Paragraph 4A F1
Directions must require that importing licence holders are required to—
notify the Authority of any serious adverse events or serious adverse reactions notified to the importing licence holder by that person’s third country supplier (including events or reactions which that supplier suspects are serious adverse events or reactions); and
provide any information specified in the direction which the Authority requires for the purposes of securing compliance with the requirements of Article 6(2) of the fourth Directive (updated information).
Annotations
Textual amendments
- F1
Sch. 2 para. 4A inserted (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)(f)
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)