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The Human Medicines Regulations 2012
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- UK Statutory Instruments
- 2012 No. 1916
- SCHEDULE 35
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Changes to legislation:
The Human Medicines Regulations 2012, SCHEDULE 35 is up to date with all changes known to be in force on or before 04 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 35:
- 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)
Regulation 349
SCHEDULE 35U.K.Repeals and revocations
This schedule has no associated Explanatory Memorandum
| Enactment or instrument | Extent of repeal or revocation |
|---|---|
| Medicines Act 1968 (c. 67) | Sections 2A to 9. Section 10(7). Sections 11 to 14. Section 15(1) and (2). Sections 16 to 57. Section 58(1A), (2) and (3). Sections 59 to 61. Sections 65 and 66. Section 67(3A), (5) and (6). Section 68. Sections 85 and 86. Section 89. Section 91(1). Sections 92 to 103. Section 108(3) to (5) and (7). Section 109(3). Section 110(3). Section 111(3). Section 112(7). Sections 115 and 116. Section 126(4). Section 130(2) to (8) and (10). Section 132(2), (3) and (5). Schedules 1A and 2. In Schedule 3, paragraphs 5 to 7. |
| Medicines (Extension to Antimicrobial Substances) Order 1973 (S.I. 1973/367) | The whole Order. |
| Medicines (Specified Articles and Substances) Order 1976 (S.I. 1976/968) | The whole Order. |
| Medicines (Fluted Bottles) Regulations 1978 (S.I. 1978/40) | The whole of the Regulations. |
| Medicines (Medicines Act 1968 Amendment) Regulations 1983 (S.I. 1983/1724) | The whole of the Regulations. |
| Medicines (Products Other than Veterinary Drugs) (General Sale List) Amendment Order 1990 (S.I. 1990/1129) | The whole Order. |
| Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992 (S.I. 1992/605) | The whole of the Regulations. |
| Medicines Act 1968 (Amendment) Regulations 1993 (S.I. 1993/834) | The whole of the Regulations. |
| Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (S.I. 1994/105) | The whole of the Regulations. |
| Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1994 (S.I. 1994/899) | The whole of the Regulations. |
| Medicines (Advertising) Regulations 1994 (S.I. 1994/1932) | The whole of the Regulations. |
| Medicines (Monitoring of Advertising) Regulations 1994 (S.I. 1994/1933) | The whole of the Regulations. |
| Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144) | The whole of the Regulations. |
| Medicines Act 1968 (Amendment) Regulations 1995 (S.I. 1995/2321) | The whole of the Regulations. |
| Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1996 (S.I. 1996/482) | The whole of the Regulations. |
| Prescription Only Medicines (Human Use) Order 1997 (S.I. 1997/1830) | The whole of the Order except articles 1(1) to (5), 5 and 10 and Schedules 1 and 2. |
| Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 1998 (S.I. 1998/3105) | The whole of the Regulations. |
| Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999 (S.I. 1999/267) | The whole of the Regulations. |
| Medicines (Monitoring of Advertising) Amendment Regulations 1999 (S.I. 1999/784) | The whole of the Regulations. |
| Medicines (Codification Amendments Etc.) Regulations 2002 (S.I. 2002/236) | The whole of the Regulations |
| Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003 (S.I. 2003/1618) | The whole of the Regulations. |
| Medicines (Child Safety) Regulations 2003 (S.I. 2003/2317) | The whole of the Regulations. |
| Medicines (Advertising) Amendment Regulations 2004 (S.I. 2004/1480) | The whole of the Regulations. |
| Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765) | The whole Order. |
| Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/768) | The whole of the Regulations. |
| Medicines (Advisory Bodies) Regulations 2005 (S.I. 2005/1094) | The whole of the Regulations except paragraph 12(1), (4) and (5) of Schedule 1, and regulation 8 as it relates to those paragraphs. |
| Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2005 (S.I. 2005/1520) | The whole of the Regulations. |
| Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/1710) | The whole of the Regulations. |
| Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (S.I. 2005/2750) | The whole of the Regulations except paragraph 8(a)(i) and (b) of Schedule 7, and regulation 12 as it relates to those paragraphs. |
| Medicines (Advisory Bodies) (No 2) Regulations 2005 (S.I. 2005/2754) | The whole of the Regulations, except Schedule 3, and regulation 4 as it relates to that Schedule, and paragraphs 3 and 7(1) and (3) of Schedule 4, and regulation 5 as it relates to those paragraphs. |
| Medicines (Advertising Amendments) Regulations 2005 (S.I. 2005/2787) | The whole of the Regulations. |
| Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/2789) | The whole of the Regulations. |
| Medicines (Traditional Herbal Medicinal Products for Human Use) (Consequential Amendment) Regulations 2006 (S.I. 2006/395) | The whole of the Regulations. |
| Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006 (S.I. 2006/1952) | The whole of the Regulations. |
| Medicines for Human Use (Prescribing by EEA Practitioners) Regulations 2008 (S.I. 2008/1692) | The whole of the Regulations. |
| Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2008 (S.I. 2008/3097) | The whole of the Regulations. |
| Medicines for Human Use (Miscellaneous Amendments) Regulations 2009 (S.I. 2009/1164) | The whole of the Regulations, except regulation 3. |
| Medicines (Exemptions and Miscellaneous Amendments) Order 2009 (S.I. 2009/3062) | The whole Order. |
| Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882) | The whole of the Regulations. |
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