# The Medicines for Human Use (Clinical Trials) Regulations 2004, Regulation 42: Obligations of manufacturing authorisation holder


The holder of a manufacturing authorisation shall—
(a) comply with the principles and guidelines of good manufacturing practice;
(b) comply with the provisions referred to in regulation 40(3);
(c) allow the licensing authority access to his premises at any reasonable time; and
(d) put and keep in place arrangements which enable the qualified person to carry out his duties, including placing at his disposal all the necessary facilities.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/regulation/42 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-42
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.