PART 9MISCELLANEOUS PROVISIONS

F1Functions in relation to good clinical practice57

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.