The Human Medicines Regulations 2012

Regulations 229, 230, 231,232, 233 and 234

SCHEDULE 16 U.K. Patient group directions

PART 1 U.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 2 U.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
[F1 Local authority	The Chief Executive or Director of Public Health of the local authority]
[F2 Public Health England	The Chief Executive of Public Health England]
[F2 Public 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) [F5 an integrated care board]; (db) [F6 NHS 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) [F5 an integrated care board], (cb) [F6 NHS 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

F1 Words 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)

F2 Words 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)

F3 Words 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)

F4 Words 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)

F5 Words 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))

F6 Words 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

F7 Word 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)

F8 Words 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)

F9 Words 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)

F10 Words 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)

F11 Word 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)

F12 Words 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)

F13 Words 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 3 U.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
[F14 Contractor 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

F14 Words 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

M1 1996 c.16.

M2 1967 c.77.

PART 4 U.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.

• Registered physiotherapists.

• Registered radiographers.

• Registered speech and language therapists.