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The Human Medicines Regulations 2012
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Changes over time for: Introductory Text
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Changes to legislation:
The Human Medicines Regulations 2012, Introductory Text is up to date with all changes known to be in force on or before 09 March 2025. 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. 3 para. 1(2)(ca)(cb) inserted by S.I. 2025/87 reg. 34(2)(b)
- Sch. 3 para. 1(3)(ba) inserted by S.I. 2025/87 reg. 34(3)
- Sch. 3 para. 1A 1B inserted by S.I. 2025/87 reg. 34(4)
- Sch. 4 Pt. 1A 1B inserted by S.I. 2025/87 reg. 35
- Sch. 7 para. 12B inserted by S.I. 2025/87 reg. 36
- Sch. 24 Pt. 6 inserted by S.I. 2025/87 reg. 38
- reg. 17(1A) inserted by S.I. 2025/87 reg. 5(3)
- reg. 17(10)(11) inserted by S.I. 2025/87 reg. 5(4)
- reg. 17A 17B inserted by S.I. 2025/87 reg. 6
- reg. 22(1A)(1B) inserted by S.I. 2025/87 reg. 8
- reg. 26(2)(d)(e) inserted by S.I. 2025/87 reg. 9(b)
- reg. 27A inserted by S.I. 2025/87 reg. 10
- reg. 29(2A)-(2F) inserted by S.I. 2025/87 reg. 11
- reg. 29A 29B inserted by S.I. 2025/87 reg. 12
- reg. 37(6)(ab)(ac) inserted by S.I. 2025/87 reg. 13(2)(b)
- reg. 37A 37B inserted by S.I. 2025/87 reg. 14
- reg. 39(5A)-(5E) inserted by S.I. 2025/87 reg. 15(3)
- reg. 50(5AA)(5AB) inserted by S.I. 2025/87 reg. 16(3)
- reg. 50K inserted by S.I. 2025/87 reg. 17
- reg. 74A 74B inserted by S.I. 2025/87 reg. 18
- reg. 167(6A)(6B) inserted by S.I. 2025/87 reg. 19(3)
- reg. 167G(1A)(1B) inserted by S.I. 2025/87 reg. 20(3)
- reg.169(A1) inserted by S.I. 2025/87 reg. 21
- reg. 170(A1) inserted by S.I. 2025/87 reg. 22
- reg. 170A 170B inserted by S.I. 2025/87 reg. 23
- reg. 171(A1) inserted by S.I. 2025/87 reg. 24
- reg. 188(1)(ca) inserted by S.I. 2025/87 reg. 27(2)(b)
- reg. 188(1A)(ba) inserted by S.I. 2025/87 reg. 27(3)(b)
- reg. 188(1B)(1C) inserted by S.I. 2025/87 reg. 27(4)
- reg. 202A(2)(d)(e) inserted by S.I. 2025/87 reg. 28
- reg. 257(10) inserted by S.I. 2025/87 reg. 29
- reg. 257CA inserted by S.I. 2025/87 reg. 31
- reg. 258(9) inserted by S.I. 2025/87 reg. 32
- reg. 346(2)(c)(ai)(bi) inserted by S.I. 2025/87 reg. 33(2)(a)
- reg. 346(2)(c)(iiza)-(iizc) inserted by S.I. 2025/87 reg. 33(2)(b)
- reg. 346(2)(c)(iiiza)(iiizb) inserted by S.I. 2025/87 reg. 33(2)(c)
- reg. 346(2)(c)(va) inserted by S.I. 2025/87 reg. 33(2)(d)
- reg. 346(2)(c)(xivb)(xivc) inserted by S.I. 2025/87 reg. 33(2)(e)
- reg. 346(2)(c)(xxviiiazb)(xxviiiazc) inserted by S.I. 2025/87 reg. 33(2)(f)
- reg. 346(2)(c)(xxviiik) inserted by S.I. 2025/87 reg. 33(2)(g)
Statutory Instruments
2012 No. 1916
Medicines
The Human Medicines Regulations 2012
Made
19th July 2012
Laid before Parliament
24th July 2012
Coming into force
14th August 2012
The Secretary of State and the Minister for Health, Social Services and Public Safety make the following Regulations. They do so in exercise of the powers conferred by section 2(2) and (5) of the European Communities Act 1972M1, having been designated for the purposes of section 2(2) of that Act in relation to medicinal productsM2 and to measures in the veterinary and phytosanitary fields for the protection of public healthM3. They do so in exercise also of the powers conferred by sections 87(1), 88(1) and (2), 91(2), and 129(1), (2) and (5) of the Medicines Act 1968M4, having consulted such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations in accordance with section 129(6) of that Act.
Modifications etc. (not altering text)
C1Instrument modified (10.5.2013) by The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013 (S.I. 2013/898), reg. 2(5)
Marginal Citations
M11972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative Reform Act 2006 (2006 c,51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (2008 c.7). Section 2(5) was amended by section 41(1) of and Part 1 of Schedule 6 to the Northern Ireland Constitution Act 1973 (1973 c.36).
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