The Human Medicines Regulations 2012

Scrutiny by Ministers U.K.

Requirement to provide copy advertisement U.K.

304.—(1) The Ministers may give a notice in writing under paragraph (2) or (3) to any person appearing to them to be concerned or likely to be concerned with the publication of advertisements relating to medicinal products.

(2) A notice under this paragraph is a notice that requires the person to whom it is given to provide the Ministers within a specified period with a copy of any advertisement that, as at the date of service of the notice, the person has published or proposes to publish and that relates to—

(a) a specified medicinal product; or

(b) medicinal products of a specified class or description.

(3) A notice under this paragraph is a notice that requires the person to whom it is given to provide the Ministers with a copy of any advertisement that the person proposes to publish during a specified period and that relates to—

(a) a specified medicinal product; or

(b) medicinal products of a specified class or description.

(4) The period specified in a notice under paragraph (3) must not exceed 12 months.

(5) A notice under paragraph (3) must specify the number of days before the proposed publication date of any advertisement by which a copy of the advertisement must be provided to the Ministers.

(6) A notice under paragraph (3) may be withdrawn by the Ministers before the expiry of the specified period.

(7) A notice under paragraph (2) or (3) may require the person to whom it is given not to publish, or further publish, during a specified period any advertisement a copy of which the person is required by the notice to provide to the Ministers.

(8) A notice under paragraph (2) or (3) must give the Ministers' reasons for giving the notice and (if appropriate) for imposing a requirement under paragraph (7).

(9) In this regulation “specified” means specified in the notice.

Invitation to make representations about compatibility U.K.

305.—(1) This regulation applies if, having considered an advertisement a copy of which is obtained by them pursuant to a notice given under regulation 304 or by some other means, the Ministers are minded to make a determination under regulation 306 that the advertisement is incompatible with the prohibitions imposed by Chapter 2.

(2) The Ministers may give a notice in writing under this regulation to any person appearing to them to be concerned or likely to be concerned with the publication of the advertisement.

(3) A notice under this regulation must—

[F1 (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) give the reasons why they are minded to make the determination;

(c) state that the person to whom it is given may make written representations to the Ministers within the period of 21 days beginning immediately after the date of the notice as to why the advertisement is compatible with the prohibitions imposed by Chapter 2; and

(d) refer to the action that may be taken by the Ministers under regulation 306.

(4) A notice under this regulation may require the person to whom it is given not to publish, or to cease to publish, the advertisement

[F2 (a) in Great Britain;

(b) in Northern Ireland; or

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

Textual Amendments

F1 Reg. 305(3)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 217A(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. 305(4)(a)-(c) inserted (31.12.2020) by S.I. 2019/775, reg. 217A(b) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)

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 [F3 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 [F4 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 [F5 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 [F6 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 [F7 ,

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

[F8 (a) in Great Britain;

(b) in Northern Ireland; or

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

Textual Amendments

F3 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)

F4 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)

F5 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)

F6 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)

F7 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)

F8 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)

Corrective statement U.K.

307.—(1) This regulation applies if the new notice—

(a) maintains the application of a requirement imposed under regulation 305(4) to cease to publish the advertisement that is the subject of the notice [F9 in—

(i) Great Britain;

(ii) Northern Ireland; or

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

(b) imposes a requirement to cease to publish that advertisement [F10 in—

(i) Great Britain;

(ii) Northern Ireland; or

(iii) both Great Britain and Northern Ireland].

(2) The new notice may require the person to whom it is given to publish—

(a) the Ministers' reasons for making the determination that the advertisement was incompatible with the prohibitions imposed by Chapter 2 [F11 in respect of—

(i) Great Britain;

(ii) Northern Ireland; or

(iii) both Great Britain and Northern Ireland,

either in full or in part; and]

(b) a corrective statement concerning the advertisement.

(3) A requirement imposed under paragraph (2)—

(a) must specify the time within which publication must take place; and

(b) may specify the form of publication.

Textual Amendments

F9 Reg. 307(1)(a)(i)-(iii) inserted (31.12.2020) by S.I. 2019/775, reg. 217C(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)

F10 Reg. 307(1)(b)(i)-(iii) inserted (31.12.2020) by S.I. 2019/775, reg. 217C(b) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)

F11 Reg. 307(2)(a)(i)-(iii) and words substituted for words (31.12.2020) by S.I. 2019/775, reg. 217C(c) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)

Offences U.K.

308.—(1) A person is guilty of an offence if that person fails to comply with a requirement imposed by a notice given to that person under—

(a) regulation 304(2) or (3);

(b) regulation 305(4) (including such a notice as maintained under regulation 306(7)); or

(c) regulation 306(8).

(2) A person guilty of an offence under paragraph (1) is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine, to imprisonment for a term not exceeding two years or to both.

(3) A person is guilty of an offence if that person fails to comply with a requirement imposed on that person under regulation 307(2).

(4) A person guilty of an offence under paragraph (3) is liable on summary conviction to a fine not exceeding level 5 on the standard scale.