# The Medicines for Human Use (Clinical Trials) Regulations 2004, Regulation 45A: Non-investigational medicinal and non-medicinal products


(1) A non-investigational medicinal product shall be manufactured or assembled in accordance with the principles and guidelines for good manufacturing practice which apply under these Regulations or the 2012 Regulations.
(2) A product which is not a medicinal product but which is used or to be used in a clinical trial, as described in the protocol, must—
(a) comply with safety standards applicable to that product; and
(b) be listed in the investigational medicinal product dossier with information about its properties, labelling, manufacture and safety controls, appropriate to the product.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/regulation/45A (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-45A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.