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The Medicines for Human Use (Clinical Trials) Regulations 2004
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The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 5 is up to date with all changes known to be in force on or before 28 February 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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5.—(1) Section 23 of the Act (special provisions as to the effect of manufacturer’s licence) F1 shall be amended as follows.U.K.
(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.”.
Textual Amendments
F1Section 23 of the Act has effect as if any reference in subsection (1) to a product licence included a reference to a marketing authorization; see regulation 9(1) of the 1994 Regulations.
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