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The Human Medicines Regulations 2012
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Changes to legislation:
The Human Medicines Regulations 2012, Section 337 is up to date with all changes known to be in force on or before 21 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.
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 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
Offences in relation to warranties and certificatesU.K.
This
adran has no associated
Memorandwm Esboniadol
337.—(1) It is an offence for a defendant in proceedings for an offence under these Regulations in respect of a contravention of a provision mentioned in regulation 336 (3)—
(a)intentionally to apply a warranty given in relation to one substance or article to a different substance or article; or
(b)intentionally to apply to one substance or article a certificate issued under regulation 330 or paragraph 19 of Schedule 31 in relation to a sample of a different substance or article.
(2) A person who intentionally or recklessly gives a purchaser a false warranty certifying a matter specified in regulation 336(2)(a) is guilty of an offence.
(3) If the defendant in proceedings for an offence under these Regulations in respect of a contravention of a provision mentioned in regulation 336(3) relies successfully on a warranty given to the defendant or to the defendant's employer, proceedings for an offence under paragraph (2) may be brought in accordance with paragraph (4).
(4) Proceedings may be brought, as the prosecutor chooses—
(a)before a court which has jurisdiction in the place where a sample of the substance or article to which the warranty relates was taken; or
(b)before a court which has jurisdiction in the place where the warranty was given.
(5) A person guilty of an offence under this regulation is liable—
(a)on summary conviction to a fine not exceeding the statutory maximum; or
(b)on conviction on indictment to a fine or to imprisonment for a term not exceeding two years, or to both.
Modifications etc. (not altering text)
C1Regs. 332-339 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))
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