SCHEDULES
SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
PART 14Amendment of Part 15 (amendment of Part 14 (advertising))
I1177
After regulation 217 (amendment of regulation 299 (medical sales representatives)) insert—
Amendment of regulation 305 (invitation to make representations about compatibility)217A
In regulation 305—
a
for paragraph (3)(a) substitute—
a
state that the Ministers are minded to make a determination under regulation 306 that the advertisement is incompatible with the prohibitions imposed by Chapter 2 and specify whether the incompatibility is insofar as the advertisement is for publication—
i
in Great Britain;
ii
in Northern Ireland; or
iii
in both Great Britain and Northern Ireland;
b
in paragraph (4), after “the advertisement” insert—
a
in Great Britain;
b
in Northern Ireland; or
c
in both Great Britain and Northern Ireland
Amendment of regulation 306 (decision about compatibility)217B
In regulation 306—
a
in paragraph (2), after “Chapter 2” insert—
and specify whether the incompatibility is insofar as the advertisement is for publication—
a
in Great Britain;
b
in Northern Ireland; or
c
in both Great Britain and Northern Ireland
b
in paragraph (4)—
i
in sub-paragraph (a), after “Chapter 2” insert—
insofar as the advertisement is for publication—
i
in Great Britain;
ii
in Northern Ireland; or
iii
in both Great Britain and Northern Ireland
ii
after “no longer applies” insert
“ in Great Britain, Northern Ireland, or both Great Britain and Northern Ireland (as appropriate) ”;c
in paragraph (5), after “Chapter 2” insert—
insofar as the advertisement is for publication—
a
in Great Britain;
b
in Northern Ireland; or
c
in both Great Britain and Northern Ireland
d
in paragraph (7)(b), after “no longer applies” insert—
,
and where that original notice related to both Great Britain and Northern Ireland, the new notice may be expressed to apply in relation to either of or both Great Britain and Northern Ireland
e
in paragraph (8), after “the advertisement” insert—
a
in Great Britain;
b
in Northern Ireland; or
c
in both Great Britain and Northern Ireland
Amendment of regulation 307 (corrective statement)217C
In regulation 307—
a
in paragraph (1)(a), after “subject of the notice” insert—
in—
i
Great Britain;
ii
Northern Ireland; or
iii
both Great Britain and Northern Ireland
b
in paragraph (1)(b), after “that advertisement” insert—
in—
i
Great Britain;
ii
Northern Ireland; or
iii
both Great Britain and Northern Ireland
c
in paragraph (2)(a), for “, either in full or in part; and” substitute—
in respect of—
i
Great Britain;
ii
Northern Ireland; or
iii
both Great Britain and Northern Ireland,
either in full or in part; and
Amendment of regulation 311 (application for injunction)217D
In regulation 311—
a
in paragraph (1)(a), for “Chapter 2; and” substitute—
Chapter 2 in respect of—
i
Great Britain;
ii
Northern Ireland; or
iii
both Great Britain and Northern Ireland; and
b
in paragraph (3), after “ the advertisement” insert—
in—
i
Great Britain;
ii
Northern Ireland; or
iii
both Great Britain and Northern Ireland,
as the case may be.