The Medicines for Human Use (Clinical Trials) Regulations 2004

[F1 Functions in relation to good clinical practice U.K.

57.— (1) Regulations may, in respect of Great Britain—

(a) amend the conditions and principles of good clinical practice to take account of technical and scientific progress;

(b) specify requirements for documentation relating to a clinical trial which constitute the master file on the trial at the time the file is archived;

(c) amend or revoke the requirements of regulation 31A relating to the content of the trial master file; and

(d) require guidance published under regulation 58 to be taken into account when interpreting any enactment or other requirement to which the guidance relates.

(2) Any power to make regulations under paragraph (1)—

(a) is exercisable by the Secretary of State by statutory instrument;

(b) includes power to make—

(i) different provision for different purposes or different areas;

(ii) consequential, supplementary, incidental, transitional, transitory or saving provisions, including consequential amendments to these Regulations.

( 3) Regulations under paragraph (1) are subject to annulment in pursuance of a resolution of either House of Parliament. ]

Textual Amendments

F1 Regs. 57, 58 inserted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 23 (as amended by by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 1 para. 7); 2020 c. 1, Sch. 5 para. 1(1)