# The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 5


(1) Section 23 of the Act (special provisions as to the effect of manufacturer’s licence) shall be amended as follows.
(2) In subsection (1)—
(a) omit “clinical trials and”;
(b) for paragraph (b), substitute the following paragraph—
“(b) the products are manufactured or assembled to the order of—
(i) a person who is the holder of such a product licence, or
(ii) if the products are to be used for the purposes of a clinical trial, the sponsor of that trial,”.
(3) After subsection (5), insert the following subsection—
“(6) In this section, “clinical trial” and “sponsor”, in relation to a clinical trial, have the meaning given by Clinical Trials Regulations.”.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/schedule/10/part/1/paragraph/5 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-10/part-1/paragraph-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.