Paragraph 8

In regulation 13 (new regulation B17 and C17 (good manufacturing practice and good distribution practice))—

(a)

in the inserted regulation B17—

(i)

in paragraph (1)—

(aa)

for “Ministers” substitute “Secretary of State”;

(bb)

after “by regulations” insert “in respect of Great Britain”;

(ii)

in paragraph (2)(b) after “UK marketing authorisation” insert “or EU marketing authorisation”;

(iii)

in paragraph (3)—

(aa)

after “have effect” insert “in Great Britain”;

(bb)

for “exit day” in both places it occurs substitute “IP completion day”;

(iv)

in paragraph (4)—

(aa)

for “Ministers” substitute “Secretary of State”;

(bb)

after “by regulations” insert “in respect of Great Britain”;

(b)

in the inserted regulation C17—

(i)

in paragraph (1), after “may publish” insert “in relation to the manufacture or assembly of a medicinal product in, or import to, Great Britain”;

(ii)

in paragraph (3) for “exit day” in both places it occurs substitute “IP completion day”.