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The Human Medicines Regulations 2012
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- UK Statutory Instruments
- 2012 No. 1916
- PART 14
- CHAPTER 3
- Complaints to Ministers
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The Human Medicines Regulations 2012, Cross Heading: Complaints to Ministers is up to date with all changes known to be in force on or before 22 September 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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Whole provisions yet to be inserted into this Instrument (including any effects on those provisions):
- Sch. 11 para. 1(1)(d)-(f) inserted by S.I. 2019/775 reg. 63(2)(a)(ii) (This amendment not applied to legislation.gov.uk. Reg. 63(2)(a)(ii) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 1 para. 7(2))
- Sch. 24 para. 18B inserted by S.I. 2024/832 reg. 142(e)
- Sch. 24 Pt. 1 para. 23 words omitted by S.I. 2024/832 reg. 142(f)
- Sch. 33A para. 57A inserted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(4) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
- Sch. 33A para. 57(3) substituted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
- Sch. 33A para. 57(2) words inserted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
- Sch. 33B inserted by S.I. 2024/832 reg. 146
- reg. 3(12)(d)(ia) omitted by S.I. 2024/832 reg. 4(a)
- reg. 4(4)(d)(ia) omitted by S.I. 2024/832 reg. 5
- reg. 43(7)(b)(ii)(bb) words omitted by S.I. 2024/832 reg. 18(b)
- reg. 49(1ZA)-(1ZD) inserted by S.I. 2024/832 reg. 26(a)
- reg. 49(3ZA) inserted by S.I. 2024/832 reg. 26(d)
- reg. 51(9) words inserted by S.I. 2019/775, reg. 56 (as amended) by S.I. 2019/1385 Sch. 1 para. 5 (This amendment not applied to legislation.gov.uk. Sch. 1 paras. 2-6 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(a))
- reg. 52(1)(a)(i)(ii) and words substituted by S.I. 2019/775 reg. 57(2) (This amendment not applied to legislation.gov.uk. Reg. 57 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 42)
- reg. 53(2)-(2C) substituted for reg. 53(2) by S.I. 2019/775 reg. 58(3) (This amendment not applied to legislation.gov.uk. Reg. 58 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 43)
- reg. 53(2)(a) substituted by S.I. 2019/775, reg. 58(3) (as amended) by S.I. 2019/1385 Sch. 1 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 1 paras. 2-6 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(a))
- reg. 55(1)(b)(iii)(bb) substituted by S.I. 2024/832 reg. 43(a)(ii)
- reg. 60A(10A) inserted by S.I. 2024/832 reg. 49(e)
- reg. 68(11H)-(A12) inserted by S.I. 2024/832 reg. 56(b)
- reg. 173(e) inserted by S.I. 2017/1322 Sch. 4 para. 2(2)(b) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(i).)
- reg. 240(2A) words inserted by S.I. 2017/1322 Sch. 4 para. 2(3)(c) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
- reg. 240(6A) inserted by S.I. 2017/1322 Sch. 4 para. 2(3)(g) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
- reg. 257(9) inserted by S.I. 2024/832 reg. 110(c)
- reg. 257AA 257AB inserted by S.I. 2024/832 reg. 111
- reg. 327(1)(c)(va) omitted by S.I. 2024/832 reg. 128(a)
- reg. 346(2)(c)(iia) omitted by S.I. 2024/832 reg. 132(b)
- reg. 346(2)(c)(iiia) omitted by S.I. 2024/832 reg. 132(b)
- reg. 346(2)(c)(iva) omitted by S.I. 2024/832 reg. 132(b)
- reg. 346(2)(c)(xviia) omitted by S.I. 2024/832 reg. 132(b)
- reg. 346(2)(c)(xxviiij) omitted by S.I. 2024/832 reg. 132(b)
- reg. 347B inserted by S.I. 2024/832 reg. 133
Complaints to MinistersU.K.
Complaints to Ministers: duty to considerU.K.
309.—(1) This regulation applies if a person makes a complaint to the Ministers that an advertisement that has been published, or that is proposed to be published, is incompatible with the prohibitions imposed by Chapter 2.
(2) Subject to the following provisions of this regulation and to regulation 310, the Ministers must consider the complaint unless it appears to the Ministers to be frivolous or vexatious.
(3) The Ministers are not under any duty to consider a complaint if either OFCOM or a body that appears to the Ministers to be a self-regulatory body that deals with complaints about advertisements of the type in question is already dealing with the same complaint.
(4) If the Ministers have served a notice in respect of the advertisement under regulation 305 (whether or not they have taken action in respect of it under regulation 306) they—
(a)may consider the complaint; but
(b)are not under any duty to do so.
(5) If the complaint is one that OFCOM would be under a duty to consider if it had been made to OFCOM (see regulation 314) the Ministers must—
(a)investigate the complaint; or
(b)seek the agreement of the complainant to the complaint being referred to OFCOM.
(6) If, within a reasonable time of being approached by the Ministers, the complainant agrees to the complaint being referred to OFCOM the Ministers must refer the complaint to OFCOM.
(7) If, within a reasonable time of being approached by the Ministers, the complainant does not agree to the referral of the complaint, the Ministers must consider the complaint.
(8) The Ministers must also consider the complaint if, having referred it to OFCOM, OFCOM—
(a)decides not to consider the complaint because it appears to OFCOM to be frivolous or vexatious; or
(b)fails to deal adequately with the complaint within a reasonable time of the referral being made.
Complaints to Ministers: power to referU.K.
310.—(1) This regulation applies if—
(a)a person (“the complainant”) makes a complaint within paragraph (2) to the Ministers that an advertisement that has been published, or that it is proposed be published, is incompatible with the prohibitions imposed by Chapter 2; and
(b)the complaint does not appear to the Ministers to be frivolous or vexatious.
(2) A complaint is within this paragraph if—
(a)it is a complaint that the advertisement contains material prohibited by any of regulations 286 to 290, but is not a complaint that OFCOM would be under a duty to consider if it had been made to OFCOM (see regulation 314); or
(b)it is a complaint that the advertisement is incompatible with any of the prohibitions imposed by regulations 294 to 300.
(3) The Ministers may—
(a)select a body that appears to them to be a self-regulatory body that deals with complaints about advertisements of the type in question (“the appropriate body”); and
(b)seek the agreement of the complainant to the complaint being referred to the appropriate body.
(4) If within a reasonable time of being approached by the Ministers the complainant agrees to the complaint being referred to the appropriate body, the Ministers must refer the complaint to that body.
(5) If within a reasonable time of being approached by the Ministers the complainant does not agree to the referral of the complaint, the Ministers must consider the complaint.
(6) The Ministers must also consider the complaint if, having referred it to the appropriate body—
(a)the appropriate body decides not to consider the complaint because it appears to the body to be frivolous or vexatious; or
(b)the Ministers think that the appropriate body has failed to deal adequately with the complaint within a reasonable time of the referral being made.
(7) But if the Ministers have served a notice in respect of the advertisement under regulation 305 (whether or not they have taken action in respect of it under regulation 306)—
(a)the duties in paragraphs (4) to (6) do not apply; and
(b)each of those paragraphs has effect as if it conferred a power on the Ministers to act as mentioned in that paragraph.
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