The National Health Service (Personal Medical Services Agreements) Regulations 2015

PART 1 E+W General

Citation and commencement E+W

1.—(1) These Regulations may be cited as the National Health Service (Personal Medical Services Agreements) Regulations 2015.

(2) They come into force on 7th December 2015.

Application E+W

2.  These Regulations apply to an agreement—

(a) to which the National Health Service (Personal Medical Services Agreements) Regulations 2004 M1 applied immediately before the date on which these Regulations come into force; or

(b) which is entered into between a contractor and the Board on or after that date.

Marginal Citations

M1 S.I. 2004/627; as amended by S.I. 2004/906 and 2694, S.I. 2005/893, 3315 and 3491, S.I. 2006/1501, S.I. 2007/3491, S.I. 2008/1700, S.I. 2009/309, 2205 and 2230, S.I. 2010/22, 231|, 234, 578 and 1621, S.I. 2012/970, 1479, 190, 1916 and 2404, S.I. 2013/363, S.I.2014/465, 1887 and 2721 and S.I. 2015/196 and 915. S.I. 2004/627 is revoked by regulation 90 of, and Schedule 4 to, these Regulations.

Interpretation E+W

3.  In these Regulations—

“the Act” means the National Health Service Act 2006;

“2004 Regulations” means the National Health Service (Personal Medical Services Agreements) Regulations 2004;

“adjudicator” means the Secretary of State or a person or persons appointed by the Secretary of State under section 9(8) of the Act M2 (NHS contracts) or under regulation 76(5)(b);

[F1 “advanced electronic signature” means an electronic signature which meets the following requirements—

(a)

it is uniquely linked to the signatory;

(b)

it is capable of identifying the signatory;

(c)

it is created using electronic signature creation data that the signatory can, with a high level of confidence, use under the signatory's sole control; and

(d)

it is linked to the data signed in such a way that any subsequent change in the data is detectable;]

“agreement”, except in regulation 88, means an agreement for primary medical services made under section 92 of the Act M3 (arrangements by the Board for the provision of primary medical services);

“appliance” means an appliance which is included in a list for the time being approved by the Secretary of State for the purposes of section 126 of the Act M4 (arrangements for pharmaceutical services);

“armed forces GP” means a medical practitioner, who is employed on a contract of service by the Ministry of Defence, whether or not as a member of the armed forces of the Crown;

“armed forces of the Crown” means the forces that are “regular forces” or “reserve forces” within the meaning given in section 374 of the Armed Forces Act 2006 M5 ;

“assessment panel” means the panel appointed by the Board for the purposes of making determinations under paragraph 40(3) of Schedule 2;

[F2 “authorised person”, in relation to a patient, is a person who is entitled to make an application for pharmaceutical services on behalf of the patient by virtue of regulation 116(a) to (c) of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (authorised persons to apply for services);]

“bank holiday” means any day that is specified or proclaimed as a bank holiday in England and Wales under section 1 of the Banking and Financial Dealings Act 1971 M6 (bank holidays);

“batch issue” means a form, in the format required by the Board and approved by the Secretary of State, which—

(a)

is issued by a repeatable prescriber at the same time as a non-electronic repeatable prescription to enable a chemist or person who provides dispensing services to receive payment for the provision of repeat dispensing services;

(b)

relates to a particular non-electronic repeatable prescription and contains the same date as that prescription;

(c)

is generated by a computer and not signed by a repeatable prescriber;

(d)

is issued as one of a sequence of forms, the number of which is equal to the number of occasions on which the drugs, medicines or appliances ordered on the non-electronic repeatable prescription may be provided; and

(e)

has included on it a number denoting its place in the sequence referred to in paragraph (d);

“the Board” means the National Health Service Commissioning Board M7 ;

“CCG” means a clinical commissioning group M8 ;

“CCT” means a certificate of completion of training awarded under section 34L(1) of the Medical Act 1983 (award and withdrawal of a Certificate of Completion of Training) M9 including any such certificate awarded in pursuance of the competent authority functions of the General Medical Council specified in section 49B of, and Schedule 4A to, that Act M10 ;

“charity trustee” means one of the persons having the general control, management and administration of a charity;

“chemist” means—

(a)

a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968 M11 (general provisions); or

(b)

a supplier of appliances,

who is included in the list held by the Board under section 129 of the Act M12 (regulations as to pharmaceutical services), or a local pharmaceutical services scheme made under Schedule 12 to the Act (LPS Schemes);

“child” means a person who has not attained the age of 16 years;

“chiropodist or podiatrist independent prescriber” means a person who—

(a)

is engaged or employed by a party to the agreement; and

(b)

is registered in Part 2 of the register maintained under article 5 of the [F3 Health Professions Order 2001] M13 (establishment and maintenance of register), and against whose name in that register is recorded an annotation signifying that the chiropodist or podiatrist is qualified to order drugs, medicines and appliances as a chiropodist or podiatrist independent prescriber;

“clinical services” means medical services under the agreement which relate to the actual observation and treatment of patients;

“closed”, in relation to a contractor's list of patients, means closed to applications for inclusion in the list of patients other than from immediate family members of registered patients;

“contractor”, except in regulation 5, means a person or persons other than the Board who is a party, or who are parties, to the agreement;

[F4 “contractor’s EPS phase 4 date” means the date, encoded within the Electronic Prescription Service software, which is the date that a contractor has agreed is to be the date on and after which the contractor’s prescribers are to use the Electronic Prescription Service for all eligible prescriptions;]

“contractor's list of patients” means the list prepared and maintained by the Board under paragraph 13 of Schedule 2;

“core hours” means [F5 , subject to regulation 3A(1),] the period beginning at 8.00am and ending at 6.30pm on any day from Monday to Friday except Good Friday, Christmas Day or bank holidays;

“dispenser” means a chemist, medical practitioner or contractor whom a patient would like to dispense the patient's electronic prescriptions;

“dispensing services” means the provision of drugs, medicines or appliances that may be provided as pharmaceutical services by a medical practitioner in accordance with arrangements under section 126 (arrangements for pharmaceutical services) and section 132 (persons authorised to provide pharmaceutical services) of the Act M14 ;

“Drug Tariff” means the publication known as the Drug Tariff which is published by the Secretary of State and which is referred to in section 127(4) of the Act M15 (arrangements for additional pharmaceutical services);

“electronic communication” has the meaning given in section 15 of the Electronic Communications Act 2000 M16 (general interpretation);

“electronic prescription” means an electronic prescription form or an electronic repeatable prescription;

“electronic prescription form” means a prescription form which falls within paragraph (b) of the definition of “prescription form”;

“Electronic Prescription Service” means the service of that name which is managed by the Health and Social Care Information Centre M17 ;

“electronic repeatable prescription” means a prescription which falls within paragraph (b) of the definition “repeatable prescription”;

[F6 “electronic signature” means data in electronic form which is attached to or logically associated with other data in electronic form and which is used by the signatory to sign;

“electronic signature creation data” means unique data which is used by the signatory to create an electronic signature;]

[F7 “EPS token” means a form (which may be an electronic form), approved by the Secretary of State, which—

(a)

is issued by a prescriber at the same time as an electronic prescription is created; and

(b)

has a barcode that enables the prescription to be dispensed by a provider of pharmaceutical services that is able to use the Electronic Prescription Service for the purposes of dispensing prescriptions, in circumstances where the provider is not dispensing the prescription as a nominated dispenser;]

“essential services” means the services required to be provided in accordance with regulation 17 of the General Medical Services Contracts Regulations;

“financial year” has the meaning given in section 275(1) of the Act (interpretation);

“general medical practitioner” means a medical practitioner whose name is included in the General Practitioner Register kept by the General Medical Council under section 2 of the Medical Act 1983 M18 (registration of medical practitioners);

“General Medical Services Contracts Regulations” means the National Health Service (General Medical Services Contracts) Regulations 2015 M19 ;

“GP Specialty Registrar” means a general medical practitioner who is being trained in general practice by a general medical practitioner who is approved under section 34I(1)(c) of the Medical Act 1983 M20 (postgraduate education and training: approvals) for the purpose of providing training in accordance with that section, whether as part of training leading to a CCT or otherwise;

“Health and Social Services Board” means a Health and Social Services Board established under article 16 the Health and Social Services (Northern Ireland) Order 1972 M21 (establishment of Health and Social Services Boards);

“Health and Social Services Trust” means a Health and Social Services Trust established under article 10 of the Health and Personal Services (Northern Ireland) Order 1991 M22 (ancillary services);

“Health Board” means a Health Board established under section 2 of the National Health Service (Scotland) Act 1978 M23 (Health Boards);

“health care professional” has the meaning given in section 108 of the Act M24 (participants in section 107 arrangements) and “health care profession” is to be construed accordingly;

“health service body” has the meaning given in section 9(4) of the Act M25 (NHS contracts);

“home oxygen order form” means a form provided by the Board and issued by a health care professional to authorise a person to supply home oxygen services to a patient requiring oxygen therapy at home;

“home oxygen services” means any of the following forms of oxygen therapy or supply—

(a)

ambulatory oxygen supply;

(b)

urgent supply;

(c)

hospital discharge supply;

(d)

long term oxygen therapy; and

(e)

short burst oxygen therapy;

“immediate family member” means—

(a)

a spouse or civil partner;

(b)

a person whose relationship with the registered patient has the characteristics of the relationship between spouses;

(c)

a parent or step-parent;

(d)

a son or daughter;

(e)

a child of whom the registered patient is—

(i)

the guardian, or

(ii)

the carer duly authorised by the local authority to whose care the child has been committed under the Children Act 1989 M26 ; or

(f)

a grandparent;

“independent nurse prescriber” means a person—

(a)

who is either engaged or employed by the contractor or who is a party to the agreement;

(b)

who is registered in the Nursing and Midwifery Register; and

(c)

against whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines and appliances as a community practitioner nurse prescriber, a nurse independent prescriber or as a nurse independent/supplementary prescriber;

“licensing body” means a body that licenses or regulates a profession;

“listed medicines” means a medicine mentioned in regulation 7C(1) of the National Health Service (Charges for Drugs and Appliances) Regulations 2015 M27 (exemption from charges in respect of listed or emergency medicines);

“listed medicines voucher” means a form provided by the Board for use for the purpose of ordering a listed medicine;

“Local Health Board” means a body established under section 11 of the National Health Service (Wales) Act 2006 M28 (Local Health Boards);

“Local Medical Committee” means a committee recognised by the Board under section 97 of the Act M29 (local medical committees);

“medical card” means a card issued by the Board or a Local Health Board, Health Authority, Health Board or Health and Social Services Board to a person for the purpose of enabling that person to obtain, or to establish entitlement to receive, primary medical services;

“medical performers list” means the list of medical practitioners maintained and published by the Board in accordance with section 91 of the Act M30 (persons performing medical services);

“Medical Register” means the registers kept under section 2 of the Medical Act 1983 M31 (registration of medical practitioners);

“national disqualification” means—

(a)

a decision made by the First-tier Tribunal under section 159 of the Act M32 (national disqualification) or under regulations corresponding to that section made under—

(i)

section 91(3) of the Act (persons performing primary medical services),

(ii)

section 106(3) of the Act (persons performing primary dental services),

(iii)

section 123(3) of the Act (persons performing primary ophthalmic services), and

(iv)

section 145, 146 or 147A (performers of pharmaceutical services and assistants),

of the Act M33 ; or

(b)

a decision under provisions in force in Wales, Scotland or Northern Ireland corresponding to section 159 of the Act (national disqualification);

“NHS contract” has the meaning given in section 9 of the Act M34 (NHS contracts);

“NHS dispute resolution procedure” means the procedure for the resolution of disputes specified—

(a)

in Part 13; or

(b)

in a case to which paragraph 41 of Schedule 2 applies, in that paragraph;

“NHS foundation trust” has the meaning given in section 30 of the Act M35 (NHS foundation trusts);

“NHS trust” means a body established under section 25 of the Act M36 (NHS trusts);

“nominated dispenser” means a chemist, medical practitioner or contractor who has been nominated in respect of a patient where the details of that nomination are held in respect of that patient in the Patient Demographics Service which is operated by the Health and Social Care Information Centre M37 ;

“non-electronic prescription form” means a prescription form which falls within paragraph (a) of the definition of “prescription form”;

“non-electronic repeatable prescription” means a prescription form for the purpose of ordering a drug, medicine or appliance which—

(a)

is provided by the Board, a local authority or the Secretary of State;

(b)

is issued, or is to be issued, by the prescriber;

(c)

indicates that the drug, medicine or appliance ordered may be provided more than once; and

(d)

specifies, or is to specify, the number of occasions on which the drug, medicine or appliance may be provided;

“normal hours” means those days and hours on which and the times at which services under the agreement are normally made available and may be different for different services;

“Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001 M38 (establishment and maintenance of register);

[F8 “online practice profile” has the meaning given in regulation 66(7);]

“open”, in relation to a contractor's list of patients, means open to applications from patients in accordance with paragraph 17 of Schedule 2;

“optometrist independent prescriber” means a person—

(a)

who is registered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989 M39 (register of opticians); and

(b)

against whose name is recorded an annotation signifying that that person is qualified to order drugs, medicines and appliances as an optometrist independent prescriber;

“out of hours period” means [F9 subject to regulation 3A(2)]—

(a)

the period beginning at 6.30pm on any day from Monday to Thursday and ending at 8.00am on the following day;

(b)

the period beginning at 6.30pm on Friday and ending at 8.00am on the following Monday; and

(c)

Good Friday, Christmas Day and bank holidays,

and “part” of an out of hours period means any part of any one or more of the periods described in paragraphs (a) to (c);

“out of hours services” means the services required to be provided in all or part of the out of hours period which would be essential services if provided by a contractor to its registered patients in core hours;

[F10 “paramedic independent prescriber” means a person—

(a)

who is either engaged or employed by the contractor or who is a party to the agreement;

(b)

who is registered in the register maintained by the Health and Care Professions Council under article 5 of the [F11 Health Professions Order 2001] (establishment and maintenance of register); and

(c)

against whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines or appliances as a paramedic independent prescriber;]

“parent” includes, in relation to any child, an adult who, in the opinion of the contractor, is for the time being discharging in respect of that child the obligations normally attaching to a parent in respect of their child;

“patient” means—

(a)

a registered patient;

(b)

a temporary resident;

(c)

persons to whom the contractor is required to provide immediately necessary treatment as part of its obligation to provide essential services; and

(d)

any other person to whom the contractor has agreed to provide services under the agreement; and

(e)

any person in respect of whom the contractor is responsible for the provision of out of hours services;

“performer” means a performer of medical services under the agreement to whom the provisions of Part 8 of these Regulations applies;

“pharmacist independent prescriber” means a person who—

(a)

is either engaged or employed by the contractor or is a party to the agreement;

(b)

is registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 M40 (establishment, maintenance and access to the Register), or the register maintained under article 6 (the registers) and 9 (the Registrar) of the Pharmacy (Northern Ireland) Order 1976 M41 ; and

(c)

against whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;

“physiotherapist independent prescriber” means a person who is—

(a)

engaged or employed by the contractor or is a party to the agreement; and

(b)

registered in Part 9 of the register maintained under article 5 of the [F12 Health Professions Order 2001] M42 (establishment and maintenance of register), and against whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines and appliances as a physiotherapist independent prescriber;

“post-registration programme” means a programme that is for the time being recognised by the General Medical Council under regulation 10A of the Medical Act 1983 M43 (programmes for provisionally registered doctors) as providing registered doctors with an acceptable foundation for future practise as a fully registered medical practitioner;

“practice” means the business operated by the contractor for the purpose of delivering services under the agreement;

“practice area” means the area specified in the agreement as the area in which essential services are to be provided;

“practice leaflet” means a leaflet drawn up in accordance with regulation 71;

“practice premises” means an address specified in the agreement as one at which services are to be provided under the agreement;

[F13 “practice website” means [F14 a] website through which the contractor advertises the primary medical services it provides;]

[F15 “prescriber” means—

(a)

a chiropodist or podiatrist independent prescriber;

(b)

an independent nurse prescriber;

(c)

a medical practitioner;

(d)

an optometrist independent prescriber;

(e)

a paramedic independent prescriber;

(f)

a pharmacist independent prescriber;

(g)

a physiotherapist independent prescriber;

(h)

a supplementary prescriber; and

(i)

a therapeutic radiographer independent prescriber;]

“prescription form” means—

(a)

a form for the purpose of ordering a drug, medicine or appliance which is—

(i)

provided by the Board, a local authority or the Secretary of State which is in the form required by the NHS Business Services Authority M44 ,

(ii)

issued, or is to be issued, by the prescriber, and

(iii)

does not indicate that the drug, medicine or appliance ordered may be provided more than once; or

(b)

in the case of an electronic prescription to which regulation 50 applies, data created in an electronic form for the purpose of ordering a drug, medicine or appliance, which—

(i)

is signed, or is to be signed, with a prescriber's electronic signature,

(ii)

is transmitted, or is to be transmitted, as an electronic communication to a [F16 nominated dispenser or via an information hub] by the Electronic Prescription Service, and

(iii)

does not indicate that the drug, medicine or appliance ordered may be provided more than once;

“prescription only medicine” means a medicine referred to in regulation 5(3) of the Human Medicines Regulations 2012 M45 (classification of medicinal products);

“primary care list” means—

(a)

a list of persons performing primary medical services, primary dental services or primary ophthalmic services or pharmaceutical services prepared in accordance with regulations made under—

(i)

section 91 of the Act (persons performing primary medical services),

(ii)

section 106 of the Act (persons performing primary dental services),

(iii)

section 123 of the Act (persons performing primary ophthalmic services), and

(iv)

sections 145, 146, 147A or 149 (performers of pharmaceutical services and assistants),

of the Act M46 ;

(b)

a list of persons undertaking to provide, or assist in the provision of—

(i)

primary medical services, prepared in accordance with regulations made under Part 4 of the Act (primary medical services),

(ii)

primary dental services, prepared in accordance with regulations made under Part 5 of the Act (primary dental services),

(iii)

primary ophthalmic services prepared in accordance with regulations made under Part 6 of the Act (persons performing primary ophthalmic services),

(iv)

pharmaceutical services, prepared in accordance with regulations made under Part 7 of the Act (pharmaceutical services and local pharmaceutical services); or

(c)

a list corresponding to any of the above in Wales, Scotland or Northern Ireland;

“Primary Care Trust” means the Primary Care Trust which was a party to the agreement immediately before the coming into force of section 34 of the Health and Social Care Act 2012 M47 (abolition of Primary Care Trusts);

“primary carer” means, in relation to an adult, the adult or organisation primarily caring for that adult;

“primary medical services” means medical services provided under or by virtue of a contract or agreement to which Part 4 of the Act applies;

[F17 “private services” means the provision of any treatment which would amount to primary medical services if it was provided under or by virtue of a contract or agreement to which the provisions of Part 4 of the Act apply;]

“registered patient” means a person—

(a)

who is recorded by the Board as being included in the contractor's list of patients; or

(b)

whom the contractor has accepted for inclusion in its list of patients, whether or not notification of that acceptance has been received by the Board and who has not been notified by the Board as having ceased to be on that list;

“relevant register” means—

(a)

in relation to a nurse, the Nursing and Midwifery Register;

(b)

in relation to a pharmacist, Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 M48 (establishment, maintenance and access to the Register), or the register maintained under article 6 (the register) and article 9 (the Registrar) of the Pharmacy (Northern Ireland) Order 1976 M49 ;

(c)

in relation to an optometrist, the register maintained by the General Optical Council under section 7(a) of the Opticians Act 1989 M50 (register of opticians); and

(d)

the part of the register maintained by the Health and Care Professions Council under article 5 of the [F18 Health Professions Order 2001] M51 (establishment and maintenance of register) relating to—

(i)

[F19 chiropodists and podiatrists,

(ii)

paramedics,

(iii)

physiotherapists, or

(iv)

radiographers;]

“repeat dispensing services” means pharmaceutical services or local pharmaceutical services which involve the provision of drugs, medicines or appliances by a chemist in accordance with a repeatable prescription;

“repeatable prescriber” means a prescriber who is—

(a)

engaged or employed by a contractor which provides repeatable prescribing services under the terms of its agreement which give effect to regulation 52; or

(b)

a party to an agreement under which such services are provided;

“repeatable prescribing services” means services which involve the prescribing of drugs, medicines or appliances on a repeatable prescription;

“repeatable prescription” means—

(a)

a form provided by the Board, a local authority or the Secretary of State for the purpose of ordering a drug, medicine or appliance, which is in the format required by the NHS Business Services Authority M52 , and which—

(i)

is issued, or is to be issued, by a repeatable prescriber to enable a chemist or person providing dispensing services to receive payment for the provision of repeat dispensing services,

(ii)

indicates, or is to indicate, that the drug, medicine or appliance ordered may be provided more than once, and

(iii)

specifies, or is to specify, the number of occasions on which the drug, medicine or appliance may be provided; or

(b)

in the case of an electronic prescription to which regulation 50 applies, data created in an electronic form for the purpose of ordering a drug, medicine or appliance, which—

(i)

is signed, or is to be signed, with a prescriber's advanced electronic signature,

(ii)

is transmitted, or is to be transmitted, as an electronic communication to a [F20 nominated dispenser or via an information hub] by the Electronic Prescription Service, and

(iii)

indicates, or is to indicate, that the drug, medicine or appliance ordered may be provided more than once and specifies, or is to specify, the number of occasions on which the drug, medicine or appliance may be provided;

“restricted availability appliance” means an appliance which is approved for particular categories of persons or particular purposes only;

“Scheduled drug” means—

(a)

a drug, medicine or other substance specified in any directions given by the Secretary of State under section 88 of the Act (GMS contracts: prescription of drugs etc) as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under the agreement; or

(b)

except where the conditions set out in regulation 54(3) are satisfied, a drug, medicine or other substance which is specified in any directions given by the Secretary of State under section 88 of the Act (GMS contracts: prescription of drugs etc) as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes;

[F21 “signatory” means a natural person who creates an electronic signature;]

“supplementary prescriber” means a person—

(a)

who is either engaged or employed by the contractor or is a party to the agreement;

(b)

whose name is registered in—

(i)

the Nursing and Midwifery Register,

(ii)

Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 M53 (establishment, maintenance of and access to the register),

(iii)

the register maintained under articles 6 (the Register) and article 9 (the Registrar) of the Pharmacy (Northern Ireland) Order 1976 M54 ,

(iv)

[F22 the register maintained by the Health and Care Professions Council under article 5 of the [F23 Health Professions Order 2001] (establishment and maintenance of register) relating to—

(aa)

chiropodists and podiatrists,

(bb)

dieticians,

(cc)

paramedics,

(dd)

physiotherapists, or

(ee)

radiographers, or]

(v)

the register of optometrists maintained by the General Optical Council under section 7(a) of the Opticians Act 1989 M55 (register of opticians); and

(c)

against whose name is recorded in the relevant register an annotation or entry signifying that that person is qualified to order drugs, medicines and appliances as a supplementary prescriber or, in the case of the Nursing and Midwifery Register, a nurse independent/supplementary prescriber;

“temporary resident” means a person accepted by the contractor as a temporary resident under paragraph 19 of Schedule 2 and for whom the contractor's responsibility has not been terminated in accordance with that paragraph;

[F24 “therapeutic radiographer independent prescriber” means a radiographer—

(a)

who is registered in Part 11 of the register maintained under article 5 of the [F25 Health Professions Order 2001]; and

(b)

against whose name in that register is recorded—

(i)

an entitlement to use the title “therapeutic radiographer”, and

(ii)

an annotation signifying that the radiographer is qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;]

“working day” means any day except Saturday, Sunday, Christmas Day, Good Friday or a bank holiday; and

“writing”, except in paragraph 52(1) of Schedule 2, includes electronic mail and “written” is to be construed accordingly.

Textual Amendments

F1 Words in reg. 3 substituted (22.7.2016) by The Electronic Identification and Trust Services for Electronic Transactions Regulations 2016 (S.I. 2016/696), reg. 1, Sch. 3 para. 16(a)

F2 Words in reg. 3 inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 20(4)

F3 Words in reg. 3 substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 36(a)(i); S.I. 2019/1436, reg. 2(b)

F4 Words in reg. 3 inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 20(5)

F5 Words in reg. 3 inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 18(a)

F6 Words in reg. 3 inserted (22.7.2016) by The Electronic Identification and Trust Services for Electronic Transactions Regulations 2016 (S.I. 2016/696), reg. 1, Sch. 3 para. 16(b)

F7 Words in reg. 3 inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 20(6)

F8 Words in reg. 3 inserted (1.4.2020) by The National Health Service (General Medical Services Contracts and Personal Medical Services Agreements) (Amendment) Regulations 2020 (S.I. 2020/226), reg. 1(2), Sch. 2 para. 6(a)

F9 Words in reg. 3 inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 18(b)

F10 Words in reg. 3 inserted (1.10.2018) by The National Health Service (General Medical Services Contracts and Personal Medical Services Agreements) (Amendment) Regulations 2018 (S.I. 2018/844), regs. 1(2), 9(a)

F11 Words in reg. 3 substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 36(a)(ii); S.I. 2019/1436, reg. 2(b)

F12 Words in reg. 3 substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 36(a)(iii); S.I. 2019/1436, reg. 2(b)

F13 Words in reg. 3 inserted (1.10.2019) by The National Health Service (General Medical Services Contracts and Personal Medical Services Agreements) (Amendment) Regulations 2019 (S.I. 2019/1137), regs. 1(2), 18(a)

F14 Word in reg. 3 substituted (1.4.2020) by The National Health Service (General Medical Services Contracts and Personal Medical Services Agreements) (Amendment) Regulations 2020 (S.I. 2020/226), reg. 1(2), Sch. 2 para. 6(b)

F15 Words in reg. 3 substituted (1.10.2018) by The National Health Service (General Medical Services Contracts and Personal Medical Services Agreements) (Amendment) Regulations 2018 (S.I. 2018/844), regs. 1(2), 9(b)

F16 Words in reg. 3 substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 20(2)

F17 Words in reg. 3 inserted (1.10.2019) by The National Health Service (General Medical Services Contracts and Personal Medical Services Agreements) (Amendment) Regulations 2019 (S.I. 2019/1137), regs. 1(2), 18(b)

F18 Words in reg. 3 substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 36(a)(iv); S.I. 2019/1436, reg. 2(b)

F19 Words in reg. 3 substituted (1.10.2018) by The National Health Service (General Medical Services Contracts and Personal Medical Services Agreements) (Amendment) Regulations 2018 (S.I. 2018/844), regs. 1(2), 9(c)

F20 Words in reg. 3 substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 20(3)

F21 Words in reg. 3 inserted (22.7.2016) by The Electronic Identification and Trust Services for Electronic Transactions Regulations 2016 (S.I. 2016/696), reg. 1, Sch. 3 para. 16(c)

F22 Words in reg. 3 substituted (1.10.2018) by The National Health Service (General Medical Services Contracts and Personal Medical Services Agreements) (Amendment) Regulations 2018 (S.I. 2018/844), regs. 1(2), 9(d)

F23 Words in reg. 3 substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 36(a)(v); S.I. 2019/1436, reg. 2(b)

F24 Words in reg. 3(1) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 24(c)

F25 Words in reg. 3 substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 36(a)(vi); S.I. 2019/1436, reg. 2(b)

Marginal Citations

M2 Section 9 of the Act was amended by section 95 of, and paragraph 82 of Schedule 5 to, the Health and Social Care Act 2008 (c.14); paragraph 6 of Schedule 4 to the Health and Social Care Act 2012 (c.7) (“the 2012 Act”); paragraphs 1, 4, 17 and 18 of Schedule 14 and paragraph 10 of Schedule 17 to, the 2012 Act; paragraph 9 of Schedule 19 to the 2012 Act; paragraphs 5 and 6 of Schedule 21 to the 2012 Act; and paragraph 16 of Schedule 5 to the Care Act 2014 (c. 23).

M3 Section 92 was amended by paragraph 36 of Schedule 4 to the 2012 Act.

M4 Section 126 was amended by sections 213(7)(k) and 220(7) of, and paragraph 63 of Schedule 4 to, the 2012 Act.

M5 2006 c.52; a relevant amendment to section 374 was made by section 44(3) and (4) of the Defence Reform Act 2014 (c.20).

M6 1971 c.80.

M7 The National Health Service Commissioning Board (known as “NHS England”) was established by section 1H of the Act. Section 1H was inserted by section 9 of the Health and Social Care Act 2012 (“the 2012 Act”).

M8 Clinical commissioning groups were established by virtue of provision in sections 1I and 14A to 14D of the Act as inserted by sections 10 and 25(1) of the 2012 Act.

M9 1983 c.54. Section 34L was inserted by S.I. 2010/234.

M10 Section 49B was inserted by S.I. 2007/3101 and was amended by S.I 2008/1774 and S.I. 2010/234 and 478.

M11 1968 c.67. Section 69 was amended by S.I. 2007/289 and 3101 and S.I. 2010/231.

M12 Section 129 was amended by sections 26 and 27 of, and paragraph 38 of and Schedule 6 to, the Health Act 2009 (c.21); section 207(1) to (9) of, and paragraph 66 of Schedule 4 to, the 2012 Act; section 115 of, and Schedule 9 to, the Protection of Freedoms Act 2012 (c.9) and by S.I. 2010/231.

M13 S.I. 2002/254; as amended by section 127 of the Health and Social Care Act 2008 (c.14), section 81(5) of the Policing and Crime Act 2009 (c.26), sections 213, 214(2) to (4), 215, 216, 218 and 219 of the Health and Social Care Act 2012, section 5(2) of, and paragraph 6 of the Schedule to, the Health and Social Care (Safety and Quality) Act 2015 (c.28), and by S.I. 2003/3148, S.I. 2004/1947 and 2033, S.I. 2007/3101, S.I. 2009/1182, S.I. 2010/233, S.I. 2011/1043, S.I. 2012/1479 and 2672 and S.I. 2014/1887.

M14 2006 c.41. Section 126 was amended by paragraph 63 of Schedule 4 to the Health and Social Care Act 2012 (c.7) (“the 2012 Act”). Section 132 was amended by paragraph 69 of Schedule 4 to the 2012 Act, paragraphs 120 and 122 of Schedule 9 to the Protection of Freedoms Act 2012 (c.9), and by S.I. 2008/289 and S.I. 2010/22 and 231.

M15 Section 127 was amended by paragraph 64 of Schedule 4 to the 2012 Act. See also regulation 89(1) of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (S.I. 2013/349) in relation to the publication known as the Drug Tariff.

M16 2000 c.7. Section 15(1) was amended by section 406(1) of, and paragraph 158 of Schedule 17 to, the Communications Act 2003 (c.21).

M17 The Health and Social Care Information Centre is a body corporate established by section 252 of the 2012 Act.

M18 1983 c.54. Section 2 was amended by S.I. 2002/3135, S.I. 2006/1914, S.I. 2007/3101, S.I. 2008/1774 and S.I. 2014/1101.

M19 S.I.2015/1862.

M20 1983 c.54. Section 34I was inserted by S.I. 2010/234.

M21 S.I. 1972/1265 (N.I.14). Article 16 was repealed by the Health and Social Care (Reform) Act 2009 (c.1) (N. I.), paragraph 6 of Schedule 3 and Schedule 7.

M22 S.I. 1991/194 (N.I.1); as amended by section 11 of, and paragraph 13 of Schedule 6 to, the Health and Social Care Reform Act (Northern Ireland) 2009 and by S.I. 1997/1177.

M23 1978 c.29. Section 2 was amended by paragraph 1 of Schedule 7 to S.I. 1991/194 (N.I. 1); and paragraph 1 of Schedule 7 to, the Health and Social Services and Social Security Adjudications Act 1983 (c.41); paragraph 1(2)(a) and (b) of Schedule 1 to the National Health Service Reform (Scotland) Act 2004 (asp 7); sections 2(1)(a) and 28(a)(ii), (b) and (c) of Schedule 1, and paragraph 19(1) of Schedule 9 and paragraph 1 of Schedule 10 to, the National Health Service and Community Care Act 1990 (c.19); paragraph 2(2) of Schedule 2 to the Smoking, Health and Social Care (Scotland) Act 2005 (asp 13), and sections 2(1), 4, 6(2) and (3), 7 and 11(1) of the Health Boards (Membership and Elections) (Scotland) Act 2005 (asp 5).

M24 Section 108 was amended by section 204 of, and paragraph 49 of Schedule 4 to, the Health and Social Care Act 2012 (“the 2012 Act”).

M25 2006 c.41. Section 9 of the Act was amended by section 95 of, and paragraph 82 of Schedule 5 to, the Health and Social Care Act 2008 (c.14); paragraph 6 of Schedule 4 to the Health and Social Care Act 2012 (c.7) (“the 2012 Act”); paragraphs 1, 4, 17 and 18 of Schedule 14 and paragraph 10 of Schedule 17 to, the 2012 Act; paragraph 9 of Schedule 19 to the 2012 Act; paragraphs 5 and 6 of Schedule 21 to the 2012 Act; and paragraph 16 of Schedule 5 to the Care Act 2014 (c. 23).

M26 1989 c.41.

M27 S.I. 2000/620. Regulation 7C was inserted by S.I. 2009/2230 and was amended by S.I. 2012/1909.

M28 2006 c.42.

M29 2006 c.41. Section 97 was amended by paragraph 41 of Schedule 4 to the Health and Social Care Act 2012 (c.7) (“the 2012 Act”).

M30 Section 91 was amended by paragraph 35 of Schedule 4 to the 2012 Act.

M31 1983 c.54. Section 2 was amended by S.I. 2002/3135, S.I. 2006/1914, S.I. 2007/3101, S.I.2008/1774 and S.I. 2014/1101.

M32 Section 159 was amended by section 306(1)(d) of, and paragraph 85(1)(d) of Schedule 4 to, the 2012 Act.

M33 Sections 91(3), 106(3) and 123(3) were respectively amended by paragraph 35(1) and (2)(b) and (4), 45 and 60(1) and (2)(b) of Schedule 4 to, the 2012 Act. Sections 146 and 149 of the Act are repealed by section 208(1) of the 2012 Act. Section 147A was inserted by section 208(2) of the 2012 Act and was amended by paragraphs 120 and 123 of Schedule 9 to the Protection of Freedoms Act 2012 (c.9). Section 208 of the 2012 Act is to be commenced on a day to be appointed. No regulations have been made under section 147A of the Act.

M34 Section 9 of the Act was amended by section 95 of, and paragraph 82 of Schedule 5 to, the Health and Social Care Act 2008 (c.14); paragraph 6 of Schedule 4 to the Health and Social Care Act 2012 (c.7) (“the 2012 Act”); paragraphs 1, 4, 17 and 18 of Schedule 14 and paragraph 10 of Schedule 17 to, the 2012 Act; paragraph 9 of Schedule 19 to the 2012 Act; paragraphs 5 and 6 of Schedule 21 to the 2012 Act; and paragraph 16 of Schedule 5 to the Care Act 2014 (c. 23).

M35 Section 30 was amended by section 159(1) of the Health and Social Care Act 2012 (c.7) (“the 2012 Act”).

M36 Section 25 of the Act is repealed by section 179(2) of the 2012 Act from a date to be appointed.

M37 The Health and Social Care Information Centre is a body corporate established by section 252(1) of the 2012 Act.

M38 S.I. 2002/253; article 5 was amended by S.I. 2009/182.

M39 1989 c.44. Section 7 was amended by S.I. 2005/848.

M40 S.I. 2010/231; as amended by S.I. 2011/1043, S.I. 2012/3006, S.I. 2013/235 and S.I. 2014/1887.

M41 S.I.1976/1231 (N.I.22). Article 6(1) was substituted by regulation 5 of S.R 2008/192 and article 9(2) was amended by regulation 9 of that instrument.

M42 S.I. 2002/254; as amended by section 127 of the Health and Social Care Act 2008 (c.14), section 81(5) of the Policing and Crime Act 2009 (c.26), sections 213, 214(2) to (4), 215, 216, 218 and 219 of the Health and Social Care Act 2012, section 5(2) of, and paragraph 6 of the Schedule to, the Health and Social Care (Safety and Quality) Act 2015 (c.28), and by S.I. 2003/3148, S.I. 2004/1947 and 2033, S.I. 2007/3101, S.I. 2009/1182, S.I. 2010/233, S.I. 2011/1043, S.I. 2012/1479 and 2672 and S.I. 2014/1887.

M43 1983 c.54. Section 10A was inserted by S.I. 2006/1914, and was amended by S.I. 2008/3131.

M44 The NHS Business Services Authority was established by the NHS Business Services Authority (Awdurdod Gwasanaethau Busnes y GIG) (Establishment and Constitution) Order 2005 (S.I. 2005/2414). S.I. 2005/2414 was amended by S.I. 2006/632, S.I. 2007/1201 and S.I. 2013/235.

M45 S.I. 2012/1916; as amended by S.I. 2013/235, 1855 and 2593 and S.I. 2014/490 and 1887, S.I 2015/323, 570, 903 and 1503.

M46 Sections 91(3), 106(3) and 123(3) were respectively amended by paragraph 35(1) and (2)(b) and (4), 45 and 60(1) and (2)(b) of Schedule 4 to, the 2012 Act. Sections 146 and 149 of the Act are repealed by section 208(1) of the 2012 Act. Section 147A was inserted by section 208(2) of the 2012 Act and was amended by paragraphs 120 and 123 of Schedule 9 to the Protection of Freedoms Act 2012 (c.9). Section 208 of the 2012 Act is to be commenced on a day to be appointed. No regulations have been made under section 147A of the Act.

M47 2012 c.7.

M48 S.I. 2010/231; as amended by S.I. 2011/1043 and 2159, , S.I. 2012/1909, 2672 and 3006, S.I. 2013/50, 235, 349 and 1478 and S.I. 2014/1887 and S.I. 2015/806 and 968.

M49 S.I.1976/1231 (N.I.22). Article 6(1) was substituted by regulation 5 of S.R. 2008/192, and article 9(2) was amended by regulation 9 of S.I. 2008/192.

M50 1989 c.44. Section 7 was amended by S.I. 2005/848.

M51 S.I.2002/254; as amended by section 127 of the Health and Social Care Act 2008 (c.14), section 81(5) of the Policing and Crime Act 2009 (c.26), sections 213, 214(2) to (4), 215, 216, 218 and 219 of the Health and Social Care Act 2012, section 5(2) of, and paragraph 6 of the Schedule to, the Health and Social Care (Safety and Quality) Act 2015 (c.28), and by S.I. 2003/3148, S.I. 2004/1947 and 2033, S.I. 2007/3101, S.I. 2009/1182, S.I. 2010/233, S.I. 2011/1043, S.I. 2012/1479 and 2672 and S.I. 2014/1887.

M52 The NHS Business Services Authority was established by the NHS Business Services Authority (Awdurdod Gwasanaethau Busnes y GIG) (Establishment and Constitution) Order 2005 (S.I.2005/2414). S.I.2005/2414 was amended by S.I. 2006/632, S.I. 2007/1201 and S.I. 2013/235.

M53 S.I. 2010/231; as amended by S.I. 2011/1043 and 2159, , S.I. 2012/1909, 2672 and 3006, S.I. 2013/50, 235, 349 and 1478 and S.I. 2014/1887 and S.I. 2015/806 and 968.

M54 S.I. 1976/1213 (N.I. 22). Article 6(1) was substituted by regulation 5 of S.R. 2008/192, and article 9(2) was amended by regulation 9 of that instrument.

M55 1989 c.44. Section 7 was amended by S.I. 2005/848.

[F26 Variation of core hours while a disease is or in anticipation of a disease being imminently pandemic etc. E+W

3A.— (1) In these Regulations, “core hours” means the period beginning at 8.00am and ending at 6.30pm on any day from Monday to Friday in circumstances where, in order to assist in the management of a serious or potentially serious risk to human health arising as a consequence of a disease being, or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially a serious risk to human health,

[F27 the Board with the agreement of the Secretary of State has made an announcement] to the effect that the core hours of contractors in the area specified in the announcement are to include Good Friday and bank holidays in the circumstances specified, and for the duration of the period specified, in the announcement.

(2) In these Regulations, in the circumstances described in paragraph (1), “out of hours period means—

(a) the period beginning at 6.30pm on any day from Monday to Friday and ending at 8.00am on the following day; and

(b) the period beginning at 6.30pm on Friday and ending at 8.00am on the following Monday.

Textual Amendments

F26 Regs. 3A, 3B inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 19

F27 Words in reg. 3A(1) substituted (E.) (1.10.2020) by The National Health Service (General Medical Services Contracts and Personal Medical Services Agreements) (Amendment) (No. 2) Regulations 2020 (S.I. 2020/911), reg. 1(2), Sch. 2 para. 2

Amendment and withdrawal of announcements and advice in respect of pandemics etc. E+W

3B.   In these Regulations, where reference is made to an announcement or advice of the Board that relates to a disease being, or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially serious risk to human health,

it is to that announcement or advice, which may be withdrawn at any time, as amended from time to time.]

Textual Amendments

F26 Regs. 3A, 3B inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 19