SCHEDULES
F1SCHEDULE 3ASUPPLEMENTARY LICENCE CONDITIONS: HUMAN APPLICATION
Annotations:
Amendments (Textual)
Serious adverse events and serious adverse reactions F4: Great Britain
Annotations:
Amendments (Textual)
F4
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))
3
F2In relation to Great Britain, licence conditions shall require such—
a
systems to report, investigate, register and transmit information about serious adverse events and serious adverse reactions, and
b
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.
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