The National Health Service (General Medical Services Contracts) (Wales) Regulations 2023

PART 1General

Title and commencement

1.—(1) The title of these Regulations is the National Health Service (General Medical Services Contracts) (Wales) Regulations 2023.

(2) These Regulations come into force on 1 October 2023.

Application

2.  These Regulations apply in relation to Wales and to a contract—

(a)to which the National Health Service (General Medical Services Contracts) (Wales) Regulations 2004(1) applied immediately before the date on which these Regulations come into force, or

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

Interpretation

3.—(1) In these Regulations—

“the Act” (“y Ddeddf”) means the National Health Service (Wales) Act 2006;

“the 2004 Regulations” (“Rheoliadau 2004”) means the National Health Service (General Medical Services Contracts) (Wales) Regulations 2004;

“the 2010 Order” (“Gorchymyn 2010”) means the Postgraduate Medical Education and Training Order of Council 2010(2);

“accredited course” (“cwrs a achredwyd”) means a course accredited by the Nursing and Midwifery Council;

“adjudicator” (“dyfarnwr”) means the Welsh Ministers or a person appointed by the Welsh Ministers under section 7(8) of the Act (NHS contracts) or paragraph 106(5) of Schedule 3;

“advanced electronic signature” (“llofnod electronig uwch”) 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;

“APMS contract” (“contract GMDdA”) means an arrangement to provide primary medical services made with a Local Health Board under section 41(2)(b) of the Act (primary medical services);

“APMS contractor” (“contractwr GMDdA”) means a party to an APMS contract, other than the Local Health Board;

“appliance” (“cyfarpar”) means an appliance which is included in a list approved by the Welsh Ministers for the purposes of section 80 of the Act (arrangements for pharmaceutical services);

“Area Integrated Partnership Board” (“Bwrdd Partneriaeth Integredig Ardal”) means an Area Integrated Partnership Board established under section 15B of the Health and Social Care (Reform) Act (Northern Ireland) 2009(3);

“armed forces of the Crown” (“lluoedd arfog y Goron”) means the forces that are “regular forces” or “reserve forces” within the meaning given to those terms in section 374 of the Armed Forces Act 2006(4) (definitions applying for the purposes of the whole Act);

“assessment panel” (“panel asesu”) means a committee or sub-committee of a Local Health Board (other than the Local Health Board which is a party to the contract in question) for the purpose of making determinations under paragraph 45(7) of Schedule 3;

“Assurance Framework” (“Fframwaith Sicrwydd”) means the national approach, using national datasets and processes, specified in guidance issued from time to time by the Welsh Ministers for Local Health Boards to use for contract governance and management;

“batch issue” (“swpddyroddiad”) means a form provided by a Local Health Board and issued by a repeatable prescriber at the same time as a non-electronic repeatable prescription to enable an NHS pharmacist or NHS appliance contractor to receive payment for the provision of repeat dispensing services which is in the required format, and which—

(a)

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

(b)

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

(c)

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

(d)

specifies a number denoting its place in the sequence referred to in paragraph (c);

“care home” (“cartref gofal”) means a place in Wales at which accommodation, together with nursing or care, is provided to persons because of their vulnerability or need but excludes a place mentioned in paragraph 1(2) of Schedule 1 to the Regulation and Inspection of Social Care (Wales) Act 2016(5);

“CCT” (“TCH”) means Certificate of Completion of Training awarded under section 34L(1) of the Medical Act 1983(6) (award and withdrawal of a Certificate of Completion of Training);

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

“child” (“plentyn”) means a person who has not attained the age of 16;

“child health surveillance services” (“gwasanaethau gwyliadwriaeth iechyd plant”) means the services described in paragraph 2 of Schedule 2;

“childhood vaccinations and immunisations services” (“gwasanaethu brechu ac imiwneiddio i blant”) means the services described in paragraph 3 of Schedule 2;

“clinical services” (“gwasanaethau clinigol”) means medical services under the contract which relate to the actual observation and treatment of patients;

“closed” (“wedi ei chau”), in relation to the 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;

“cluster” (“clwstwr”) means a group of local service providers involved in health and care who have agreed to collaboratively work together to deliver primary medical services across a specified geographical area;

“contraceptive services” (“gwasanaethau atal cenhedlu”) means the services described in paragraph 4 of Schedule 2;

“contract” (“contract”) except in regulation 31 (general transitional provision and saving) means a general medical services contract made under section 42 of the Act (general medical services contracts: introductory);

“contractor” (“contractwr”), except in regulation 6 (general condition relating to all contracts), has the meaning given in section 42(5) of the Act (general medical services contracts: introductory);

“contractor’s list of patients” (“rhestr contractwr o gleifion”) means the list prepared and maintained by the Local Health Board under paragraph 22 of Schedule 3;

“core hours” (“oriau craidd”) means the period beginning with 8.00am and ending with 6.30pm on a working day;

“dentist” (“deintydd”) means a dental practitioner registered in the dentists register under the Dentists Act 1984(7);

“Digital Health and Care Wales” (“Iechyd a Gofal Digidol Cymru”) means the organisation established under the Digital Health and Care Wales (Establishment and Membership) Order 2020(8);

“dispenser” (“gweinyddydd”) means an NHS pharmacist, medical practitioner or contractor whom a patient wishes to dispense the patient’s electronic prescriptions;

“dispensing services” (“gwasanaethau gweinyddu”) 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 80 (arrangement for pharmaceutical services) and section 86 (persons authorised to provide pharmaceutical services) of the Act;

“Drug Tariff” (“Tariff Cyffuriau”) means the publication known as the Drug Tariff which is referred to in section 81(4) of the Act (arrangements for additional pharmaceutical services);

“electronic communication” (“cyfathrebiad electronig”) has the meaning given by section 15(1) of the Electronic Communications Act 2000(9) (general interpretation);

“electronic prescription” (“presgripsiwn electronig”) means an electronic prescription form or an electronic repeatable prescription;

“electronic prescription form” (“ffurflen bresgripsiwn electronig”) means data created in an electronic form for the purpose of ordering a drug or appliance which—

(a)

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

(b)

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

(c)

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

“Electronic Prescription Service” (“Gwasanaeth Presgripsiynau Electronig”) means the service of that name which is managed by NHS England;

“electronic repeatable prescription” (“presgripsiwn amlroddadwy electronig”) means a prescription which falls within paragraph (a)(ii) of the definition of “repeatable prescription”;

“electronic signature” (“llofnod electronig”) 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” (“data creu llofnod electronig”) means unique data which is used by the signatory to create an electronic signature;

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

(a)

may be issued by a prescriber at the same time as an electronic prescription is created, and

(b)

has a barcode or unique identifier 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;

“ETP service” (“gwasanaeth TPE”) means the 2-dimensional barcoded prescription service which forms part of the information technology systems in prescribing and dispensing systems in Wales and used by the health service in Wales to transfer and hold prescription information relating to patients;

“general medical practitioner” (“ymarferydd meddygol cyffredinol”) 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(10) (registration of medical practitioners);

“General Practice Escalation Tool” (“Offeryn Uwchgyfeirio Ymarfer Cyffredinol”) means the tool agreed by Welsh Ministers, Local Health Boards and the General Practitioner Committee (Wales) containing a framework for reporting pressures on service delivery within practices;

“global sum” (“swm craidd”) is to be interpreted in accordance with Part 2 of the GMS Statement of Financial Entitlements;

“GMS contract” (“contract GMC”) means a general medical services contract under section 42 of the Act (general medical services contracts: introductory);

“GMS contractor” (“contractwr GMC”) means a party to a GMS contract, other than the Local Health Board;

“GMS Statement of Financial Entitlements” (“Datganiad ar Hawlogaethau Ariannol yr GMC”) means the Directions to Local Health Boards as to the Statement of Financial Entitlements given by Welsh Ministers under section 45 of the Act (GMS contracts: payments);

“GP Collaborative” (“Cydweithredfa Ymarfer Cyffredinol”) means a group of primary medical service providers working together, within the area in which the registered patients of those primary medical service providers reside, to deliver co-ordinated primary medical services in that area, and to promote the wellbeing of patients across the area in which the registered patients of those primary medical service providers reside;

“GP Specialty Registrar” (“Cofrestrydd Arbenigol Ymarfer Cyffredinol”) means a medical practitioner who is being trained in general practice by a general medical practitioner who is approved under section 34I of the Medical Act 1983(11) for the purpose of providing training under that section, whether as part of training leading to the award of a CCT or otherwise;

“Health and Social Care Trust” (“Ymddiriedolaeth Iechyd a Gofal Cymdeithasol”) means a Health and Social Care Trust established under article 10 of the Health and Personal Social Services (Northern Ireland) Order 1991(12) (Health and Social Care trusts);

“Health Board” (“Bwrdd Iechyd”) means a Health Board established under section 2 of the National Health Service (Scotland) Act 1978(13) (Health Boards);

“health care professional” (“proffesiynolyn gofal iechyd”) means a person other than a social worker who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002(14);

“health service body” (“corff gwasanaeth iechyd”) has the meaning given in section 7(4)(15) of the Act (NHS contracts);

“home oxygen order form” (“ffurflen archebu ocsigen cartref”) means a form provided by a Local Health 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” (“gwasanaethau ocsigen cartref”) 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” (“aelod o deulu agos”) means—

(a)

a spouse or civil partner,

(b)

a person (whether or not of the opposite sex) whose relationship with the registered patient has the characteristics of the relationship between husband and wife,

(c)

a parent or step-parent,

(d)

a son,

(e)

a daughter,

(f)

a child of whom the registered patient is—

(i)

the guardian, or

(ii)

the carer duly authorised by a local authority to whose care the child has been committed under the Children Act 1989(16), or

(iii)

a grandparent;

“independent nurse prescriber” (“nyrs sy’n rhagnodi’n annibynnol”) means a person—

(a)

who is registered in the Nursing and Midwifery Register, and

(b)

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

“LHBMS practice” (“practis GMBILl”) means a practice providing Local Health Board Medical Services;

“licensing authority” (“awdurdod trwyddedu”) is to be interpreted in accordance with regulation 6 of the Human Medicines Regulations 2012(17);

“licensing body” (“corff trwyddedu”) means a body that licenses or regulates a profession;

“limited partnership” (“partneriaeth gyfyngedig”) means a partnership registered in accordance with section 5 of the Limited Partnerships Act 1907(18) (registration of limited partnerships required);

“Local Health Board” (“Bwrdd Iechyd Lleol”) means, unless the context otherwise requires, the Local Health Board which is a party, or prospective party, to a contract;

“Local Health Board Medical Services” (“Gwasanaethau Meddygol Bwrdd Iechyd Lleol”) means primary medical services provided by a Local Health Board under section 41(2)(a) of the Act (primary medical services);

“Local Medical Committee” (“Pwyllgor Meddygol Lleol”) means a committee recognised under section 54 of the Act (Local Medical Committees);

“local pharmaceutical services” (“gwasanaethau fferyllol lleol”) has the meaning given by regulation 2(1) of the Pharmaceutical Regulations;

“maternity medical services” (“gwasanaethau meddygol mamolaeth”) means the services described in paragraph 5 of Schedule 2;

“medical performers list” (“rhestr cyflawnwyr meddygol”) means a list of medical practitioners prepared and published pursuant to regulation 3(1) of the National Health Service (Performers Lists) (Wales) Regulations 2004(19);

“medical practitioner” (“ymarferydd meddygol”) has the meaning given by section 206(1) of the Act;

“Medical Register” (“Cofrestr Feddygol”) means the register kept under section 2 of the Medical Act 1983(20) (registration of medical practitioners);

“minor surgery” (“mân lawdriniaeth”) means the services described in paragraph 6 of Schedule 2;

“national disqualification” (“anghymhwysiad cenedlaethol”) means—

(a)

a decision made by the First Tier Tribunal under section 115 of the Act (national disqualification) or under regulations corresponding to that section made under—

(i)

section 49 of the Act (persons performing primary medical services),

(ii)

section 63 of the Act (persons performing primary dental services),

(iii)

section 72 of the Act (regulations as to general ophthalmic services), and

(iv)

sections 83, 86, 103 or 105 (performers of pharmaceutical services and assistants) of the Act, or

(b)

any decision in England, Scotland or Northern Ireland corresponding to a national disqualification under section 115(2) and (3) of the Act;

“NHS appliance contractor (“contractwr cyfarpar GIG”) means a person who is included in a pharmaceutical list under regulation 10 of the Pharmaceutical Regulations (preparation and maintenance of pharmaceutical lists) for the provision of pharmaceutical services only by the provision of appliances;

“NHS contract” (“contract GIG”) has the meaning given to it by section 7 of the Act;

“NHS dispute resolution procedure” (“gweithdrefn datrys anghydfodau’r GIG”) means the procedure for resolution of disputes specified—

(a)

in paragraphs 106 and 107 of Schedule 3, or

(b)

in a case to which paragraph 46 of Schedule 3 applies, in that paragraph;

“NHS pharmacist” (“fferyllydd GIG”) means—

(a)

a registered pharmacist, or

(b)

person lawfully carrying on a retail pharmacy business in accordance with section 69 of the Medicines Act 1968(21),

whose name is included in a pharmaceutical list under regulation 10 of the Pharmaceutical Regulations (preparation and maintenance of pharmaceutical lists) for the provision of pharmaceutical services in particular by the provision of drugs;

“nominated dispenser” (“gweinyddydd enwebedig”) means an NHS pharmacist, 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 Personal Demographic Service which is managed by NHS England;

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

“non-electronic repeatable prescription” (“presgripsiwn amlroddadwy anelectronig”) means a prescription which falls within paragraph (a)(i) of the definition of “repeatable prescription”;

“nurse independent prescriber” (“nyrs-ragnodydd annibynnol”) means a person—

(a)

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

(b)

whose name is registered in the Nursing and Midwifery Register,

(c)

against whose name in that register is recorded an annotation or entry signifying that they are qualified to order drugs, medicines and appliances as—

(i)

a nurse independent prescriber, or

(ii)

a nurse independent/supplementary prescriber, and

who, in respect of a person practising in Wales on or after 19 July 2010, has passed an accredited course to practise as a nurse independent prescriber;

“Nursing and Midwifery Register” (“Cofrestr Nyrsio a Bydwreigiaeth”) means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001(22) (establishment and maintenance of register);

“online practice profile” (“proffil practis ar-lein”) means a profile—

(a)

which is on a website (other than the NHS website), or online platform, provided by another person for use by the contractor, and

(b)

through which the contractor advertises the primary medical services it provides;

“online resource” (“adnodd ar-lein”) means a practice website or online practice profile;

“open” (“agored”), in relation to a contractor’s list of patients, means open to applications from patients in accordance with paragraphs 23, 24 and 25 of Schedule 3;

“optometrist independent prescriber” (“optometrydd-ragnodydd annibynnol”) means a person—

(a)

who is an optometrist registered in the register of optometrists maintained under section 7 of the Opticians Act 1989(23) (which relates to the register of optometrists and the register of dispensing opticians) or the register of visiting optometrists from relevant European States maintained under section 8B(1)(a)(35) of that Act, and

(b)

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

“out of hours period” (“cyfnod y tu allan i oriau”) means any days or times outside of the core hours;

“out of hours services” (“gwasanaethau y tu allan i oriau”) means services provided in all or part of an out of hours period which would be unified services if provided by a contractor to its registered patients in core hours;

“paramedic independent prescriber” (“parafeddyg-ragnodydd annibynnol”) means a person—

(a)

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

(b)

who is registered as a paramedic in Part 8 of the Health and Care Professions Council register, and

(c)

against whose name is recorded in Part 8 of that register an annotation signifying that the person is qualified to order drugs, medicines and appliances as a paramedic independent prescriber;

“parent” (“rhiant”) 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” (“claf”) 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 17(9), and

(d)

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

“performer” (“cyflawnydd”) means a performer of medical services under the contract to whom the provisions of Part 6 of Schedule 3 apply;

“Pharmaceutical Regulations” (“Rheoliadau Fferyllol”) means the National Health Service (Pharmaceutical Services) (Wales) Regulations 2020(24);

“pharmaceutical services” (“gwasanaethau fferyllol”) means pharmaceutical services that fall within sections 80 and 81 of the Act and includes directed services;

“pharmacist independent prescriber” (“fferyllydd-ragnodydd annibynnol”) means a registered pharmacist—

(a)

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

(b)

against whose name in Part 1 of the General Pharmaceutical Council Register or in the register maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976(25) (which relates to registers and the registrar) is recorded an annotation signifying that they are qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;

“physiotherapist independent prescriber” (“ffisiotherapydd-ragnodydd annibynnol”) means a person—

(a)

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

(b)

against whose name in Part 9 of the register maintained under article 5 of the Health and Social Work Professions Order 2002(26) is recorded an annotation signifying that they are qualified to order drugs, medicines and appliances as a physiotherapist independent prescriber;

“podiatrist or chiropodist independent prescriber” (“podiatrydd-ragnodydd neu giropodydd-ragnodydd annibynnol”) means a person—

(a)

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

(b)

who is registered in Part 2 of the register maintained under article 5 of the Health Professions Order 2001(27) (establishment and maintenance of register), and

(c)

against whose name in Part 2 of that register is recorded an annotation signifying that they are qualified to order drugs, medicines and appliances as a podiatrist or chiropodist independent prescriber;

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

“practice” (“practis”) means the business operated by the contractor for the purpose of delivering services under the contract;

“practice area” (“ardal practis”) means the area referred to in regulation 18(1)(d);

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

“practice website” (“gwefan practis”) means a website through which the contractor advertises the primary medical services it provides;

“Pre-employment Checks Standards” (“Safonau Gwirio Cyn Cyflogaeth”) means the pre-appointment checks that an employer must undertake as part of their recruitment process before recruiting staff which must at least include the following elements of the NHS Employment Checks Standards published by the NHS Confederation—

(a)

identity checks standard,

(b)

right to work checks standard,

(c)

professional registration and qualification checks standard,

(d)

reference checks standard, and

(e)

criminal record checks standard;

“prescriber” (“rhagnodydd”) means a—

(a)

dentist,

(b)

independent nurse prescriber,

(c)

medical practitioner,

(d)

nurse independent prescriber,

(e)

optometrist independent prescriber,

(f)

paramedic independent prescriber,

(g)

pharmacist independent prescriber,

(h)

physiotherapist independent prescriber,

(i)

podiatrist or chiropodist independent prescriber,

(j)

supplementary prescriber, or

(k)

therapeutic radiographer independent prescriber,

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

“prescription form” (“ffurflen bresgripsiwn”) means—

(a)

a form provided by a Local Health Board, an NHS Trust, an NHS Foundation Trust or an equivalent body and issued by a prescriber, or

(b)

an electronic prescription form,

that enables a person to obtain pharmaceutical services and does not include a repeatable prescription;

“prescription only medicine” (“meddyginiaeth a roddir ar bresgripsiwn yn unig”) means a medicine referred to in regulation 5(3) (classification of medicinal products) of the Human Medicines Regulations 2012;

“primary care list” (“rhestr gofal sylfaenol”) means—

(a)

a list of persons performing primary medical or dental services prepared in accordance with regulations made under section 49 and 63 of the Act,

(b)

a list of persons undertaking to provide or assist in primary medical services, primary dental services, general ophthalmic services or, as the case may be, pharmaceutical services prepared in accordance with regulations made under Part 4, Part 5, Part 6, Part 7 and Part 8 of the Act, or

(c)

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

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

“primary medical services” (“gwasanaethau meddygol sylfaenol”) means medical services provided under or by virtue of a contract or agreement to which the provisions of Part 4 of the Act applies;

“private services” (“gwasanaethau preifat”) means the provision of any paid treatment of a type which would usually amount to primary medical services if it were provided under or by virtue of a contract or agreement to which the provisions of Part 4 of the Act apply;

“prohibited act” (“gweithred waharddedig”) means committing an offence under the Bribery Act 2010;

“Public Health Wales” (“Iechyd Cyhoeddus Cymru”) means the Public Health Wales Trust as established by the Public Health Wales National Health Service Trust (Establishment) Order 2009(28);

“registered paramedic” (“parafeddyg cofrestredig”) means a person registered in Part 8 of the Health and Care Professions Council register;

“registered patient” (“claf cofrestredig”) means—

(a)

a person who is recorded by the Local Health Board as being on the contractor’s list of patients, or

(b)

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

“registered pharmacist” (“fferyllydd cofrestredig”) means a person who is registered in Part 1 of the General Pharmaceutical Council Register or in the register maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;

“registered radiographer” (“radiograffydd cofrestredig”) means a person registered in Part 11 of the Health and Care Professions Council register;

“regulatory or supervisory body” (“corff rheoleiddio neu oruchwylio”) means any statutory or other body having authority to issue guidance, standards or recommendations with which the contractor, or those persons employed or engaged by it, must comply or have regard, including—

(a)

the Welsh Ministers,

(b)

the Department of Health and Social Care,

(c)

NICE,

(d)

Healthwatch England and Local Healthwatch,

(e)

the UK Health Security Agency,

(f)

the General Pharmaceutical Council,

(g)

the Health Services Safety Investigation Body,

(h)

the Information Commissioner, and

(i)

any other body listed in section 25(2) of the National Health Service Reform and Health Care Professions Act 2002;

“relevant register” (“cofrestr berthnasol”) 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 (establishment, maintenance of and access to the register) of the Pharmacy Order 2010(29) or the register maintained under Article 6 (the Register) and Article 9 (the Registrar) of the Pharmacy (Northern Ireland) Order 1976(30),

(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 (register of opticians)(31), and

(d)

the part of the register maintained by the Health and Care Professions Council under article 5 of the Health Professions Order 2001(32) (establishment and maintenance of register) relating to—

(i)

chiropodists and podiatrists,

(ii)

paramedics,

(iii)

physiotherapists, or

(iv)

radiographers;

“repeat dispensing services” (“gwasanaethau amlweinyddu”) means pharmaceutical services or local pharmaceutical services which involve the provision of drugs, medicines or appliances by an NHS pharmacist or an NHS appliance contractor in accordance with a repeatable prescription;

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

“repeatable prescriber” (“rhagnodydd amlroddadwy”) means a person who is—

(a)

a GMS contractor who provides repeatable prescribing services under the terms of its contract which give effect to paragraph 52 (repeatable prescribing services) of Schedule 3,

(b)

an APMS contractor who provides repeatable prescribing services under the terms of its agreement which give effect to a provision in directions made by the Welsh Ministers under section 12(3) of the 2006 Act in relation to APMS contracts which is the equivalent provision to paragraph 52 of Schedule 3, or

(c)

employed or engaged by—

(i)

a GMS contractor who provides repeatable prescribing services under the terms of a contract which give effect to paragraph 52 of Schedule 3,

(ii)

an APMS contractor who provides repeatable prescribing services under the terms of an agreement which give effect to a provision in directions made by the Welsh Ministers under section 12(3) of the 2006 Act in relation to APMS contracts which is the equivalent provision to paragraph 52 of Schedule 3, or

(iii)

a Local Health Board for the purposes of providing primary medical services within a LHBMS practice which provides repeatable prescribing services in accordance with a provision in directions made by the Welsh Ministers under section 12(3) of the 2006 Act in relation to Local Health Board Medical Services which is the equivalent provision to paragraph 52 of Schedule 3;

“repeatable prescription” (“presgripsiwn amlroddadwy”) means a prescription contained in a form provided by a Local Health Board for the purpose of ordering a drug, medicine or appliance which is in the format required by the NHS Business Services Authority and which—

(a)

is either—

(i)

generated by computer but signed by a repeatable prescriber, or

(ii)

a form created in an electronic format, identified using a repeatable prescriber’s code, transmitted as an electronic communication to a nominated NHS pharmacist, NHS appliance contractor or dispensing doctor by the ETP service and is signed with a repeatable prescriber’s advanced electronic signature,

(b)

is issued or created to enable a person to obtain pharmaceutical services, and

(c)

indicates that the drugs or appliances ordered on that form may be provided more than once, and specifies the number of occasions on which they may be provided;

“restricted availability appliance” (“cyfarpar argaeledd cyfyngedig”) means an appliance which is approved for particular categories of persons or particular purposes only;

“Scheduled drug” (“cyffur Atodlen”) means a drug or other substance specified in Schedule 1 or 2 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Wales) Regulations 2004(33) (which relate to drugs, medicines and other substances not to be ordered under a general medical services contract or that may be ordered only in certain circumstances);

“service provider” (“darparwr gwasanaeth”) has the meaning given by section 3(1)(c) of the Regulation and Inspection of Social Care (Wales) Act 2016(34);

“signatory” (“llofnodwr”) means a natural person who creates an electronic signature;

“supplementary prescriber” (“rhagnodydd atodol”) means—

(a)

a registered pharmacist against whose name in Part 1 of the General Pharmaceutical Council Register or in the register maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 is recorded an annotation signifying that they are qualified to order drugs, medicines and appliances as a supplementary prescriber,

(b)

a person whose name is registered in the Nursing and Midwifery Register and against whose name in that Register is recorded an annotation signifying that they are qualified to order drugs, medicines and appliances as a nurse independent/supplementary prescriber,

(c)

a person—

(i)

who is registered in a part of the register maintained under article 5 of the Health Professions Order 2001 (establishment and maintenance of register) which relates to chiropodists and podiatrists, dieticians, paramedics, physiotherapists or radiographers, and

(ii)

against whose name in that register is recorded an annotation signifying that they are qualified to order drugs, medicines and appliances as a supplementary prescriber, or

(d)

an optometrist against whose name in the register of optometrists maintained under section 7 or 8B(1)(a) of the Opticians Act 1989 is recorded an annotation signifying that the optometrist is qualified to order drugs, medicines and appliances as a supplementary prescriber;

“supplementary services” (“gwasanaethau atodol”) are—

(a)

services other than unified services or out of hours services, or

(b)

unified 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 must generally provide in relation to that unified service or element of service;

“temporary resident” (“preswylydd dros dro”) means a person accepted by the contractor as a temporary resident under paragraph 25 of Schedule 3 and for whom the contractor’s responsibility has not been terminated in accordance with that paragraph;

“therapeutic radiographer independent prescriber” (“radiograffydd therapiwtig-ragnodydd annibynnol”) means a radiographer—

(a)

who is a registered radiographer, and

(b)

against whose name is recorded in Part 11 of the Health and Care Professions Council register—

(i)

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

(ii)

an annotation signifying that they are qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;

“unified services” (“gwasanaethau unedig”) means the services required to be provided in accordance with regulation 17;

“vaccine and immunisation services” (“gwasanaethau brechu ac imiwneiddio”) means the services described in paragraph 7 of Schedule 2;

“working day” (“diwrnod gwaith”) means any day apart from Saturday, Sunday, Christmas Day, Good Friday or a bank holiday;

“writing” (“ysgrifennu”), except in paragraph 109 of Schedule 3 and unless the context otherwise requires, includes electronic mail and “written” is to be construed accordingly.

(2) In these Regulations, the use of the term “it” in relation to the contractor is to be deemed to include a reference to a contractor that is an individual medical practitioner, two or more individuals practising in partnership or a company limited by shares and related expressions are to be construed accordingly.

(3) Expressions used in these Regulations and in the Act have the same meaning as in that Act.

(1)

S.I. 2004/478 (W. 48) was amended by section 6(4) and (5) of the Charities Act 2006 (c. 50), and S.I. 2004/1016, S.I. 2004/477.

(2)

S.I. 2010/473, as amended by S.I. 2019/593.

(3)

2009 c. 1. Section 15B was inserted into the Health and Social Care (Reform) Act (Northern Ireland) 2009 by section 4(1) of the Health and Social Care Act (Northern-Ireland) 2022 (c. 3).

(4)

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).

(5)

2016 anaw 2. Paragraph 1(2) of Schedule 1 to the Regulation and Inspection of Social Care (Wales) Act 2016 prescribes places which do not constitute care home services, those places are excluded from the definition of care homes for the purposes of these Regulations.

(6)

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

(9)

2000 c. 7. The definition of “electronic communication” was amended by the Communications Act 2003 (c. 21), Schedule 17, paragraph 158.

(11)

Section 34I was inserted by S.I. 2010/234.

(12)

S.I. 1991/194 (N.I. 1). Article 10 was amended by sections 43 and 44 of the Health and Personal Social Services Act (Northern Ireland) 2001 (c. 3), and section 11 of, and paragraphs 1 and 13 of Schedule 6 to, the Health and Social Care Reform Act (Northern Ireland) 2009 (c. 1) (N.I.) and S.I. 1997/1177.

(13)

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).

(14)

2002 c. 17. Section 25(3) was amended by paragraph 10(2) of Schedule 4 to S.I. 2010/231, paragraph 17(2) and 17(3) of Schedule 10 to the Health and Social Care Act 2008 (c. 14), paragraph 56(b) of Schedule 15 to the Health and Social Care Act 2012 (c. 7), and paragraph 2(2) of Schedule 4 to the Children and Social Work Act 2017 (c. 16).

(15)

Section 7(4) was amended by section 306(4) of, and paragraph 21 of Schedule 7, paragraph 11 of Schedule 17 and paragraphs 13(a), (b), (c), (d), (e), (f) of Schedule 21 to, the Health and Social Care Act 2012 (c.7), section 186(6) of, and paragraph 1(1) of Schedule 1 and paragraph 140 of Schedule 4 to the Health and Care Act 2022 (c. 31), sections 95 and 170 of, and paragraph 87 of Schedule 5 to the Health and Social Care Act 2008 (c. 14), S.I. 2022/1174, and S.I. 2023/98.

(17)

S.I. 2012/1916. Regulation 6 was amended by regulation 3 of the Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352).

(18)

1907 c. 24. Section 5 was amended by section 5 of the Legislative Reform (Limited Partnerships) Order 2009 (S.I. 2009/1940).

(23)

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

(26)

S.I. 2002/254, amended by S.I. 2009/1182.

(28)

S.I. 2009/177, amended by S.I. 2022/251.

(29)

S.I. 2010/231, as amended by paragraph 9(a), 9(b), 9(c), 9(d) and 9(e) of Schedule 2(1) to S.I. 2019/593.

(30)

S.I. 1976/1213, as amended by regulation 5 of S.R. 2008/192, and paragraph 6(a), 6(b) and 6(c) of Part 1 of the Schedule to S.I. 2019/585.

(31)

Section 7(a) as amended by article 7(1)(b) of S.I. 2005/848.

(35)

Section 8B(1)(a) of the Act was repealed by the European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/593). Paragraph 26 of Schedule 5 to those regulations saves the provision indefinitely but with the condition the person in question does not practice for more than 90 days in a calendar year.