SCHEDULE 10CONSEQUENTIAL AND OTHER AMENDMENTS OF ENACTMENTS
PART 1ACTS OF PARLIAMENT
The Act5
1
Section 23 of the Act (special provisions as to the effect of manufacturer’s licence)60 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.