Paragraph 4ZA F1
In relation to Northern Ireland, 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,
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.
Annotations
Textual amendments
- F1
Sch. 2 para. 4ZA inserted (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)(ca) (as inserted by S.I. 2020/1306, regs. 1, 25(e)); 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)