Regulation 4 Amendment to regulation 3

(1)

Regulation 3 (sponsor of a clinical trial) is amended as follows.

(2)

In paragraphs (4) and (5)—

(a)

for “request for authorisation”, in both places where it occurs, substitute “request for approval”;

(b)

for “regulation 17”, in both places where it occurs, substitute “regulation 16”.

(3)

In paragraph (6)—

(a)

for “authorised by the licensing authority” substitute “approved”;

(b)

for “, 19 or 20” substitute “or 18A”;

(c)

for “substantial amendment” substitute “modification of an important detail as defined in Part 3”;

(d)

for “authorisation” substitute “approval”;

(e)

for “regulations 24 to 26” substitute “regulation 22”.

(4)

In paragraph (7)—

(a)

in sub-paragraph (a), omit “, except regulation 15”;

(b)

in sub-paragraph (b), omit “Parts 2 to 4 of”;

(c)

in sub-paragraph (c), omit “, in so far as it relates to decisions of the licensing authority under Part 3”.

(5)

In paragraph (10)—

(a)

in sub-paragraph (a), for “regulations 15 and 28(1)” substitute “regulation 28(1)”;

(b)

in sub-paragraph (c), omit “, and Part 1 of Schedule 3”.