# The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024, Regulation 4: Amendment to regulation 3


(1) Regulation 3 (sponsor of a clinical trial) is amended as follows.
(2) In paragraphs (4) and (5)—
(a) for “request for authorisation”, in both places where it occurs, substitute “request for approval”;
(b) for “regulation 17”, in both places where it occurs, substitute “regulation 16”.
(3) In paragraph (6)—
(a) for “authorised by the licensing authority” substitute “approved”;
(b) for “, 19 or 20” substitute “or 18A”;
(c) for “substantial amendment” substitute “modification of an important detail as defined in Part 3”;
(d) for “authorisation” substitute “approval”;
(e) for “regulations 24 to 26” substitute “regulation 22”.
(4) In paragraph (7)—
(a) in sub-paragraph (a), omit “, except regulation 15”;
(b) in sub-paragraph (b), omit “Parts 2 to 4 of”;
(c) in sub-paragraph (c), omit “, in so far as it relates to decisions of the licensing authority under Part 3”.
(5) In paragraph (10)—
(a) in sub-paragraph (a), for “regulations 15 and 28(1)” substitute “regulation 28(1)”;
(b) in sub-paragraph (c), omit “, and Part 1 of Schedule 3”.

---
Source: https://www.legislation.gov.uk/ukdsi/2024/9780348267167/regulation/4 (the official version)
Page: https://openlegislation.uk/draft-medicines-for-human-use-clinical-trials-amendment-regulations-2024/regulation-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.