Paragraph 3 F1
F2In relation to Great Britain, licence conditions shall require 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,
to be in place as F3the Authority considers appropriate.
Annotations
Textual amendments
- F1
Sch. 3A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs 1, 30
- F2
Words in Sch. 3A para. 3 substituted (31.12.2020) by S.I. 2019/482, reg. 2(17)(b)(ii) (as substituted by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 16(b))
- F3
Words in Sch. 3A para. 3 substituted (31.12.2020) by S.I. 2019/482, reg. 2(17)(b)(iii) (as substituted by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 16(b))
Notes on Serious adverse events and serious adverse reactions : Great Britain
Textual amendments
- F2
Words in Sch. 3A para. 3 heading inserted (31.12.2020) by S.I. 2019/482, reg. 2(17)(b)(i) (as substituted by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 16(b))