SCHEDULES
F1SCHEDULE 3ASUPPLEMENTARY LICENCE CONDITIONS: HUMAN APPLICATION
F2Serious adverse events and serious adverse reactions: Northern Ireland
Sch. 3A para. 3A and cross-heading inserted (31.12.2020) by S.I. 2019/482, reg. 2(17)(ba) (as substituted by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 16(b))
3A
In relation to Northern Ireland, 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 are necessary to secure compliance with the requirements of Article 11 (notification of serious adverse events and reactions) of the first Directive and Article 5 (notification of serious adverse reactions) and Article 6 (notification of serious adverse events) of the third Directive.
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