The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 No. 1488

SCHEDULES

SCHEDULE 2 Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 14 Amendment of Part 15 (amendment of Part 14 (advertising))

177.  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.”.”.