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

• Citation: S.I. 2013/349
• Sections: 362

Section 1 Citation and commencement

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.

Section 2 Interpretation

(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; and

it 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; and

has 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);

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“ 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, and

any 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; and

does 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; and

specifies 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; and

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

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“ 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; and

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

...

“ 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); and

may 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; or

an 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; or

in 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; or

a 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; and

any 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;

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“ 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;

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“ 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 ;

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“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, and

any 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, or

an NHS Foundation Trust;

if—

it has been so provided for use by a prescriber in England, and

a 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; and

does 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); or

an 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, or

in 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, or

in relation to any time prior to 1st April 2010, a Health and Social Services Board; and

as 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); or

a subsisting outline consent, means outline consent—

granted under these Regulations, or

which 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 ; and

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

“ 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; and

who 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, nor

local 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); or

a subsisting premises approval, means premises approval—

granted under these Regulations, or

which 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); or

except 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; and

approved 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; and

which 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)); and

in 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; or

a 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, and

any 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, or

an NHS Foundation Trust;

if—

it has been so provided for use by a prescriber in England, and

a 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; and

specifies 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; or

regulation 35 of the 2005 Regulations (pharmaceutical services in reserved locations), whether or not by virtue of—

paragraph 8 of Schedule 9, or

paragraph 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); or

in 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, or

drugs 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, or

a 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, and

specifies 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, or

a drainage wound pouch;

an incontinence appliance listed in Part IXB of the Drug Tariff; or

a 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; and

that 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, and

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

an 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 ; and

against whose name in that register is recorded—

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

an 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.

Section 3 Pharmaceutical needs assessments

(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).

Section 4 Information to be contained in pharmaceutical needs assessments

(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).

Section 5 Date by which the first HWB pharmaceutical needs assessments are to be published

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

Section 6 Subsequent assessments and later first assessments

(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

(c) the risks to the health or well-being of people in its area,

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.

Section 7 Temporary extension of earlier pharmaceutical needs assessments and access by NHS England and HWBs to pharmaceutical needs assessments

(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

(c) any pharmaceutical needs assessment of a Primary Care Trust that it holds,

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.

Section 8 Consultation on pharmaceutical needs assessments

(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);

(c) any persons on the pharmaceutical lists and any dispensing doctors list for its area;

(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).

Section 9 Matters for consideration when making assessments

(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;

(c) any different needs of different localities within its area;

(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.

Section 10 Pharmaceutical lists ...

(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

(c) other related matters.

(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).

Section 11 Terms of service of NHS chemists: general

(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.

Section 12 Routine applications for inclusion in or amendments to a pharmaceutical list

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.

Section 13 Current needs: additional matters to which NHS England must have regard

(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.

Section 14 Current needs: consequences of additional matters

(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

(c) consider, at the same time as the applicant's application, any application it receives—

(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.

Section 15 Future needs: additional matters to which NHS England must have regard

(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,

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 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.

Section 16 Future needs: consequences of additional matters

(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

(c) consider, at the same time as the applicant's application, any application it receives—

(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.

Section 17 Improvements or better access to the current service: additional matters to which NHS England must have regard

(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,

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 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.

Section 18 Unforeseen benefits applications: additional matters to which NHS England must have regard

(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,

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 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).

Section 19 Applications to which regulation 17 or 18 applies: consequences of additional matters

(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

(c) consider, at the same time as the applicant's application, any application it receives—

(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

(c) consider, at the same time as the applicant's application, any application it receives—

(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.

Section 20 Future improvements or better access: additional matters to which NHS England must have regard

(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,

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 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.

Section 21 Future improvements or better access: consequences of additional matters

(1) If NHS England is satisfied as mentioned in regulation 20(2)(a), it may—

(a) defer determination of the application;

(b) invite applications from other persons to offer to secure the future improvements or better access mentioned in regulation 20(1) that the applicant is offering to secure; and

(c) consider, at the same time as the applicant's application, any application it receives—

(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 future improvements or better access mentioned in regulation 20(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 20(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 4(b) of Schedule 1 are likely to arise.

(3) If NHS England is satisfied as mentioned in regulation 20(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 20(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 20(2)(e) to (i), it must refuse the application.

Section 21A PNA based applications for new premises offering additional or different opening hours

(1) Paragraph (2) applies where NHS England receives a routine application which is in respect of premises not already listed, where—

(a) the applicant’s stated intention (in accordance with paragraph 7(1)(a) of Schedule 2) is to meet a need, or secure improvements or better access, identified in the relevant pharmaceutical needs assessment (whether current or future gaps in provision); and

(b) the need is, or the improvements are or the better access is, in respect of the days on which or the times at which essential services are provided in the area of the relevant HWB.

(2) In determining whether or not it is satisfied as mentioned in section 129(2A) of the 2006 Act (regulations as to pharmaceutical services), NHS England must have regard to whether granting the application would result in an undesirable increase in the availability of essential services in the area of the relevant HWB.

(3) If NHS England is satisfied that granting the application would result in the undesirable increase in availability mentioned in paragraph (2), it must refuse the application.

Section 22 Refusal of routine applications that are based on neither a pharmaceutical needs assessment nor unforeseen benefits

(1) If NHS England receives a routine application to which regulation 19(6) does not apply, NHS England must refuse it unless granting it, or granting it in respect of some only of the services specified in it, would—

(a) meet a current or future need for pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB that has been included in the relevant pharmaceutical needs assessment in accordance with paragraph 2 of Schedule 1; or

(b) secure (including in the future) improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB that have or has been included in the relevant pharmaceutical needs assessment in accordance with paragraph 4 of Schedule 1.

(2) For the purposes of paragraph (1), the relevant pharmaceutical needs assessment is—

(a) the pharmaceutical needs assessment of the relevant HWB that is current at the time that NHS England takes its decision to grant or refuse the application, unless in the opinion of NHS England (or on appeal the Secretary of State) 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; or

(b) if the relevant HWB has not published a pharmaceutical needs assessment, the pharmaceutical needs assessment of a Primary Care Trust (as extended by regulation 7(1)) that relates to the locality in which the location or premises to which the application relates is or are situated.

Section 23 Applications from NHS chemists in respect of providing directed services

Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application by a person already included in a pharmaceutical list for inclusion in that list also in respect of services that are directed services that are not already listed in relation to that person.

Section 24 Relocations that do not result in significant change to pharmaceutical services provision

(1) Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application from a person already included in a pharmaceutical list to relocate to different premises in the area of the relevant HWB (HWB1) if—

(a) for the patient groups that are accustomed to accessing pharmaceutical services at or from the existing premises, the location of the new premises is not significantly less accessible;

(b) in the opinion of NHS England , granting the application would not result in a significant change to the arrangements that are in place for the provision of local pharmaceutical services or of pharmaceutical services other than those provided by a person on a dispensing doctor list—

(i) in any part of the area of HWB1, or

(ii) in a controlled locality in the area of a neighbouring HWB, where that controlled locality is within 1.6 kilometres of the premises to which the applicant is seeking to relocate;

(c) NHS England is not of the opinion that granting the application would cause significant detriment to proper planning in respect of the provision of pharmaceutical services in the area of HWB1;

(d) the services the applicant undertakes to provide at or from the new premises are the same as the services the applicant has been providing at or from the existing premises (whether or not, in the case of enhanced services, NHS England chooses to commission them); and

(e) the provision of pharmaceutical services will not be interrupted (except for such period as NHS England may for good cause allow).

(2) Section 129(2A) of the 2006 Act does not apply to an application from a person already included in a pharmaceutical list for the area of a HWB (HWB2) for inclusion in the pharmaceutical list for the area of a neighbouring HWB (HWB3), or inclusion in the pharmaceutical list for the area of HWB3 also in respect of other premises than those already listed in relation to that person, if—

(a) the purpose of the application is to relocate to different premises;

(b) for the patient groups that are accustomed to accessing pharmaceutical services at or from the existing premises (P1), the location of the new premises (P2) is not significantly less accessible;

(c) in the opinion of NHS England , granting the application would not result in a significant change to the arrangements that are in place for the provision of local pharmaceutical services or of pharmaceutical services other than those provided by a person on a dispensing doctor list—

(i) in any part of HWB3's area; or

(ii) in a controlled locality in the area of a neighbouring HWB (including HWB2), where that controlled locality is within 1.6 kilometres of P2;

(d) NHS England is not of the opinion that granting the application would cause significant detriment to proper planning in respect of the provision of pharmaceutical services in the area of HWB3;

(e) the services the applicant undertakes to provide at or from P2 are the same as the services the applicant has been providing at or from P1 (whether or not, in the case of enhanced services, NHS England chooses to commission them);

(f) the provision of pharmaceutical services will not be interrupted (except for such period as NHS England may for good cause allow); and

(g) the applicant consents to—

(i) where the applicant has only one set of listed chemist premises in the pharmaceutical list for the area of HWB2, the removal of the applicant's name from that pharmaceutical list, or

(ii) where the applicant has more than one set of listed chemist premises in the pharmaceutical list for the area of HWB2, the removal of P1 from being listed in relation to the applicant in that pharmaceutical list,

with effect from the date on which the applicant undertakes to provide pharmaceutical services from P2.

(3) An application pursuant to this regulation must be refused if the existing pharmacy premises from which the applicant is seeking to relocate (P3)—

(a) were listed in relation to an NHS pharmacist as a result of an application to which regulation 13(1)(a) of the 2005 Regulations (exemption from the necessary or expedient test) applied, and—

(i) P3 are located in an area that, immediately before the 2012 Regulations came into force, was an approved retail area (within the meaning given in regulation 15 of the 2005 Regulations (approved retail areas)), and

(ii) the applicant proposes to relocate from P3 to premises that are outside that area;

(b) were listed in relation to an NHS pharmacist as a result of an application to which regulation 13(1)(c) of the 2005 Regulations applied, unless—

(i) the provider, or where there is more than one provider all the providers, of primary medical services at the one-stop primary care centre (within the meaning given in regulation 16 of the 2005 Regulations (new one-stop primary care centres)) at which P3 are located are relocating with the applicant to a new discrete site or building,

(ii) at or from that new discrete site or building primary medical services are or are to be provided by one or more providers of primary medical services with a patient list of, or patient lists with a combined total of, 18,000 patients, and

(iii) at or from that site or building the services of a broad range of health care professionals are or will be regularly and frequently provided (together, where appropriate, with other health or social services); ...

(c) have been listed in relation to the applicant for a period of less than 12 months prior to the application, and—

(i) that listing arose out of the applicant relocating to P3 from other pharmacy premises,

(ii) that relocation arose out of the grant of an application—

(aa) that was an excepted application by virtue of this regulation or regulation 24 of the 2012 Regulations (relocations that do not result in significant change to pharmaceutical services provision), or

(bb) to which regulation 6 or 7 of the 2005 Regulations (which related to minor relocations) applied, and

(iii) the applicant is unable to satisfy NHS England that relocation from P3 is necessary for reasons that NHS England accepts are good cause ; or

(d) are distance selling premises, unless—

(i) the premises to which the applicant is seeking to relocate are also distance selling premises, and

(ii) if the application was one to which regulation 25(1) applied, it would not be refused pursuant to regulation 25(2).

Section 25 Distance selling premises applications

(1) Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application to relocate to different premises —

(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) by a person already included in a pharmaceutical list for inclusion in that list ...in respect of premises other than those already listed in relation to that person,

in respect of pharmacy premises that are distance selling premises.

(2) NHS England must refuse an application to which paragraph (1) applies—

(a) if the premises in respect of which the application is made are on the same site or in the same building as the premises of a provider of primary medical services with a patient list; and

(b) unless NHS England is satisfied that the pharmacy procedures for the pharmacy premises are likely to secure—

(i) the uninterrupted provision of essential services, during the opening hours of the premises, to persons anywhere in England who request those services, and

(ii) the safe and effective provision of pharmaceutical services without face to face contact at the pharmacy premises between any person receiving the services, whether on their own or on someone else's behalf, and the applicant or the applicant's staff.

Section 25A Transitional provision: distance selling premises applications for new inclusions made before 23rd June 2025

In the case of an application made before 23rd June 2025 to which regulation 25(1)(a) applied (applications for inclusion in a pharmaceutical list by a person not already included), notwithstanding the repeal of regulation 25(1)(a), that application is to be determined in accordance with regulation 25(1) as it had effect on 22nd June 2025.

Section 26 Change of ownership applications

(1) Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application from a person who is not included in a pharmaceutical list for inclusion in the list, or from a person included in a pharmaceutical list for inclusion in that list also in respect of other premises than those already listed in relation to that person, if—

(a) the applicant (X) is undertaking to provide pharmaceutical services at or from premises—

(i) that are already listed chemist premises, and

(ii) at or from which another person (Y) is providing pharmaceutical services;

(b) X is proposing to carry on at or from the listed chemist premises, in place of Y, the business in the course of which Y is providing pharmaceutical services at or from those premises;

(c) X is undertaking to provide the same pharmaceutical services as those that Y is providing; and

(d) the provision of pharmaceutical services at or from the premises will not be interrupted (except for such period as NHS England may for good cause allow).

(2) Section 129(2A) of the 2006 Act does not apply to an application from a person who is not included in a pharmaceutical list for the area of a HWB (HWB1) for inclusion in that list, or from a person included in a pharmaceutical list for inclusion in that list also in respect of other premises than those already listed in relation to that person, if—

(a) the applicant (X) is undertaking to provide the pharmaceutical services that another person (Y)—

(i) is providing at or from listed chemist premises (“Y's premises”), whether in the area of HWB1 or a neighbouring HWB, or

(ii) has provided at or from Y's premises but Y is no longer able to provide pharmaceutical services at or from those premises for reasons that NHS England accepts are good cause;

(b) X is proposing to carry on, in place of Y, the business in the course of which Y is providing, or has provided, pharmaceutical services at or from Y's premises;

(c) X is undertaking to provide the same pharmaceutical services as Y is providing or has provided at or from Y's premises, but at or from different premises (“X's premises”);

(d) had Y applied to move to X's premises, that application would have been granted under regulation 24; and

(e) in a case where pharmaceutical services—

(i) are being provided at or from Y's premises, the provision of pharmaceutical services will not be interrupted (except for such period as NHS England may for good cause allow) by the move of the business from Y's premises to X's premises, or

(ii) are not being provided at or from Y's premises, the provision of pharmaceutical services will commence at or from X's premises within the period that NHS England considers is an acceptable period for the interruption of the provision of pharmaceutical services by the business that X is taking over.

(3) An application pursuant to paragraph (1) must be refused if it relates to distance selling premises, unless the application, if made pursuant to regulation 25(1), would not be refused pursuant to regulation 25(2).

(4) An application pursuant to paragraph (2) must be refused if the existing pharmacy premises from which the applicant is seeking to relocate are distance selling premises, unless the premises to which the applicant is seeking to relocate are also distance selling premises (and this is in addition to the requirement that arises by virtue of paragraph (2)(d) that the application, if made pursuant to regulation 25(1), would not be refused pursuant to regulation 25(2)).

Section 26A Consolidation onto an existing site

(1) A person already included in a pharmaceutical list may make an application pursuant to this paragraph (“a consolidation application”) in respect of the consolidation onto the site (S1) of listed chemist premises in the area of the relevant HWB (HWB1) of the provision of pharmaceutical services provided at or from S1 and other listed chemist premises (S2) in the area of HWB1.

(2) Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to a consolidation application by a person already included in a pharmaceutical list for inclusion in respect of premises not already listed in relation to that person.

(3) Subject to paragraph (4), a consolidation application—

(a) must be made by the person (P1) included in the pharmaceutical list in relation to S1; and

(b) if different persons are listed in relation to S1 and S2, must include as part of the application an application by P1 to change the ownership of S2.

(4) If different persons are listed in relation to S1 and S2, and the person (P2) listed in relation to S2 is seeking to become the person listed in relation to S1, a consolidation application—

(a) must be made by P2; and

(b) must include as part of the application an application by P2 to change the ownership of S1.

(5) NHS England must refuse a consolidation application—

(a) if it is satisfied that granting the application would create a gap in pharmaceutical services provision that could be met by a routine application—

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

(i) to secure improvements, or better access, to pharmaceutical services; or

(b) if either S1 or S2 are distance selling premises or appliance contractor premises.

(6) In the case of an application to which paragraph (3) applies, NHS England must refuse the application unless it is satisfied—

(a) if NHS England intends to commission from P1 at or from S1 enhanced services which P2 provides at or from S2 but which P1 has not been providing at or from S1, that the provision of those services will not be interrupted except for such period as NHS England may for good cause allow;

(b) in the case of an application to which paragraph (3)(b) applies, that—

(i) P2 consents to the change of ownership of S2, and

(ii) P1 and P2 consent to S2 ceasing to be listed chemist premises as a consequence of the application; and

(c) in the case of an application to which paragraph (3)(b) does not apply, that P1 consents to S2 ceasing to be listed chemist premises as a consequence of the application.

(7) In the case of an application to which paragraph (4) applies, NHS England must refuse the application unless it is satisfied—

(a) that P2 is proposing to carry on at or from S1, in place of P1, the business in the course of which P1 is providing pharmaceutical services at or from S1;

(b) that P2 is undertaking to provide the same pharmaceutical services as those that P1 is providing (whether or not P2 is also to provide other services that P2 is providing at S2);

(c) that the provision of pharmaceutical services at or from S1 is not to be interrupted, except for such period as NHS England may for good cause allow;

(d) if NHS England intends to commission from P2 at or from S1 enhanced services which P2 provides at or from S2 but which P1 has not been providing at or from S1, that the provision of those services will not be interrupted except for such period as NHS England may for good cause allow; and

(e) that—

(i) P1 consents to the change of ownership of S1, and

(ii) P1 and P2 consent to S2 ceasing to be listed chemist premises as a consequence of the application.

(8) If two or more consolidation applications are being considered together, as regards the issue of a gap in provision, as mentioned in paragraph (5)(a), each application may be refused on the basis of the cumulative effect on provision of all the applications being considered together.

Section 27 Applications for temporary listings arising out of suspensions

(1) Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application—

(a) for temporary inclusion in a pharmaceutical list by a person not already included; or

(b) by a person already included in a pharmaceutical list for temporary inclusion in that list in respect of services, or services and premises, other than those already listed in relation to that person,

from a person (X) who proposes to provide pharmaceutical services which are not being provided because the person listed in relation to them (Y) is suspended from the pharmaceutical list.

(2) NHS England must refuse an application to which paragraph (1) applies—

(a) unless it is satisfied that—

(i) Y has nominated X as the person to provide those services for the duration of Y's suspension and consents to X doing so,

(ii) X will provide the same pharmaceutical services as those that Y provided or had undertaken to provide before the suspension, and

(iii) there is no direct or indirect connection between X and Y (including such a connection through a third party) the nature of which makes it unlikely that X will be able to exercise an appropriate degree of autonomy;

(b) if Y is a body corporate and X—

(i) is an employee of Y,

(ii) is, or was at the time of the suspension or of the originating events, a director or superintendent of Y,

(iii) is a body corporate in which Y or an employee of Y is a majority shareholder,

(iv) is a body corporate in which a majority shareholder of Y is, or was at the time of the suspension or of the originating events, a director or superintendent of X,

(v) is a body corporate which has a director or superintendent who is an employee of Y, or

(vi) is a body corporate which has as a director or superintendent someone who is, or was at the time of the suspension or of the originating events, a director or superintendent of Y;

(c) if Y is an individual and X—

(i) is an employee of Y,

(ii) is a body corporate of which Y or an employee of Y is a director or superintendent,

(iii) is a body corporate in which Y or an employee of Y is a majority shareholder, or

(iv) is a body corporate which has a director or superintendent who is an employee of Y; or

(d) if Y is a partnership and X—

(i) is or has been a member or employee of Y,

(ii) is a body corporate of which a member or employee of Y is or has been a director, superintendent or majority shareholder, or

(iii) is a partnership of which X, or a member or employee of X, is or has been a member.

(3) If an application to which—

(a) paragraph (1)(a) applies is granted, the applicant must only be included in the pharmaceutical list for a fixed period;

(b) paragraph (1)(b) applies is granted, the premises or services must only be listed in relation to the applicant for a fixed period.

(4) The fixed periods referred to in paragraph (3) must be no longer than—

(a) the period of Y's suspension; or

(b) until Y notifies NHS England , with effect from a specified date (which must be at least 2 working days after the date of the notification), that Y no longer consents to X providing the services that X is providing because of Y's suspension from the pharmaceutical list.

Section 28 Applications from persons exercising a right of return to a pharmaceutical list

(1) Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application—

(a) for inclusion in a pharmaceutical list by a person not already included; or

(b) by a person already included in a pharmaceutical list for inclusion in that list also in respect of premises other than those already listed in relation to that person,

in the circumstances set out in paragraph (2).

(2) Those circumstances are—

(a) it has been determined in accordance with—

(i) regulation 4 of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002 (right of return to pharmaceutical lists),

(ii) regulation 15 of the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 (right of return to pharmaceutical lists), or

(iii) regulation 108,

that the applicant is to be given a right of return to a pharmaceutical list;

(b) the applicant is seeking to exercise that right after ceasing to provide local pharmaceutical services under the LPS scheme as a consequence of entering into which, or of the variation of which, the applicant was given the right of return; and

(c) the granting of the right of return arose out of the provision of the local pharmaceutical services which the applicant is ceasing to provide.

(3) NHS England must refuse an application to which paragraph (1) applies, unless—

(a) the change from providing local pharmaceutical services to providing pharmaceutical services will not give rise to any interruption in the receipt and dispensing of prescriptions by the applicant (except for such period as NHS England may for good cause allow); and

(b) any conditions in the relevant determination of the right of return are satisfied.

Section 29 Temporary arrangements during emergencies or because of circumstances beyond the control of NHS chemists

(1) Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application for a temporary amendment to a pharmaceutical list in the following circumstances—

(a) there is an emergency requiring the flexible provision of pharmaceutical services; or

(b) there is a temporary suspension in the provision of pharmaceutical services at or from listed chemist premises (P1) for a reason (for example, fire or flooding) that is beyond the control of the NHS chemist (C) listed in relation to P1.

(2) In the circumstances described in paragraph (1)(a), NHS England may make a temporary amendment to an entry in a pharmaceutical list, but—

(a) only for a specified period (which must not be longer than the specified period of the emergency given by the Secretary of State) which NHS England may extend or curtail in appropriate circumstances; and

(b) the applicant may revert to the applicant's overridden entry in the pharmaceutical list before the end of the period specified by NHS England , on giving NHS England at least 24 hours notice.

(3) In the circumstances described in paragraph (1)(b), NHS England may make a temporary amendment to the entry of C in the relevant pharmaceutical list in order to allow C to provide the services that C ordinarily provided at or from P1 at or from other premises nearby (P2), at the days on which and times at which those services were ordinarily provided at or from P1, for a period specified by NHS England .

(4) A period specified under paragraph (3) must not be longer (initially) than 6 months, and NHS England may under that paragraph—

(a) if it has good cause to do so, extend the period specified under that paragraph (but not beyond 12 months from the date on which C starts to provide the services in question from P2); or

(b) curtail the period specified,

in appropriate circumstances.

(5) For the period specified under paragraph (3), but subject to paragraph (6) and regulation 118, P2 instead of P1 are to be treated as listed in relation to C for the purposes of these Regulations (albeit that the premises actually listed in relation to C are P1).

(6) The applicant may revert to the applicant's overridden entry in the pharmaceutical list before the end of the period specified by under paragraph (3), on giving NHS England at least 24 hours notice.

(7) Planned refurbishment is not a “reason beyond the control” of C for the purposes of paragraph (1)(b).

(8) There is no right of appeal under these Regulations in respect of a decision of NHS England under this regulation.

Section 30 Refusal: language requirement for some NHS pharmacists

An application for inclusion in a pharmaceutical list by a person not already included must be refused if the applicant is an individual (X) who qualified as a pharmacist in Switzerland or an EEA state other than the United Kingdom, unless X satisfies NHS England that X has the level of knowledge of English which, in the interests of X and the persons making use of the services to which the application relates, is necessary for the provision of those services in the area of the relevant HWB.

Section 31 Refusal: same or adjacent premises

(1) A routine or excepted application , other than a consolidation application, must be refused where paragraph (2) applies.

(2) This paragraph applies where—

(a) a person on the pharmaceutical list (which may or may not be the applicant) is providing or has undertaken to provide pharmaceutical services (“the existing services”) at or from—

(i) the premises to which the application relates, or

(ii) adjacent premises; and

(b) NHS England is satisfied that it is reasonable to treat the services that the applicant proposes to provide as part of the same service as the existing services (and so the premises to which the application relates and the existing listed chemist premises should be treated as the same site).

Section 32 Deferrals arising out of LPS designations

(1) A routine application may be deferred where paragraph (2) applies to the relevant premises.

(2) This paragraph applies where the relevant premises are premises or part of premises, or are located within an area, designated under—

(a) regulation 99; or

(b) regulation 4 of the 2006 Regulations (designation of priority neighbourhoods or premises),

and that designation has neither been varied so that it no longer applies to the relevant premises nor been cancelled.

(3) For the purposes of this regulation, “the relevant premises” are—

(a) the listed chemist premises or proposed listed chemist premises in the application; or

(b) as regards an application for inclusion in a pharmaceutical list by a person not already included, if no particular premises are proposed for listing in the application, premises located at the best estimate that NHS England is able to make as to where the proposed listed chemist premises would be, having regard to the best estimate given by the applicant under paragraph 1(7)(a)(ii) of Schedule 2.

Section 33 Refusal of applications for inclusion in a pharmaceutical list on fitness grounds

(A1) In this regulation, “A” means, where an application for inclusion in a pharmaceutical list is made by a person who is—

(a) an individual, the individual making the application;

(b) a partnership, any partner in the partnership making the application; or

(c) a body corporate—

(i) except for the purposes of paragraphs (1)(a) and (b) and (3)(h)(i), the body corporate making the application, and

(ii) except for the purposes of paragraph (2)(b) and (e), any director or superintendent of the body corporate making the application.

(1) An application for inclusion in a pharmaceutical list by a person ... who is not already included in it must be refused if NHS England is satisfied that—

(a) A ...has been convicted in the United Kingdom of murder;

(b) A ...—

(i) has been convicted in the United Kingdom of a criminal offence, other than murder, which was committed after 1st April 2005, and

(ii) has been sentenced to a term of imprisonment of over 6 months;

(c) A is the subject of a national disqualification; or

(d) where, on appeal, the First-tier Tribunal determines A may be included in the pharmaceutical list subject to conditions, A has not within 30 days of that decision notified NHS England that A agrees to the imposition of the conditions.

(2) An application for inclusion in a pharmaceutical list by a person who is not already included may be refused if NHS England —

(a) having contacted the referees mentioned in paragraph 3(8) of Schedule 2, is not satisfied with the references given;

(b) considers that A is unsuitable to be included in the list;

(c) having—

(i) checked with the NHS CFA for any facts that it considers relevant relating to past or current fraud investigations involving or related to A ..., and

(ii) considered these and any other facts in its possession relating to fraud involving or relating to A ...,

considers the outcome of these enquiries justify such refusal;

(d) having—

(i) checked with the Secretary of State for any facts considered by the Secretary of State to be relevant relating to past or current investigations or proceedings involving or relating to A ..., and

(ii) considered these and any other facts in its possession involving or relating to A ...,

considers the outcome of these enquiries justify such refusal; or

(e) considers that granting the application would be prejudicial to the efficiency of the service which A has undertaken to provide.

(3) Where NHS England is considering refusal of an application under paragraph (2), it must consider all facts which appear to it to be relevant and must in particular take into consideration in relation to paragraph (2)(b) to (e)—

(a) the nature of any offence, investigation or incident;

(b) the length of time since any offence, incident, conviction or investigation;

(c) whether there are other offences, incidents or investigations to be considered;

(d) any action taken or penalty imposed by any licensing or regulatory body, the police or the courts as a result of any such offence, incident or investigation;

(e) the relevance of any offence, investigation or incident to the provision by A of pharmaceutical services and any likely risk to users of pharmaceutical services or to public finances;

(f) whether any offence was a sexual offence to which Part 1 of the Sexual Offences Act 2003 (sexual offences) or section 2 of the Modern Slavery Act 2015 in respect of sexual exploitation (human trafficking) applies, or if it had been committed in England and Wales, would have applied;

(g) whether A ... has been refused inclusion in, conditionally included in, removed, contingently removed or is currently suspended from a relevant list for a reason relating to unsuitability, fraud or efficiency of service provision, and if so, the facts relating to the matter which led to such action and the reasons given by NHS England or another primary care organisation for such action; or

(h) whether A ...was, at the time of the originating events, or has in the preceding 6 months been—

(i) a director or superintendent of a body corporate which has been refused inclusion in, conditionally included in, removed or contingently removed from a relevant list, or

(ii) is currently suspended from a relevant list,

for a reason relating to unsuitability, fraud or efficiency of service provision, and if so, what the facts were in each such case and the reasons given by NHS England or another primary care organisation in each case.

(4) When NHS England takes into consideration the matters set out in paragraph (3), it must consider the overall effect of all the matters being considered.

(5) If an application for inclusion in a pharmaceutical list by a person who is not already included in it is refused under paragraph (1) or (2), NHS England must notify the applicant of that decision and it must include with the notification an explanation of—

(a) the reasons for the decision;

(b) the applicant's right of appeal against the decision to the First-tier Tribunal, which must be exercised within 30 days of the date on which the applicant was notified of the decision.

Section 34 Deferral of consideration of applications for inclusion in a pharmaceutical list on fitness grounds

(A1) In this regulation, “A” means, where an application for inclusion in a pharmaceutical list is made by a person who is—

(a) an individual, the individual making the application;

(b) a partnership, any partner in the partnership making the application; or

(c) a body corporate—

(i) except for the purposes of paragraph (1)(b), (c)(ii), (e), (g), (i) and (k), the body corporate making the application, and

(ii) any director or superintendent of the body corporate making the application.

(1) An application for inclusion in a pharmaceutical list by a person ...who is not already included in it may be deferred if NHS England is satisfied that—

(a) there are, in respect of A ...—

(i) criminal proceedings in the United Kingdom, or

(ii) proceedings elsewhere relating to conduct, which, if it had occurred in the United Kingdom, would constitute a criminal offence,

which, if they result in a conviction, or the equivalent of a conviction, would be likely to lead to the person’s removal from the pharmaceutical list, if the person were to be included in it;

(b) in respect of a body corporate of which A is, or has in the preceding 6 months been, or was at the time of the originating events, a director or superintendent, there are—

(i) criminal proceedings in the United Kingdom, or

(ii) proceedings elsewhere relating to conduct, which, if it had occurred in the United Kingdom, would constitute a criminal offence,

which, if they resulted in a conviction, or the equivalent of a conviction, would be likely to lead to the person’s removal from the pharmaceutical list, if the person were to be included in it;

(c) there is an investigation anywhere in the world—

(i) by A's ... licensing or regulatory body, or

(ii) relating to A ... in A's professional capacity (including one by NHS England or another primary care organisation),

which, if the outcome were adverse, would be likely to lead to the removal of the person from the pharmaceutical list if the person were to be included in it;

(d) A ...is suspended from a relevant list;

(e) a body corporate of which A ... was, at the time of the originating events, a director or superintendent, is suspended from a relevant list;

(f) the First-tier Tribunal is considering an appeal by A ... against a decision of NHS England or another primary care organisation—

(i) to refuse an application for inclusion in a relevant list, or

(ii) to include A conditionally in, or to remove or contingently remove A from, a relevant list,

and if that appeal were to be unsuccessful, NHS England would be likely to remove the person from the pharmaceutical list if the person were to be included in it;

(g) the First-tier Tribunal is considering an appeal by a body corporate of which A ... was, at the time of the originating events, or has in the preceding 6 months been, a director or superintendent, against a decision of NHS England or another primary care organisation—

(i) to refuse an application by that body corporate for inclusion in its list,

(ii) to include A conditionally in, or to remove or contingently remove A from, a relevant list,

and if that appeal were to be unsuccessful NHS England would be likely to remove the person from the pharmaceutical list if the person were to be included in it;

(h) A ... is being investigated by the NHS CFA in relation to any fraud, where the result, if adverse, would be likely to lead to the removal of the person from the pharmaceutical list if the person were to be included in it;

(i) a body corporate, of which A ...was, at the time of the originating events, a director or superintendent, is being investigated by the NHS CFA in relation to any fraud, where the result if adverse would be likely to lead to the removal of the person from the pharmaceutical list if the person were to be included in it;

(j) the First-tier Tribunal is considering an application from NHS England or a Local Health Board for a national disqualification of A ...;

(k) the First-tier Tribunal is considering an application from NHS England or a Local Health Board for a national disqualification of a body corporate of which A ... was, at the time of the originating events, a director or superintendent; or

(l) NHS England or another primary care organisation, for a reason relating to unsuitability, fraud or efficiency of service provision—

(i) is considering removal (other than voluntary removal) or contingent removal of the applicant from a relevant list, or

(ii) has taken a decision to remove (other than voluntary removal) or contingently remove the applicant from a relevant list but that decision has yet to take effect.

(2) NHS England may only defer a decision under paragraph (1) until—

(a) the outcome of the cause for the deferral is known; or

(b) the reason for the deferral no longer exists.

Section 35 Granting applications for inclusion in a pharmaceutical list subject to efficiency conditions and conditions to combat fraud

(1) An application for inclusion in a pharmaceutical list by a person (P) who is not already included may be granted subject to a condition of a type mentioned in paragraph (3), which is determined by NHS England and which NHS England decides to impose with regard to P.

(2) NHS England may vary the terms of service of an NHS chemist for the purpose of or in connection with the imposition of the condition.

(3) A condition imposed under paragraph (1) must be a condition with a view to—

(a) preventing any prejudice to the efficiency of the services, or any of the services, which P has undertaken to provide; or

(b) preventing any act or omission within section 151(3)(a) of the 2006 Act (disqualification of practitioners).

(4) If NHS England decides to grant an application subject to a condition imposed under paragraph (1), it must notify P of that decision and it must include with the notification an explanation of—

(a) the reasons for the decision;

(b) P's right of appeal against its decision to the First-tier Tribunal;

(c) the time limit within which, in accordance with the Tribunal Procedure (First-tier Tribunal) (Health, Education and Social Care Chamber) Rules 2008 , the application notice must be sent to the Tribunal if an appeal is to be brought; and

(d) the effect of paragraph (5).

(5) If P issues a notice of commencement before the First-tier Tribunal has determined an appeal against a condition imposed under paragraph (1), P is to be included in the pharmaceutical list subject to the condition, but only pending the outcome of the appeal if the appeal is successful.

(6) The appeal is to be by way of redetermination of—

(a) the decision of NHS England to impose the condition; and

(b) if P has, at the time the appeal is determined, been included in the pharmaceutical list, any decision under paragraph (2) to vary the terms of service of P for the purpose of or in connection with the imposition of the condition.

(7) If at the time the appeal is determined, P has not been included in the pharmaceutical list, and—

(a) the First-tier Tribunal confirms the decision of NHS England ; or

(b) imposes a different condition,

P must, within 30 days of P being notified of the First-tier Tribunal's decision, notify NHS England as to whether or not P wishes to withdraw P's application

(8) If P fails, in the circumstances described in paragraph (7), to notify NHS England within that 30 days that P does not wish to withdraw P's application, the grant of P's application lapses.

Section 36 Determination that an area is a controlled locality

(1) Any area that was, or was part of, a controlled locality for the purposes of the 2012 Regulations immediately before these Regulations come into force 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 no longer part of, a controlled locality).

(2) Subject to paragraph (3), NHS England may at any time consider and determine whether or not any locality, because it is rural in character, is to be, or to be part of, a controlled locality.

(3) Where the question of whether or not an area is to be, or to be part of, a controlled locality has been determined by NHS England , a Primary Care Trust or on appeal (whether under these Regulations, the 2012 Regulations or the 2005 Regulations), that question must not be considered again in relation to that area—

(a) for 5 years, beginning with the date of the determination of NHS England or the Primary Care Trust, or if that determination was appealed, the date of the decision on appeal;

(b) unless NHS England is satisfied (within that 5 years) that there has been a substantial change in circumstances in relation to that area since the question was last determined.

Section 37 Process for determining controlled localities: preliminary matters

(1) A Local Medical Committee or Local Pharmaceutical Committee may apply in writing to NHS England for it to determine whether or not an area specified in the application (which must be all or part of the Committee's area) is to be, or is to be part of, a controlled locality.

(2) Before considering the application, NHS England must consider whether or not the application raises a question that it cannot consider by virtue of regulation 36(3).

(3) If NHS England decides that the application does raise a question that it cannot consider by virtue of regulation 36(3), it must take no further action in relation to that application other than informing the Committee making the application of that decision and its right of appeal against that decision under regulation 45(1)(b).

Section 38 Process for determining controlled localities: local notification and deferment of routine applications

(1) If NHS England is considering making a determination that an area (A1) is or is not to be, or is or is not to be part of, a controlled locality (whether or not of its own motion), before making the proposed determination, it must give notice of the proposed determination to—

(a) any Local Pharmaceutical Committee whose area includes all or part of A1;

(b) any Local Medical Committee whose area includes all or part of A1;

(c) any person on a pharmaceutical list or dispensing doctors list who, in the opinion of NHS England , may be affected by the determination;

(d) any LPS chemist who, in the opinion of NHS England , may be affected by the determination;

(e) any provider of primary medical services who, in the opinion of NHS England , may be affected by the determination;

(f) where it is considering making a determination as a consequence of a routine application, the person making that application; and

(g) any HWB whose area includes all or part of A1.

(2) NHS England may also give notice of the proposed determination to such other persons as it considers appropriate to do so.

(3) A notice under paragraph (1) or (2) must inform the person notified—

(a) that they may make representations (or in the case of a Committee being notified that applied for the determination, any further representations) in writing within 30 days beginning on the day on which the notification was sent to them;

(b) of the date by which NHS England expects to make its determination, which must be no later than 6 months after the day on which NHS England first gives notice to any person in respect of the proposed determination under paragraph (1) or (2).

(4) Once NHS England has issued notice under paragraph (1), it must defer consideration of any routine application where the applicant is seeking the listing of pharmacy premises and the outcome of the application could (if the application is deferred) be affected as a result of the proposed determination, until—

(a) it has determined whether the area in question is or is not to be, or is or is not to be part of, a controlled locality; and

(b) the proceedings relating to that determination have reached their final outcome.

Section 39 Process of determining controlled localities: formulation of NHS England’s decision

(1) When it is determining whether or not an area is or is part of a controlled locality, NHS England must have regard to whether the provision of—

(a) primary medical services by a provider of primary medical services;

(b) pharmaceutical services by a person on a pharmaceutical list; or

(c) local pharmaceutical services by a provider of such services,

is likely to be adversely affected by the consequences of the determination.

(2) Once it has determined whether or not an area is or is part of a controlled locality, NHS England must—

(a) if it determines that the area is to become or become part of a controlled locality, or is to cease to be part of a controlled locality—

(i) delineate precisely the boundary of the resulting controlled locality on a map,

(ii) publish that map, and

(iii) make that map available as soon as is practicable to any HWB that has all or part of that controlled locality in its area;

(b) give notice of the determination to the persons mentioned in paragraph (3) informing them of—

(i) its determination and the reasons for it,

(ii) their right of appeal, if the person has a right of appeal under regulation 45(1)(a)(i), and

(iii) their right of appeal under regulation 45(1)(a)(ii), in the case of a person notified who is a Local Pharmaceutical Committee, a Local Medical Committee, a provider of primary medical services, an LPS chemist or a person on a pharmaceutical or dispensing doctors list.

(3) The persons mentioned in this paragraph are—

(a) if the determination resulted from an application from a Local Pharmaceutical Committee or Local Medical Committee pursuant to regulation 37(1), that Committee;

(b) if a routine application was deferred pursuant to regulation 38(4) until the proceedings relating to the determination reached their final outcome, the person making that application; and

(c) the persons notified in accordance with regulation 38(1) and (2) in relation to the proposal to make the determination.

(4) A HWB to which a map is made available under paragraph (2)(a)(iii) must—

(a) publish that map alongside its pharmaceutical needs assessment map (once it has one); or

(b) include the boundary of the controlled locality (in so far as it is in, or part of the boundary of, the HWB's area) in its pharmaceutical needs assessment map (once it has one).

Section 40 Applications for new pharmacy premises in controlled localities: refusals because of preliminary matters

(1) This paragraph applies to all routine applications—

(a) for inclusion in a pharmaceutical list as an NHS pharmacist; or

(b) from an NHS pharmacist included in such a list—

(i) to relocate to different pharmacy premises in the area of the relevant HWB, or

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

where the applicant is seeking the listing of pharmacy premises which are in a controlled locality.

(2) If NHS England receives an application (A1) to which paragraph (1) applies, it must refuse A1 (without needing to make any notification of that application under Part 3 of Schedule 2), where the applicant is seeking the listing of premises at a location which is—

(a) in an area in relation to which outline consent has been granted under these Regulations, the 2012 Regulations or under the 2005 Regulations within the 5 year period—

(i) starting on the date on which the proceedings relating to the grant of outline consent reached their final outcome, and

(ii) ending on the date on which A1 is made; or

(b) within 1.6 kilometres of the location of proposed pharmacy premises (other than proposed distance selling premises), in respect of which—

(i) a routine application under these Regulations or the 2012 Regulations, or

(ii) an application to which regulation 22(1) or (3) of the 2005 Regulations (relevant procedures for applications) applied,

was refused within the 5 year period starting on the date on which the proceedings relating to the refusal reached their final outcome and ending on the date on which A1 is made,

unless NHS England is satisfied that since the date on which the 5 year period started, there has been a substantial and relevant change of circumstances affecting the controlled locality.

(3) For the purposes of paragraphs (1) and (2), if no particular premises are proposed for listing in A1, the applicant is to be treated as seeking the listing of pharmacy premises at the location which is the best estimate that NHS England is able to make of where the proposed listed pharmacy premises would be, having regard to the best estimate given by the applicant under paragraph 1(7)(a)(ii) of Schedule 2.

(4) Paragraph (2)(b) does not apply where NHS England is satisfied that there are reasonable grounds for believing the person making the refused application was motivated (wholly or partly) by a desire for that application to be refused.

(5) The refusal of an application pursuant to paragraph (2)(b), or regulation 40(2)(b) of the 2012 Regulations (applications for new pharmacy premises in controlled localities: refusals because of preliminary matters), is to be ignored for the purposes of the calculation of a 5 year period pursuant to paragraph (2)(b).

Section 41 Applications for new pharmacy premises in controlled localities: reserved locations

(1) This paragraph applies to any routine application—

(a) for inclusion in a pharmaceutical list as an NHS pharmacist; or

(b) from an NHS pharmacist included in such a list—

(i) to relocate to different pharmacy premises in the area of the relevant HWB, or

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

where the applicant is seeking the listing of pharmacy premises which are in a controlled locality and NHS England is required to notify the application under Part 3 of Schedule 2.

(2) If paragraph (1) applies to an application (referred to in this regulation and regulation 42 as “A1”), subject to paragraph (5), NHS England must determine whether or not the “relevant location”, that is—

(a) the location of the premises for which the applicant is seeking the listing; or

(b) if no particular premises are proposed for listing in A1, the location which is the best estimate that NHS England is able to make of where the proposed pharmacy premises would be, having regard to the best estimate given by the applicant under paragraph 1(7)(a)(ii) of Schedule 2,

is, on basis of the circumstances that pertained on the day on which A1 was received by NHS England , in a reserved location.

(3) Subject to regulation 43(2), the area within a 1.6 kilometre radius of a relevant location is a “reserved location” if—

(a) the number of individuals residing in that area who are on a patient list (which may be an aggregate number of patients on more than one patient list) is less than 2,750; and

(b) NHS England is not satisfied that if pharmaceutical services were provided at or from the relevant location, the use of those services would be similar to, or greater than, the use that might be expected if the number of individuals residing in that area who are on a patient list were 2,750 or more.

(4) Before making a determination under paragraph (2) (referred to in this regulation and regulation 42 as “D1”), NHS England must—

(a) notify the persons notified under Part 3 of Schedule 2 about A1 that NHS England is required to make D1 (and it may make this notification at the same time as it notifies those persons about A1); and

(b) invite them, within a specified period of not less than 30 days, to make representations to NHS England with regard to D1 (and the period specified must end no earlier than the date by which the person notified needs to make any representations that they have with regard to A1).

(5) NHS England must not make a determination under paragraph (2) in respect of A1 in circumstances where an earlier application which was in respect of the relevant premises and to which paragraph (1), regulation 44(1) of the 2012 Regulations (prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved location) or regulation 18ZA of the 2005 Regulations (refusal: premises which are in a controlled locality but not a reserved location) applied was refused—

(a) for the reasons relating to prejudice in—

(i) regulation 44(3),

(ii) regulation 44(3) of the 2012 Regulations, or

(iii) regulation 18ZA(2) of the 2005 Regulations; and

(b) within the 5 year period starting on the date on which the proceedings relating to the refusal reached their final outcome and ending on the date on which A1 is made,

unless NHS England is satisfied that since the date on which the 5 year period started, there has been a substantial and relevant change of circumstances affecting the controlled locality.

(6) For the purposes of paragraph (5), the “relevant premises” are—

(a) the premises which are proposed for listing; or

(b) if no particular premises are proposed for listing in A1, premises at the location which is the best estimate that NHS England is able to make of where the proposed listed pharmacy premises would be, having regard to the best estimate given by the applicant under paragraph 1(7)(a)(ii) of Schedule 2.

Section 42 Second and subsequent determinations of reserved location status

(1) Where NHS England has made D1, or a reserved location determination has been made in accordance with the 2012 Regulations or the 2005 Regulations, and the person in relation to whose proposed listing of premises that determination was made (or that person's successor as the owner of the relevant pharmacy business) requests a further determination (referred to in this regulation as “ D2 ”), NHS England may determine (subject to paragraph (3) and regulation 43(2))—

(a) whether or not a location that has become the relevant location for the purposes of a listing application is in a reserved location, on the basis of the circumstances that pertained on the day on which the request for D2 was received by NHS England , in circumstances where the relevant location in relation to which the earlier determination was made has changed because—

(i) no particular premises were proposed for listing in the application, but

(ii) particular premises have since been identified; or

(b) that, on the basis of the circumstances that pertained on the day on which the request for D2 was received by NHS England , there is no longer—

(i) a reserved location, or

(ii) in the case of a determination of a reserved location that has not yet taken effect, a determination of a reserved location,

with regard to the premises proposed for listing (which may have become pharmacy premises) because the relevant location no longer meets (or does not meet) the criteria for being a reserved location in regulation 41(3).

(2) Before making D2, NHS England must—

(a) notify the persons that it would notify under Part 3 of Schedule 2, if the request for a determination were an application seeking the listing of pharmacy premises at the relevant location, that NHS England is required to make a determination under paragraph (1); and

(b) invite them, within a specified period of up to 3 months but not less than 30 days, to make representations to NHS England with regard to that determination.

(3) NHS England must only determine under paragraph (1) that the area, or any part of an area, that is within a 1.6 kilometre radius of a relevant location is no longer to be classed as a reserved location if it is satisfied that the change in classification of that area, or part of an area, will not prejudice the proper provision of relevant NHS services in the area of—

(a) the relevant HWB; or

(b) a neighbouring HWB of the relevant HWB.

(4) Where NHS England makes D2—

(a) D1 lapses as soon as D2 is made; and

(b) NHS England may (in accordance with regulation 50) postpone the termination of the arrangements that it has with the provider of primary medical services or dispensing doctor that would otherwise take place as a consequence of D2.

(5) Where—

(a) NHS England has made D2; and

(b) the person who sought the determination, or that person's successor as the person carrying on a pharmacy business at or from the relevant location, believes that the reserved location no longer meets the criteria for being a reserved location in regulation 41(3),

that person may request a further determination, under paragraph (1)(b), and if that person does, paragraphs (1) to (4) apply as if the references to D1 were to the most recent determination and the references to D2 were to the new further determination.

Section 43 Determinations of reserved locations: supplemental matters

(1) Once NHS England has determined whether or not an area is a reserved location under regulation 41(2) or 42(1), it must—

(a) give notice of the determination to the person in relation to whose pharmacy premises or proposed pharmacy premises the determination relates, and to the persons notified in accordance with regulation 41(4) or 42(2); and

(b) as part of that notice, inform them of—

(i) its determination and the reasons for it, and

(ii) in the case of any person notified who is a Local Pharmaceutical Committee, a Local Medical Committee, a provider of primary medical services, an LPS chemist or a person on a pharmaceutical or dispensing doctors list, their right of appeal under regulation 45(1)(c) or (d).

(2) Where—

(a) part of the area of what would otherwise be determined under regulation 41(2) or 42(1) to be a reserved location is within 1.6 kilometres of the location of other pharmacy premises (that is, pharmacy premises other than the pharmacy premises at the relevant location); and

(b) there is no reserved location arising out of the presence of those other pharmacy premises,

that part of that area is not to be part of the reserved location.

(3) A reserved location (as opposed to the determination of a reserved location) takes effect once the pharmacy premises to which it relates are listed in the pharmaceutical list.

(4) Once a reserved location takes effect, NHS England must—

(a) delineate precisely the boundary of the reserved location on a map;

(b) publish that map; and

(c) make that map available as soon as is practicable to any HWB that has all or part of that reserved location in its area.

Section 44 Prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved location

(1) This paragraph applies to all routine applications—

(a) for inclusion in a pharmaceutical list as an NHS pharmacist; or

(b) from an NHS pharmacist included in such a list—

(i) to relocate to different pharmacy premises in the area of the relevant HWB, or

(ii) to open, within the area of the relevant HWB, additional pharmacy premises at or from which to provide pharmaceutical services.

(2) As regards any application to which paragraph (1) applies, NHS England must have regard to whether or not the applicant is seeking the listing of pharmacy premises which are in a part of a controlled locality that is not a reserved location.

(3) If the applicant is seeking the listing of pharmacy premises which are in a part of a controlled locality that is not in a reserved location, NHS England must refuse the application if granting it would, in the opinion of NHS England , prejudice the proper provision of relevant NHS services in the area of—

(a) the relevant HWB; or

(b) a neighbouring HWB of the relevant HWB.

(4) For the purposes of paragraphs (2) and (3), if no particular premises are proposed for listing in the application, the applicant is to be treated as seeking the listing of pharmacy premises which are in a controlled locality if the best estimate that NHS England is able to make of where the proposed pharmacy premises would be is at a location which is in a controlled locality, having regard to the best estimate given by the applicant under paragraph 1(7)(a)(ii) of Schedule 2.

Section 45 Appeals against decisions under Part 7

(1) A person with appeal rights (as provided for in this regulation) may appeal to the Secretary of State against the following decisions by NHS England —

(a) a determination of whether or not an area is or is part of a controlled locality as mentioned in regulation 36(2), in respect of which the only people with appeal rights are—

(i) a person, as mentioned in regulation 38(4), who is making a routine application to which the determination relates, and

(ii) a person given notice of the determination who is mentioned in regulation 39(2)(b)(iii);

(b) a decision under regulation 37(3) that an application by a Local Pharmaceutical Committee or Local Medical Committee raises a question that it cannot consider by virtue of regulation 36(3), in respect of which only the Committee making the application to which the decision relates is a person with appeal rights;

(c) a determination as to whether or not a relevant location is in a reserved location under regulation 41(2), in respect of which the only people with appeal rights are—

(i) the person making the application to which the determination relates, and

(ii) a person given notice of the determination who is mentioned in regulation 43(1)(b)(ii); and

(d) a determination under regulation 42(1), in respect of which the only people with appeal rights are—

(i) the person making the application to which the determination relates, and

(ii) a person given notice of the determination who is mentioned in regulation 43(1)(b)(ii),

provided that, within 30 days of the date on which they were notified of the decision that is being appealed, they notify the Secretary of State with a valid notice of appeal.

(2) A notice of appeal under paragraph (1) is only valid if it includes a concise and reasoned statement of the grounds of appeal.

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

Section 46 Dispensing doctor lists

(1) In respect of the area of each HWB, NHS England must prepare and publish a list (a “dispensing doctor list”) of the names of any “dispensing doctors” in that area, that is to say—

(a) providers of primary medical services who provide pharmaceutical services at or from medical practice premises in that area; and

(b) general practitioners who are not providers of primary medical services but who provide pharmaceutical services at or from medical practice premises in that area (not including general practitioners who are listed as part of the listing of a provider by virtue of paragraph (6)(b)).

(2) Each dispensing doctor list must include—

(a) the address of any premises in the area of the relevant HWB for which a listed dispensing doctor has premises approval (“the listed dispensing premises”) and any other medical practice premises of the dispensing doctor in that area; and

(b) any area in relation to which the dispensing doctor has outline consent (which may be in the area of a neighbouring HWB).

(3) NHS England must remove a dispensing doctor from a dispensing doctor list if—

(a) in the case of a listed provider of primary medical services, that person or partnership ceases to be a provider of primary medical services or ceases to be a provider of those services at or from (what were) the relevant listed dispensing premises;

(b) in the case of a listed general practitioner, that person is no longer on the medical performers list or no longer performs primary medical services within the area of the relevant HWB; or

(c) all the arrangements that the dispensing doctor has with NHS England to perform or provide pharmaceutical services at or from (what were) the relevant listed dispensing premises have been discontinued, or the permissions that the dispensing doctor requires in order to have such arrangements have lapsed, in accordance with this Part.

(4) If—

(a) a general practitioner who is the only member of a provider of primary medical services who is a dispensing doctor so elects; or

(b) all the general practitioners who are the members of a provider of primary medical services who are dispensing doctors so elect,

they may request that NHS England lists that provider instead of them as the dispensing doctor (or doctors) on a dispensing doctors list.

(5) In the circumstances described in paragraph (4)—

(a) NHS England must agree to that request;

(b) the arrangements that NHS England had with the individual dispensing doctor or doctors become arrangements with the provider of primary medical services; and

(c) the premises approvals and related outline consents of that individual general practitioner or those general practitioners become the premises approvals and outline consents of the provider of primary medical services.

(6) Where a provider of primary medical services is listed in a dispensing doctors list—

(a) the provider must notify NHS England —

(i) of any general practitioner who performs primary medical services on behalf of the provider who the provider anticipates will provide pharmaceutical services on behalf of the provider, and

(ii) if and when, in the case of a general practitioner who has been so notified, the provider no longer anticipates that the general practitioner will provide pharmaceutical services on behalf of the provider; and

(b) as part of the listing of the provider in its dispensing doctors list, NHS England must include the names of any general practitioner notified under sub-paragraph (a)(i), unless NHS England has received a further notification in respect of that general practitioner under sub-paragraph (a)(ii).

Section 47 Terms of service of dispensing doctors: general

(1) The arrangements under which a dispensing doctor undertakes to provide pharmaceutical services (and so their terms of service) are to include any provisions affecting their rights or obligations that—

(a) are included in these Regulations, including—

(i) the terms of service set out in Schedule 6 (which accordingly has effect), and

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

(b) were imposed, in relation to the dispensing doctor's ability to provide pharmaceutical services, by virtue of regulation 20(2) of the 2005 Regulations (imposition of conditions);

(c) are included in the arrangements for remuneration for services provided by dispensing doctors that give effect to regulation 92, in so far as those rights or obligations are applicable in the case of the dispensing doctor; and

(d) 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.

(2) NHS England must ensure that those terms of service—

(a) if the dispensing doctor has arrangements with NHS England for the provision of primary medical services to the patients to whom the dispensing doctor provides pharmaceutical services, are conditions of and so are enforceable under those arrangements; or

(b) if the dispensing doctor has no such arrangements, are terms of service of, and so are enforceable under, the arrangements that NHS England has with a provider of primary medical services for the provision of primary medical services to the patients to whom the dispensing doctor provides pharmaceutical services.