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The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

Type Statutory-Instrument

Publication 2013-02-14

Last updated 2025-10-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Made: 14th February 2013

Laid before Parliament: 22nd February 2013

Coming into force: 1st April 2013

The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 7, 8, 126, 128A, 129, 130, 132, 136, 139, 140, 142(b), 143, 145, 148, 150A, 151(5) and (7), 154, 159(9), 160, 161, 162, 163(3), 164, 169(3) and 272(7) and (8) of, and paragraph 1(2)(b) of Schedule 11 and paragraphs 2 and 3 of Schedule 12 to, the National Health Service Act 2006 .

PART 1 — Introductory

Citation and commencement

1

These Regulations may be cited as the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 and come into force on 1st April 2013.

Interpretation

2

(1) Subject to paragraph (7), in these Regulations—

“100 hours condition” is to be construed in accordance with regulation 65(1);

“the 1968 Act” means the Medicines Act 1968 ;

“the 1992 Regulations” means the National Health Service (Pharmaceutical Services) Regulations 1992 , as in force on 31st March 2005;

“the 2005 Regulations” means the National Health Service (Pharmaceutical Services) Regulations 2005 , as in force on 31st August 2012;

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

“the 2006 Regulations” means the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 , as in force immediately before the appointed day;

“the 2007 Act” means the Local Government and Public Involvement in Health Act 2007 ;

“the 2012 Regulations” means the National Health Service (Pharmaceutical Services) Regulations 2012 , as in force immediately before the appointed day;

“additional opening hours” is to be construed, as the context requires, in accordance with paragraph 23(13) of Schedule 4 or paragraph 13(12) of Schedule 5, or both;

“advanced electronic signature” 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;

“advanced services” means the directed services which NHS England is required (as opposed to authorised) to arrange by virtue of directions under section 127 of the 2006 Act (arrangements for additional pharmaceutical services);

“APMS contractor” means a person or partnership that provides primary medical services under contractual arrangements with NHS England under section 83(2)(b) of the 2006 Act (primary medical services);

“APMS practice” means an APMS contractor that has a patient list;

“appliance” means an appliance included in a list approved by the Secretary of State for the purposes of section 126 of the 2006 Act (arrangements for pharmaceutical services);

“appliance contractor premises” means listed chemist premises (or in the context of an applicant seeking the listing of premises, proposed listed chemist premises) of an NHS appliance contractor;

“appliance use review service” means arrangements made in accordance with directions under section 127 of the 2006 Act for a pharmacist or a specialist nurse to review a person's use of a specified appliance;

“appointed day” means 1st April 2013;

“armed forces of the Crown” means the forces that are “regular forces” or “reserve forces” within the meanings given in section 374 of the Armed Forces Act 2006 (definitions applying for the purposes of whole Act).

“arrangements for recharging” means arrangements under paragraph 3 of Schedule 12A to the 2006 Act (pharmaceutical remuneration – other pharmaceutical remuneration) under which NHS England requires a person to reimburse it for any pharmaceutical remuneration to which that paragraph applies;

“bank holiday” means any day that is by virtue of section 1 of or Schedule 1 to the Banking and Financial Dealings Act 1971 (which relate to bank holidays) a bank holiday in England;

“batch issue” means a form, in the format required by NHS England (or a person exercising its functions) and approved by the Secretary of State, which—is issued by a prescriber at the same time as a non-electronic repeatable prescription to enable an NHS chemist, an LPS chemist or a dispensing doctor to receive payment for the provision of repeat dispensing services;relates to a particular non-electronic repeatable prescription and contains the same date as that prescription;is generated by a computer and not signed by a prescriber;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; andhas included on it a number denoting its place in the sequence referred to in sub-paragraph (d);

“best estimate”, in the context of the location of proposed appliance contractor premises or pharmacy premises mentioned in a routine application, is to be construed in accordance with paragraph 1(10) of Schedule 2;

“breach notice” is to be construed in accordance with regulation 71(1);

“change of ownership application” means an application pursuant to regulation 26;

“Charges Regulations” means the National Health Service (Charges for Drugs and Appliances) Regulations 2015;

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

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

“consolidation application” means an application pursuant to regulation 26A(1);

“continuity principles” is to be construed in accordance with paragraph 1(8) of Schedule 9;

“controlled locality” means an area that is a controlled locality by virtue of regulation 36(1) or is determined to be so in accordance with regulation 36(2) or paragraph 7(4) of Schedule 9;

“core opening hours” is to be construed, as the context requires, in accordance with paragraph 23(2) of Schedule 4 or paragraph 13(2) of Schedule 5, or both;

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

“directed services” means additional pharmaceutical services provided in accordance with directions under section 127 of the 2006 Act;

“director” includes a member of a limited liability partnership;

“dispensing contractor” means an NHS chemist, an LPS chemist or a dispensing doctor whom or which a patient wishes to dispense their electronic prescriptions;

“dispensing doctor” is to be construed in accordance with regulation 46(1);

“dispensing doctor list” is to be construed in accordance with regulation 46(1);

“distance selling premises” are listed chemist premises, or potential pharmacy premises, at or from which essential services are or are to be provided but the means of providing those services are such that all persons receiving those services do so otherwise than at those premises;

“drugs” includes medicines;

“Drug Tariff” is to be construed in accordance with regulation 89(1);

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

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

“electronic prescription form” means data created in an electronic form for the purpose of ordering a drug or appliance, which—is compatible with the systems used by NHS England (or a person exercising its functions) for—the remuneration of persons providing pharmaceutical services, andany apportionment of, or any arrangements for recharging in respect of, that remuneration,unless the NHS chemist, dispensing doctor or LPS chemist dispensing the prescription is to receive no pharmaceutical remuneration of any kind in respect of any drug or appliance ordered on the form;is signed with a prescriber's advanced electronic signature;is transmitted as an electronic communication to a nominated dispensing contractor or via an information hub by the Electronic Prescription Service; anddoes not indicate that the drug or appliance ordered may be provided more than once;

“electronic repeatable prescription” means data created in an electronic form, which—is signed with a prescriber's advanced electronic signature;is transmitted as an electronic communication to a nominated dispensing contractor or via an information hub by the Electronic Prescription Service;indicates that the drugs or appliances ordered may be provided more than once; andspecifies the number of occasions on which they may be provided;

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

“employment” includes unpaid employment and employment under a contract for services, and “employed”, “employer” and “employs” are to be construed accordingly;

“enhanced services” means the directed services which NHS England is authorised (as opposed to required) to arrange by virtue of directions under section 127 of the 2006 Act;

“EPS token” means a form (which may be an electronic form), approved by the Secretary of State, which—is issued by a prescriber at the same time as an electronic prescription is created; andhas a barcode that enables the prescription to be dispensed by a provider of pharmaceutical services that is able to use the Electronic Prescription Service for the purposes of dispensing prescriptions, in circumstances where the provider is not dispensing the prescription as a nominated dispensing contractor;

“essential services”, except in the context of the definition of “distance selling premises”, is to be construed in accordance with paragraph 3 of Schedule 4;

“EPS list” is to be construed in accordance with regulation 10(4)(a);

“Electronic Prescription Service” means the service of that name which is managed by NHS England;

“excepted application” means an application to which section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply by virtue of any provision of Part 4 or a consolidation application to which regulation 26A(2) does not apply;

“financial year” means the 12 months ending with 31st March;

“general practitioner” means a medical practitioner who is on a medical performers list;

“GMS contract” means a general medical services contract;

“GMS practice” means a party (which may be a partnership) to a GMS contract other than NHS England;

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

“GPhC register” means the register maintained under article 19 of the Pharmacy Order 2010 (establishment, maintenance of and access to the register);

“Health Board”, except in the context of “Local Health Board”, means a Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978 (Health Boards);

“health care professional” 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 (the Professional Standards Authority for Health and Social Care);

“home Primary Care Trust” has the same meaning as in the 2012 Regulations;

“HWB” means a Health and Wellbeing Board ;

“independent nurse prescriber” 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;

“integrated care board” means an integrated care board established under Chapter A3 of Part 2 of the National Health Service Act 2006;

“licensing body” means any body anywhere in the world that licenses or regulates any profession;

“listed chemist premises” is to be construed in accordance with regulation 10(3)(a);

“listed dispensing premises” is to be construed in accordance with regulation 46(2)(a);

“listed HRT prescription item” is to be construed in accordance with regulation 17A(1)(a) of the Charges Regulations (HRT only pre-payment certificates), read with regulation 17A(7) of those Regulations;

“listed prescription items voucher” means a form which—is provided or approved by NHS England for the purposes of ordering a prescription item mentioned in regulation 13(1) of the Charges Regulations (exemption from charges: risks to public health); andmay be an electronic form sent or to be sent via a secure service approved for this purpose by NHS England;

“LPIV” means a listed prescription items voucher;

“Local Healthwatch organisation” is to be construed in accordance with section 222(2A) of the 2007 Act (arrangements under section 221(1));

“LPS chemist” means a party, other than the commissioning body, to—an LPS pilot scheme; oran LPS scheme for the provision of LP services;

“LPS contractor” means a person who is an LPS chemist by virtue of being a party to an LPS scheme which is not an LPS pilot scheme;

“LPS pilot scheme” means a pilot scheme within the meaning given in section 134(2) of the 2006 Act (pilot schemes);

“LPS scheme”, except in the context of Part 13 or Schedule 7, includes an LPS pilot scheme;

“medical performers list” means a list of medical practitioners prepared, maintained and published under regulations under section 91 of the 2006 Act (persons performing primary medical services);

“medical practice premises” means—in relation to a provider of primary medical services, premises which are identified in the provider's arrangements with NHS England as the practice premises at or from which primary medical services are to be provided during core hours to patients on the provider's patient list; orin relation to a general practitioner on a dispensing doctor list who is not a provider of primary medical services but who performs services on behalf of a provider of primary medical services, the practice premises at or from which primary medical services are to be provided during core hours to patients on the provider's patient list;

“member”, in relation to a provider of primary medical services, means—a member of or partner in the partnership that is the provider; ora shareholder in the company limited by shares that is the provider,but no other providers of primary medical services are to be treated as having members;

“national disqualification” includes, in addition to a national disqualification as mentioned in section 159 of the 2006 Act (national disqualification)—a national disqualification as mentioned in section 115 of the National Health Service (Wales) Act 2006 (national disqualification);any decision in Scotland or Northern Ireland corresponding to a national disqualification as mentioned in section 159 to the 2006 Act; andany other decision that was a national disqualification for the purposes of the 2012 Regulations;

“neighbouring HWB”, in relation to a HWB (HWB1), means the HWB of an area that borders any part of the area of HWB1;

“NHS appliance contractor” means a person included in a pharmaceutical list of the type referred to in regulation 10(2)(b);

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

“NHS CFA” means the NHS Counter Fraud Authority, established by the NHS Counter Fraud Authority (Establishment, Constitution, and Staff and Other Transfer Provisions) Order 2017;

“NHS chemist” means an NHS appliance contractor or an NHS pharmacist;

“NHS England” means the body corporate established under section 1H of the 2006 Act;

“NHS England directory of services” means the directory of services, maintained by NHS England, which is accessed by NHS urgent and emergency care services if a patient is in need of urgent assistance from a health care professional or urgent access to health care advice;

“NHS dispute resolution procedure”, in relation to an LPS scheme which is not an LPS pilot scheme, means the dispute resolution procedure set out in paragraphs 22 and 23 of Schedule 7;

“NHS Litigation Authority” means the National Health Service Litigation Authority established by the National Health Service Litigation Authority (Establishment and Constitution) Order 1995 ;

“NHS.net Connect” means the secure e-mail service of that name for the sharing of patient identifiable and patient sensitive information, for which NHS England is responsible;

“NHS pharmacist” means a person included in a pharmaceutical list of the type referred to in regulation 10(2)(a);

“NHS services” means services provided as part of the health service (so includes services provided as part of the health service in pursuance of the public health functions of the Secretary of State or local authorities);

“nominated dispensing contractor” means an NHS chemist, an LPS chemist or a dispensing doctor who has been nominated in a particular patient's PDS patient details to dispense the electronic prescriptions of that patient;

“non-electronic prescription form” means a form for ordering a drug or appliance which—is compatible with the systems used by NHS England (or a person exercising its functions) for—the remuneration of persons providing pharmaceutical services, andany apportionment of, or any arrangements for recharging in respect of, that remuneration,unless the NHS chemist, dispensing doctor or LPS chemist dispensing the prescription is to receive no pharmaceutical remuneration of any kind in respect of any drug or appliance ordered on the form;has been provided for use by a prescriber by—NHS England,another primary care organisation,a local authority, under arrangements for providing NHS services which include, with the consent of NHS England, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,the Secretary of State, an integrated care board, under arrangements for providing NHS services which include, with the consent of NHS England, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,an NHS Trust, oran NHS Foundation Trust;if—it has been so provided for use by a prescriber in England, anda prescription charge may be payable in relation to the prescription or a prescription charge exemption in the Charges Regulations may apply to it,is in a format that has been approved by the Secretary of State;has been issued by a prescriber; anddoes not indicate that the drug or appliance ordered may be provided more than once;

“non-electronic repeatable prescription” means a repeatable prescription which is not an electronic repeatable prescription;

“non-proprietary name” 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 in accordance with regulation 318 of the Human Medicines Regulations 2012 (lists of names) and which is in force;

“notice” or “notification”, except in the context of a period of notice, means a notice or notification in writing, which may (except in the context of a notice to be exhibited) be in an electronic form, and “notify” is to be construed accordingly;

“notice of commencement” means a notice given, or to be given, under paragraph 34(2) of Schedule 2;

“notifiable application” is to be construed in accordance with paragraph 18 of Schedule 2;

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

“optometrist independent prescriber” means an optometrist against whose name in the register of optometrists maintained under section 7 of the Opticians Act 1989 (which relates to the register of optometrists and the register of dispensing opticians) is recorded an annotation signifying that the optometrist is qualified to order drugs and appliances as an optometrist independent prescriber;

“other primary care organisation” or “another primary care organisation” means—as regards Wales—a Local Health Board, orin relation to any time prior to 1st April 2003 a Health Authority;as regards Scotland, a Health Board;as regards Northern Ireland—the Regional Health and Social Care Board, orin relation to any time prior to 1st April 2010, a Health and Social Services Board; andas regards England in relation to any time prior to 1st April 2013, a Primary Care Trust;

“outline consent”, in the context of—an application for outline consent, is to be construed in accordance with regulation 51(1)(a); ora subsisting outline consent, means outline consent—granted under these Regulations, orwhich was outline consent for the purposes of the 2012 Regulations;

“outstanding pharmacy application” has the meaning given in regulation 53(7);

“paramedic independent prescriber” means a person—who is registered in Part 8 of the register maintained under article 5 of the Health Professions Order 2001; andagainst whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines or appliances as a paramedic independent prescriber;

“patient list” means a list of patients that is a registered patient list for the purposes of the Primary Medical Services (Sale of Goodwill and Restrictions on Sub-contracting) Regulations 2004 ;

“PDS patient details” means the information held about a patient in the Patient Demographics Service managed by NHS England;

“pharmaceutical needs assessment” is to be construed in accordance with regulations 3(1) and 7;

“pharmaceutical needs assessment map” means the map which a HWB includes in its pharmaceutical needs assessment pursuant to paragraph 7 of Schedule 1;

“pharmacist independent prescriber” means a registered pharmacist (P)—against whose name in Part 1 of the GPhC register or in the register maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 (which relate to the registers and the registrar) is recorded an annotation signifying that P is qualified to order drugs and appliances as a pharmacist independent prescriber; andwho is prescribing under arrangements for the provision of NHS services which are neither—pharmaceutical services, unless they are arrangements for the provision of enhanced services, norlocal pharmaceutical services, unless they are arrangements for the provision of services that are of the same type as enhanced services;

“pharmacy premises” means listed chemist premises (or in the context of an applicant seeking the listing of premises, proposed listed chemist premises) of an NHS pharmacist;

“pharmacy procedures” are the procedures required by section 72A(3) of the 1968 Act (the responsible pharmacist);

“physiotherapist independent prescriber” means a physiotherapist who is registered in Part 9 of the register maintained under article 5 of the Health Professions Order 2001, and against whose name in that register is recorded an annotation signifying that the physiotherapist is qualified to order drugs and appliances as a physiotherapist independent prescriber;

“PMS contractor” means—a person with whom arrangements have been made under section 92 of the 2006 Act (which relates to arrangements for the provision of primary medical services), unless that person is in a partnership and the other members of the partnership have also made parallel arrangements under that section;a partnership, the members of which have made arrangements in parallel under section 92 of the 2006 Act;

“PMS practice” means a PMS contractor that has, or each of whose members (in the case of a partnership) has, a patient list;

“PMS Regulations” means the National Health Service (Personal Medical Services Agreements) Regulations 2015;

“practice amalgamation” is to be construed in accordance with regulation 59(1);

“premises approval”, in the context of—an application for premises approval, is to be construed in accordance with regulation 51(1)(b); ora subsisting premises approval, means premises approval—granted under these Regulations, orwhich was a premises approval for the purposes of the 2012 Regulations;

“prescriber”, unless the context otherwise requires, means a medical practitioner, a dental practitioner, a pharmacist independent prescriber, a supplementary prescriber, a chiropodist or podiatrist independent prescriber, a physiotherapist independent prescriber, an independent nurse prescriber , an optometrist independent prescriber, a paramedic independent prescriber or a therapeutic radiographer independent prescriber;

“prescription form”, except in the context of the expression “electronic prescription form” or “non-electronic prescription form”, means an electronic prescription form or a non-electronic prescription form;

“prescription item” means an item available on prescription, whether or not it is supplied in pursuance of a prescription or another basis for supply (for example a serious shortage protocol or a patient group direction);

“Prescription of Drugs Regulations” means the National Health Service (General Medical Services) (Prescription of Drugs etc.) Regulations 2004 ;

“prescription only medicine” has the same meaning as in the Human Medicines Regulations 2012 ;

“product with an appropriate non-proprietary name” means a product with a non-proprietary name which is not mentioned in—Schedule 1 to the Prescription of Drugs Regulations (drugs and other substances not to be ordered under a general medical services contract); orexcept where the conditions set out in paragraph 42(2)(a) and (b) of Schedule 6 to the GMS Regulations (other contractual terms – restrictions on prescribing by medical practitioners) are satisfied, in Schedule 2 of the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances);

“protected characteristic” means a characteristic listed in section 149(7) of the Equality Act 2010 (public sector equality duty), and references to people sharing a protected characteristic are to be understood by referral to the provisions of Chapter 1 of Part 2 of that Act (protected characteristics);

“provider of primary medical services” means a GMS practice, a PMS practice or an APMS practice, and “provides” in the context of primary medical services, is to be construed accordingly;

“provisional date” is to be construed in accordance with regulation 53(8)(b);

“PTP” means a pandemic treatment protocol, which is a protocol—relating to the supply of a prescription only medicine to be used for the prevention of or as a treatment for a disease that is, or in anticipation of it being imminently, pandemic; andapproved in accordance with regulation 247 of the Human Medicines Regulations 2012 (exemption for supply in the event or anticipation of pandemic disease);

“PTPGD” means a pandemic treatment patient group direction, which is a patient group direction—relating to the supply of a prescription only medicine to be used for the prevention of or as a treatment for a disease that is, or in anticipation of it being imminently, pandemic; andwhich is in accordance with regulation 233 of the Human Medicines Regulations 2012 (exemption for supply etc under a PGD by a person conducting a retail pharmacy business);

“Regional Health and Social Care Board” means the Regional Health and Social Care Board established under section 7 of the Health and Social Care (Reform) Act (Northern Ireland) 2009 (Regional Health and Social Care Board);

“registered pharmacist” means a person who is registered in Part 1 ... of the GPhC register or in the register maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;

“registered pharmacy technician” means a person registered as a pharmacy technician in Part 2 ... of the GPhC register;

“relevant HWB” means—in the context of an application for any entry of any type in a pharmaceutical list or dispensing doctor list (including from a person already included in the list), the HWB for the area to which the list relates;as regards a person with an entry of any type in a pharmaceutical list or dispensing doctor list, the HWB for the area to which the list relates;in the context of an application by a person for dispensing services, the HWB which is, as regards the dispensing doctor from whom the applicant is seeking dispensing services, the relevant HWB (by virtue of sub-paragraph (b)); andin the context of a decision to suspend or remove any type of entry of a person in a pharmaceutical list or dispensing doctor list, the HWB for the area to which the list relates;

“relevant list” means—a pharmaceutical list or an equivalent list maintained by another primary care organisation; ora list maintained by NHS England or another primary care organisation of approved performers or providers of primary medical, dental or ophthalmic services;

“relevant NHS services” means pharmaceutical services, local pharmaceutical services and primary medical services;

“remedial notice” is to be construed in accordance with regulation 70(1);

“Remission of Charges Regulations” means the National Health Service (Travel Expenses and Remission of Charges) Regulations 2003 ;

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

“repeatable prescription” means an electronic repeatable prescription or a form for ordering drugs or appliances which—is compatible with the systems used by NHS England (or a person exercising its functions) for—the remuneration of persons providing pharmaceutical services, andany apportionment of, or any arrangements for recharging in respect of, that remuneration,unless the NHS chemist, dispensing doctor or LPS chemist dispensing the prescription is to receive no pharmaceutical remuneration of any kind in respect of any drug or appliance ordered on the form;has been provided for use by a prescriber by—NHS England,another primary care organisation,a local authority, under arrangements for providing NHS services which include, with the consent of NHS England, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,the Secretary of State, an integrated care board, under arrangements for providing NHS services which include, with the consent of NHS England, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,an NHS Trust, oran NHS Foundation Trust;if—it has been so provided for use by a prescriber in England, anda prescription charge may be payable in relation to the prescription or a prescription charge exemption in the Charges Regulations may apply to it,is in a format that has been approved by the Secretary of State;has been issued by a prescriber,indicates that the drugs or appliances ordered may be provided more than once; andspecifies the number of occasions on which they may be provided;

“reserved location” means, unless the context otherwise requires, an area classified as such following a determination (that has not lapsed) under—regulation 41(2) or 42(1);regulation 41(2) or 42(1) of the 2012 Regulations (which related to initial, second and subsequent determinations of reserved location status), whether or not by virtue of paragraph 8 of Schedule 9; orregulation 35 of the 2005 Regulations (pharmaceutical services in reserved locations), whether or not by virtue of—paragraph 8 of Schedule 9, orparagraph 6 of Schedule 7 to the 2012 Regulations (transitional provisions – reserved locations);

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

“routine application” is to be construed in accordance with regulation 12;

“the SCAT Regulations” means the National Health Service (Service Committees and Tribunal) Regulations 1992 , as in force on 31st August 2012;

“Scheduled drug” means a drug 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);

“scheme premises” is to be construed in accordance with regulation 102(1)(b);

“serious shortage protocol” 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 (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 Secretary of State in circumstances where England or any part of England is, in the opinion of the Secretary of State, 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 a provider of 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 England (which may be all of England) in which, the protocol is to have effect;

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

“specified appliance” 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 drainage wound pouch;an incontinence appliance listed in Part IXB of the Drug Tariff; ora stoma appliance listed in Part IXC of the Drug Tariff;

“SSP” means a serious shortage protocol;

“stoma appliance customisation” 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;

“superintendent” has the same meaning as in section 71 of the 1968 Act (bodies corporate);

“staff” includes locums and other persons engaged on contracts for services who act as staff;

“supplementary opening hours” is to be construed, as the context requires, in accordance with paragraph 23(3) of Schedule 4 or paragraph 13(4)(a) of Schedule 5, or both;

“supplementary prescriber” means—a registered pharmacist against whose name in Part 1 of the GPhC 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 and appliances as a supplementary prescriber;a person—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, dietitians, physiotherapists or radiographers, andagainst whose name in that register is recorded an annotation signifying that they are qualified to order drugs and appliances as a supplementary prescriber; oran optometrist against whose name in the register of optometrists maintained under section 7 of the Opticians Act 1989 is recorded an annotation signifying that the optometrist is qualified to order drugs and appliances as a supplementary prescriber;

“therapeutic radiographer independent prescriber” means a radiographer—who is registered in Part 11 of the register maintained under article 5 of the Health Professions Order 2001; andagainst whose name in that register is recorded—an entitlement to use the title “therapeutic radiographer”, andan annotation signifying that the radiographer is qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;

“transfer scheme” means a property transfer scheme under section 300 of the Health and Social Care Act 2012 (transfer schemes) that transfers the rights and liabilities of a Primary Care Trust under arrangements for the provision of pharmaceutical or local pharmaceutical services to other persons.

(2) In these Regulations, “pharmaceutical services”, in the context of—

(a) Part 2 and Schedule 1, means the pharmaceutical services to which a pharmaceutical needs assessment must relate by virtue of regulation 3(2); or

(b) arrangements made or to be made for the provision of pharmaceutical services by a medical practitioner, means the dispensing of drugs and appliances but not pharmaceutical services as mentioned in section 132(7)(a) or (b) of the 2006 Act (persons authorised to provide pharmaceutical services),

but otherwise (except in the phrase “local pharmaceutical services”) has the meaning given in section 126(8) of the 2006 Act (arrangements for pharmaceutical services).

(3) Where reference is made in these Regulations to proceedings (but not investigations) reaching their final outcome—

(a) in relation to any proceedings where there are rights of appeal under these Regulations either to the Secretary of State or the First-tier Tribunal, means the outcome of the proceedings—

(i) once the period for bringing an appeal has expired without an appeal being brought, or

(ii) if an appeal is brought in accordance with those rights, once the Secretary of State or the First-tier Tribunal has determined the appeal,

whether or not the matter is thereafter appealed through the courts; or

(b) in relation to any other proceedings where there are rights of appeal (but not including appeals through the courts against decisions referred to in sub-paragraph (a)(ii)), means the outcome of the proceedings—

(i) once the period for bringing an appeal has expired without an appeal being brought, or

(ii) if an appeal is brought in accordance with those rights, once those rights have been exhausted.

(4) Where reference is made in these Regulations to a decision of NHS England and that decision is changed on appeal (whether by the Secretary of State, the First-Tier Tribunal or a court), unless the context otherwise requires, the reference to that decision is to be construed as a reference to the decision as changed on appeal.

(5) For the purposes of these Regulations, “emergency requiring the flexible provision of pharmaceutical services” means an emergency declared by means of directions given by the Secretary of State under section 168A of the 2006 Act (exercise of functions) to the effect that, as a result of threatened or actual serious damage to human welfare caused or which may be caused by the circumstances specified in the directions, NHS England must for a specified period—

(a) exercise, or

(b) where a discretion is conferred, consider exercising,

one or more of their functions under regulation 29(2), regulation 61, paragraph 27 of Schedule 4, paragraph 17 of Schedule 5 or paragraph 26(3) of Schedule 7, subject to any conditions or limitations set out in the directions.

(6) Where—

(a) directions of the type mentioned in paragraph (5) are given; and

(b) the Secretary of State issues further directions changing the specified period of the emergency,

the duration of the emergency is to be construed in accordance with the specified period as so changed.

(7) Where a word or expression used in Schedule 9 has a different meaning in the 2005 Regulations, the 2006 Regulations or the 2012 Regulations from that given in paragraphs (1) to (3), that word or expression bears the meaning that it bears in the 2005 Regulations, the 2006 Regulations or 2012 the Regulations, or is given in paragraphs (1) to (3), as the context requires.

(8) In these Regulations, where reference is made to an announcement or advice of NHS England that relates to a disease being, or in anticipation of a disease being imminently—

(a) pandemic; and

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

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

PART 2 — Pharmaceutical needs assessments

Pharmaceutical needs assessments

3

(1) The statement of the needs for pharmaceutical services which each HWB is required to publish by virtue of section 128A of the 2006 Act (pharmaceutical needs assessments), 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 NHS England for—

(a) the provision of pharmaceutical services (including directed services) by a person on a pharmaceutical list;

(b) the provision of local pharmaceutical services under an LPS scheme (but not LP services which are not local pharmaceutical services); or

(c) the dispensing of drugs and appliances by a person on a dispensing doctors list (but not other NHS services that may be provided under arrangements made by NHS England 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 HWB must, in so far as is practicable, keep up to date the map which it includes in its pharmaceutical needs assessment pursuant to paragraph 7 of Schedule 1 (without needing to republish the whole of the assessment or publish a supplementary statement).

Date by which the first HWB pharmaceutical needs assessments are to be published

5

Each HWB must publish its first pharmaceutical needs assessment by 1st April 2015.

Subsequent assessments

6

(A1) Subject to paragraph (A3), any HWB that has not published a pharmaceutical needs assessment before 1st July 2020 must publish its first pharmaceutical needs assessment by 1st October 2022.

(A2) Any HWB that has published a pharmaceutical needs assessment before 1st July 2020 must publish a revised assessment by 1st October 2022 (but it is not required to publish a revised assessment before that date).

(A3) Any HWB established on or after 1st January 2022 must publish its first pharmaceutical needs assessment no later than twelve months after it is established.

(1) Subject to paragraph (2), after it has published its first assessment as required by paragraph (A1) or (A3), or a revised assessment as required by paragraph (A2) or (2), each HWB must publish a statement of its revised assessment within 3 years of its previous publication of a pharmaceutical needs assessment.

(2) Each HWB that has published a pharmaceutical needs assessment must make a revised assessment as soon as is reasonably practicable after identifying changes since the previous assessment, which are of a significant extent, to the need for pharmaceutical services in its area, having regard in particular to changes to—

(a) the number of people in its area who require pharmaceutical services;

(b) the demography of its area; and

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 HWB may publish a supplementary statement explaining changes to the availability of pharmaceutical services since the publication of its or a Primary Care Trust's pharmaceutical needs assessment (and any such supplementary statement becomes part of that assessment), where—

(a) the changes are relevant to the granting of applications referred to in section 129(2)(c)(i) or (ii) of the 2006 Act; and

(b) the HWB—

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

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

(3ZA) Except in the circumstances provided for in paragraph (4), a supplementary statement must not provide (and if it does, it must not be read as providing) a new analysis of service provision (for example, by identifying gaps in service provision).

(3ZB) Paragraph (3ZA) does not apply in the case of a routine application submitted before 1st October 2025 based on a need, an improvement or better access identified in a supplementary statement as part of the provision of a new analysis of service provision (but does apply to consideration after that date of an unforeseen benefits application submitted before that date).

(3A) Pending the publication of a first pharmaceutical needs assessment under paragraph (A1) or (A3), a HWB (“HWB1”) may publish a supplementary statement explaining changes to the availability of pharmaceutical services since the publication of a pharmaceutical needs assessment by another HWB (“HWB2”) prior to the establishment of HWB1, where—

(a) the changes are relevant to the granting of applications referred to in section 129(2)(c)(i) or (ii) of the 2006 Act in respect of premises in a locality in the area of HWB1 that was, prior to HWB1’s establishment, in the area of HWB2; and

(b) HWB1 is in the course of making its first pharmaceutical needs assessment and is satisfied that immediate modification of HWB2’s assessment is essential in order to prevent significant detriment to the provision of pharmaceutical services in that locality in the area of HWB1.

(4) Where chemist premises are removed from a pharmaceutical list as a consequence of the grant of a consolidation application, if in the opinion of the relevant HWB the removal does not create a gap in pharmaceutical services provision that could be met by a routine application—

(a) to meet a current or future need for pharmaceutical services; or

(b) to secure improvements, or better access, to pharmaceutical services,

the relevant HWB must publish a supplementary statement explaining that, in its view, the removal does not create such a gap, and any such statement becomes part of its pharmaceutical needs assessment.

Temporary extension of Primary Care Trust pharmaceutical needs assessments and access by the NHSCB and HWBs to pharmaceutical needs assessments

7

(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(1A) Prior to the publication by a HWB (“HWB1”) of the first pharmaceutical needs assessment that it prepares for its area, as required by regulation 6(A1) or (A3), the pharmaceutical needs assessment that relates to any locality within its area is the pharmaceutical needs assessment of the HWB (“HWB2”) for that locality prior to the establishment of HWB1, read with—

(a) any supplementary statement relating to that assessment published by HWB2 under regulation 6(3) (which has become part of that assessment); and

(b) any supplementary statement relating to that assessment published by HWB1 under regulation 6(3A).

(2) Each HWB must ensure that NHS England has access to—

(a) the HWB's pharmaceutical needs assessment (including any supplementary statement that it publishes, in accordance with regulation 6(3), that becomes part of that assessment);

(b) any supplementary statement that the HWB publishes, in accordance with regulation 6(3A), in relation to another HWB’s pharmaceutical needs assessment; and

which is sufficient to enable NHS England to carry out its functions under these Regulations.

(3) Each HWB must ensure that, as necessary, other HWBs have access to any pharmaceutical needs assessment of a Primary Care Trust that it holds, which is sufficient to enable the other HWBs to carry out their functions under these Regulations.

Consultation on pharmaceutical needs assessments

8

(1) When making an assessment for the purposes of publishing a pharmaceutical needs assessment, each HWB (HWB1) must consult the following about the contents of the assessment it is making—

(a) any Local Pharmaceutical Committee for its area (including any Local Pharmaceutical Committee for part of its area or for its area and that of all or part of the area of one or more other HWBs);

(b) any Local Medical Committee for its area (including any Local Medical Committee for part of its area or for its area and that of all or part of the area of one or more other HWBs);

(d) any LPS chemist in its area with whom NHS England has made arrangements for the provision of any local pharmaceutical services;

(e) any Local Healthwatch organisation for its area, and any other patient, consumer or community group in its area which in the opinion of HWB1 has an interest in the provision of pharmaceutical services in its area; and

(f) any NHS trust or NHS foundation trust in its area;

(g) NHS England; and

(h) any neighbouring HWB.

(2) The persons mentioned in paragraph (1) must together be consulted at least once during the process of making the assessment on a draft of the proposed pharmaceutical needs assessment.

(3) Where a HWB is consulted on a draft under paragraph (2), if there is a Local Pharmaceutical Committee or Local Medical Committee for its area or part of its area that is different to a Local Pharmaceutical Committee or Local Medical Committee consulted under paragraph (1)(a) or (b), that HWB—

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

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

(4) The persons consulted on the draft under paragraph (2) must be given a minimum period of 60 days for making their response to the consultation, beginning with the day by which all those persons have been served with the draft.

(5) For the purposes of paragraph (4), a person is to be treated as served with a draft if that person is notified by HWB1 of the address of a website on which the draft is available and is to remain available (except due to accident or unforeseen circumstances) throughout the period for making responses to the consultation.

(6) If a person consulted on a draft under paragraph (2)—

(a) is treated as served with the draft by virtue of paragraph (5); or

(b) has been served with copy of the draft in an electronic form,

but requests a copy of the draft in hard copy form, HWB1 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).

Matters for consideration when making assessments

9

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

(a) the demography of its area;

(b) whether in its area there is sufficient choice with regard to obtaining pharmaceutical services;

(d) the pharmaceutical services provided in the area of any neighbouring HWB which affect—

(i) the need for pharmaceutical services in its area, or

(ii) whether further provision of pharmaceutical services in its area would secure improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in its area; and

(e) any other NHS services provided in or outside its area (which are not covered by sub-paragraph (d)) which affect—

(i) the need for pharmaceutical services in its area, or

(ii) whether further provision of pharmaceutical services in its area would secure improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in its area.

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

(a) to the extent necessary to make a proper assessment of the matters mentioned in paragraphs 2 and 4 of Schedule 1; and

(b) having regard to likely changes to—

(i) the number of people in its area who require pharmaceutical services,

(ii) the demography of its area, and

(iii) the risks to the health or well-being of people in its area.

PART 3 — General matters relating to pharmaceutical lists and applications in respect of them

Pharmaceutical lists and EPS lists

10

(1) In respect of the area of each HWB, NHS England must prepare, maintain and publish 2 lists of persons (if there are any), other than medical practitioners or dental practitioners, who undertake to provide pharmaceutical services at or from premises situated in that area.

(2) Those lists (which are pharmaceutical lists) are—

(a) a list of persons who undertake to provide pharmaceutical services in particular by way of the provision of drugs; and

(b) a list of persons who undertake to provide pharmaceutical services only by way of the provision of appliances.

(3) Those lists must include—

(a) the address of the premises in the area of the HWB at or from which the listed person has undertaken to provide pharmaceutical services (“the listed chemist premises”);

(b) the days on which and times at which, at or from those premises, the listed person is to provide those services during the core opening hours and any supplementary opening hours of the premises.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) NHS England must ensure that each HWB has access to the pharmaceutical lists ... that it holds which is sufficient to enable the HWB to carry out its functions under these Regulations, and must notify it of changes to the lists that are relevant to the carrying out of its functions.

(7) Schedule 2, which has effect, contains provisions with regard to—

(a) the information to be supplied by a person—

(i) seeking inclusion in a pharmaceutical list who is not already included in it, or

(ii) who is included in a pharmaceutical list and who is seeking—

(aa) to open, within the area of the relevant HWB, additional premises at or from which to provide the same or different pharmaceutical services,

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

(cc) to provide, at or from the person's listed chemist premises, services that are in addition to those already listed in relation to that person; and

(b) the procedure to be followed by persons as mentioned in sub-paragraph (a) when making a routine application or an excepted application; and

(8) Schedule 3 has effect in relation to appeals to the Secretary of State against decisions under Parts 2 to 5 and Schedule 2 (as it does in relation to appeals against decisions under Parts 7, 8, 10 and 12).

Terms of service of NHS chemists: general

11

(1) The arrangements under which an NHS pharmacist undertakes to provide pharmaceutical services (and so their terms of service) are to include any provisions affecting their rights or obligations—

(a) that are included in these Regulations, including—

(i) the terms of service set out in Schedule 4 (which accordingly has effect), and

(ii) any obligation that is only applicable in prescribed cases, if the NHS pharmacist is a person to whom the obligation is applicable;

(b) that are included in the Drug Tariff, in so far as those rights or obligations relate to NHS pharmacists and are applicable in the case of the NHS pharmacist;

(c) where NHS England makes an arrangement with the NHS pharmacist for the provision of any directed services, that are included in that arrangement; and

(d) that are—

(i) included in regulations under section 225 of the 2007 Act (duties of services-providers to allow entry by Local Healthwatch organisations or contractors), and

(ii) made for the purpose of imposing on a services-provider (within the meaning of that section) a duty to allow authorised representatives (within the meaning of that section) to enter and view, and observe the carrying-on of activities at or from, premises owned or controlled by the services-provider,

as varied, where applicable, in accordance with regulation 35 or Chapter 6 of Part 7 of the 2006 Act.

(2) The arrangements under which an NHS appliance contractor undertakes to provide pharmaceutical services (and so their terms of service) are to include any provisions affecting their rights or obligations—

(a) that are included in these Regulations, including—

(i) the terms of service set out in Schedule 5 (which accordingly has effect), and

(ii) any obligation that is only applicable in prescribed cases, if the NHS appliance contractor is a person to whom the obligation is applicable;

(b) that are included in the Drug Tariff, in so far as those rights or obligations relate to NHS appliance contractors and are applicable in the case of the NHS appliance contractor;

(c) where NHS England makes an arrangement with the NHS appliance contractor for the provision of any directed services, that are included in that arrangement; and

(d) that are—

(i) included in regulations under section 225 of the 2007 Act (duties of services-providers to allow entry by Local Healthwatch organisations or contractors), and

(ii) made for the purpose of imposing on a services-provider (within the meaning of that section) a duty to allow authorised representatives (within the meaning of that section) to enter and view, and observe the carrying-on of activities at or from, premises owned or controlled by the services-provider,

as varied, where applicable, in accordance with regulation 35 or Chapter 6 of Part 7 of the 2006 Act.

(3) A term of service of an NHS chemist that would otherwise be part of the arrangements mentioned in paragraphs (1) and (2) is temporarily not part of those arrangements, in the particular circumstances mentioned in sub-paragraph (c)(ii) and during the period mentioned in sub-paragraph (c)(iii), in the following circumstances—

(a) as a consequence of a disease being, or in anticipation of a disease being imminently—

(i) pandemic, and

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

NHS England with the agreement of the Secretary of State has made an announcement in respect of the prioritisation of services to be provided in, or in any part of, England as part of the health service;

(b) the prioritisation is in order to assist in the management of the serious risk or potentially serious risk to human health;

(c) as part of the announcement, NHS England with the agreement of the Secretary of State has issued advice to the effect that NHS chemists are not to comply with a specified term of service—

(i) in the area to which the announcement relates,

(ii) in the circumstances specified in the announcement, and

(iii) during the period specified in the announcement; and

(d) the NHS chemist is situated in the area to which the announcement relates and compliance with the term of service (it being the specified term of service) would, but for the effect of this paragraph, be a requirement of the NHS chemist’s terms of service.

Routine applications for inclusion in or amendments to a pharmaceutical list

12

In these Regulations, a “routine application” is any application, other than an excepted application, by a person—

(a) for inclusion in a pharmaceutical list who is not already included in it; or

(b) who is included in a pharmaceutical list and who is seeking—

(i) to open, within the area of the relevant HWB, additional premises at or from which to provide the same or different pharmaceutical services,

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

(iii) to provide, at or from the person's listed chemist premises, services that are in addition to those already listed in relation to that person.

Current needs: additional matters to which NHS England must have regard

13

(1) If—

(a) NHS England receives a routine application and is required to determine whether granting it, or granting it in respect of some only of the services specified in it, would meet a current need for pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB; and

(b) the current need has been included in the relevant pharmaceutical needs assessment in accordance with paragraph 2(a) of Schedule 1,

in determining whether it is satisfied as mentioned in section 129(2A) of the 2006 Act (regulations as to pharmaceutical services), NHS England must have regard to the matters set out in paragraph (2).

(2) Those matters are—

(a) whether it is satisfied that it would be desirable to consider, at the same time as the applicant's application, applications from other persons offering to meet the current need mentioned in paragraph (1) that the applicant is offering to meet;

(b) whether it is satisfied that another application offering to meet the current need mentioned in paragraph (1) has been submitted to it, and it would be desirable to consider, at the same time as the applicant's application, that other application;

(c) whether it is satisfied that an appeal relating to another application offering to meet the current need mentioned in paragraph (1) is pending, and it would be desirable to await the outcome of that appeal before considering the applicant's application;

(d) whether it is satisfied that, since the publication of the relevant pharmaceutical needs assessment, there have been changes to the needs for pharmaceutical services in the area of the relevant HWB that are such that refusing the application is essential in order to prevent significant detriment to the provision of pharmaceutical services in that area;

(e) whether it is satisfied that—

(i) granting the application would only meet the current need mentioned in paragraph (1) in part, and

(ii) if the application were granted, it would be unlikely, in the reasonably foreseeable future, that the remainder of that need would be met;

(f) whether—

(i) it is satisfied that granting the application would only meet the current need mentioned in paragraph (1) in part, but

(ii) it considers that, if the application were granted, it would not be unlikely, in the reasonably foreseeable future, that the remainder of that need would be met;

(g) whether it is satisfied that—

(i) the current need mentioned in paragraph (1) was for services other than essential services, and

(ii) granting the application would result in an increase in the availability of essential services in the area of the relevant HWB;

(h) whether it is satisfied that, since the publication of the relevant pharmaceutical needs assessment, the current need mentioned in paragraph (1) has been met by another person who is providing, or is due to be met by another person who has undertaken to provide, either in the area of the relevant HWB or in the area of another HWB, NHS services;

(i) whether the application needs to be deferred or refused by virtue of any provision of Parts 5 to 7.

(3) For the purposes of paragraph (2)(h), a need is to be treated as due to be met if—

(a) the person (P) undertaking to meet that need is entitled to give NHS England a notice of commencement, as a consequence of which P will be able to commence the provision of services to meet that need, but P has not yet given that notice; or

(b) P has entered into an LPS scheme with NHS England, as a consequence of which P will be able to commence the provision of services to meet that need, but P has not yet commenced the provision of those services.

Current needs: consequences of additional matters

14

(1) If NHS England is satisfied as mentioned in regulation 13(2)(a), it may—

(a) defer determination of the application;

(b) invite applications from other persons to offer to meet the current need mentioned in regulation 13(1) that the applicant is offering to meet; and

(i) as a consequence of the invitation issued in accordance with sub-paragraph (b), or

(ii) that, even if it was not received in response to that invitation, is in any event from another person offering to meet the current need mentioned in regulation 13(1) that the applicant is offering to meet,

but it must not defer consideration of the application for longer than 6 months.

(2) If NHS England is satisfied as mentioned in regulation 13(2)(b), it may defer consideration of the application until it can be considered at the same time as the other application.

(3) If NHS England is satisfied as mentioned in regulation 13(2)(c), it may defer consideration of the application until after the appeal has reached its final outcome.

(4) If NHS England is satisfied as mentioned in regulation 13(2)(d) or (e), it must refuse the application.

(5) If NHS England is satisfied as mentioned in regulation 13(2)(f) to (h), it may only grant the application if it is satisfied that to do so would secure improvements, or better access, to pharmaceutical services in the area of the relevant HWB.

Future needs: additional matters to which NHS England must have regard

15

(1) If—

(a) NHS England receives a routine application and is required to determine whether granting it, or granting it in respect of some only of the services specified in it, would meet a future need for pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB; and

(b) the future need has been included in the relevant pharmaceutical needs assessment in accordance with paragraph 2(b) of Schedule 1,

(2) Those matters are—

(a) whether it is satisfied that it would be desirable to consider, at the same time as the applicant's application, applications from other persons offering to meet the future need mentioned in paragraph (1) that the applicant is offering to meet;

(b) whether it is satisfied that it would be desirable to defer consideration of the application until some or all of the future circumstances specified in accordance with paragraph 2(b) of Schedule 1 have arisen (should they arise);

(c) whether it is satisfied that another application offering to meet the future need mentioned in paragraph (1) has been submitted to it, and it would be desirable to consider, at the same time as the applicant's application, that other application;

(d) whether it is satisfied that an appeal relating to another application offering to meet the future need mentioned in paragraph (1) is pending, and it would be desirable to await the outcome of that appeal before determining the applicant's application;

(e) whether it is satisfied that, since the publication of the relevant pharmaceutical needs assessment, there have been changes to the needs, or future needs, for pharmaceutical services in the area of the relevant HWB that are such that refusing the application is essential in order to prevent significant detriment to the provision of pharmaceutical services in that area;

(f) whether it is satisfied that, since the publication of the relevant pharmaceutical needs assessment, there have been changes to the needs, or future needs, for pharmaceutical services in the area of the relevant HWB that are such that—

(i) the future circumstances specified in accordance with paragraph 2(b) of Schedule 1 will not, or are now unlikely to, arise (in whole or in part), and

(ii) granting the application would not secure improvements, or better access, to pharmaceutical services in that area;

(g) whether it is satisfied that—

(i) granting the application would only meet the future need mentioned in paragraph (1) in part, and

(ii) if the application were granted, it would be unlikely, in the reasonably foreseeable future, that the remainder of that need would be met;

(h) whether —

(i) it is satisfied that granting the application would only meet the future need mentioned in paragraph (1) in part, but

(ii) it considers that, if the application were granted, it would not be unlikely, in the reasonably foreseeable future, that the remainder of that need would be met;

(i) whether it is satisfied that—

(i) the future need mentioned in paragraph (1) was for services other than essential services, and

(ii) granting the application would result in an increase in the availability of essential services in the area of the relevant HWB;

(j) whether it is satisfied that, since the publication of the relevant pharmaceutical needs assessment, the future need mentioned in paragraph (1) has been met by another person who is providing, or is due to be met by another person who has undertaken to provide, either in the area of the relevant HWB or in the area of another HWB, NHS services;

(k) whether the application needs to be deferred or refused by virtue of any provision of Parts 5 to 7.

(3) For the purposes of paragraph (2)(j), a future need is to be treated as due to be met if—

(a) the person (P) undertaking to meet that need is entitled to give NHS England a notice of commencement, as a consequence of which P will be able to commence the provision of services to meet that need, but P has not yet given that notice;

(b) the grant of P's application to meet that need is subject to a condition imposed by virtue of paragraph 33(2) of Schedule 2; or

(c) P has entered into an LPS scheme with NHS England, as a consequence of which P will be able to commence the provision of services to meet that need, but P has not yet commenced the provision of those services.

Future needs: consequences of additional matters

16

(1) If NHS England is satisfied as mentioned in regulation 15(2)(a), it may—

(a) defer determination of the application;

(b) invite applications from other persons to offer to meet the future need mentioned in regulation 15(1) that the applicant is offering to meet; and

(i) as a consequence of the invitation issued in accordance with sub-paragraph (b), or

(ii) that, even if it was not received in response to that invitation, is in any event from another person offering to meet the future need mentioned in regulation 15(1) that the applicant is offering to meet,

but it must not, pursuant to this paragraph, defer consideration of the application for longer than 6 months.

(2) If NHS England is satisfied as mentioned in regulation 15(2)(b), it may defer consideration of the application for such period as is reasonable in the circumstances, having regard to when the future circumstances specified in accordance with paragraph 2(b) of Schedule 1 are likely to arise.

(3) If NHS England is satisfied as mentioned in regulation 15(2)(c), it may defer consideration of the application until it can be considered at the same time as the other application.

(4) If NHS England is satisfied as mentioned in regulation 15(2)(d), it may defer consideration of the application until after the appeal has reached its final outcome.

(5) If NHS England is satisfied as mentioned in regulation 15(2)(e) to (g), it must refuse the application.

(6) If NHS England is satisfied as mentioned in regulation 15(2)(h) to (j), it may only grant the application if it is satisfied that to do so would secure improvements, or better access, to pharmaceutical services in the area of the relevant HWB.

Improvements or better access to the current service: additional matters to which NHS England must have regard

17

(1) If—

(a) NHS England receives a routine application and is required to determine whether granting it, or granting it in respect of some only of the services specified in it, would secure improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB; and

(b) the improvements or better access that would be secured have or has been included in the relevant pharmaceutical needs assessment in accordance with paragraph 4(a) of Schedule 1,

(2) Those matters are—

(a) whether it is satisfied that it would be desirable to consider, at the same time as the applicant's application, applications from other persons offering to secure the improvements or better access mentioned in paragraph (1) that the applicant is offering to secure;

(b) whether it is satisfied that another application offering to secure the improvements or better access mentioned in paragraph (1) has been submitted to it, and it would be desirable to consider, at the same time as the applicant's application, that other application;

(c) whether it is satisfied that an appeal relating to another application offering to secure the improvements or better access mentioned in paragraph (1) is pending, and it would be desirable to await the outcome of that appeal before considering the applicant's application;

(d) whether it is satisfied that, since the publication of the relevant pharmaceutical needs assessment, there have been changes to the profile of pharmaceutical services in the area of the relevant HWB that are such that refusing the application is essential in order to prevent significant detriment to the provision of pharmaceutical services in that area;

(e) whether it is satisfied that—

(i) granting the application would only secure the improvements or better access mentioned in paragraph (1) in part, and

(ii) if the application were granted, it would be unlikely, in the reasonably foreseeable future, that the remainder of those improvements or that better access would be secured;

(f) whether it is satisfied that, since the publication of the relevant pharmaceutical needs assessment, the improvements or better access mentioned in paragraph (1) have or has been secured by another person who is providing, or is due to be secured by another person who has undertaken to provide, either in the area of the relevant HWB or in the area of another HWB, NHS services;

(g) whether it is satisfied that—

(i) the improvements or better access mentioned in paragraph (1) were or was in respect of services other than essential services, and

(ii) granting the application would result in an undesirable increase in the availability of essential services in the area of the relevant HWB;

(h) whether the application needs to be deferred or refused by virtue of any provision of Part 5 to 7.

(3) For the purposes of paragraph (2)(f), the improvements are or better access is to be treated as due to be secured by another person who has undertaken to provide services if—

(a) the person (P) undertaking to secure the improvements or better access is entitled to give NHS England a notice of commencement, as a consequence of which P will be able to commence the provision of services to secure the improvements or better access, but P has not yet given that notice;

(b) P has entered into an LPS scheme with NHS England, as a consequence of which P will be able to commence the provision of services to secure the improvements or better access, but P has not yet commenced the provision of those services.

Unforeseen benefits applications: additional matters to which NHS England must have regard

18

(1) If—

(a) NHS England receives a routine application and is required to determine whether it is satisfied that granting the application, or granting it in respect of some only of the services specified in it, would secure improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB; and

(b) the improvements or better access that would be secured were or was not included in the relevant pharmaceutical needs assessment in accordance with paragraph 4 of Schedule 1,

(2) Those matters are—

(a) whether it is satisfied that granting the application would cause significant detriment to—

(i) proper planning in respect of the provision of pharmaceutical services in the area of the relevant HWB, or

(ii) the arrangements NHS England has in place for the provision of pharmaceutical services in that area;

(b) whether, notwithstanding that the improvements or better access were not included in the relevant pharmaceutical needs assessment, it is satisfied that, having regard in particular to the desirability of—

(i) there being a reasonable choice with regard to obtaining pharmaceutical services in the area of the relevant HWB (taking into account also NHS England’s duties under sections 13I and 13P of the 2006 Act (duty as to patient choice and duty as respects variation in provision of health services)),

(ii) people who share a protected characteristic having access to services that meet specific needs for pharmaceutical services that, in the area of the relevant HWB, are difficult for them to access (taking into account also NHS England’s duties under section 13G of the 2006 Act (duty as to reducing inequalities)), or

(iii) there being innovative approaches taken with regard to the delivery of pharmaceutical services (taking into account also NHS England’s duties under section 13K of the 2006 Act (duty to promote innovation)),

granting the application would confer significant benefits on persons in the area of the relevant HWB which were not foreseen when the relevant pharmaceutical needs assessment was published;

(c) whether it is satisfied that it would be desirable to consider, at the same time as the applicant's application, applications from other persons offering to secure the improvements or better access that the applicant is offering to secure;

(d) whether it is satisfied that another application offering to secure the improvements or better access has been submitted to it, and it would be desirable to consider, at the same time as the applicant's application, that other application;

(e) whether it is satisfied that an appeal relating to another application offering to secure the improvements or better access is pending, and it would be desirable to await the outcome of that appeal before considering the applicant's application;

(f) whether the application needs to be deferred or refused by virtue of any provision of Part 5 to 7.

(g) whether it is satisfied that the application presupposes that a gap in pharmaceutical services provision has been or is to be created—

(i) by the removal of chemist premises from a pharmaceutical list as a consequence of the grant of a consolidation application, and

(ii) since the last revision of the relevant HWB’s pharmaceutical needs assessment other than by way of a supplementary statement.

(3) NHS England need only consider whether it is satisfied in accordance with paragraphs (2)(c) to (e) if it has reached at least a preliminary view (although this may change) that it is satisfied in accordance with paragraph (2)(b).

Applications to which regulation 17 or 18 applies: consequences of additional matters

19

(1) If NHS England is satisfied as mentioned in regulation 17(2)(a), it may—

(a) defer determination of the application;

(b) invite applications from other persons to offer to secure the improvements or better access mentioned in regulation 17(1) that the applicant is offering to secure; and

(i) as a consequence of the invitation issued in accordance with sub-paragraph (b), or

(ii) that, even if it was not received in response to that invitation, is in any event from another person offering to secure the improvements or better access mentioned in regulation 17(1) that the applicant is offering to secure,

but it must not, pursuant to this paragraph, defer consideration of the application for longer than 6 months.

(2) If NHS England is satisfied as mentioned in regulation 18(2)(c), it may—

(a) defer determination of the application;

(b) invite applications from other persons to offer to secure the improvements or better access that the applicant is offering to secure; and

(i) as a consequence of the invitation issued in accordance with sub-paragraph (b), or

(ii) that, even if it was not received in response to that invitation, is in any event from another person offering to secure the improvements or better access that the applicant is offering to secure,

but it must not, pursuant to this paragraph, defer consideration of the application for longer than 6 months.

(3) If NHS England is satisfied as mentioned in regulation 17(2)(b) or 18(2)(d), it may defer consideration of the application until it can be considered at the same time as the other application.

(4) If NHS England is satisfied as mentioned in regulation 17(2)(c) or 18(2)(e), it may defer consideration of the application until after the appeal has reached its final outcome.

(5) If NHS England is satisfied as mentioned in regulation 17(2)(d) to (g) or 18(2)(a) or (g), it must refuse the application.

(6) If NHS England is satisfied as mentioned in regulation 18(2)(b), it may grant the application notwithstanding that the improvements or better access were or was not included in the relevant pharmaceutical needs assessment.

Future improvements or better access: additional matters to which NHS England must have regard

20

(1) If—

(a) NHS England receives a routine application and is required to determine whether granting it, or granting it in respect of some only of the services specified in it, would secure improvements, or better access, in the future to pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB; and

(b) the improvements or better access that would be secured have or has been included in the relevant pharmaceutical needs assessment in accordance with paragraph 4(b) of Schedule 1,

(2) Those matters are—

(a) whether it is satisfied that it would be desirable to consider, at the same time as the applicant's application, applications from other persons offering to secure the future improvements or better access mentioned in paragraph (1) that the applicant is offering to secure;

(b) whether it would be desirable to defer consideration of the application until some or all of the future circumstances specified in accordance with paragraph 4(b) of Schedule 1 have arisen (should they arise);

(c) whether it is satisfied that another application offering to secure the future improvements or better access mentioned in paragraph (1) has been submitted to it, and it would be desirable to consider, at the same time as the applicant's application, that other application;

(d) whether it is satisfied that an appeal relating to another application offering to secure the future improvements or better access mentioned in paragraph (1) is pending, and it would be desirable to await the outcome of that appeal before considering the applicant's application;

(e) whether it is satisfied that, since the publication of the relevant pharmaceutical needs assessment, there have been changes to the profile of pharmaceutical services in the area of the relevant HWB that are such that refusing the application is essential in order to prevent significant detriment to the provision of pharmaceutical services in that area;

(f) whether it is satisfied that, since the publication of the relevant pharmaceutical needs assessment, there have been changes to the profile or future profile of pharmaceutical services in the area of the relevant HWB that are such that the future circumstances specified in accordance with paragraph 4(b) of Schedule 1 will not, or are now unlikely to, arise (in whole or in part);

(g) whether it is satisfied that—

(i) granting the application would only secure the future improvements or better access mentioned in paragraph (1) in part, and

(ii) if the application were granted, it would be unlikely, in the reasonably foreseeable future, that the remainder of those improvements or that better access would be secured;

(h) whether it is satisfied that, since the publication of the relevant pharmaceutical needs assessment, the future improvements or better access mentioned in paragraph (1) have or has been secured by another person who is providing, or is due to be secured by another person who has undertaken to provide, either in the area of the relevant HWB or in the area of another HWB, NHS services;

(i) whether it is satisfied that—

(i) the future improvements or better access mentioned in paragraph (1) were or was in respect of services other than essential services, and

(ii) granting the application would result in an undesirable increase in the availability of essential services in the area of the relevant HWB;

(j) whether the application needs to be deferred or refused by virtue of any provision of Part 5 to 7.

(3) For the purposes of paragraph (2)(h), the improvements are or better access is to be treated as due to be secured by another person who has undertaken to provide services if—

(a) the person (P) undertaking to secure the improvements or better access is entitled to give NHS England a notice of commencement, as a consequence of which P will be able to commence the provision of services to meet that need, but P has not yet given that notice;

(b) the grant of P's application to secure the improvements or better access is subject to a condition imposed by virtue of paragraph 33(2) of Schedule 2; or

(c) P has entered into an LPS scheme with NHS England, as a consequence of which P will be able to commence the provision of services to secure the improvements or better access, but P has not yet commenced the provision of those services.

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