- Latest available (Revised)
- Point in Time (01/10/2015)
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Version Superseded: 01/07/2022
Point in time view as at 01/10/2015.
The Human Medicines Regulations 2012, SCHEDULE 16 is up to date with all changes known to be in force on or before 28 October 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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Regulations 229, 230, 231,232, 233 and 234
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.
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)a clinical commissioning group; (db)the National Health Service Commissioning Board; (dc)a local authority; F5...] [F6(dd)Public Health England; (de)Public Health Agency; or] (e)an NHS foundation trust; F7... F7(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, [F8(ca)a clinical commissioning group, (cb)the National Health Service Commissioning Board, (cc)a local authority, F9...] [F10(cd)Chief Executive of Public Health England, (ce)Public Health Agency, or] (d)NHS foundation trust, F11... F11(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)
F5Word 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)
F6Words 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)
F7Words 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)
F8Words 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)
F9Word 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)
F10Words 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)
F11Words 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)
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 |
[F12Contractor 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
F12Words 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
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.
Registered physiotherapists.
Registered radiographers.
Registered speech and language therapists.
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