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The Human Medicines Regulations 2012
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Changes to legislation:
The Human Medicines Regulations 2012, Paragraph 4 is up to date with all changes known to be in force on or before 02 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 Schedule 34 Paragraph 4:
- 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)
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)
This section has no associated Explanatory Memorandum
4. In section 15 (provision for extending or modifying exemptions)—U.K.
(a)omit subsections (1) and (2); and
(b)in subsection (3) M1 for “sections 9 to 14” substitute “ section 10 ”.
Marginal Citations
M1Section 15(3) was amended by paragraphs 1 and 11(b) of Part 1 of Schedule 8 to S.I. 2006/2407.
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