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The Human Medicines Regulations 2012
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Changes over time for: Section 187
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Changes to legislation:
The Human Medicines Regulations 2012, Section 187 is up to date with all changes known to be in force on or before 04 November 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.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.
Changes and effects yet to be applied to Regulation 187:
- reg. 187(1) words substituted by S.I. 2019/775 reg. 147(2) (This amendment not applied to legislation.gov.uk. Reg. 147(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 114)
Changes and effects yet to be applied to the whole Instrument associated Parts and Chapters:
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
Recording obligations on holdersU.K.
This section has no associated Explanatory Memorandum
187.—(1) Subject to paragraph (2), the holder must record all suspected adverse reactions to the product [F1(including listed NIMAR products in Northern Ireland)] occurring [F2in the United Kingdom or another country] which are brought to its attention irrespective of whether the reaction—
(a)is reported spontaneously by patients or health care professionals; or
(b)occurred in the context of a post-authorisation study.
(2) Paragraph (1) does not apply where the suspected adverse reaction occurred in the context of a clinical trial within the meaning of the Clinical Trials Regulations.
(3) The holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals.
(4) The holder must ensure that reports recorded under paragraph (1) are accessible (electronically or physically) at a single point within the [F3United Kingdom].
Textual Amendments
F1Words in reg. 187(1) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 15
F2Words in reg. 187(1) substituted (31.12.2020) by S.I. 2019/775, reg. 147(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 114)
F3Words in reg. 187(4) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 147(3); 2020 c. 1, Sch. 5 para. 1(1)
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