The Medicines for Human Use (Clinical Trials) Regulations 2004

The Act

5.—(1) Section 23 of the Act (special provisions as to the effect of manufacturer’s licence)(1) 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.”.

(1)

Section 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.