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The Medicines for Human Use (Clinical Trials) Regulations 2004

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Changes over time for: Section 57

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Point in time view as at 06/11/2023.

Changes to legislation:

The Medicines for Human Use (Clinical Trials) Regulations 2004, Section 57 is up to date with all changes known to be in force on or before 04 March 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations. Help about Changes to Legislation

[F1Functions in relation to good clinical practiceU.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. ]

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