# The Medicines for Human Use (Clinical Trials) Regulations 2004, Regulation 12: Requirement for authorisation and ethics committee opinion

Extent: E+W+S+N.I.

(1) No person shall—
(a) start a clinical trial or cause a clinical trial to be started; or
(b) conduct a clinical trial,
unless the conditions specified in paragraph (3) are satisfied.
(2) No person shall—
(a) recruit an individual to be a participant in a trial;
(b) issue an advertisement for the purpose of recruiting individuals to be participants in a trial,
unless the condition specified in paragraph (3)(a) has been satisfied.
(3) The conditions referred to in paragraphs (1) and (2) are—
(a) an ethics committee has given a favourable opinion in relation to the clinical trial; and
(b) the clinical trial has been authorised by the licensing authority,
in accordance with these Regulations.
(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Source: https://www.legislation.gov.uk/uksi/2004/1031/regulation/12 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.