SCHEDULE 10CONSEQUENTIAL AND OTHER AMENDMENTS OF ENACTMENTS

PART 1ACTS OF PARLIAMENT

5

1

Section 23 of the Act (special provisions as to the effect of manufacturer’s licence) F1 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.