1. The name and address of—U.K.
(a)the sponsor,
(b)if the sponsor is not established in [F1the United Kingdom or a country that is included in the list referred to in regulation 3(11A)] , his legal representative,
(c)if any person has been authorised by the sponsor to make the request on his behalf, that person,
(d)if the persons taking responsibility for the initiation, management and financing (or arranging the financing) of the clinical trial have allocated responsibility in accordance with regulation 3(4), any person responsible for carrying out the functions of the sponsor under Part 4 or 5 of these Regulations, and
(e)any other person to whom the sponsor has delegated any of his responsibilities in relation to the proposed trial.
Textual Amendments
F1Words in Sch. 3 Pt. 2 para. 1(b) substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 24(3)(a); 2020 c. 1, Sch. 5 para. 1(1)