The National Health Service (General Medical Services Contracts) Regulations 2015

PART 1 E+W General

Citation and commencement E+W

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

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

Application E+W

2.  These Regulations apply to a contract—

(a) to which the National Health Service (General Medical Services Contracts) 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. 2004/291; as amended by S.I. 2004/906 and 2694, S.I. 2005/893 and 3315, S.I. 2006/1501, S.I. 2007/3491, S.I. 2008/528 and 1700, S.I. 2009/309, 2205 and 2230, S.I. 2010/22, 231 and 578, S.I. 2012/970, 1479, 1909, 1916 and 2404, S.I. 2013/363, S.I. 2014/465, 1887 and 2721 and S.I. 2015/196 and 915. S.I. 2004/291 is revoked by regulation 98 of, and Schedule 5 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 (General Medical Services Contracts) Regulations 2004;

“2010 Order” means the Postgraduate Medical Education and Training Order of Council 2010 M2 ;

“additional services” means one or more of the following—

(a)

cervical screening services;

(b)

contraceptive services;

(c)

childhood vaccines and immunisations;

(d)

vaccines and immunisations;

(e)

child health surveillance services;

(f)

maternity medical services; and

(g)

minor surgery;

“adjudicator” means the Secretary of State or one or more people appointed by the Secretary of State under section 9(8) of the Act M3 (NHS contracts) or under regulation 83(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;]

“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 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 purpose of making determinations under paragraph 41(7) of Schedule 3;

“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 ;

“Care Quality Commission” means the body established under section 1 of the Health and Social Care Act 2008 M8 (The Care Quality Commission);

“CCG” means a clinical commissioning group M9 ;

“CCT” means a certificate of completion of training awarded under section 34L(1) of the Medical Act 1983 M10 (award and withdrawal of a Certificate of Completion of Training) 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 M11 (The Directive: designation of competent authority etc.);

“cervical screening services” means the services described in paragraph 2(2) of Schedule 1;

“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 M12 (general provisions); or

(b)

a supplier of appliances,

who is included in the list held by the Board under section 129 of the Act M13 (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;

“child health surveillance services” means the services described in paragraph 6(2) of Schedule 1;

“childhood vaccines and immunisations” means the services described in paragraph 5(2) of Schedule 1;

“chiropodist or podiatrist independent prescriber” means a person—

(a)

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

(b)

who is registered in Part 2 of the register maintained under article 5 of the Health and Social Work Professions Order 2001 M14 (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 contract 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;

“contraceptive services” means the services described in paragraph 3(2) of Schedule 1;

“contract”, except in regulation 96, means a general medical services contract made under section 84(2) of the Act M15 (general medical services contracts: introductory);

“contractor”, except in regulation 6, has the meaning given in section 84(5) of the Act (general medical services contracts: introductory);

“contractor's list of patients” means the list prepared and maintained by the Board under paragraph 17 of Schedule 3;

“core hours” means 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 wishes 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 M16 ;

“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 M17 (arrangements for additional pharmaceutical services);

“electronic communication” has the meaning given in section 15 of the Electronic Communications Act 2000 M18 (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 M19 ;

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

[F2 “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;]

“enhanced services” are—

(a)

services other than essential services, additional services or out of hours services; or

(b)

essential services, additional services or out of hours services, or an element of such a service, that a contractor agrees under the contract to provide in accordance with specifications set out in a plan, which requires of the contractor an enhanced level of service provision compared to that which it needs generally to provide in relation to that service or element of that service;

“essential services” means the services required to be provided in accordance with regulation 17;

“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 M20 (registration of medical practitioners);

“global sum” has the meaning given in the GMS Statement of Financial Entitlements;

“GMS Statement of Financial Entitlements” M21 means the directions given by the Secretary of State under section 87 of the Act M22 (GMS contracts: payments);

“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 M23 (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 of the Health and Social Services (Northern Ireland) Order 1972 M24 (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 M25 (ancillary services);

“Health Board” means a Health Board established under section 2 of the National Health Service (Scotland) Act 1978 M26 (Health Boards);

“health care professional” has the meaning given in section 108 of the Act M27 (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 M28 (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 M29 ; 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 contract;

(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 or 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;

“limited partnership” means a partnership registered in accordance with section 5 of the Limited Partnerships Act 1907 M30 (registration of limited partnerships required);

“listed medicines” means the drugs mentioned in regulation 13(1) of the National Health Service (Charges for Drugs and Appliances) Regulations 2015 M31 ;

“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 M32 (Local Health Boards);

“Local Medical Committee” means a committee recognised by the Board under section 97 of the Act M33 (local medical committees);

“maternity medical services” means the services described in paragraph 7(1) of Schedule 1;

“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 M34 (persons performing primary medical services);

“Medical Register” means the registers kept under section 2 of the Medical Act 1983 M35 (registration of medical practitioners);

“minor surgery” means the services described in paragraph 8(2) of Schedule 1;

“national disqualification” means—

(a)

a decision made by the First Tier Tribunal under section 159 of the Act M36 (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)

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

of the Act M37 ; 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 M38 (NHS contracts);

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

(a)

in Part 12; or

(b)

in a case to which paragraph 42 of Schedule 3 applies, in that paragraph;

“NHS foundation trust” has the meaning given in section 30 of the Act M39 (NHS foundation trusts);

“NHS trust” means a body established under section 25 of the Act M40 (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 managed by the Health and Social Care Information Centre M41 ;

“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 drag, medicine or appliance may be provided;

“normal hours” means those days and hours on which and the times at which services under the contract are normally made available and normal hours 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 M42 (establishment and maintenance of register);

“open”, in relation to a contractor's list of patients, means open to applications from patients in accordance with paragraph 18 of Schedule 3;

“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 M43 (register of opticians); and

(b)

against whose name in that register 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—

(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—

(a)

would be essential services if provided by a contractor to its registered patients in core hours; or

(b)

are included in the contract as additional services funded under the global sum;

“parent” includes, in relation to any child, any 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 under regulation 17(7) or (9) respectively;

(d)

any other person to whom the contractor has agreed to provide services under the contract; 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 contract to whom the provisions of Part 7 of these Regulations apply;

“pharmacist independent prescriber” means a person—

(a)

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

(b)

who is registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 M44 (establishment, maintenance of 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 M45 ; 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 contract; and

(b)

registered in Part 9 of the register maintained under article 5 of the Health and Social Work Professions Order 2001 M46 (establishment and maintenance of register), and against whose name in that register is recorded an annotation signifying that that physiotherapist 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 M47 (programmes for provisionally registered doctors) as providing provisionally 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 contract;

“practice area” means the area referred to in regulation 20(1)(d);

“practice leaflet” means a leaflet drawn up in accordance with regulation 78;

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

“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 pharmacist independent prescriber;

(f)

a physiotherapist independent prescriber; F3 ...

(g)

a supplementary [F4 prescriber; and]

(h)

[F5 a therapeutic radiographer independent prescriber,]

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

“prescription form” means—

(a)

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

(i)

is provided by the Board, a local authority or the Secretary of State and is in the format required by the NHS Business Services Authority M48 ,

(ii)

is 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 57 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 nominated dispensing contractor 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 M49 (classification of medicinal products);

“primary care list” means—

(a)

a list of persons performing primary medical services, primary dental services, 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), or

(iv)

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

of the Act M50 ;

(b)

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

(i)

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

(ii)

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

(iii)

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

(iv)

pharmaceutical services 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 contract immediately before the coming into force of section 34 of the Health and Social Care Act 2012 M51 (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 the provisions of Part 4 of the Act applies;

“registered patient” means—

(a)

a person who is recorded by the Board as being on the contractor's list of patients; or

(b)

a person 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 M52 (establishment, maintenance of 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 M53 ;

(c)

in relation to an optometrist, the register maintained by the General Optical Council in pursuance of section 7(a) of the Opticians Act 1989 M54 (register of opticians); and

(d)

the part of the register maintained by the Health and Care Professions Council under article 5 of the Health and Social Work Professions Order 2001 M55 (establishment and maintenance of register) relating to—

(i)

chiropodists and podiatrists,

(ii)

physiotherapists, or

(iii)

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 contract which give effect to regulation 59; or

(b)

a party to a contract 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

(b)

Business Services Authority M56 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

(c)

in the case of an electronic prescription to which regulation 57 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 nominated dispensing contractor 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 for 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 contract; or

(b)

except where the conditions in regulation 61(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 as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes;

“section 92 provider” means a person who is providing services in accordance with arrangements under section 92 of the Act M57 (arrangements for the provision of primary medical services);

“service provider” has the meaning given in regulation 2 of the Care Quality Commission (Registration) Regulations 2009 M58 (interpretation);

[F6 “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 contract;

(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 M59 (establishment, maintenance of and access to the register),

(iii)

the register maintained under article 6 (the Register) and article 9 (the Registrar) of the Pharmacy (Northern Ireland) Order 1976 M60 ,

(iv)

the part of the register maintained by the Health Professions Council under of article 5 of the Health Professions Order 2001 M61 (establishment and maintenance of register) relating to—

(aa)

chiropodists and podiatrists,

(bb)

physiotherapists, F7 ...

(cc)

radiographers, or

(dd)

[F8 dietitians, or]

(v)

the register of optometrists maintained by the General Optical Council under section 7(a) of the Opticians Act 1989 M62 (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 20 of Schedule 3 and for whom the contractor's responsibility has not been terminated in accordance with that paragraph;

[F9 “therapeutic radiographer independent prescriber” means a radiographer—

(a)

who is registered in Part 11 of the register maintained under article 5 of the Health and Social Work 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 57 of Schedule 3, 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. 15(1)(a)

F2 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. 15(1)(b)

F3 Word in reg. 3(1) omitted (5.12.2016) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 23(a)(i)

F4 Words in reg. 3(1) substituted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 23(a)(ii)

F5 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), 23(a)(iii)

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. 15(1)(c)

F7 Word in reg. 3(1) omitted (5.12.2016) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 23(b)(i)

F8 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), 23(b)(ii)

F9 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), 23(c)

Marginal Citations

M2 S.I. 2010/473; as amended by S.I. 2012/344 and 2013/3036.

M3 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).

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 into the Act by section 9(1) of the 2012 Act.

M8 2008 c.14.

M9 Clinical commissioning groups were established by virtue of sections 1I and 14A to 14D of the Act, as inserted by sections 10 and 25(1) of the 2012 Act.

M10 1983 c.54. Section 34L was inserted by S.I. 2010/234.

M11 Section 49B was inserted by S.I. 2007/3101 and was amended by S.I. 2008/1774 and S.I. 2010/234.

M12 1968 c.67. Section 69 was amended by section 1(1) of the Statute Law Repeals Act 1993 (c.50), and by S.I. 2007/289 and 3101 and S.I. 2010/231.

M13 Section 129 was amended by sections 26, 27 and 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 Health and Social Care Act 2012 (c.7); section 115 of, and paragraph 120 and 121 of Schedule 9 to, the Protection of Freedoms Act 2012 (c.9); and by S.I. 2010/231.

M14 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.

M15 Section 84 of the Act was amended by paragraph 31 of Schedule 4 to the Health and Social Care Act 2012.

M16 2006 c.41. Section 126 was amended by section 213(7)(k) and 220(7) of, and 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. 2007/289 and S.I. 2010/22 and 231.

M17 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.

M18 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).

M19 The Health and Social Care Information Centre is a body corporate established by section 252(1) of the 2012 Act.

M20 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.

M21 See the General Medical Services Statement of Financial Entitlements Directions 2013 which were signed on 27th March 2013, as amended, for the directions given by the Secretary of State under section 87 of the Act. Copies are available at: https://www.gov.uk/government/publications/nhs-primary-medical-services-directions-2013. Copies of these directions, and of the subsequent amendments to them, may also be obtained from the Department of Health, Richmond House, 79 Whitehall, London, SW1A 2NS.

M22 Section 87 was amended by paragraph 33 of Schedule 4 to the 2012 Act.

M23 1983 c.54. Section 34I was inserted by S.I. 2010/234.

M24 S.I. 1972/1265 (N.I.14).

M25 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 (c.1) (N.I.) and S.I. 1997/1177.

M26 1978 c.29. Section 2 was amended by paragraph 1 of Schedule 7 to S.I. 1991/194) (N.I. 1); section 14(2) of, 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 2009 (asp 5).

M27 Section 108 was amended by section 204 of, and paragraph 49 of Schedule 4 to, the Health and Social Care Act 2012 (c.7) (“the 2012 Act”).

M28 2006 c.41. Section 9 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).

M29 1989 c.41.

M30 1907 c.24. Section 5 was amended by S.I. 2009/1940.

M31 S.I. 2015/570.

M32 2006 c.42.

M33 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”).

M34 Section 91 was amended by paragraph 35 of Schedule 4 to the 2012 Act.

M35 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.

M36 Section 159 was amended by section 306(1)(d) of, and paragraph 85 of Schedule 4 to, the 2012 Act and by S.I. 2010/22.

M37 Sections 91(3), 106(3) and 123(3) were respectively amended by paragraphs 35(1) and (2)(b) and (4), 47 (1) and (4) and 60(1), (2)(b) and (4) of Schedule 4 to the 2012 Act. Sections 146 and 149 are repealed by section 208(1) of the 2012 Act from a date to be appointed. 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 from a day to be appointed. No regulations have yet been made under section 147A of the Act.

M38 Section 9 was amended by section 95 of, and paragraph 82 of Schedule 5 to, the Health and Social Care Act 2008 (c.14); paragraph 6(1), (2)(a) and (2)(c) of Schedule 4 to, 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).

M39 Section 30 was amended by section 159(1) of the Health and Social Care Act 2012 (c.7) (“the 2012 Act”).

M40 Section 25 is repealed by section 179(2) of the 2012 Act from a date to be appointed.

M41 The Health and Social Care Information Centre is a body corporate established by section 252(1) of the 2012 Act.

M42 S.I. 2002/253; article 5 was amended by S.I. 2009/1182.

M43 1989 c.44. Section 7 was amended by S.I. 2005/848.

M44 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, S.I. 2014/1887 and S.I. 2015/806 and 968.

M45 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.

M46 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.

M47 1983 c.54. Section 10A was inserted by S.I. 2006/1914, and was amended by S.I. 2008/3131.

M48 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.

M49 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.

M50 Sections 146 and 149 are repealed by section 208(1) of the Health and Social Care Act 2012 (c.7) from a date to be appointed. Section 147A was inserted by section 208(2) of that Act and was amended by paragraphs 120 and 132 of Schedule 9 to the Protection of Freedoms Act 2012 (c. ).

M51 2012 c.7.

M52 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, S.I. 2014/1887 and S.I. 2015/806 and 968.

M53 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.

M54 1989 c.44. Section 7 was amended by S.I. 2005/848.

M55 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.

M56 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.

M57 Section 92 was amended by paragraph 36 of Schedule 4 to the Health and Social Care Act 2012 (c.7).

M58 S.I. 2009/3112. There are no relevant amendments to regulation 2.

M59 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, S.I. 2014/1887 and S.I. 2015/806 and 968.

M60 S.R. 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 S.R. 2008/192.

M61 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.

M62 1989 c.44. Section 7 was amended by S.I. 2005/848.