# The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 7


If the holder of the authorisation is not the sponsor of the clinical trial for which the investigational medicinal product is manufactured or assembled, he shall comply with the provisions of the product specification that relates to the supply of that investigational medicinal product for use in the trial.

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