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The Human Medicines Regulations 2012
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- UK Statutory Instruments
- 2012 No. 1916
- SCHEDULE 16
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The Human Medicines Regulations 2012, SCHEDULE 16 is up to date with all changes known to be in force on or before 12 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.
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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
Regulations 229, 230, 231,232, 233 and 234
SCHEDULE 16U.K.Patient group directions
This schedule has no associated Explanatory Memorandum
PART 1U.K.Particulars to be included in a patient group direction
1. The period during which the direction is to have effect.U.K.
2. The description or class of medicinal product to which the direction relates.U.K.
3. The clinical situations which medicinal products of that description or class may be used to treat or manage in any form.U.K.
4. Whether there are any restrictions on the quantity of medicinal product that may be sold or supplied on any one occasion and, if so, what restrictions.U.K.
5. The clinical criteria under which a person is to be eligible for treatment.U.K.
6. Whether any class of person is excluded from treatment under the direction and, if so, what class of person.U.K.
7. Whether there are circumstances in which further advice should be sought from a doctor or dentist and, if so, what circumstances.U.K.
8. The pharmaceutical form or forms in which medicinal products of that description or class are to be administered.U.K.
9. The strength, or maximum strength, at which medicinal products of that description or class are to be administered.U.K.
10. The applicable dosage or maximum dosage.U.K.
11. The route of administration.U.K.
12. The frequency of administration.U.K.
13. Any minimum or maximum period of administration applicable to medicinal products of that description or class.U.K.
14. Whether there are any relevant warnings to note and, if so, what warnings.U.K.
15. Whether there is any follow up action to be taken in any circumstances and, if so, what action and in what circumstances.U.K.
16. Arrangements for referral for medical advice.U.K.
17. Details of the records to be kept of the supply, or the administration, of products under the direction.U.K.
PART 2U.K.Persons on whose behalf a patient group Direction must be signed
| Column 1: Class of person by whom product is supplied | Column 2: Person on whose behalf direction must be signed |
|---|---|
| Common Services Agency | The Agency |
| Health authority | The health authority |
| Special health authority | The special health authority |
| NHS trust or NHS foundation trust | The trust |
| [F1Local authority | The Chief Executive or Director of Public Health of the local authority] |
| [F2Public Health England | The Chief Executive of Public Health England] |
| [F2Public Health Agency | The Public Health Agency] |
| F3... | F3... |
A person who supplies medicinal products pursuant to an arrangement made with— (a)the Common Services Agency; (b)a health authority; (c)a special health authority; (d)an NHS trust; [F4(da)[F5an integrated care board]; (db)[F6NHS England]; (dc)a local authority; F7...] [F8(dd)Public Health England; (de)Public Health Agency; or] (e)an NHS foundation trust; F9... F9(f). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . | The Common Services Agency (where the arrangement has been made with the Agency); otherwise the— (a)health authority, (b)special health authority, (c)NHS trust, [F10(ca)[F5an integrated care board], (cb)[F6NHS England], (cc)a local authority, F11...] [F12(cd)Chief Executive of Public Health England, (ce)Public Health Agency, or] (d)NHS foundation trust, F13... F13(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . with which the arrangement has been made. |
Textual Amendments
F1Words in Sch. 16 Pt. 2 inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(a) (with Sch. 3 para. 28)
F2Words in Sch. 16 Pt. 2 added (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(a) and words in Sch. 16 Pt. 2 added (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(a)
F3Words in Sch. 16 Pt. 2 omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(b) (with Sch. 3 para. 28)
F4Words in Sch. 16 Pt. 2 inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(c)(i) (with Sch. 3 para. 28)
F5Words in Regulations substituted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), reg. 1(2), Sch. para. 1(1)(3) (with Sch. para. 1(2))
F6Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1
F7Word in Sch. 16 Pt. 2 omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(b)(i) and word in Sch. 16 Pt. 2 omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(b)(i)
F8Words in Sch. 16 Pt. 2 inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(b)(ii) and words in Sch. 16 Pt. 2 inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(b)(ii)
F9Words in Sch. 16 Pt. 2 omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(c)(ii) (with Sch. 3 para. 28)
F10Words in Sch. 16 Pt. 2 inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(d)(i) (with Sch. 3 para. 28)
F11Word in Sch. 16 Pt. 2 omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(c)(i) and word in Sch. 16 Pt. 2 omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(c)(i)
F12Words in Sch. 16 Pt. 2 inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(c)(ii) and words in Sch. 16 Pt. 2 inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(c)(ii)
F13Words in Sch. 16 Pt. 2 omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(d)(ii) (with Sch. 3 para. 28)
PART 3U.K.Persons by whom or on whose behalf a patient group direction used as described in regulation 234 must be signed
| Column 1: Force or service by whom or on whose behalf the health care is provided | Column 2: Person by whom or on whose behalf direction must be signed |
|---|---|
| A police force in England and Wales | The chief officer of police for that police force (within the meaning of the Police Act 1996 M1) |
| A police force in Scotland | The chief constable of that police force (within the meaning of the Police (Scotland) Act 1967 M2) |
| The Police Service of Northern Ireland | The Chief Constable of the Police Service of Northern Ireland |
| The prison service in England and Wales | The governor of the prison in relation to which the health care in question is being provided |
| The prison service in Scotland | The Scottish Prison Service Management Board |
| The prison service in Northern Ireland | The Northern Ireland Prison Service Management Board |
| Her Majesty's Forces | (a) the Surgeon General, (b) a Medical Director General, or (c) a chief executive of an executive agency of the Ministry of Defence |
| [F14Contractor carrying out helicopter search and rescue operations on behalf of the Maritime and Coastguard Agency | Medical Director of the contractor carrying out search and rescue operations on behalf of the Maritime and Coastguard Agency] |
Textual Amendments
F14Words in Sch. 16 Pt. 3 added (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(3) and words in Sch. 16 Pt. 3 added (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(3)
Marginal Citations
PART 4U.K.Classes of individuals by whom supplies may be made
Pharmacists.
Registered chiropodists and podiatrists.
Registered dental hygienist.
Registered dental therapist.
Registered dietitians.
Registered midwives.
Registered nurses.
Registered occupational therapists.
Registered optometrists.
Registered orthoptists.
Registered orthotists and prosthetists.
Registered paramedics.
[F15Registered pharmacy technicians.]
Registered physiotherapists.
Registered radiographers.
Registered speech and language therapists.
Textual Amendments
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