The Human Medicines Regulations 2012

Decision about compatibility U.K.

306.—(1) This regulation applies if the Ministers have given a notice under regulation 305 (“the original notice”) to a person.

(2) After the end of the period of 21 days referred to in that regulation, the Ministers must give a further notice in writing (“the new notice”) to that person of their determination whether the advertisement is compatible with the prohibitions imposed by Chapter 2 [F1 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].

(3) In making that determination, the Ministers must take account of any representations made in accordance with that regulation.

(4) If—

(a) the Ministers make a determination that the advertisement is compatible with the prohibitions imposed by Chapter 2 [F2 insofar as the advertisement is for publication—

(i) in Great Britain;

(ii) in Northern Ireland; or

(iii) in both Great Britain and Northern Ireland]; and

(b) the original notice imposed a requirement under regulation 305(4),

the new notice must provide that the requirement no longer applies [F3 in Great Britain, Northern Ireland, or both Great Britain and Northern Ireland (as appropriate)].

(5) The following provisions apply if the Ministers make a determination that the advertisement is incompatible with the prohibitions imposed by Chapter 2 [F4 insofar as the advertisement is for publication—

(a) in Great Britain;

(b) in Northern Ireland; or

(c) in both Great Britain and Northern Ireland].

(6) The new notice must give the Ministers' reasons for the determination.

(7) If the original notice imposed a requirement under regulation 305(4), the new notice may provide—

(a) that the requirement is to continue to apply; or

(b) that the requirement no longer applies [F5 ,

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].

(8) If the original notice did not impose a requirement under regulation 305(4), the new notice may require the person to whom it is given not to publish, or to cease to publish, the advertisement

[F6 (a) in Great Britain;

(b) in Northern Ireland; or

(c) in both Great Britain and Northern Ireland].

Textual Amendments

F1 Reg. 306(2)(a)-(c) and words inserted (31.12.2020) by S.I. 2019/775, reg. 217B(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)

F2 Reg. 306(4)(a)(i)-(iii) and words inserted (31.12.2020) by S.I. 2019/775, reg. 217B(b)(i) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)

F3 Words in reg. 306(4) inserted (31.12.2020) by S.I. 2019/775, reg. 217B(b)(ii) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)

F4 Reg. 306(5)(a)-(c) and words inserted (31.12.2020) by S.I. 2019/775, reg. 217B(c) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)

F5 Words in reg. 306(7)(b) inserted (31.12.2020) by S.I. 2019/775, reg. 217B(d) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)

F6 Reg. 306(8)(a)-(c) inserted (31.12.2020) by S.I. 2019/775, reg. 217B(e) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)