The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 No. 744

Amendment of regulation 34 (clinical trials conducted in third countries) U.K.

15.—(1) In the heading of regulation 34, for “third countries” substitute “ countries other than the United Kingdom ”.

(2) In regulation 34—

(a) for “a third country” substitute “ another country ”; and

(b) for the words “entered into” to the end, substitute—

“reported 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.”.

Commencement Information

I1 Reg. 15 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1