Amendment of regulation 4317

1

Regulation 4322 (qualified persons) is amended as follows.

2

In paragraph (1)—

a

in sub-paragraph (b), after “United Kingdom,” insert “except, in relation to a EAMS medicinal product, to the extent that conditions attached to the scientific opinion in respect of that product in accordance with regulation 167C(2)(c) of the 2012 Regulations provide otherwise,”; and

b

after “in paragraph” insert “(1A) or”.

3

After paragraph (1), insert—

1A

The qualified person is responsible for ensuring that, in relation to an EAMS medicinal product, if conditions attached to the scientific opinion in respect of that product in accordance with regulation 167C(2)(c) of the 2012 Regulations require the qualified person to carry out any duties in respect of that product, that qualified person carries out those duties.

4

In paragraph (4), after “with paragraph” insert “(1A) or”.