any product which may be related to a serious adverse event or serious adverse reaction,
F2as the Authority considers appropriate.
Annotations
Textual amendments
- F1
Words in Sch. 2 para. 4 substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(c)(i) (as substituted by S.I. 2020/1306, regs. 1, 25(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Words in Sch. 2 para. 4 substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(c)(ii) (as substituted by S.I. 2020/1306, regs. 1, 25(d)); 2020 c. 1, Sch. 5 para. 1(1)
Notes on Schedule 2
Textual amendments
- F1
Sch. 2 restricted (temp.) (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 4 (as amended by S.I. 2020/1306, regs. 1, 26(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Sch. 2 heading substituted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 8(1)(a)