Paragraph 5

(1)

Section 23 of the Act (special provisions as to the effect of manufacturer’s licence) M1 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.”.

Annotations

Marginal citations

M1: 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.