# The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 2


Where a direction is given in accordance with paragraph 1(1)(a)—
(a) the Authority shall—
(i) send the application for that opinion, and
(ii) any additional information provided by the sponsor,
to the ethics committee specified in the direction; ...
(b) that committee shall consider the application in accordance with regulation 17; and
(c) that committee shall within 30 days beginning with the day on which the application is sent to the committee under paragraph (a), or such extended period as the Authority may in any particular case allow, either confirm the opinion or give a favourable opinion.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/schedule/4/paragraph/2 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-4/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.