# The Medicines for Human Use (Clinical Trials) Regulations 2004, Regulation 18C: Approval procedure time periods in special circumstances


(1) For the purposes of regulations 18(4) and 18B(4)—
(a) where the sponsor selects a date other than the next available ethics committee meeting, then the time periods referred to in those regulations will begin from the date that is 7 days before the chosen ethics committee meeting date; and
(b) where the clinical trial involves a medical device, then the time periods referred to in those regulations may begin from the date of formal acceptance under regulation 16(4) of the Medical Devices Regulations 2002.
(2) Where the valid request for approval or amended request for approval falls under both paragraphs (1)(a) and (1)(b), the time periods referred to in regulations 18(4) and 18B(4) will begin from the later of the dates mentioned in paragraphs (1)(a) and (1)(b).

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Source: https://www.legislation.gov.uk/uksi/2004/1031/regulation/18C (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-18C
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.