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.”.
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.