34. If a clinical trial is being conducted at a trial site in [F2another country] in addition to sites in the United Kingdom, the sponsor of that trial shall ensure that all suspected unexpected serious adverse reactions occurring at that site are [F3reported as soon as possible to the licensing authority, and in any event—
(a)in the case of a reaction that is fatal or life-threatening, within 7 days beginning with the day after the sponsor was first aware of the reaction; or
(b)in any other case, within 15 days beginning with the day after the sponsor is first aware of the reaction.]
Textual Amendments
F1Words in reg. 34 heading substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 15(1); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in reg. 34 substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 15(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in reg. 34 substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 15(2)(b); 2020 c. 1, Sch. 5 para. 1(1)