Amendment of regulation 35 (annual list of suspected serious adverse reactions and safety report) U.K.

16.—(1) Regulation 35 is amended as follows.

(2) In paragraph (2)(b), for “EEA State” substitute “ any country ”.

(3) In paragraph (3)—

(a) for “an EEA State” substitute “ a country ”; and

(b) for sub-paragraphs (a) and (b), substitute—

“(a) the date on which the trial was authorised by a regulatory body responsible for authorising clinical trials in that country; or

(b) where the clinical trial was conducted in a country without a formal authorisation process, a date designated by the sponsor that is linked to the commencement of the first clinical trial.”.

Commencement Information

I1 Reg. 16 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1