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The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020

Type Welsh-Statutory-Instrument

Publication 2020-09-29

Last updated 2026-03-28

State In force

Jurisdiction Wales

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Made: 29 September 2020

Coming into force in accordance with regulation 1(2) and (3)

A draft of these Regulations has been approved by a resolution of Senedd Cymru in accordance with section 203(6A) of that Act.

PART 1 — Introductory

Title, commencement and application

1

(1) The title of these Regulations is the National Health Service (Pharmaceutical Services) (Wales) Regulations 2020.

(2) The following provisions come into force on 1 October 2020—

(a) this Part;

(b) Parts 2 to 4;

(3) Parts 5 to 8 come into force on 1 October 2021.

(4) These Regulations apply in relation to Wales.

Interpretation

2

(1) In these Regulations—

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

“the 1992 Regulations” (“Rheoliadau 1992”) means the National Health Service (Pharmaceutical Services) Regulations 1992[^f00002] as in force immediately before 10 May 2013;

“the 2005 Regulations” (“Rheoliadau 2005”) means the National Health Service (Pharmaceutical Services) Regulations 2005[^f00003] as in force immediately before 1 September 2012;

“the 2013 Regulations” (“Rheoliadau 2013”) means the National Health Service (Pharmaceutical Services) (Wales) Regulations 2013[^f00004] as in force immediately before 1 October 2020;

“additional opening hours” (“oriau agor ychwanegol”) is to be construed, as the context requires, in accordance with paragraph 23(11) of Schedule 5 or paragraph 13(10) of Schedule 6, or both;

“advanced electronic signature” (“llofnod electronig uwch”) means an electronic signature which meets the following requirements—it is uniquely linked to the signatory,it is capable of identifying the signatory,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, andit is linked to the data signed in such a way that any subsequent change in the data is detectable;

“APMS” (“GMDdA”) means primary medical services provided in accordance with an APMS contract;

“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 2006 Act (primary medical services);

“APMS contractor” (“contractwr GMDdA”) means a party to an APMS contract, other than a 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 2006 Act (arrangements for pharmaceutical services);

“appliance use review service” (“gwasanaeth adolygu defnyddio cyfarpar”) means arrangements made in accordance with directions under section 81 of the 2006 Act (arrangements for additional pharmaceutical services) for an NHS pharmacist or NHS appliance contractor to review a person’s use of any specified appliance;

“appropriate batch issue” (“swp-ddyroddiad priodol”) means, in relation to a non-electronic repeatable prescription, one of the batch issues relating to that prescription and containing the same date as that prescription;

“appropriate non-proprietary name” (“enw amherchnogol priodol”) means a non-proprietary name which is not mentioned in Schedule 1 to the Prescription of Drugs Regulations or, except where the conditions in paragraph 56(2) of Schedule 3 to the GMS Regulations are satisfied, in Schedule 2 to the Prescription of Drugs Regulations;

“bank holiday” (“gŵyl banc”) means any day that is specified or proclaimed as a bank holiday in Wales pursuant to section 1 of the Banking and Financial Dealings Act 1971[^f00005];

“batch issue” (“swp-ddyroddiad”) 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 a NHS pharmacist or NHS appliance contractor to receive payment for the provision of repeat dispensing services which is in the required format, and which—is generated by a computer and not signed by a repeatable prescriber,relates to a particular non-electronic repeatable prescription and contains the same date as that prescription,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, andspecifies a number denoting its place in the sequence referred to in paragraph (c);

“Charges Regulations” (“Rheoliadau Ffioedd”) means the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007[^f00006];

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

“Citizen Voice Body” (“Corff Llais y Dinesydd”) means the Citizen Voice Body for Health and Social Care, Wales, established under section 12(1) of the Health and Social Care (Quality and Engagement) (Wales) Act 2020;

“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;

“conditional inclusion” (“cynnwys yn amodol”) means inclusion in a pharmaceutical list or the grant of preliminary consent to be included in a pharmaceutical list subject to conditions imposed under Part 7 of these Regulations;

“contingent removal” (“dileu yn ddigwyddiadol”) means removal from a pharmaceutical list contingently, within the meaning of section 108 of the 2006 Act (contingent removal);

“controlled locality” (“ardal reoledig”) means an area which a Local Health Board has determined to be rural in accordance with regulation 13 (areas that are controlled localities), which the Welsh Ministers have determined on appeal, in accordance with Parts 1 and 2 of Schedule 4, to be rural or which is a controlled locality by virtue of the operation of regulation 13(1);

“core hours” (“oriau craidd”) means the hours during which pharmacy, or appliance contractor, premises must be open by virtue of paragraph 23(1) of Schedule 5, or paragraph 13(1) of Schedule 6;

“coronavirus” (“coronafeirws”) has the meaning given in section 1(1) of the Coronavirus Act 2020[^f00003] (meaning of “coronavirus” and related terminology);

“dentist” (“deintydd”) means a dental practitioner;

“directed services” (“gwasanaethau cyfeiriedig”) means additional pharmaceutical services provided in accordance with directions under section 81 of the 2006 Act (arrangements for additional pharmaceutical services);

“director” (“cyfarwyddwr”) means—a director of a body corporate, ora member of the body of persons controlling a body corporate (whether or not a limited liability partnership);

“dispensing doctor” (“meddyg fferyllol”) means a doctor who provides pharmaceutical services under arrangements with a Local Health Board made under regulation 26 (arrangements for the provision of pharmaceutical services by doctors);

“dispensing doctor list” (“rhestr meddygon fferyllol”) means a list that a Local Health Board is required to prepare and maintain under regulation 11 (preparation and maintenance of dispensing doctor lists);

“doctor” (“meddyg”) means a registered medical practitioner;

“Drug Tariff” (“Tariff Cyffuriau”) has the meaning given to it in regulation 55 (the Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors);

“drugs” (“cyffuriau”) includes medicines;

“EEA” (“AEE”) means the European Economic Area created by the EEA agreement;

“electronic communication” (“cyfathrebiad electronig”) has the meaning given in section 15(1) of the Electronic Communications Act 2000[^f00007] (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—is signed with a prescriber’s advanced electronic signature,is transmitted as an electronic communication to a nominated NHS pharmacist, NHS appliance contractor or dispensing doctor by the electronic prescription service, anddoes 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 Digital Health and Care Wales;

“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;

“employment” (“cyflogaeth”) includes unpaid employment and employment under a contract for services;

“equivalent body” (“corff cyfatebol”) means NHS England in England, a Health Board in Scotland, a Health and Social Services Board in Northern Ireland or any successor body in England, Scotland or Northern Ireland and, in relation to any time prior to 1 April 2003, a Health Authority in Wales or in relation to any time prior to 1 April 2013 and after 30 September 2002 a Primary Care Trust in England, or in relation to any time prior to 1 October 2002, a Health Authority in England;

“equivalent list” (“rhestr gyfatebol”) means a list kept by an equivalent body;

“essential services” (“gwasanaethau hanfodol”) for NHS pharmacists means the services specified in paragraph 3 of Schedule 5 and for NHS appliance contractors means the services specified in paragraphs 3 to 12 of Schedule 6;

“General Pharmaceutical Council Register” (“Cofrestr y Cyngor Fferyllol Cyffredinol”) means the register maintained under article 19 of the Pharmacy Order 2010[^f00008] (establishment, maintenance of and access to the Register);

“GMS contract” (“contract GMC”) means a general medical services contract under section 42 of the 2006 Act (general medical services contracts: introductory);

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

“GMS Regulations” (“Rheoliadau GMC”) means the National Health Service (General Medical Services Contracts) (Wales) Regulations 2023;

“the Health and Care Professions Council register” (“cofrestr y Cyngor Proffesiynau Iechyd a Gofal”) means the register established and maintained by the Health and Care Professions Council under article 5 of the Health and Social Work Professions Order 2002[^f00010];

“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 Healthcare Professions Act 2002[^f00011];

“independent nurse prescriber” (“nyrs sy’n rhagnodi’n annibynnol”) means a person—who is registered in the Nursing and Midwifery Register, andagainst 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;

“joint discipline committee” (“cyd-bwyllgor disgyblu”) has the same meaning as in regulation 2 of the National Health Service (Service Committees and Tribunal) Regulations 1992[^f00012] (interpretation);

“LHBMS” (“GMBILl”) means primary medical services provided by a Local Health Board under section 41(2)(a) of the 2006 Act (primary medical services);

“LHBMS practice” (“practis GMBILl”) means a practice providing LHBMS;

“licensing or regulatory body” (“corff trwyddedu neu reoleiddio”) means any body that licences or regulates any profession of which the person is or has been a member, and includes any body which licences or regulates any such profession in a country other than the United Kingdom;

“list” (“rhestr”), unless the context otherwise requires, means a pharmaceutical list or a dispensing doctor list;

“listed premises” (“mangre restredig”) means the premises that are included in—a pharmaceutical list, ora dispensing doctor list pursuant to regulation 11 (preparation and maintenance of dispensing doctor lists);

“Local Health Board” (“Bwrdd Iechyd Lleol”) means a Local Health Board established under section 11 of the 2006 Act (local health boards);

“Local Medical Committee” (“Pwyllgor Meddygol Lleol”) means a committee recognised under section 54 of the 2006 Act (local medical committees);

“Local Pharmaceutical Committee” (“Pwyllgor Fferyllol Lleol”) means a committee recognised under section 90 of the 2006 Act (local pharmaceutical committees);

“local pharmaceutical services” (“gwasanaethau fferyllol lleol”) means services of a kind which may be provided under section 80, or by virtue of section 81, of the 2006 Act, other than practitioner dispensing services, and which are provided under a pilot scheme;

“medical performers list” (“rhestr cyflawnwyr meddygol”) means a list of doctors prepared and published pursuant to regulation 3(1) of the National Health Service (Performers Lists) (Wales) Regulations 2026;

“national disqualification” (“anghymhwysiad cenedlaethol”) means—a national disqualification as mentioned in section 115(2) and (3) of the 2006 Act (national disqualification),a national disqualification as mentioned in section 159(2) and (3) of the National Health Service Act 2006[^f00014] (national disqualification),any decision in Scotland or Northern Ireland corresponding to a national disqualification under section 115(2) and (3) of the 2006 Act, andany other decision that was a national disqualification for the purposes of the 2005 Regulations;

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

“NHS Business Services Authority” (“Awdurdod Gwasanaethau Busnes y GIG”) means the NHS Business Services Authority (Awdurdod Gwasanaethau Busnes y GIG) established by the NHS Business Services Authority (Awdurdod Gwasanaethau Busnes y GIG) (Establishment and Constitution) Order 2005[^f00015];

“NHS pharmacist” (“fferyllydd GIG”) means—a registered pharmacist, orperson lawfully carrying on a retail pharmacy business in accordance with section 69 of the Medicines Act 1968[^f00016],whose name is included in a pharmaceutical list under regulation 10 (preparation and maintenance of pharmaceutical lists) for the provision of pharmaceutical services in particular by the provision of drugs;

“NHS services” (“gwasanaethau GIG”) means services provided as part of the health service in Wales;

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

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

“non-proprietary name” (“enw amherchnogol”) means a name which is, or which is a permitted variation of—an International Nonproprietary Name (INN),an International Nonproprietary Name Modified (INNM),a British Approved Name (BAN),a British Approved Name Modified (BANM), oran approved name,and for this purpose these names (and their permitted variations) have the same meanings as in a list of names which has been prepared and caused to be published by the British Pharmacopoeia Commission and which has not been superseded[^f00017];

“notice” (“hybysiad”) means a notice in writing;

“nurse independent prescriber” (“nyrs-ragnodydd annibynnol”) means a person—whose name is registered in the Nursing and Midwifery Register,against whose name in that register is recorded an annotation or entry signifying that they are qualified to order drugs, medicines and appliances as—a nurse independent prescriber, ora nurse independent/supplementary prescriber, andwho, 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[^f00018] (establishment and maintenance of register);

“optometrist independent prescriber” (“optometrydd-ragnodydd annibynnol”) means a person—who is an optometrist registered in the register of optometrists maintained under section 7 of the Opticians Act 1989[^f00019] (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) of that Act, andagainst whose name is recorded an annotation signifying that the optometrist is qualified to order drugs, medicines and appliances as an optometrist independent prescriber;

“originating events” (“digwyddiadau cychwynnol”) means the events that gave rise to the conviction, investigation, proceedings, suspension, refusal to admit, conditional inclusion, removal or contingent removal that took place;

“ophthalmic listed medicine” (“meddyginiaeth restredig offthalmig”) means a drug on the list of preparations approved by the Welsh Ministers which may be ordered by a qualifying optometrist for national health service primary ophthalmic services patients;

“ophthalmic listed appliance” (“cyfarpar rhestredig offthalmig”) means an appliance on the list of preparations approved by the Welsh Ministers which may be ordered by a qualifying optometrist for national health service primary ophthalmic services patients;

“Ophthalmic Combined List” (“Rhestr Gyfunol Offthalmig”) means the list required to be prepared by Local Health Boards by virtue of regulation 10 of the National Health Service (Ophthalmic Services) (Wales) Regulations 2023;

“optometrist” (“optometrydd”) means a person registered as an optometrist in the register maintained under section 7 of the Opticians Act 1989 (register of opticians);

“outline consent” (“cydsyniad amlinellol”) has the meaning given to it in regulation 30(1)(a) (outline consent and premises approval);

“outstanding pharmacy application” (“cais am fferyllfa yn yr arfaeth”) has the meaning given to it in regulation 31(11) (taking effect of outline consent and premises approval);

“paramedic independent prescriber” (“parafeddyg-ragnodydd annibynnol”) means a person—who is registered as a paramedic in Part 8 of the Health and Care Professions Council register, andagainst 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;

“patient list” (“rhestr cleifion”) means a list of patients kept in accordance with paragraph 22 (list of patients) of Schedule 3 to the GMS Regulations or in respect of an APMS contractor or an LHBMS practice, in accordance with directions given by the Welsh Ministers under section 12(3) of the 2006 Act;

“pharmaceutical discipline committee” (“pwyllgor disgyblu fferyllol”) has the same meaning as in regulation 2 of the National Health Service (Service Committees and Tribunal) Regulations 1992[^f00020];

“pharmaceutical list” (“rhestr fferyllol”) means a list that a Local Health Board is required to prepare and maintain under regulation 10 (preparation and maintenance of pharmaceutical lists);

“pharmaceutical services” (“gwasanaethau fferyllol”) means pharmaceutical services that fall within sections 80 and 81 of the 2006 Act and includes directed services;

“pharmacist independent prescriber” (“fferyllydd-ragnodydd annibynnol”) means 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[^f00021] (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;

“pharmacy” (“fferyllfa”) means—listed premises under regulation 10 (preparation and maintenance of pharmaceutical lists) at which pharmaceutical services are provided by an NHS pharmacist pursuant to arrangements made to section 80 of the 2006 Act, orpremises where under a pharmacy pilot scheme under section 92 of the 2006 Act (pilot schemes) the range of pharmaceutical services and the hours on which they are provided are comparable to a pharmacy falling within paragraph (a);

“physiotherapist independent prescriber” (“ffisiotherapydd-ragnodydd annibynnol”) means a person—who is a physiotherapist, andagainst whose name in Part 9 of the register maintained under article 5 of the Health and Social Work Professions Order 2002[^f00022] is recorded an annotation signifying that they are qualified to order drugs, medicines and appliances as a physiotherapist independent prescriber;

“pilot scheme” (“cynllun peilot”) has the same meaning as in section 92(2) of the 2006 Act (pilot schemes);

“podiatrist or chiropodist independent prescriber” (“podiatrydd-ragnodydd neu giropodydd-ragnodydd annibynnol”) means a person—who is a podiatrist or a chiropodist, andagainst whose name in Part 2 of the register maintained under article 5 of the Health and Social Work Professions Order 2002 is recorded an annotation signifying that they are qualified to order drugs, medicines and appliances as a podiatrist or chiropodist independent prescriber;

“practice premises” (“mangre practis”), in relation to a provider of primary medical services, means the address or addresses specified in the contract (in the case of a GMS or APMS contractor) or practice statement (in the case of an LHBMS practice) at which pharmaceutical services are to be provided under the contract or practice statement;

“preliminary consent” (“cydsyniad rhagarweiniol”) has the meaning given to it in regulation 18 (applications for preliminary consent and effect of preliminary consent);

“premises approval” (“cymeradwyaeth mangre”) has the meaning given to it in regulation 30(1)(b) (outline consent and premises approval) and includes temporary premises approval granted under regulation 34(13) (premises approval: additional and new premises after outline consent has taken effect) or residual premises approval granted under regulation 35(9) (premises approval: practice amalgamations);

“prescriber” (“rhagnodydd”) means a doctor, dentist, ... independent nurse prescriber, nurse independent prescriber, optometrist independent prescriber, pharmacist independent prescriber, physiotherapist independent prescriber, podiatrist or chiropodist independent prescriber, therapeutic radiographer independent prescriber, paramedic independent prescriber or a supplementary prescriber;

“prescription form” (“ffurflen bresgripsiwn”) means—a form provided by a Local Health Board, an NHS Trust, an NHS Foundation Trust or an equivalent body and issued by a prescriber, oran electronic prescription form,that enables a person to obtain pharmaceutical services and does not include a repeatable prescription;

“Prescription of Drugs Regulations” (“Rheoliadau Rhagnodi Cyffuriau”) means the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Wales) Regulations 2004[^f00023];

“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 Ophthalmic Services” (“Gwasanaethau Offthalmig Sylfaenol”) has the meaning given in regulation 4 of the National Health Service (Ophthalmic Services) (Wales) Regulations 2023;

“provider of primary medical services” (“darparwr gwasanaethau meddygol sylfaenol”) means a GMS contractor, APMS contractor or an LHBMS practice;

“qualifying optometrist” (“optometrydd cymhwysol”) means a person who is an optometrist included on a Local Health Board’s combined list who is providing or assisting in the provision of primary ophthalmic services in Wales;

“Regional Partnership Board” (“Bwrdd Partneriaeth Rhanbarthol”) has the meaning given to it in regulation 1(4) of the Partnership Arrangements (Wales) Regulations 2015[^f00024];

“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;

“relevant APMS contractor” (“contractwr GMDdA perthnasol”), in relation to any doctor, means—the APMS contractor, where the doctor is an APMS contractor, orwhere the doctor is not the APMS contractor, the APMS contractor by whom the doctor is employed or engaged;

“relevant European State” (“Gwladwriaeth Ewropeaidd perthnasol”) means an EEA State or Switzerland;

“relevant GMS contractor” (“contractwr GMC perthnasol”), in relation to any doctor, means—the GMS contractor, where the doctor is a GMS contractor, orwhere the doctor is not a GMS contractor, the GMS contractor by whom the doctor is employed or engaged;

“relevant list” (“rhestr berthnasol”) means—a pharmaceutical list or an equivalent list, ora list maintained by a Local Health Board or an equivalent body of approved performers or providers of primary medical, dental or ophthalmic services;

“relevant patient list” (“rhestr cleifion berthnasol”) means—in relation to a doctor who is (or is a legal and beneficial shareholder in a company which is) a GMS contractor or APMS contractor, the patient list for that contractor, orwhere the doctor is not a contractor, the patient list for the GMS contractor or APMS contractor by whom the doctor is employed or engaged or for the LHBMS practice within which the doctor provides primary medical services;

“relevant pharmaceutical needs assessment” (“asesiad perthnasol o anghenion fferyllol”) means the pharmaceutical needs assessment of the relevant Local Health Board that is current at the time that the Local Health Board takes its decision to grant or refuse an application, unless in the opinion of the Local Health Board (or on appeal the Welsh Ministers) the only way to determine the application justly is with regard to an earlier pharmaceutical needs assessment, in which case the relevant pharmaceutical needs assessment is that earlier assessment;

“Remission of Charges Regulations” (“Rheoliadau Peidio â Chodi Tâl”) means the National Health Service (Travelling Expenses and Remission of Charges) (Wales) Regulations 2007[^f00025];

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

“repeatable prescriber” (“rhagnodydd amlroddadwy”) means a person who is—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 to the GMS Regulations,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 to the GMS Regulations, oremployed or engaged by—a GMS contractor who provides repeatable prescribing services under the terms of a contract which give effect to paragraph 52 of Schedule 3 to the GMS Regulations,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 to the GMS Regulations, ora 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 LHBMS which is the equivalent provision to paragraph 52 of Schedule 3 to the GMS Regulations;

“repeatable prescription” (“presgripsiwn amlroddadwy”) means a prescription contained in a form provided by a Local Health Board which—is either—generated by computer but signed by a repeatable prescriber, ora 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 electronic prescription service and is signed with a repeatable prescriber’s advanced electronic signature,is issued or created to enable a person to obtain pharmaceutical services, andindicates 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;

“reserved location” (“lleoliad neilltuedig”) has the meaning given to it by regulation 17(4) (locations in controlled localities that are reserved locations);

“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 Prescription of Drugs Regulations (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);

“serious shortage protocol” (“protocol prinder difrifol”) means—in the case of a prescription only medicine, a serious shortage protocol for the purposes of regulation 226A of the Human Medicines Regulations 2012[^f00026] (sale etc. by a pharmacist in accordance with a serious shortage protocol), orin the case of any other drug or appliance, a written protocol that—is issued by the Welsh Ministers in circumstances where Wales or any part of Wales is, in the opinion of the Welsh Ministers, experiencing or may experience a serious shortage of—a specified drug or appliance, ordrugs or appliances of a specified description,provides for the supply by an NHS pharmacist or an NHS appliance contractor providing pharmaceutical or local pharmaceutical services, where there is an order on a prescription form or a repeatable prescription for—the specified drug or appliance, ora drug or appliance of the specified description,of a different product or quantity of product to the product or quantity of product ordered, subject to such conditions as may be specified in the protocol, andspecifies the period for which, and the parts of Wales (which may be all of Wales) in which, the protocol is to have effect;

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

“specified appliance” (“cyfarpar penodedig”) means—any of the following appliances listed in Part IXA of the Drug Tariff—a catheter appliance (including a catheter accessory and maintenance solution),a laryngectomy or tracheostomy appliance,an anal irrigation system,a vacuum pump or constrictor ring for erectile dysfunction, ora wound drainage pouch,an incontinence appliance listed in Part IXB of the Drug Tariff, ora stoma appliance listed in Part IXC of the Drug Tariff;

“stoma appliance customisation” (“addasu cyfarpar stoma”) means the customisation of a quantity of more than one stoma appliance, where—the stoma appliances to be customised are listed in Part IXC of the Drug Tariff,the customisation involves modification to the same specification of multiple identical parts for use with each appliance, andthat modification is based on the patient’s measurements or a record of those measurements and, if applicable, a template;

“SSP” (“PPD”) means a serious shortage protocol;

“superintendent” (“uwcharolygydd”) has the same meaning as in section 71 of the Medicines Act 1968[^f00027] (bodies corporate);

“supplementary opening hours” (“oriau agor atodol”) is to be construed, as the context requires, in accordance with paragraph 23(2) of Schedule 5 or paragraph 13(3)(a) of Schedule 6, or both;

“supplementary prescriber” (“rhagnodydd atodol”) means—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,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,a person—who is registered in a part of the register maintained under article 5 of the Health and Social Work Professions Order 2001[^f00028] (establishment and maintenance of register) which relates to chiropodists and podiatrists, dieticians, paramedics, physiotherapists or radiographers, andagainst whose name in that register is recorded an annotation signifying that they are qualified to order drugs, medicines and appliances as a supplementary prescriber, oran 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;

“therapeutic radiographer independent prescriber” (“radiograffydd therapiwtig-ragnodydd annibynnol”) means a person—who is a registered radiographer, andagainst whose name is recorded in Part 11 of the Health and Care Professions Council register—an entitlement to use the title “therapeutic radiographer”, andan annotation signifying that they are qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;

“Tribunal” (“Tribiwnlys”) means the First-tier Tribunal established under the Tribunals, Courts and Enforcement Act 2007[^f00029].

(2) Where reference is made in these Regulations to a decision of a Local Health Board and that decision is changed on appeal, unless the context otherwise requires, the reference to that decision is to be construed as a reference to the decision changed on appeal.

(3) In these Regulations—

(a) the term “pharmaceutical services”, in the context of arrangements for the provision of pharmaceutical services by a doctor, means the dispensing of drugs and appliances but not pharmaceutical services as mentioned in section 86(7)(a) or (b) of the 2006 Act (persons authorised to provide pharmaceutical services), and

(b) the term “dispensing services”, in relation to a doctor or GMS contractor, means any corresponding service provided, not as pharmaceutical services, but under the terms of a GMS contract which give effect to paragraphs 60 ... of Schedule 3 to the GMS Regulations.

(4) Except where expressly provided to the contrary, any document which is required or authorised to be given or sent to a person or body under these Regulations may be given or sent by delivering it to the person or, in the case of a body, to the secretary or general manager of that body, or by sending it in a prepaid letter addressed to that person or, in the case of a body, to the secretary or general manager of that body at his usual or last known address, and delivering it includes sending it electronically to an electronic address which that person has notified for the purpose.

(5) Where the term “community practitioner nurse prescriber” appears in the Human Medicines Regulations 2012[^f00030] or the Nursing and Midwifery Register it is to be construed for the purposes of these Regulations as a reference to an “independent nurse prescriber”.

PART 2 — Pharmaceutical needs assessments

Pharmaceutical needs assessments

3

(1) The statement of the needs for pharmaceutical services which each Local Health Board is required to publish by virtue of section 82A of the 2006 Act[^f00031], whether it is the statement of its first assessment or of any revised assessment, is referred to in these Regulations as a “pharmaceutical needs assessment”.

(2) The pharmaceutical services to which each pharmaceutical needs assessment must relate are all the pharmaceutical services that may be provided under arrangements made by a Local Health Board for—

(a) the provision of pharmaceutical services by a person on a pharmaceutical list,

(b) the provision of local pharmaceutical services under a pilot scheme, or

(c) the dispensing of drugs and appliances with a person on a dispensing doctors list (but not other NHS services that may be provided under arrangements made by a Local Health Board with a dispensing doctor).

Information to be contained in pharmaceutical needs assessments

4

(1) Each pharmaceutical needs assessment must contain the information set out in Schedule 1.

(2) Each Local Health Board must, so far as is practicable, keep up to date the map which it includes in its pharmaceutical needs assessment pursuant to paragraph 5 of Schedule 1 (without needing to republish the whole assessment or publish a supplementary statement).

Date by which the first pharmaceutical needs assessment is to be published

5

Each Local Health Board must publish its first pharmaceutical needs assessment within 12 months of the date on which these Regulations come into force.

Subsequent assessments

6

(1) After it has published its first pharmaceutical need assessment, each Local Health Board must publish a statement of its revised assessment—

(a) no later than 5 years after its previous publication of a pharmaceutical needs assessment, or

(b) at any point within 5 years of its previous publication of a pharmaceutical needs assessment, having regard to any other needs assessments the Local Health Board is under a statutory duty to publish.

(2) A Local Health Board must make a revised assessment as soon as is reasonably practicable after identifying changes, which are of a significant extent, since the publication of its pharmaceutical needs assessment which are relevant to the granting of applications referred to in section 83 of the 2006 Act, unless it is satisfied that making a revised assessment would be a disproportionate response to those changes.

(3) Pending the publication of a statement of a revised assessment, a Local Health Board may publish a supplementary statement explaining changes to the availability of pharmaceutical services since the publication of its pharmaceutical needs assessment (which becomes part of the assessment), where—

(a) the changes are relevant to the granting of applications referred to in section 83 of the 2006 Act, and

(b) the Local Health Board—

(i) is satisfied that making a revised assessment would be a disproportionate response to those changes, or

(ii) is in the course of making a revised assessment and is satisfied that immediate modification of its pharmaceutical needs assessment is essential in order to prevent detriment to the provision of pharmaceutical services in its area.

(4) Where a Local Health Board publishes a supplementary statement in accordance with paragraph (3), the Local Health Board must notify those bodies listed in regulation 7(1) of its publication as soon as reasonably practicable.

Consultation on pharmaceutical needs assessments

7

(1) When making an assessment for the purposes of publishing a pharmaceutical needs assessment, each Local Health Board must consult on the contents of the assessment with the following—

(a) the Local Pharmaceutical Committee for Wales,

(b) the Local Medical Committee for its area (including one for its area and that of one or more other Local Health Boards relevant to the assessment);

(d) any pilot scheme pharmacy with whom the Local Health Board has made arrangements for the provision of any local pharmaceutical services,

(e) the persons on its dispensing doctors list (if it has one),

(f) any person with whom the Local Health Board has made arrangements for the provision of dispensing services,

(g) any provider of primary medical services in its area,

(h) the Citizen Voice Body and any other group representing patients, consumers or a community in its area which in the opinion of the Local Health Board has an interest in the provision of pharmaceutical services in its area,

(i) any Regional Partnership Board for its area,

(j) any local authority for its area,

(k) any NHS Trust in its area, and

(l) any neighbouring Local Health Board.

(2) A draft of the proposed pharmaceutical needs assessment must be published on the website of the Local Health Board for a minimum of 60 days.

(3) The Local Health Board must, no later than 24 hours after the draft pharmaceutical needs assessment is published in accordance with paragraph (2), notify the persons listed in paragraph (1) that—

(a) a draft of the proposed pharmaceutical needs assessment has been published on the website of the Local Health Board, and

(b) the date by which any consultation response must be provided to the Local Health Board.

(4) If a person listed in paragraph (1) requests a copy of the draft pharmaceutical needs assessment in hard copy form, the Local Health Board must as soon as is practicable, and in any event within 14 days, supply a hard copy of the draft to that person (free of charge).

(5) Where a Local Health Board is notified in accordance with paragraph (3) and there is a Local Medical Committee for its area that is different to the Local Medical Committee consulted under paragraph (1)(b), the Local Health Board notified—

(a) must consult that Committee before making its response to the consultation, and

(b) must have regard to any representation received from the Committee when making its response to the consultation.

Matters for consideration when making assessments

8

(1) When making an assessment for the purposes of publishing a pharmaceutical needs assessment, each Local Health Board must have regard, in so far as it is practicable to do so, to the following matters—

(a) any assessment or further assessment of relevant needs prepared under section 82A of the 2006 Act—

(i) where it relates to the area of the Local Health Board, and

(ii) which has not been superseded by a further assessment under that section,

(b) the demography of its area,

(d) the pharmaceutical services provided under arrangements with any neighbouring Local Health Board which affect the need for pharmaceutical services in its area, and

(e) any dispensing services or other NHS services provided in or outside its area (which are not covered by sub-paragraph (d)) which affect the need for pharmaceutical services in its area.

(2) When making an assessment for the purposes of publishing a pharmaceutical needs assessment, each Local Health Board must take account of the likely future needs—

(a) to the extent necessary to make a proper assessment of the matters mentioned in paragraph 3 of Schedule 1, and

(b) having regard to changes to the number of people in its area who will require pharmaceutical services.

Publication of pharmaceutical needs assessments

9

(1) A Local Health Board must publish on its website—

(a) the pharmaceutical needs assessment for its area,

(b) any subsequent assessment made pursuant to regulation 6(1), and

(2) If a Local Health Board receives a request for a copy of any of the documents in paragraph (1) in hard copy form, the Local Health Board must, as soon as is practicable and in any event within 14 days, supply a hard copy (free of charge).

PART 3 — Pharmaceutical lists and dispensing doctor lists

Preparation and maintenance of pharmaceutical lists

10

(1) Each Local Health Board must prepare and maintain pharmaceutical lists of NHS pharmacists and NHS appliance contractors who have applied in accordance with Part 5 of these Regulations and Schedule 2, to provide pharmaceutical services from premises in the Local Health Board’s area and whose applications have been approved by the Local Health Board in accordance with Schedule 3 or on appeal by the Welsh Ministers in accordance with Schedule 4 and who are authorised—

(a) to provide pharmaceutical services in particular by way of the provision of drugs, or

(b) to provide pharmaceutical services only by way of the provision of appliances.

(2) Each pharmaceutical list must include—

(a) the address of the premises at which the listed person has undertaken to provide pharmaceutical services,

(b) the days on which and times at which at those premises the listed person provides pharmaceutical services, and

(3) Part 7 of these Regulations makes provision for the removal of persons from pharmaceutical lists.

(4) A pharmaceutical list of a Local Health Board that is the current list immediately before these Regulations come into force is also the current pharmaceutical list when these Regulations come into force, unless the Local Health Board is required or entitled to give effect to a decision reached before the coming into force date to change, remove or include an entry from or in the list from the start of the coming into force date, in which case the current list at the start of the coming into force date is the list as modified to give effect to that decision.

Preparation and maintenance of dispensing doctor lists

11

(1) Each Local Health Board must prepare and maintain a dispensing doctor list of doctors with whom the Local Health Board has made an arrangement in accordance with regulation 26 (arrangements for the provision of pharmaceutical services by doctors) to provide pharmaceutical services to their patients in the area of the Local Health Board.

(2) Each dispensing doctor list must include—

(a) the name of the doctor—

(i) whose application under Part 6 for outline consent and premises approval has been approved by the Local Health Board in accordance with Schedule 3 or on appeal by the Welsh Ministers in accordance with Schedule 4, and

(ii) who has made arrangements with the Local Health Board under regulation 26 to provide pharmaceutical services,

(b) the area in relation to which outline consent has been granted and the date on which the outline consent took effect,

(i) the date on which premises approval took effect or, where it has not taken effect, the date on which it was granted, and

(ii) if premises approval is deemed, temporary or residual, that this is the case,

(d) the address of any practice premises in relation to which the doctor has outstanding applications for premises approval, and

(e) where the doctor whose name is included in the dispensing doctor list provides primary medical services with an LHBMS practice, the name and address of the Local Health Board.

(3) A doctor included in a dispensing doctor list maintained by a Local Health Board who is a provider of primary medical services or who is employed or engaged by a provider of primary medical services may make a request to that Local Health Board for another doctor who is a provider of primary medical services or who is employed or engaged by a provider of primary medical services to be included in the dispensing doctor list in their place.

(4) A Local Health Board that receives a request described in paragraph (3) must agree to that request and—

(a) the doctor that made the request (“the original doctor”) must be substituted by the other doctor (“the new doctor”) by the Local Health Board in the dispensing doctor list that it maintains,

(b) the arrangements that the Local Health Board had with the original doctor become arrangements with the new doctor, and

(c) the outline consents and premises approvals of the original doctor become the outline consents and premises approvals of the new doctor.

(5) A Local Health Board must remove a listed doctor from a dispensing doctor list if—

(a) the doctor has died,

(b) the doctor is no longer performing primary medical services within the area of the Local Health Board,

(c) outline consent and premises approval has lapsed under regulation 32 (lapse of outline consent and premises approval),

(d) the doctor has been removed from the medical performers list, or

(e) more than 12 months have elapsed since the doctor last provided drugs, medicines or appliances under an arrangement made pursuant to regulation 26.

(6) A dispensing doctor list of a Local Health Board that is the current list immediately before these Regulations come into force is also the current dispensing doctor list when these Regulations come into force unless the Local Health Board is required or entitled to give effect to a decision reached before the coming into force date to change, remove or include an entry in the list from the start of the coming into force date, in which case the current list at the start of the coming into force date is the list as modified to give effect to that decision.

Terms of service

12

(1) The terms on which a person is included in a pharmaceutical list (and therefore the person’s terms of service) are those that are included—

(a) in the terms of service—

(i) for NHS pharmacists who provide pharmaceutical services in particular by the provision of drugs, set out in Schedule 5, or

(ii) for NHS appliance contractors who provide pharmaceutical services only by way of the provision of appliances, set out in Schedule 6,

as may be varied by conditions imposed by a Local Health Board by virtue of regulation 38 (conditional inclusion on fitness grounds),

(b) in the Drug Tariff, in so far as the rights and liabilities in the Drug Tariff relate to NHS pharmacists or NHS appliance contractors and are applicable in the case of the NHS pharmacist or NHS appliance contractor, and

(c) in an arrangement made by a Local Health Board with the NHS pharmacist or NHS appliance contractor for the provision of any pharmaceutical services.

(2) The terms on which a person is included in a dispensing doctor list (and therefore the person’s terms of service) are those that are—

(a) included in the terms of service for doctors providing pharmaceutical services set out in Schedule 7,

(b) in accordance with any conditions imposed regarding the postponement or termination of the provision of pharmaceutical services to eligible patients made under paragraph 6 of Schedule 3, paragraph 13 of Schedule 3 or regulation 17(6), and

(c) in accordance with any conditions imposed in relation to the dispensing doctor’s ability to provide pharmaceutical services by virtue of regulation 9(7) of the 1992 Regulations or regulation 6(4) of, and paragraph 6 of Schedule 2 to, the 2013 Regulations.

PART 4 — Determination of controlled localities

Areas that are controlled localities

13

(1) Any area that was, or was part of, a controlled locality for the purposes of the 2013 Regulations—

(a) immediately before these Regulations come into force, or

(b) following a determination made in accordance with regulation 63(2),

continues to be, or to be part of, a controlled locality for the purposes of these Regulations (unless or until it is determined that the area is no longer, or is no longer part of, a controlled locality).

(2) Subject to paragraph (3), a Local Health Board must in response to an application submitted in writing by a Local Medical Committee or a Local Pharmaceutical Committee, or may at any other time that it may decide, consider the question of whether or not any particular area within the area for which it is established is, because it is rural in character, a controlled locality or part of a controlled locality.

(3) Where the question of whether or not any particular area is, or is part of, a controlled locality has been determined by a Local Health Board or on appeal by the Welsh Ministers (whether under these Regulations or the 2013 Regulations) that question must not be considered again in relation to the particular area—

(a) for 5 years, beginning on the date of the determination of the Local Health Board or, if that determination was appealed, the date of the decision of the appeal, unless

(b) the Local Health Board is satisfied (within that 5 years) that there has been a substantial change in circumstances affecting the area since the question was last determined.

(4) Parts 1 and 2 of Schedule 4 specify the procedures to be followed by a Local Health Board when determining whether or not an area is a controlled locality under this regulation.

Appeals against decisions under Part 4

14

Parts 1 and 2 of Schedule 4 make provision for appeals to the Welsh Ministers in respect of decisions made under this Part.

PART 5 — Applications by NHS pharmacists and NHS appliance contractors for inclusion in or amendment to pharmaceutical lists

Applications to be included in or make amendment to a pharmaceutical list

15

(1) A person may submit an application to a Local Health Board where that person—

(a) wishes to be included in a pharmaceutical list maintained by the Local Health Board,

(b) is already included in a pharmaceutical list maintained by the Local Health Board but wishes, within the Local Health Board’s area, to—

(i) open additional premises from which to provide the same or different pharmaceutical services,

(ii) relocate to different premises and at those premises to provide the same or different pharmaceutical services, or

(iii) provide from the listed premises pharmaceutical services that are of a different description to those pharmaceutical services already listed in relation to that person, or

(c) is already included in a pharmaceutical list maintained by a neighbouring Local Health Board but wishes to relocate to different premises in the area of the Local Health Board to which the application is made and, at those premises, to provide the same or different pharmaceutical services.

(2) An application to a Local Health Board made under this regulation must be made in writing and must provide the information set out in Part 1 of Schedule 2.

(3) Subject to regulation 60 (home Local Health Board), a person making an application under paragraph (1)(a) must provide the information and undertakings specified in Part 2 of Schedule 2.

(4) If a Local Health Board considers that an application does not contain all of the information required under paragraphs (2) and (3)—

(a) it may request the missing relevant information or documentation from the applicant, and

(b) the applicant must, within the period reasonably specified by the Local Health Board in the request under sub-paragraph (a)—

(i) provide any information or documentation reasonably requested,

(ii) notify the Local Health Board that there is to be a delay in providing the requested information or documentation, for specified reasons, and specify a date by which the applicant undertakes to provide the information or documentation, or

(iii) if the applicant considers that any information or documentation has been unreasonably requested, notify the Local Health Board of that and seek a review by the Local Health Board of the reasonableness of the request.

(5) If an applicant refuses to comply with a request under paragraph (4)(a)—

(a) within the period—

(i) reasonably specified by the Local Health Board under paragraph (4)(b), or

(ii) ending on the date specified by the applicant in accordance with paragraph (4)(b)(ii), if the Local Health Board is satisfied that a delay beyond the period it specified, and the length of the delay, are for good cause,

unless sub-paragraph (b) applies, the application is to be treated as withdrawn;

(b) in circumstances where the applicant has, in accordance with paragraph (4)(b)(iii), sought a review by the Local Health Board of the reasonableness of the request, if the review determines that any or all of the information or documentation requested—

(i) must after all, be provided, the application is to be treated as withdrawn unless the information or documentation that must still be provided is provided within a new period reasonably specified by the Local Health Board for the provision of that information or documentation, or

(ii) need not be provided by the applicant, the request of the Local Health Board is to be treated as withdrawn to the extent that it relates to information or documentation that need not be provided.

(6) The Local Health Board may request information or documentation under this paragraph at any time after it receives an application and before its determination of that application.

(7) An application to be included in a pharmaceutical list by a person not already included must be refused if the applicant is an individual who qualified as a pharmacist in Switzerland or an EEA State other than the United Kingdom, unless that person satisfies the Local Health Board they have the level of knowledge of English which, in the interests of that individual and the persons making use of the pharmaceutical services to which the application relates, is necessary for the provision of those pharmaceutical services in the area of the Local Health Board.

(8) All applications made under regulation 15(1) will be determined in accordance with regulation 16 (determination of applications to be included in or to make amendment to a pharmaceutical list) except for applications to which—

(a) regulation 19 (applications involving relocation within a Local Health Board’s area),

(b) regulation 20 (applications involving relocation between neighbouring Local Health Board areas),

(d) regulation 22 (applications involving a change of ownership),

applies and which are determined in accordance with those regulations.

(9) Parts 1 and 3 of Schedule 3 specify the procedures to be followed by a Local Health Board when determining applications made under this Part.

Determination of applications to be included in or to make amendment to a pharmaceutical list

16

(1) Where the premises specified in an application are not in a controlled locality, the Local Health Board may grant the application only if it is satisfied that it would meet a need for pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant Local Health Board and which have been included in the pharmaceutical needs assessment of that Local Health Board in accordance with Schedule 1.

(2) Where the premises specified in an application are in a controlled locality but not in a reserved location (as defined in regulation 17(4) and (5)), the Local Health Board may—

(a) refuse the application where it is of the opinion that to grant it would prejudice the proper provision of primary medical services, dispensing services or pharmaceutical services in the controlled locality within which the premises specified in the application are situated (the “prejudice test”), and

(b) where the application has not been refused under the prejudice test, grant the application only if it is satisfied that it meets a need identified in the pharmaceutical needs assessment of the relevant Local Health Board.

(3) The prejudice test does not apply to the Local Health Board’s determination of an application where the premises specified in an application are situated in a reserved location.

(4) A Local Health Board must refuse an application in which the applicant does not meet a need that is identified in the pharmaceutical needs assessment of the relevant Local Health Board.

(5) In determining an application under this regulation, which has been made in accordance with regulation 15(1), (except where the application is made by a person who has been granted preliminary consent pursuant to regulation 18 which is valid in accordance with regulation 18(5)), or in accordance with regulation 18 where the applicant is not already included in that Local Health Board’s pharmaceutical list, a Local Health Board may—

(a) defer consideration of the application on fitness grounds in accordance with regulation 36 (deferral of applications on fitness grounds),

(b) refuse the application on fitness grounds in accordance with regulation 37 (refusal of applications on fitness grounds), or

(c) impose conditions on the grant of the application in accordance with regulation 38 (conditional inclusion on fitness grounds).

Locations in controlled localities that are reserved locations

17

(1) A Local Health Board must determine whether premises specified in an application submitted to it under regulation 15 (applications to be included in or make amendment to a pharmaceutical list) or premises or the relevant location from which the applicant wishes to provide pharmaceutical services, specified in an application submitted to it under regulation 18 (applications for preliminary consent and effect of preliminary consent) that are in a controlled locality are also in a reserved location.

(2) Where it has been determined by the Local Health Board, or on appeal by the Welsh Ministers (under paragraph (1) and Schedule 4 respectively) or pursuant to regulation 11 of, or Part 2 of Schedule 3 to, the 2013 Regulations, in relation to premises or a relevant location, from which pharmaceutical services are to be or are being provided, that those premises are or the relevant location is in a reserved location, the person included in the pharmaceutical list in relation to those premises, or that relevant location, may make an application in writing to the Local Health Board to make a further determination as to whether, on the date of the application, those premises are, or that relevant location is, in a reserved location.

(3) For the purposes of this regulation the “relevant location” means, where the location of the premises from which the pharmaceutical services are to be provided is specified in writing by the applicant before the Local Health Board makes its determination, that location, and where that location is not so specified, the best estimate the Local Health Board is able to make of where those premises may be.

(4) Subject to paragraph (5), a reserved location is a location in a controlled locality in respect of which the number of individuals on the patient lists for the area within 1.6 kilometres of the premises or the location of the premises is less than 2,750 persons.

(5) A location is not a reserved location under paragraph (4) if the Local Health Board considers that if a pharmacy were to operate from the location, the extent to which it would be used would be similar to or greater than might be expected if the number of individuals on the patient lists for the area within 1.6 kilometres of the premises or the location were equal to or more than 2,750 persons.

(6) Where in making a further determination applied for in accordance with paragraph (2) the Local Health Board determines that those premises are, or the relevant location is, not in a reserved location, or there is an appeal against a determination by the Local Health Board and it is determined on appeal that the premises are not, or that the relevant location is not, in a reserved location—

(a) the Local Health Board may determine that the premises are, or the relevant location is, to be treated for the purposes of these Regulations as if they were in a reserved location, where it is of the opinion that not to do so would prejudice the proper provision of primary medical services (other than those provided by the Local Health Board itself), dispensing services or pharmaceutical services in any controlled locality, or

(b) if the Local Health Board considered that the provision of primary medical services by a provider of primary medical services (other than one employed by the Local Health Board), pharmaceutical services by a NHS pharmacist or NHS appliance contractor, local pharmaceutical services provided under a pilot scheme or pharmaceutical services provided by a doctor is likely to be adversely affected by a determination that the premises are not in a reserved location, it may make such determination but may impose conditions to postpone, for such period as it thinks fit, the making or termination of arrangements under regulation 26 (or equivalent under the GMS Regulations) for the provision by a doctor or GMS contractor of pharmaceutical services or dispensing services to patients.

18

(1) A person who wishes to be granted the right to be included in a pharmaceutical list maintained by the Local Health Board on a subsequent application under regulation 15(1)(a) or 15(1)(b)(i) (applications to be included in or make amendment to a pharmaceutical list) may submit an application to a Local Health Board for preliminary consent under this regulation.

(2) An application made under this regulation must be made in writing and must provide the information and undertakings set out in—

(a) Part 1 of Schedule 2, and

(b) subject to regulation 60 (home Local Health Board), Part 2 of Schedule 2.

(3) A Local Health Board must determine an application for preliminary consent as if it were an application made pursuant to regulation 15(1)(a) or 15(1)(b)(i).

(4) A preliminary consent will be valid for a period of 6 months from the date on which it is granted, which is the later of either—

(a) 30 days after notice of the Local Health Board’s decision on the application was sent by the Local Health Board in accordance with paragraph 14 of Schedule 3, or

(b) where an appeal is made against the decision of the Local Health Board, the date on which the Welsh Ministers give notice of their decision on the appeal under paragraph 8 of Schedule 4.

(5) A Local Health Board must grant a subsequent application made under regulation 15(1)(a) or 15(1)(b)(i) by a person who has been granted preliminary consent if—

(a) the date on which the application was received by the Local Health Board is within the period specified in paragraph (4),

(b) the pharmaceutical services specified in the application are the same as those that were specified in the application for preliminary consent, and

(c) the premises specified in the application are in the same location as the premises or a location that is relevant to a need identified in the pharmaceutical needs assessment of the Local Health Board.

(6) Where sub-paragraphs (a) and (b) in respect of paragraph (5) are satisfied but the premises specified in the application have a different location from that in respect of which preliminary consent was granted, the Local Health Board must treat the application as though it were an application made pursuant to regulation 15(1)(b)(ii).

(7) The grant of an application under paragraph (5) must be subject to any conditions that were imposed by the Local Health Board, or the Welsh Ministers on appeal, in relation to the final grant of the corresponding preliminary consent.

(8) In determining an application under this regulation from a person who is not already included in the Local Health Board’s pharmaceutical list (apart from an application from a person who has a valid preliminary consent in accordance with paragraph (4)), a Local Health Board may—

(a) defer consideration of the application on fitness grounds under regulation 36 (deferral of application on fitness grounds),

(b) refuse the application on fitness grounds under regulation 37 (refusal of applications on fitness grounds), or

Applications involving relocation within a Local Health Board’s area

19

(1) A person who has made an application under regulation 15(1)(a) (applications to be included in or make amendment to a pharmaceutical list) may at any time after making the application, but before the end of the relevant period (as defined in regulation 23 (procedure following grant of an application)), notify the Local Health Board that they wish to change the premises from which they intend to provide pharmaceutical services specified in the application and the Local Health Board may amend the premises specified in the original application if it is satisfied that—

(a) the change is a relocation,

(b) the pharmaceutical services specified in the application that would have been provided at the premises specified in the original application will be provided at the new premises, and

(c) the relocation still meets the need for pharmaceutical services, or pharmaceutical services of a specified type, identified in the relevant pharmaceutical needs assessment.

(2) A Local Health Board may grant an application made by a person under regulation 15(1)(b)(ii) to relocate from listed premises to new premises at which the person intends to provide pharmaceutical services, if it is satisfied that—

(a) the relocation is to meet a need for pharmaceutical services, or pharmaceutical services of a specified type, identified in the relevant pharmaceutical needs assessment and—

(i) the provision of pharmaceutical services will not be interrupted (except for such period as the Local Health Board may for good reason permit),

(ii) the premises specified in the application from which the person wishes to relocate are not premises to which the person has temporarily relocated under regulation 21 (applications involving temporary relocation), and

(iii) would not, if granted, result in a significant change to the arrangements that are in place for the provision of pharmaceutical services (other than those provided by a person on a dispensing doctor list) in any part of the Local Health Board’s area, or in a controlled locality in the area of a neighbouring Local Health Board where that controlled locality is within 1.6 kilometres of the new premises, or

(b) the relocation is not to meet a need for pharmaceutical services, or pharmaceutical services of a specified type, identified in the relevant pharmaceutical needs assessment but—

(i) for the patients who are accustomed to accessing pharmaceutical services at the existing premises, the location of the new premises is not significantly less accessible,

(ii) the same pharmaceutical services will be provided at the new premises as are provided at the listed premises,

(iii) the provision of pharmaceutical services will not be interrupted (except for such period as the Local Health Board may for good reason permit),

(iv) the premises specified in the application from which the person wishes to relocate are not premises to which the person has temporarily relocated under regulation 21 (applications involving temporary relocation), and

(v) would not, if granted, result in a significant change to the arrangements that are in place for the provision of pharmaceutical services (other than those provided by a person on a dispensing doctor list) in any part of the Local Health Board’s area, or in a controlled locality in the area of a neighbouring Local Health Board where that controlled locality is within 1.6 kilometres of the new premises.

(3) A person who has had an application granted under this regulation may not, within 12 months of the date of the grant of the application (as defined in regulation 23(3)(a)), submit another application for determination pursuant to this regulation or regulation 20.

Applications involving relocation between neighbouring Local Health Board areas

20

(1) A Local Health Board may grant an application made by a person under regulation 15(1)(c) (applications to be included in or make amendment to a pharmaceutical list) to relocate from listed premises in the area of neighbouring Local Health Board to new premises in the area of the Local Health Board to which the application is made, and at those premises the person intends to provide pharmaceutical services, if—

(a) the Local Health Board, to which the application is made, is satisfied that—

(i) the change is a relocation to meet a need identified in the relevant pharmaceutical needs assessment of the Local Health Board,

(ii) for the patients who are accustomed to accessing pharmaceutical services at the existing premises, the location of the new premises is not significantly less accessible,

(iii) the provision of pharmaceutical services will not be interrupted (except for such period as the Local Health Board may for good reason permit),

(iv) the premises specified in the application from which the person wishes to relocate are not premises to which the person has temporarily relocated under regulation 21 (applications involving temporary relocation),

(v) the application would not, if granted, result in a significant change in the arrangements that are in place for the provision of pharmaceutical services (other than those provided by a person on a dispensing doctor list) in any part of the Local Health Board’s area, or in a controlled locality in the area of a neighbouring Local Health Board where that controlled locality is within 1.6 kilometres of the new premises, and

(b) the person consents to the removal of the premises from the pharmaceutical list maintained by the Local Health Board in whose area the current listed premises are located with effect from the date on which the provision of pharmaceutical services from the new premises commences.

(2) A person who has had an application granted pursuant to this regulation may not, within 12 months of the date of the grant of the application (as defined in regulation 23(3)(a)), submit another application for determination under this regulation or regulation 19.

Applications involving temporary relocation

21

(1) A Local Health Board may make a temporary amendment to an entry in a pharmaceutical list by granting an application made by a person under regulation 15(1)(b)(ii) (applications to be included in or make amendment to a pharmaceutical list) to relocate to different premises on a temporary basis if it is satisfied that—

(a) the circumstances in which the application is made require the flexible provision of pharmaceutical services,

(b) for the patients who are accustomed to accessing pharmaceutical services at the existing premises, the location of the temporary premises is not significantly less accessible,

(c) the same pharmaceutical services will be provided at the temporary premises as are provided at the listed premises, and

(d) the provision of pharmaceutical services will not be interrupted (except for such period as the Local Health Board may for good cause allow).

(2) A temporary amendment to an entry in the pharmaceutical list will have effect from the date on which the Local Health Board approved the application made to it and will be valid for such period of up to 6 months and any further periods of up to 3 months each that the Local Health Board considers necessary.

(3) A person may revert to the overridden entry in the pharmaceutical list maintained by the Local Health Board before the end of the period determined by the Local Health Board under paragraph (2) on giving the Local Health Board at least 7 days’ notice in writing.

(4) Where, in accordance with this regulation, an entry in a pharmaceutical list is overridden by a temporary amendment, any proceedings with regard to the overridden arrangements are unaffected by that overriding (although they may need to be stayed for other reasons) and if, as a result of those proceedings the overridden arrangements require amendment before the end of the temporary amendment, the reversion to the overridden arrangements is to be to the original overridden amendments as amended as a result of those proceedings.

Applications involving a change of ownership

22

(1) A Local Health Board must grant an application made by a person under regulation 15(1)(a), (b)(i) or (ii) (applications to be included in or make amendment to a pharmaceutical list) who intends to provide pharmaceutical services at premises from which those services are, at the time of the application, provided by another person who is included in a pharmaceutical list maintained by the Local Health Board under regulation 10 (preparation and maintenance of pharmaceutical lists) if the Local Health Board is satisfied that—

(a) the premises are already included in a pharmaceutical list maintained by the Local Health Board,

(b) the same pharmaceutical services will continue to be provided from the premises, and

(c) the provision of pharmaceutical services will not be interrupted (except for such period as the Local Health Board may for good cause allow).

(2) In determining an application under this regulation which has been made under regulation 15(1)(a) (except where the application has been made by a person who has been granted preliminary consent under regulation 18 which is valid in accordance with regulation 18(5)), or under regulation 18 where the applicant is not already included in that Local Health Board’s pharmaceutical list a Local Health Board may—

(a) defer consideration of the application on fitness grounds under regulation 36 (deferral of applications on fitness grounds),

(b) refuse the application on fitness grounds under regulation 37 (refusal of applications on fitness grounds), or

Procedure following grant of an application

23

(1) Following the date of the grant of an application made under regulation 15 (applications to be included in or make amendment to a pharmaceutical list), a Local Health Board must not include a person in a pharmaceutical list or amend a pharmaceutical list unless—

(a) the condition in paragraph (2) is satisfied, and

(b) the requirements of regulation 38 (conditional inclusion on fitness grounds), if any, are met as regards the imposition of conditions on any person.

(2) A person will be included in the relevant pharmaceutical list or the relevant pharmaceutical list will be amended as appropriate if, not less than 14 days before the end of the relevant period, that person notifies the Local Health Board in writing, providing the information specified in Part 3 of Schedule 2, that they will within the next 14 days commence the provision at the premises of the pharmaceutical services that were specified in the application.

(3) For the purposes of this regulation and, where relevant, regulation 24—

(a) “the date of the grant of an application” is the date which is the later of either—

(i) 30 days after notice of the Local Health Board’s decision on the application was sent by the Local Health Board in accordance with paragraph 14 of Schedule 3, or

(ii) the date of the determination of any appeal that is brought against the decision of the Local Health Board, and

(b) “the relevant period” is—

(i) the period of 6 months from the date of the grant of an application, or

(ii) such further period in addition to that specified in paragraph (i) not exceeding 3 months that the Local Health Board may for good reason allow.

Application to extend the relevant period

24

(1) A person may make an application to the Local Health Board to extend the relevant period no later than 5 months after the date of the grant of an application.

(2) In accordance with regulation 23(3)(b)(ii) a person may apply for an extension of up to 3 months.

(3) An application to the Local Health Board under this regulation must be made in writing and must provide reasons why an extension of the relevant period is sought.

(4) Parts 1 and 3 of Schedule 3 specify the procedures to be followed by a Local Health Board when determining applications made under this regulation.

(5) For the purposes of this regulation, “person” means the person who would be entitled to provide notification to a Local Health Board in accordance with regulation 23(2) of commencement of provision of pharmaceutical services.

Appeals

25

(1) Schedule 4 makes provision for appeals to the Welsh Ministers in respect of decisions of Local Health Boards made under this Part, save for those regulations listed in paragraph (2).

(2) There is no right of appeal in respect of a decision of a Local Health Board—

(a) to make or not to make, or to extend, a temporary amendment to a pharmaceutical list under regulation 21 (applications involving temporary relocation), or

(b) to extend or not to extend the relevant period under regulation 24 (application to extend the relevant period).

PART 6 — Applications by doctors for inclusion in or amendment to dispensing doctors lists

Arrangements for the provision of pharmaceutical services by doctors

26

(1) A Local Health Board may make an arrangement with a doctor who falls within paragraph (8) for the doctor to provide pharmaceutical services to a patient included on the doctor’s patient list or the patient list of a provider of primary medical services by whom the doctor is employed or engaged, if the patient—

(a) would have serious difficulty in obtaining any necessary drugs or appliances from a pharmacy because of distance or inadequacy of means of communication, and the conditions in paragraph (2) are satisfied,

(b) is resident in a controlled locality, at a distance of more than 1.6 kilometres from any pharmacy, and the conditions specified in paragraph (4) are satisfied, or

(c) is resident in a controlled locality and any pharmacy within a distance of 1.6 kilometres from where the patient lives has been determined to be in a reserved location, and that determination has not been altered on appeal or by way of a further determination and the conditions specified in paragraph (4) are satisfied.

(2) The conditions referred to in paragraph (1)(a) are—

(a) the patient has made a request in writing to the Local Health Board for the doctor to provide them with pharmaceutical services for the reasons specified in paragraph (1)(a), and

(b) the Local Health Board is satisfied that the patient would have serious difficulty in obtaining any necessary drugs or appliances for those reasons.

(3) In making an arrangement with a doctor for the doctor to provide a patient under paragraph (1)(a) with pharmaceutical services from practice premises, the Local Health Board must give reasonable notice in writing to the doctor of when the arrangement is to take effect unless the doctor satisfies the Local Health Board that—

(a) the doctor does not normally provide pharmaceutical services to patients, or

(b) the patient would not have serious difficulty in obtaining drugs and appliances from a pharmacy because of distance or inadequacy of means of communication.

(4) The conditions referred to in paragraph (1)(b) and (c) are that—

(a) outline consent has been granted to the doctor or the provider of primary medical services by whom the doctor is employed or engaged,

(b) premises approval has been granted in relation to the premises from which the doctor will provide pharmaceutical services to that patient,

(c) the outline consent and premises approval has taken effect under regulation 31 (taking effect of outline consent and premises approval), and

(d) any conditions imposed under these Regulations in connection with the grant of outline consent or premises approval are such as to permit arrangements to be made under this regulation for the provision of pharmaceutical services by that doctor to patients under paragraph (1)(b) or (c).

(5) References in paragraph (4) to outline consent, premises approval and conditions imposed include references to those in effect under the 2013 Regulations.

(6) A doctor with whom an arrangement has been made to provide pharmaceutical services to a patient under this regulation may, with the consent of the patient, instead of providing the drugs or appliances order them by issuing a prescription to the patient.

(7) Where an arrangement for a doctor to provide pharmaceutical services to a patient was in effect immediately before these Regulations came into force, that arrangement will have effect as though made under this regulation notwithstanding that the conditions in paragraph (4) are not satisfied.

(8) A doctor falls within this paragraph if they are—

(a) a GMS contractor or an APMS contractor,

(b) engaged or employed by a GMS contractor or an APMS contractor, or

(9) A doctor may appeal to the Welsh Ministers against a decision of a Local Health Board under paragraph (3). The appeal must be made in writing within 30 days beginning with the date on which notice of the decision was sent to the doctor and must contain a concise statement of the grounds of appeal.

(10) The Welsh Ministers must, on receipt of any notice of appeal under paragraph (9), send a copy of that notice to the Local Health Board and the relevant GMS contractor or APMS contractor, and the Local Health Board and the relevant GMS contractor or APMS contractor may, within 30 days from the date on which the Welsh Ministers sent a copy of the notice of appeal, make representations in writing to the Welsh Ministers.

(11) The Welsh Ministers may determine an appeal pursuant to paragraph (9) in such manner as they see fit, taking into consideration the preliminary matters in Part 1 of Schedule 4.

(12) The Welsh Ministers must, upon determination by them of any appeal under paragraph (9), give notice of their decision in writing, together with the reasons for it, to the appellant, to the Local Health Board, and to the relevant GMS contractor or APMS contractor.

Necessary services for temporary patients

27

A doctor who provides pharmaceutical services to patients on a patient list by arrangement made with a Local Health Board under regulation 26 (arrangements for the provision of pharmaceutical services by doctors) may provide necessary pharmaceutical services to a person who has been accepted by the doctor as a temporary patient.

Provision of pharmaceutical services for immediate treatment or personal administration

28

(1) Subject to paragraph (2), a doctor whose name is included in a medical performers list may—

(a) provide to a patient any appliance or drug, not being a Scheduled drug, where such provision is needed for the immediate treatment of that patient before a provision can otherwise be obtained, and

(b) provide to a patient any appliance or drug, not being a Scheduled drug, which the doctor personally administers or applies to the patient.

(2) A doctor may only provide a restricted availability appliance if it is for a person or a purpose specified in the Drug Tariff.

Discontinuation of arrangements for the provision of pharmaceutical services by doctors

29

(1) A Local Health Board must give reasonable notice in writing to a doctor that they must discontinue the provision of pharmaceutical services to a patient under an arrangement pursuant to regulation 26 where the patient no longer falls within regulation 26(1)(a), (b) or (c).

(2) A notice given under paragraph (1)—

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