# The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 14I


The holder of a manufacturing authorisation (MM) shall ensure that—
(a) the requirements of paragraphs 1 to 14 and 14C to 14H are complied with in relation to manufacturing carried out at the modular units specified in the MM (IMP) master file;
(b) only the MM investigational medicinal products specified in the MM (IMP) master file are manufactured or assembled at those modular units; and
(c) an MM investigational medicinal product specified in the MM (IMP) master file is only manufactured on premises specified in the MM (IMP) master file.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/schedule/7/paragraph/14I (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-7/paragraph-14I
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.