Regulation 12 Amendment to regulation 12I1

Regulation 12 (requirement for authorisation and ethics committee opinion) is amended as follows.

In paragraph (2)—

For paragraph (3)^f1 substitute—

“(3)

The conditions referred to in paragraphs (1) and (2) are—

(a)

an ethics committee has given a favourable opinion in relation to the clinical trial; and

(b)

the clinical trial has been authorised by the licensing authority,

in accordance with these Regulations.”.

Omit paragraph (4).