# The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 3


The holder of the authorisation shall place the quality control system referred to in Article 11(1) of Commission Directive 2003/94/EC in respect of Great Britain, or Article 10(1) of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland, under the authority of the person notified to the licensing authority in accordance with paragraph 6(3) of Schedule 6 as being responsible for quality control.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/schedule/7/part/2/paragraph/3 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-7/part-2/paragraph-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.