http://www.legislation.gov.uk/uksi/2013/349The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013texttext/xmlenStatute Law DatabaseNATIONAL HEALTH SERVICE, ENGLAND2025-10-23Expert Participation2025-10-01 These Regulations replace the National Health Service (Pharmaceutical Services) Regulations 2012 (“the 2012 Regulations”) and the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 (“the 2006” Regulations”) as the Regulations which govern the arrangements, in England, for the provision of pharmaceutical and local pharmaceutical services under Part 7 of the National Health Service Act 2006 (“the 2006 Act”). 2013 No. 349Made14th February 2013Laid before Parliament22nd February 2013Coming into force1st April 2013The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 7, 8, 126, 128A, 129, 130, 132, 136, 139, 140, 142(b), 143, 145, 148, 150A, 151(5) and (7), 154, 159(9), 160, 161, 162, 163(3), 164, 169(3) and 272(7) and (8) of, and paragraph 1(2)(b) of Schedule 11 and paragraphs 2 and 3 of Schedule 12 to, the National Health Service Act 2006 .PART 11These Regulations may be cited as the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 and come into force on 1st April 2013.21Subject to paragraph (7), in these Regulations—“100 hours condition” is to be construed in accordance with regulation 65(1);“the 1968 Act” means the Medicines Act 1968 ;“the 1992 Regulations” means the National Health Service (Pharmaceutical Services) Regulations 1992 , as in force on 31st March 2005;“the 2005 Regulations” means the National Health Service (Pharmaceutical Services) Regulations 2005 , as in force on 31st August 2012;“the 2006 Act” means the National Health Service Act 2006;“the 2006 Regulations” means the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 , as in force immediately before the appointed day;“the 2007 Act” means the Local Government and Public Involvement in Health Act 2007 ;“the 2012 Regulations” means the National Health Service (Pharmaceutical Services) Regulations 2012 , as in force immediately before the appointed day;“additional opening hours” is to be construed, as the context requires, in accordance with paragraph 23(13) of Schedule 4 or paragraph 13(12) of Schedule 5, or both; “advanced electronic signature” means an electronic signature which meets the following requirements— it is uniquely linked to the signatory;it is capable of identifying the signatory;it is created using electronic signature creation data that the signatory can, with a high level of confidence, use under the signatory's sole control; andit is linked to the data signed in such a way that any subsequent change in the data is detectable;“advanced services” means the directed services which NHS England is required (as opposed to authorised) to arrange by virtue of directions under section 127 of the 2006 Act (arrangements for additional pharmaceutical services);“APMS contractor” means a person or partnership that provides primary medical services under contractual arrangements with NHS England under section 83(2)(b) of the 2006 Act (primary medical services);“APMS practice” means an APMS contractor that has a patient list;“appliance” means an appliance included in a list approved by the Secretary of State for the purposes of section 126 of the 2006 Act (arrangements for pharmaceutical services);“appliance contractor premises” means listed chemist premises (or in the context of an applicant seeking the listing of premises, proposed listed chemist premises) of an NHS appliance contractor;“appliance use review service” means arrangements made in accordance with directions under section 127 of the 2006 Act for a pharmacist or a specialist nurse to review a person's use of a specified appliance;“appointed day” means 1st April 2013;“armed forces of the Crown” means the forces that are “regular forces” or “reserve forces” within the meanings given in section 374 of the Armed Forces Act 2006 (definitions applying for the purposes of whole Act).“arrangements for recharging” means arrangements under paragraph 3 of Schedule 12A to the 2006 Act (pharmaceutical remuneration – other pharmaceutical remuneration) under which NHS England requires a person to reimburse it for any pharmaceutical remuneration to which that paragraph applies;“bank holiday” means any day that is by virtue of section 1 of or Schedule 1 to the Banking and Financial Dealings Act 1971 (which relate to bank holidays) a bank holiday in England;“batch issue” means a form, in the format required by NHS England (or a person exercising its functions) and approved by the Secretary of State, which—is issued by a prescriber at the same time as a non-electronic repeatable prescription to enable an NHS chemist, an LPS chemist or a dispensing doctor to receive payment for the provision of repeat dispensing services;relates to a particular non-electronic repeatable prescription and contains the same date as that prescription;is generated by a computer and not signed by a prescriber;is issued as one of a sequence of forms, the number of which is equal to the number of occasions on which the drugs or appliances ordered on the non-electronic repeatable prescription may be provided; andhas included on it a number denoting its place in the sequence referred to in sub-paragraph (d);“best estimate”, in the context of the location of proposed appliance contractor premises or pharmacy premises mentioned in a routine application, is to be construed in accordance with paragraph 1(10) of Schedule 2;“breach notice” is to be construed in accordance with regulation 71(1);...“change of ownership application” means an application pursuant to regulation 26; “Charges Regulations” means the National Health Service (Charges for Drugs and Appliances) Regulations 2015; “child” means a person who has not attained the age of 16 years;“chiropodist or podiatrist independent prescriber” means a chiropodist or podiatrist who is registered in Part 2 of the register maintained under article 5 of the Health Professions Order 2001 (establishment and maintenance of register), and against whose name in that register is recorded an annotation signifying that the chiropodist or podiatrist is qualified to order drugs and appliances as a chiropodist or podiatrist independent prescriber; “consolidation application” means an application pursuant to regulation 26A(1); “continuity principles” is to be construed in accordance with paragraph 1(8) of Schedule 9;“controlled locality” means an area that is a controlled locality by virtue of regulation 36(1) or is determined to be so in accordance with regulation 36(2) or paragraph 7(4) of Schedule 9;“core opening hours” is to be construed, as the context requires, in accordance with paragraph 23(2) of Schedule 4 or paragraph 13(2) of Schedule 5, or both; “coronavirus” has the meaning given in section 1(1) of the Coronavirus Act 2020 (meaning of “coronavirus” and related terminology); “directed services” means additional pharmaceutical services provided in accordance with directions under section 127 of the 2006 Act;“director” includes a member of a limited liability partnership;“dispensing contractor” means an NHS chemist, an LPS chemist or a dispensing doctor whom or which a patient wishes to dispense their electronic prescriptions;“dispensing doctor” is to be construed in accordance with regulation 46(1);“dispensing doctor list” is to be construed in accordance with regulation 46(1);“distance selling premises” are listed chemist premises, or potential pharmacy premises, at or from which essential services are or are to be provided but the means of providing those services are such that all persons receiving those services do so otherwise than at those premises;“drugs” includes medicines;“Drug Tariff” is to be construed in accordance with regulation 89(1);“electronic communication” has the meaning given in section 15(1) of the Electronic Communications Act 2000 (general interpretation);“electronic prescription” means an electronic prescription form or an electronic repeatable prescription;“electronic prescription form” means data created in an electronic form for the purpose of ordering a drug or appliance, which—is compatible with the systems used by NHS England (or a person exercising its functions) for—the remuneration of persons providing pharmaceutical services, andany apportionment of, or any arrangements for recharging in respect of, that remuneration,unless the NHS chemist, dispensing doctor or LPS chemist dispensing the prescription is to receive no pharmaceutical remuneration of any kind in respect of any drug or appliance ordered on the form;is signed with a prescriber's advanced electronic signature;is transmitted as an electronic communication to a nominated dispensing contractor or via an information hub by the Electronic Prescription Service; anddoes not indicate that the drug or appliance ordered may be provided more than once;“electronic repeatable prescription” means data created in an electronic form, which—is signed with a prescriber's advanced electronic signature;is transmitted as an electronic communication to a nominated dispensing contractor or via an information hub by the Electronic Prescription Service;indicates that the drugs or appliances ordered may be provided more than once; andspecifies the number of occasions on which they may be provided; “electronic signature” means data in electronic form which is attached to or logically associated with other data in electronic form and which is used by the signatory to sign; “employment” includes unpaid employment and employment under a contract for services, and “employed”, “employer” and “employs” are to be construed accordingly;“enhanced services” means the directed services which NHS England is authorised (as opposed to required) to arrange by virtue of directions under section 127 of the 2006 Act; “EPS token” means a form (which may be an electronic form), approved by the Secretary of State, which—is issued by a prescriber at the same time as an electronic prescription is created; andhas a barcode that enables the prescription to be dispensed by a provider of pharmaceutical services that is able to use the Electronic Prescription Service for the purposes of dispensing prescriptions, in circumstances where the provider is not dispensing the prescription as a nominated dispensing contractor; “essential services”, except in the context of the definition of “distance selling premises”, is to be construed in accordance with paragraph 3 of Schedule 4;“EPS list” is to be construed in accordance with regulation 10(4)(a);“Electronic Prescription Service” means the service of that name which is managed by NHS England;“excepted application” means an application to which section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply by virtue of any provision of Part 4 or a consolidation application to which regulation 26A(2) does not apply; “financial year” means the 12 months ending with 31st March; “general practitioner” means a medical practitioner who is on a medical performers list;“GMS contract” means a general medical services contract;“GMS practice” means a party (which may be a partnership) to a GMS contract other than NHS England; “GMS Regulations” means the National Health Service (General Medical Services Contracts) Regulations 2015; “GPhC register” means the register maintained under article 19 of the Pharmacy Order 2010 (establishment, maintenance of and access to the register);“Health Board”, except in the context of “Local Health Board”, means a Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978 (Health Boards);“health care professional” means a person other than a social worker who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 (the Professional Standards Authority for Health and Social Care); ... “home Primary Care Trust” has the same meaning as in the 2012 Regulations;“HWB” means a Health and Wellbeing Board ;“independent nurse prescriber” means a person—who is registered in the Nursing and Midwifery Register; andagainst whose name in that register is recorded an annotation signifying that they are qualified to order drugs and appliances as a community practitioner nurse prescriber, a nurse independent prescriber or a nurse independent/supplementary prescriber;... “integrated care board” means an integrated care board established under Chapter A3 of Part 2 of the National Health Service Act 2006; “licensing body” means any body anywhere in the world that licenses or regulates any profession;“listed chemist premises” is to be construed in accordance with regulation 10(3)(a);“listed dispensing premises” is to be construed in accordance with regulation 46(2)(a); “listed HRT prescription item” is to be construed in accordance with regulation 17A(1)(a) of the Charges Regulations (HRT only pre-payment certificates), read with regulation 17A(7) of those Regulations; “listed prescription items voucher” means a form which—is provided or approved by NHS England for the purposes of ordering a prescription item mentioned in regulation 13(1) of the Charges Regulations (exemption from charges: risks to public health); andmay be an electronic form sent or to be sent via a secure service approved for this purpose by NHS England; “LPIV” means a listed prescription items voucher; “Local Healthwatch organisation” is to be construed in accordance with section 222(2A) of the 2007 Act (arrangements under section 221(1));“LPS chemist” means a party, other than the commissioning body, to—an LPS pilot scheme; oran LPS scheme for the provision of LP services;“LPS contractor” means a person who is an LPS chemist by virtue of being a party to an LPS scheme which is not an LPS pilot scheme;“LPS pilot scheme” means a pilot scheme within the meaning given in section 134(2) of the 2006 Act (pilot schemes);“LPS scheme”, except in the context of Part 13 or Schedule 7, includes an LPS pilot scheme;“medical performers list” means a list of medical practitioners prepared, maintained and published under regulations under section 91 of the 2006 Act (persons performing primary medical services);“medical practice premises” means—in relation to a provider of primary medical services, premises which are identified in the provider's arrangements with NHS England as the practice premises at or from which primary medical services are to be provided during core hours to patients on the provider's patient list; orin relation to a general practitioner on a dispensing doctor list who is not a provider of primary medical services but who performs services on behalf of a provider of primary medical services, the practice premises at or from which primary medical services are to be provided during core hours to patients on the provider's patient list;“member”, in relation to a provider of primary medical services, means—a member of or partner in the partnership that is the provider; ora shareholder in the company limited by shares that is the provider,but no other providers of primary medical services are to be treated as having members;“national disqualification” includes, in addition to a national disqualification as mentioned in section 159 of the 2006 Act (national disqualification)—a national disqualification as mentioned in section 115 of the National Health Service (Wales) Act 2006 (national disqualification);any decision in Scotland or Northern Ireland corresponding to a national disqualification as mentioned in section 159 to the 2006 Act; andany other decision that was a national disqualification for the purposes of the 2012 Regulations;“neighbouring HWB”, in relation to a HWB (HWB1), means the HWB of an area that borders any part of the area of HWB1;...“NHS appliance contractor” means a person included in a pharmaceutical list of the type referred to in regulation 10(2)(b);“NHS BSA” means the NHS Business Services Authority established by the NHS Business Services Authority (Awdurdod Gwasanaethau Busnes y GIG) (Establishment and Constitution) Order 2005 ; “NHS CFA” means the NHS Counter Fraud Authority, established by the NHS Counter Fraud Authority (Establishment, Constitution, and Staff and Other Transfer Provisions) Order 2017; “NHS chemist” means an NHS appliance contractor or an NHS pharmacist;... “NHS England” means the body corporate established under section 1H of the 2006 Act; “NHS England directory of services” means the directory of services, maintained by NHS England, which is accessed by NHS urgent and emergency care services if a patient is in need of urgent assistance from a health care professional or urgent access to health care advice; “NHS dispute resolution procedure”, in relation to an LPS scheme which is not an LPS pilot scheme, means the dispute resolution procedure set out in paragraphs 22 and 23 of Schedule 7;“NHS Litigation Authority” means the National Health Service Litigation Authority established by the National Health Service Litigation Authority (Establishment and Constitution) Order 1995 ; ... “NHS.net Connect” means the secure e-mail service of that name for the sharing of patient identifiable and patient sensitive information, for which NHS England is responsible; “NHS pharmacist” means a person included in a pharmaceutical list of the type referred to in regulation 10(2)(a);“NHS services” means services provided as part of the health service (so includes services provided as part of the health service in pursuance of the public health functions of the Secretary of State or local authorities);“nominated dispensing contractor” means an NHS chemist, an LPS chemist or a dispensing doctor who has been nominated in a particular patient's PDS patient details to dispense the electronic prescriptions of that patient;“non-electronic prescription form” means a form for ordering a drug or appliance which—is compatible with the systems used by NHS England (or a person exercising its functions) for—the remuneration of persons providing pharmaceutical services, andany apportionment of, or any arrangements for recharging in respect of, that remuneration,unless the NHS chemist, dispensing doctor or LPS chemist dispensing the prescription is to receive no pharmaceutical remuneration of any kind in respect of any drug or appliance ordered on the form;has been provided for use by a prescriber by—NHS England,another primary care organisation,a local authority, under arrangements for providing NHS services which include, with the consent of NHS England, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,the Secretary of State, an integrated care board, under arrangements for providing NHS services which include, with the consent of NHS England, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,an NHS Trust, oran NHS Foundation Trust;if—it has been so provided for use by a prescriber in England, anda prescription charge may be payable in relation to the prescription or a prescription charge exemption in the Charges Regulations may apply to it,is in a format that has been approved by the Secretary of State;has been issued by a prescriber; anddoes not indicate that the drug or appliance ordered may be provided more than once;“non-electronic repeatable prescription” means a repeatable prescription which is not an electronic repeatable prescription;“non-proprietary name” means a name which is, or which is a permitted variation of—an International Nonproprietary Name (INN);an International Nonproprietary Name Modified (INNM);a British Approved Name (BAN);a British Approved Name Modified (BANM); oran approved name,and for this purpose these names (and their permitted variations) have the same meanings as in a list of names which has been prepared and caused to be published in accordance with regulation 318 of the Human Medicines Regulations 2012 (lists of names) and which is in force;“notice” or “notification”, except in the context of a period of notice, means a notice or notification in writing, which may (except in the context of a notice to be exhibited) be in an electronic form, and “notify” is to be construed accordingly;“notice of commencement” means a notice given, or to be given, under paragraph 34(2) of Schedule 2;“notifiable application” is to be construed in accordance with paragraph 18 of Schedule 2;“Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001 (establishment and maintenance of register);“optometrist independent prescriber” means an optometrist against whose name in the register of optometrists maintained under section 7 of the Opticians Act 1989 (which relates to the register of optometrists and the register of dispensing opticians) is recorded an annotation signifying that the optometrist is qualified to order drugs and appliances as an optometrist independent prescriber;“other primary care organisation” or “another primary care organisation” means—as regards Wales—a Local Health Board, orin relation to any time prior to 1st April 2003 a Health Authority;as regards Scotland, a Health Board;as regards Northern Ireland—the Regional Health and Social Care Board, orin relation to any time prior to 1st April 2010, a Health and Social Services Board; andas regards England in relation to any time prior to 1st April 2013, a Primary Care Trust;“outline consent”, in the context of—an application for outline consent, is to be construed in accordance with regulation 51(1)(a); ora subsisting outline consent, means outline consent—granted under these Regulations, orwhich was outline consent for the purposes of the 2012 Regulations;“outstanding pharmacy application” has the meaning given in regulation 53(7); “paramedic independent prescriber” means a person—who is registered in Part 8 of the register maintained under article 5 of the Health Professions Order 2001; andagainst whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines or appliances as a paramedic independent prescriber; “patient list” means a list of patients that is a registered patient list for the purposes of the Primary Medical Services (Sale of Goodwill and Restrictions on Sub-contracting) Regulations 2004 ;“PDS patient details” means the information held about a patient in the Patient Demographics Service managed by NHS England;“pharmaceutical needs assessment” is to be construed in accordance with regulations 3(1) and 7;“pharmaceutical needs assessment map” means the map which a HWB includes in its pharmaceutical needs assessment pursuant to paragraph 7 of Schedule 1;“pharmacist independent prescriber” means a registered pharmacist (P)—against whose name in Part 1 of the GPhC register or in the register maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 (which relate to the registers and the registrar) is recorded an annotation signifying that P is qualified to order drugs and appliances as a pharmacist independent prescriber; andwho is prescribing under arrangements for the provision of NHS services which are neither—pharmaceutical services, unless they are arrangements for the provision of enhanced services, norlocal pharmaceutical services, unless they are arrangements for the provision of services that are of the same type as enhanced services;“pharmacy premises” means listed chemist premises (or in the context of an applicant seeking the listing of premises, proposed listed chemist premises) of an NHS pharmacist;“pharmacy procedures” are the procedures required by section 72A(3) of the 1968 Act (the responsible pharmacist);“physiotherapist independent prescriber” means a physiotherapist who is registered in Part 9 of the register maintained under article 5 of the Health Professions Order 2001, and against whose name in that register is recorded an annotation signifying that the physiotherapist is qualified to order drugs and appliances as a physiotherapist independent prescriber;“PMS contractor” means—a person with whom arrangements have been made under section 92 of the 2006 Act (which relates to arrangements for the provision of primary medical services), unless that person is in a partnership and the other members of the partnership have also made parallel arrangements under that section;a partnership, the members of which have made arrangements in parallel under section 92 of the 2006 Act;“PMS practice” means a PMS contractor that has, or each of whose members (in the case of a partnership) has, a patient list; “PMS Regulations” means the National Health Service (Personal Medical Services Agreements) Regulations 2015; “practice amalgamation” is to be construed in accordance with regulation 59(1);“premises approval”, in the context of—an application for premises approval, is to be construed in accordance with regulation 51(1)(b); ora subsisting premises approval, means premises approval—granted under these Regulations, orwhich was a premises approval for the purposes of the 2012 Regulations;“prescriber”, unless the context otherwise requires, means a medical practitioner, a dental practitioner, a pharmacist independent prescriber, a supplementary prescriber, a chiropodist or podiatrist independent prescriber, a physiotherapist independent prescriber, an independent nurse prescriber , an optometrist independent prescriber, a paramedic independent prescriber or a therapeutic radiographer independent prescriber; “prescription form”, except in the context of the expression “electronic prescription form” or “non-electronic prescription form”, means an electronic prescription form or a non-electronic prescription form; “prescription item” means an item available on prescription, whether or not it is supplied in pursuance of a prescription or another basis for supply (for example a serious shortage protocol or a patient group direction); “Prescription of Drugs Regulations” means the National Health Service (General Medical Services) (Prescription of Drugs etc.) Regulations 2004 ;“prescription only medicine” has the same meaning as in the Human Medicines Regulations 2012 ;“product with an appropriate non-proprietary name” means a product with a non-proprietary name which is not mentioned in—Schedule 1 to the Prescription of Drugs Regulations (drugs and other substances not to be ordered under a general medical services contract); orexcept where the conditions set out in paragraph 42(2)(a) and (b) of Schedule 6 to the GMS Regulations (other contractual terms – restrictions on prescribing by medical practitioners) are satisfied, in Schedule 2 of the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances);“protected characteristic” means a characteristic listed in section 149(7) of the Equality Act 2010 (public sector equality duty), and references to people sharing a protected characteristic are to be understood by referral to the provisions of Chapter 1 of Part 2 of that Act (protected characteristics);“provider of primary medical services” means a GMS practice, a PMS practice or an APMS practice, and “provides” in the context of primary medical services, is to be construed accordingly;“provisional date” is to be construed in accordance with regulation 53(8)(b); “PTP” means a pandemic treatment protocol, which is a protocol—relating to the supply of a prescription only medicine to be used for the prevention of or as a treatment for a disease that is, or in anticipation of it being imminently, pandemic; andapproved in accordance with regulation 247 of the Human Medicines Regulations 2012 (exemption for supply in the event or anticipation of pandemic disease); “PTPGD” means a pandemic treatment patient group direction, which is a patient group direction—relating to the supply of a prescription only medicine to be used for the prevention of or as a treatment for a disease that is, or in anticipation of it being imminently, pandemic; andwhich is in accordance with regulation 233 of the Human Medicines Regulations 2012 (exemption for supply etc under a PGD by a person conducting a retail pharmacy business); “Regional Health and Social Care Board” means the Regional Health and Social Care Board established under section 7 of the Health and Social Care (Reform) Act (Northern Ireland) 2009 (Regional Health and Social Care Board);“registered pharmacist” means a person who is registered in Part 1 ... of the GPhC register or in the register maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;“registered pharmacy technician” means a person registered as a pharmacy technician in Part 2 ... of the GPhC register;“relevant HWB” means—in the context of an application for any entry of any type in a pharmaceutical list or dispensing doctor list (including from a person already included in the list), the HWB for the area to which the list relates;as regards a person with an entry of any type in a pharmaceutical list or dispensing doctor list, the HWB for the area to which the list relates;in the context of an application by a person for dispensing services, the HWB which is, as regards the dispensing doctor from whom the applicant is seeking dispensing services, the relevant HWB (by virtue of sub-paragraph (b)); andin the context of a decision to suspend or remove any type of entry of a person in a pharmaceutical list or dispensing doctor list, the HWB for the area to which the list relates;“relevant list” means—a pharmaceutical list or an equivalent list maintained by another primary care organisation; ora list maintained by NHS England or another primary care organisation of approved performers or providers of primary medical, dental or ophthalmic services;“relevant NHS services” means pharmaceutical services, local pharmaceutical services and primary medical services;“remedial notice” is to be construed in accordance with regulation 70(1);“Remission of Charges Regulations” means the National Health Service (Travel Expenses and Remission of Charges) Regulations 2003 ;“repeat dispensing services” means pharmaceutical or local pharmaceutical services which involve the provision of drugs or appliances in accordance with a repeatable prescription;“repeatable prescription” means an electronic repeatable prescription or a form for ordering drugs or appliances which—is compatible with the systems used by NHS England (or a person exercising its functions) for—the remuneration of persons providing pharmaceutical services, andany apportionment of, or any arrangements for recharging in respect of, that remuneration,unless the NHS chemist, dispensing doctor or LPS chemist dispensing the prescription is to receive no pharmaceutical remuneration of any kind in respect of any drug or appliance ordered on the form;has been provided for use by a prescriber by—NHS England,another primary care organisation,a local authority, under arrangements for providing NHS services which include, with the consent of NHS England, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,the Secretary of State, an integrated care board, under arrangements for providing NHS services which include, with the consent of NHS England, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,an NHS Trust, oran NHS Foundation Trust;if—it has been so provided for use by a prescriber in England, anda prescription charge may be payable in relation to the prescription or a prescription charge exemption in the Charges Regulations may apply to it,is in a format that has been approved by the Secretary of State;has been issued by a prescriber,indicates that the drugs or appliances ordered may be provided more than once; andspecifies the number of occasions on which they may be provided;“reserved location” means, unless the context otherwise requires, an area classified as such following a determination (that has not lapsed) under—regulation 41(2) or 42(1);regulation 41(2) or 42(1) of the 2012 Regulations (which related to initial, second and subsequent determinations of reserved location status), whether or not by virtue of paragraph 8 of Schedule 9; orregulation 35 of the 2005 Regulations (pharmaceutical services in reserved locations), whether or not by virtue of—paragraph 8 of Schedule 9, orparagraph 6 of Schedule 7 to the 2012 Regulations (transitional provisions – reserved locations);“restricted availability appliance” means an appliance which is approved for particular categories of person or particular purposes only;“routine application” is to be construed in accordance with regulation 12;“the SCAT Regulations” means the National Health Service (Service Committees and Tribunal) Regulations 1992 , as in force on 31st August 2012;“Scheduled drug” means a drug specified in Schedule 1 or 2 to the Prescription of Drugs Regulations (which relate to drugs, medicines and other substances not to be ordered under a general medical services contract or that may be ordered only in certain circumstances);“scheme premises” is to be construed in accordance with regulation 102(1)(b); “serious shortage protocol” means—in the case of a prescription only medicine, a serious shortage protocol for the purposes of regulation 226A of the Human Medicines Regulations 2012 (sale etc. by a pharmacist in accordance with a serious shortage protocol); orin the case of any other drug or appliance, a written protocol that—is issued by the Secretary of State in circumstances where England or any part of England is, in the opinion of the Secretary of State, experiencing or may experience a serious shortage of—a specified drug or appliance, ordrugs or appliances of a specified description,provides for the supply by a provider of pharmaceutical or local pharmaceutical services, where there is an order on a prescription form or a repeatable prescription for—the specified drug or appliance, ora drug or appliance of the specified description,of a different product or quantity of product to the product or quantity of product ordered, subject to such conditions as may be specified in the protocol, andspecifies the period for which, and the parts of England (which may be all of England) in which, the protocol is to have effect; “signatory” means a natural person who creates an electronic signature; “specified appliance” means—any of the following appliances listed in Part IXA of the Drug Tariff—a catheter appliance (including a catheter accessory and maintenance solution),a laryngectomy or tracheostomy appliance,an anal irrigation system,a vacuum pump or constrictor ring for erectile dysfunction, ora drainage wound pouch;an incontinence appliance listed in Part IXB of the Drug Tariff; ora stoma appliance listed in Part IXC of the Drug Tariff; “SSP” means a serious shortage protocol; “stoma appliance customisation” means the customisation of a quantity of more than one stoma appliance, where—the stoma appliances to be customised are listed in Part IXC of the Drug Tariff;the customisation involves modification to the same specification of multiple identical parts for use with each appliance; andthat modification is based on the patient's measurements or a record of those measurements and, if applicable, a template;“superintendent” has the same meaning as in section 71 of the 1968 Act (bodies corporate);“staff” includes locums and other persons engaged on contracts for services who act as staff;“supplementary opening hours” is to be construed, as the context requires, in accordance with paragraph 23(3) of Schedule 4 or paragraph 13(4)(a) of Schedule 5, or both;“supplementary prescriber” means—a registered pharmacist against whose name in Part 1 of the GPhC register or in the register maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 is recorded an annotation signifying that they are qualified to order drugs and appliances as a supplementary prescriber;a person—who is registered in a part of the register maintained under article 5 of the Health Professions Order 2001 (establishment and maintenance of register) which relates to chiropodists and podiatrists, dietitians, physiotherapists or radiographers, andagainst whose name in that register is recorded an annotation signifying that they are qualified to order drugs and appliances as a supplementary prescriber; oran optometrist against whose name in the register of optometrists maintained under section 7 of the Opticians Act 1989 is recorded an annotation signifying that the optometrist is qualified to order drugs and appliances as a supplementary prescriber; “therapeutic radiographer independent prescriber” means a radiographer—who is registered in Part 11 of the register maintained under article 5 of the Health Professions Order 2001; andagainst whose name in that register is recorded—an entitlement to use the title “therapeutic radiographer”, andan annotation signifying that the radiographer is qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber; “transfer scheme” means a property transfer scheme under section 300 of the Health and Social Care Act 2012 (transfer schemes) that transfers the rights and liabilities of a Primary Care Trust under arrangements for the provision of pharmaceutical or local pharmaceutical services to other persons.2In these Regulations, “pharmaceutical services”, in the context of—aPart 2 and Schedule 1, means the pharmaceutical services to which a pharmaceutical needs assessment must relate by virtue of regulation 3(2); orbarrangements 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).3Where reference is made in these Regulations to proceedings (but not investigations) reaching their final outcome—ain 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—ionce the period for bringing an appeal has expired without an appeal being brought, oriiif 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; orbin 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—ionce the period for bringing an appeal has expired without an appeal being brought, oriiif an appeal is brought in accordance with those rights, once those rights have been exhausted.4Where 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.5For 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—aexercise, orbwhere 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.6Where—adirections of the type mentioned in paragraph (5) are given; andbthe 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.7Where 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.8In 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—apandemic; andba serious risk or potentially serious risk to human health,it is to that announcement or advice, which may be withdrawn at any time, as amended from time to time.PART 231The 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”.2The 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—athe provision of pharmaceutical services (including directed services) by a person on a pharmaceutical list;bthe provision of local pharmaceutical services under an LPS scheme (but not LP services which are not local pharmaceutical services); orcthe 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).41Each pharmaceutical needs assessment must contain the information set out in Schedule 1.2Each 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).5Each HWB must publish its first pharmaceutical needs assessment by 1st April 2015.6A1 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.A2Any 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).A3Any 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—athe number of people in its area who require pharmaceutical services;bthe demography of its area; andcthe 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.3Pending 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—athe changes are relevant to the granting of applications referred to in section 129(2)(c)(i) or (ii) of the 2006 Act; andbthe HWB—iis satisfied that making its first or a revised assessment would be a disproportionate response to those changes, oriiis 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.3ZAExcept 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).3ZBParagraph (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).3APending 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—athe 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; andbHWB1 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 HWB1.4Where 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—ato meet a current or future need for pharmaceutical services; orbto 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.71. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1APrior 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—aany supplementary statement relating to that assessment published by HWB2 under regulation 6(3) (which has become part of that assessment); andbany supplementary statement relating to that assessment published by HWB1 under regulation 6(3A).2Each HWB must ensure that NHS England has access to—athe HWB's pharmaceutical needs assessment (including any supplementary statement that it publishes, in accordance with regulation 6(3), that becomes part of that assessment);bany supplementary statement that the HWB publishes, in accordance with regulation 6(3A), in relation to another HWB’s pharmaceutical needs assessment; andcany 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.3Each 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.81When 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—aany 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);bany 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);cany persons on the pharmaceutical lists and any dispensing doctors list for its area;dany LPS chemist in its area with whom NHS England has made arrangements for the provision of any local pharmaceutical services;eany 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; andfany NHS trust or NHS foundation trust in its area;gNHS England; andhany neighbouring HWB.2The 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.3Where 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—amust consult that Committee before making its response to the consultation; andbmust have regard to any representations received from the Committee when making its response to the consultation.4The 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.5For 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.6If a person consulted on a draft under paragraph (2)—ais treated as served with the draft by virtue of paragraph (5); orbhas 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).91When 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—athe demography of its area;bwhether in its area there is sufficient choice with regard to obtaining pharmaceutical services;cany different needs of different localities within its area;dthe pharmaceutical services provided in the area of any neighbouring HWB which affect—ithe need for pharmaceutical services in its area, oriiwhether 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; andeany other NHS services provided in or outside its area (which are not covered by sub-paragraph (d)) which affect—ithe need for pharmaceutical services in its area, oriiwhether 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.2When making an assessment for the purposes of publishing a pharmaceutical needs assessment, each HWB must take account of likely future needs—ato the extent necessary to make a proper assessment of the matters mentioned in paragraphs 2 and 4 of Schedule 1; andbhaving regard to likely changes to—ithe number of people in its area who require pharmaceutical services,iithe demography of its area, andiiithe risks to the health or well-being of people in its area.PART 3101In 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.2Those lists (which are pharmaceutical lists) are—aa list of persons who undertake to provide pharmaceutical services in particular by way of the provision of drugs; andba list of persons who undertake to provide pharmaceutical services only by way of the provision of appliances.3Those lists must include—athe 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”);bthe 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6NHS 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.7Schedule 2, which has effect, contains provisions with regard to—athe information to be supplied by a person—iseeking inclusion in a pharmaceutical list who is not already included in it, oriiwho is included in a pharmaceutical list and who is seeking—aato open, within the area of the relevant HWB, additional premises at or from which to provide the same or different pharmaceutical services,bbto relocate to different premises, and at or from those premises to provide the same or different pharmaceutical services, orccto provide, at or from the person's listed chemist premises, services that are in addition to those already listed in relation to that person; andbthe procedure to be followed by persons as mentioned in sub-paragraph (a) when making a routine application or an excepted application; andcother related matters.8Schedule 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).111The 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—athat are included in these Regulations, including—ithe terms of service set out in Schedule 4 (which accordingly has effect), andiiany obligation that is only applicable in prescribed cases, if the NHS pharmacist is a person to whom the obligation is applicable;bthat 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;cwhere NHS England makes an arrangement with the NHS pharmacist for the provision of any directed services, that are included in that arrangement; anddthat are—iincluded in regulations under section 225 of the 2007 Act (duties of services-providers to allow entry by Local Healthwatch organisations or contractors), andiimade 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.2The 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—athat are included in these Regulations, including—ithe terms of service set out in Schedule 5 (which accordingly has effect), andiiany obligation that is only applicable in prescribed cases, if the NHS appliance contractor is a person to whom the obligation is applicable;bthat 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;cwhere NHS England makes an arrangement with the NHS appliance contractor for the provision of any directed services, that are included in that arrangement; anddthat are—iincluded in regulations under section 225 of the 2007 Act (duties of services-providers to allow entry by Local Healthwatch organisations or contractors), andiimade 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.3A 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—aas a consequence of a disease being, or in anticipation of a disease being imminently—ipandemic, andiia 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;bthe prioritisation is in order to assist in the management of the serious risk or potentially serious risk to human health;cas 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—iin the area to which the announcement relates,iiin the circumstances specified in the announcement, andiiiduring the period specified in the announcement; anddthe 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.12In these Regulations, a “routine application” is any application, other than an excepted application, by a person—afor inclusion in a pharmaceutical list who is not already included in it; orbwho is included in a pharmaceutical list and who is seeking—ito open, within the area of the relevant HWB, additional premises at or from which to provide the same or different pharmaceutical services,iito relocate to different premises, and at or from those premises to provide the same or different pharmaceutical services, oriiito provide, at or from the person's listed chemist premises, services that are in addition to those already listed in relation to that person.131If—aNHS 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; andbthe 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).2Those matters are—awhether 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;bwhether 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;cwhether 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;dwhether 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;ewhether it is satisfied that—igranting the application would only meet the current need mentioned in paragraph (1) in part, andiiif the application were granted, it would be unlikely, in the reasonably foreseeable future, that the remainder of that need would be met;fwhether—iit is satisfied that granting the application would only meet the current need mentioned in paragraph (1) in part, butiiit 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;gwhether it is satisfied that—ithe current need mentioned in paragraph (1) was for services other than essential services, andiigranting the application would result in an increase in the availability of essential services in the area of the relevant HWB;hwhether 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;iwhether the application needs to be deferred or refused by virtue of any provision of Parts 5 to 7.3For the purposes of paragraph (2)(h), a need is to be treated as due to be met if—athe 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; orbP 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.141If NHS England is satisfied as mentioned in regulation 13(2)(a), it may—adefer determination of the application;binvite applications from other persons to offer to meet the current need mentioned in regulation 13(1) that the applicant is offering to meet; andcconsider, at the same time as the applicant's application, any application it receives—ias a consequence of the invitation issued in accordance with sub-paragraph (b), oriithat, 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.2If 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.3If 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.4If NHS England is satisfied as mentioned in regulation 13(2)(d) or (e), it must refuse the application.5If 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.151If—aNHS 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; andbthe 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).2Those matters are—awhether 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;bwhether 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);cwhether 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;dwhether 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;ewhether 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;fwhether 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—ithe 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), andiigranting the application would not secure improvements, or better access, to pharmaceutical services in that area;gwhether it is satisfied that—igranting the application would only meet the future need mentioned in paragraph (1) in part, andiiif the application were granted, it would be unlikely, in the reasonably foreseeable future, that the remainder of that need would be met;hwhether —iit is satisfied that granting the application would only meet the future need mentioned in paragraph (1) in part, butiiit 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;iwhether it is satisfied that—ithe future need mentioned in paragraph (1) was for services other than essential services, andiigranting the application would result in an increase in the availability of essential services in the area of the relevant HWB;jwhether 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;kwhether the application needs to be deferred or refused by virtue of any provision of Parts 5 to 7.3For the purposes of paragraph (2)(j), a future need is to be treated as due to be met if—athe 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;bthe grant of P's application to meet that need is subject to a condition imposed by virtue of paragraph 33(2) of Schedule 2; orcP 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.161If NHS England is satisfied as mentioned in regulation 15(2)(a), it may—adefer determination of the application;binvite applications from other persons to offer to meet the future need mentioned in regulation 15(1) that the applicant is offering to meet; andcconsider, at the same time as the applicant's application, any application it receives—ias a consequence of the invitation issued in accordance with sub-paragraph (b), oriithat, 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.2If 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.3If 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.4If 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.5If NHS England is satisfied as mentioned in regulation 15(2)(e) to (g), it must refuse the application.6If 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.171If—aNHS 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; andbthe 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).2Those matters are—awhether 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;bwhether 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;cwhether 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;dwhether 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;ewhether it is satisfied that—igranting the application would only secure the improvements or better access mentioned in paragraph (1) in part, andiiif 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;fwhether 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;gwhether it is satisfied that—ithe improvements or better access mentioned in paragraph (1) were or was in respect of services other than essential services, andiigranting the application would result in an undesirable increase in the availability of essential services in the area of the relevant HWB;hwhether the application needs to be deferred or refused by virtue of any provision of Part 5 to 7.3For 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—athe 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;bP 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.181If—aNHS 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; andbthe 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).2Those matters are—awhether it is satisfied that granting the application would cause significant detriment to—iproper planning in respect of the provision of pharmaceutical services in the area of the relevant HWB, oriithe arrangements NHS England has in place for the provision of pharmaceutical services in that area;bwhether, 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—ithere 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)),iipeople 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 iiithere 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;cwhether 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;dwhether 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;ewhether 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;fwhether the application needs to be deferred or refused by virtue of any provision of Part 5 to 7.gwhether it is satisfied that the application presupposes that a gap in pharmaceutical services provision has been or is to be created—iby the removal of chemist premises from a pharmaceutical list as a consequence of the grant of a consolidation application, andiisince the last revision of the relevant HWB’s pharmaceutical needs assessment other than by way of a supplementary statement.3NHS 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).191If NHS England is satisfied as mentioned in regulation 17(2)(a), it may—adefer determination of the application;binvite 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; andcconsider, at the same time as the applicant's application, any application it receives—ias a consequence of the invitation issued in accordance with sub-paragraph (b), oriithat, 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.2If NHS England is satisfied as mentioned in regulation 18(2)(c), it may—adefer determination of the application;binvite applications from other persons to offer to secure the improvements or better access that the applicant is offering to secure; andcconsider, at the same time as the applicant's application, any application it receives—ias a consequence of the invitation issued in accordance with sub-paragraph (b), oriithat, 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.3If 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.4If 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.5If NHS England is satisfied as mentioned in regulation 17(2)(d) to (g) or 18(2)(a) or (g), it must refuse the application.6If 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.201If—aNHS 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; andbthe 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).2Those matters are—awhether 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;bwhether 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);cwhether 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;dwhether 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;ewhether 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;fwhether 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);gwhether it is satisfied that—igranting the application would only secure the future improvements or better access mentioned in paragraph (1) in part, andiiif 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;hwhether 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;iwhether it is satisfied that—ithe future improvements or better access mentioned in paragraph (1) were or was in respect of services other than essential services, andiigranting the application would result in an undesirable increase in the availability of essential services in the area of the relevant HWB;jwhether the application needs to be deferred or refused by virtue of any provision of Part 5 to 7.3For 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—athe 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;bthe 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; orcP 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.211If NHS England is satisfied as mentioned in regulation 20(2)(a), it may—adefer determination of the application;binvite 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; andcconsider, at the same time as the applicant's application, any application it receives—ias a consequence of the invitation issued in accordance with sub-paragraph (b), oriithat, 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.2If 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.3If 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.4If 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.5If NHS England is satisfied as mentioned in regulation 20(2)(e) to (i), it must refuse the application.21A1Paragraph (2) applies where NHS England receives a routine application which is in respect of premises not already listed, where—athe 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); andbthe 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.2In 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.3If 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.221If 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—ameet 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; orbsecure (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 1.2For the purposes of paragraph (1), the relevant pharmaceutical needs assessment is—athe 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; orbif 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.PART 423Section 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.241Section 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—afor 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;bin 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—iin any part of the area of HWB1, oriiin 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;cNHS 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;dthe 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); andethe provision of pharmaceutical services will not be interrupted (except for such period as NHS England may for good cause allow).2Section 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—athe purpose of the application is to relocate to different premises;bfor 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;cin 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—iin any part of HWB3's area; oriiin a controlled locality in the area of a neighbouring HWB (including HWB2), where that controlled locality is within 1.6 kilometres of P2;dNHS 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;ethe 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);fthe provision of pharmaceutical services will not be interrupted (except for such period as NHS England may for good cause allow); andgthe applicant consents to—iwhere 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, oriiwhere 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 P2.3An application pursuant to this regulation must be refused if the existing pharmacy premises from which the applicant is seeking to relocate (P3)—awere 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—iP3 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)), andiithe applicant proposes to relocate from P3 to premises that are outside that area;bwere 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—ithe 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,iiat 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, andiiiat 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); ...chave been listed in relation to the applicant for a period of less than 12 months prior to the application, and—ithat listing arose out of the applicant relocating to P3 from other pharmacy premises,iithat relocation arose out of the grant of an application—aathat 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), orbbto which regulation 6 or 7 of the 2005 Regulations (which related to minor relocations) applied, andiiithe applicant is unable to satisfy NHS England that relocation from P3 is necessary for reasons that NHS England accepts are good cause ; ordare distance selling premises, unless—ithe premises to which the applicant is seeking to relocate are also distance selling premises, andiiif the application was one to which regulation 25(1) applied, it would not be refused pursuant to regulation 25(2).251Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application to relocate to different premises—a. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .bby 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.2NHS England must refuse an application to which paragraph (1) applies—aif 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; andbunless NHS England is satisfied that the pharmacy procedures for the pharmacy premises are likely to secure—ithe uninterrupted provision of essential services, during the opening hours of the premises, to persons anywhere in England who request those services, andiithe 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.25AIn 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 2025.261Section 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—athe applicant (X) is undertaking to provide pharmaceutical services at or from premises—ithat are already listed chemist premises, andiiat or from which another person (Y) is providing pharmaceutical services;bX 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;cX is undertaking to provide the same pharmaceutical services as those that Y is providing; anddthe 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).2Section 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—athe applicant (X) is undertaking to provide the pharmaceutical services that another person (Y)—iis providing at or from listed chemist premises (“Y's premises”), whether in the area of HWB1 or a neighbouring HWB, oriihas 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;bX 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;cX 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; ande in a case where pharmaceutical services—iare 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, oriiare 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.3An 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).4An 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)).26A1A 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 HWB1.2Section 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.3Subject to paragraph (4), a consolidation application—amust be made by the person (P1) included in the pharmaceutical list in relation to S1; andbif 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 S2.4If 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—amust be made by P2; andbmust include as part of the application an application by P2 to change the ownership of S1.5NHS England must refuse a consolidation application—aif it is satisfied that granting the application would create a gap in pharmaceutical services provision that could be met by a routine application—ito meet a current or future need for pharmaceutical services, orito secure improvements, or better access, to pharmaceutical services; orbif either S1 or S2 are distance selling premises or appliance contractor premises.6In the case of an application to which paragraph (3) applies, NHS England must refuse the application unless it is satisfied—aif 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;bin the case of an application to which paragraph (3)(b) applies, that—iP2 consents to the change of ownership of S2, andiiP1 and P2 consent to S2 ceasing to be listed chemist premises as a consequence of the application; andcin 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.7In the case of an application to which paragraph (4) applies, NHS England must refuse the application unless it is satisfied—athat 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;bthat 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);cthat 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;dif 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; andethat—iP1 consents to the change of ownership of S1, andiiP1 and P2 consent to S2 ceasing to be listed chemist premises as a consequence of the application.8If 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.271Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application—afor temporary inclusion in a pharmaceutical list by a person not already included; orbby 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.2NHS England must refuse an application to which paragraph (1) applies—aunless it is satisfied that—iY has nominated X as the person to provide those services for the duration of Y's suspension and consents to X doing so,iiX will provide the same pharmaceutical services as those that Y provided or had undertaken to provide before the suspension, andiiithere 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;bif Y is a body corporate and X—iis an employee of Y,iiis, or was at the time of the suspension or of the originating events, a director or superintendent of Y,iiiis a body corporate in which Y or an employee of Y is a majority shareholder,ivis 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,vis a body corporate which has a director or superintendent who is an employee of Y, orviis 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;cif Y is an individual and X—iis an employee of Y,iiis a body corporate of which Y or an employee of Y is a director or superintendent,iiiis a body corporate in which Y or an employee of Y is a majority shareholder, orivis a body corporate which has a director or superintendent who is an employee of Y; ordif Y is a partnership and X—iis or has been a member or employee of Y,iiis a body corporate of which a member or employee of Y is or has been a director, superintendent or majority shareholder, oriiiis a partnership of which X, or a member or employee of X, is or has been a member.3If an application to which—aparagraph (1)(a) applies is granted, the applicant must only be included in the pharmaceutical list for a fixed period;bparagraph (1)(b) applies is granted, the premises or services must only be listed in relation to the applicant for a fixed period.4The fixed periods referred to in paragraph (3) must be no longer than—athe period of Y's suspension; orbuntil 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.281Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application—afor inclusion in a pharmaceutical list by a person not already included; orbby 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).2Those circumstances are—ait has been determined in accordance with—iregulation 4 of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002 (right of return to pharmaceutical lists),iiregulation 15 of the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 (right of return to pharmaceutical lists), oriiiregulation 108,that the applicant is to be given a right of return to a pharmaceutical list;bthe 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; andcthe granting of the right of return arose out of the provision of the local pharmaceutical services which the applicant is ceasing to provide.3NHS England must refuse an application to which paragraph (1) applies, unless—athe 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); andbany conditions in the relevant determination of the right of return are satisfied.291Section 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—athere is an emergency requiring the flexible provision of pharmaceutical services; orbthere 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 P1.2In the circumstances described in paragraph (1)(a), NHS England may make a temporary amendment to an entry in a pharmaceutical list, but—aonly 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; andbthe 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.3In 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.4A period specified under paragraph (3) must not be longer (initially) than 6 months, and NHS England may under that paragraph—aif 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); orbcurtail the period specified,in appropriate circumstances.5For 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).6The 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.7Planned refurbishment is not a “reason beyond the control” of C for the purposes of paragraph (1)(b).8There is no right of appeal under these Regulations in respect of a decision of NHS England under this regulation.PART 530An 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.311A routine or excepted application, other than a consolidation application, must be refused where paragraph (2) applies.2This paragraph applies where—aa 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—ithe premises to which the application relates, oriiadjacent premises; andbNHS 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).321A routine application may be deferred where paragraph (2) applies to the relevant premises.2This paragraph applies where the relevant premises are premises or part of premises, or are located within an area, designated under—aregulation 99; orbregulation 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.3For the purposes of this regulation, “the relevant premises” are—athe listed chemist premises or proposed listed chemist premises in the application; orbas 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.PART 633A1In this regulation, “A” means, where an application for inclusion in a pharmaceutical list is made by a person who is—aan individual, the individual making the application;ba partnership, any partner in the partnership making the application; orca body corporate—iexcept for the purposes of paragraphs (1)(a) and (b) and (3)(h)(i), the body corporate making the application, andiiexcept for the purposes of paragraph (2)(b) and (e), any director or superintendent of the body corporate making the application.1An 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—aA ...has been convicted in the United Kingdom of murder;bA ...—ihas been convicted in the United Kingdom of a criminal offence, other than murder, which was committed after 1st April 2005, andiihas been sentenced to a term of imprisonment of over 6 months;cA is the subject of a national disqualification; ordwhere, 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.2An application for inclusion in a pharmaceutical list by a person who is not already included may be refused if NHS England—ahaving contacted the referees mentioned in paragraph 3(8) of Schedule 2, is not satisfied with the references given;bconsiders that A is unsuitable to be included in the list;chaving—ichecked with the NHS CFA for any facts that it considers relevant relating to past or current fraud investigations involving or related to A ..., andiiconsidered 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;dhaving—ichecked 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 ..., andiiconsidered these and any other facts in its possession involving or relating to A ...,considers the outcome of these enquiries justify such refusal; oreconsiders that granting the application would be prejudicial to the efficiency of the service which A has undertaken to provide.3Where 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)—athe nature of any offence, investigation or incident;bthe length of time since any offence, incident, conviction or investigation;cwhether there are other offences, incidents or investigations to be considered;dany 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;ethe 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;fwhether 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;gwhether 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; orhwhether A ...was, at the time of the originating events, or has in the preceding 6 months been—ia director or superintendent of a body corporate which has been refused inclusion in, conditionally included in, removed or contingently removed from a relevant list, oriiis 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.4When NHS England takes into consideration the matters set out in paragraph (3), it must consider the overall effect of all the matters being considered.5If 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—athe reasons for the decision;bthe 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.34A1In this regulation, “A” means, where an application for inclusion in a pharmaceutical list is made by a person who is—aan individual, the individual making the application;ba partnership, any partner in the partnership making the application; orca body corporate—iexcept for the purposes of paragraph (1)(b), (c)(ii), (e), (g), (i) and (k), the body corporate making the application, andiiany director or superintendent of the body corporate making the application.1An 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—athere are, in respect of A ...—icriminal proceedings in the United Kingdom, oriiproceedings 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;bin 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—icriminal proceedings in the United Kingdom, oriiproceedings 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;cthere is an investigation anywhere in the world—iby A's ... licensing or regulatory body, oriirelating 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;dA ...is suspended from a relevant list;ea body corporate of which A ... was, at the time of the originating events, a director or superintendent, is suspended from a relevant list;fthe First-tier Tribunal is considering an appeal by A ... against a decision of NHS England or another primary care organisation—ito refuse an application for inclusion in a relevant list, oriito 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;gthe 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—ito refuse an application by that body corporate for inclusion in its list,iito 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;hA ... 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;ia 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;jthe First-tier Tribunal is considering an application from NHS England or a Local Health Board for a national disqualification of A ...;kthe 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; orlNHS England or another primary care organisation, for a reason relating to unsuitability, fraud or efficiency of service provision—iis considering removal (other than voluntary removal) or contingent removal of the applicant from a relevant list, oriihas 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.2NHS England may only defer a decision under paragraph (1) until—athe outcome of the cause for the deferral is known; orbthe reason for the deferral no longer exists.351An 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.2NHS England may vary the terms of service of an NHS chemist for the purpose of or in connection with the imposition of the condition.3A condition imposed under paragraph (1) must be a condition with a view to—apreventing any prejudice to the efficiency of the services, or any of the services, which P has undertaken to provide; orbpreventing any act or omission within section 151(3)(a) of the 2006 Act (disqualification of practitioners).4If 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—athe reasons for the decision;bP's right of appeal against its decision to the First-tier Tribunal;cthe 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; anddthe effect of paragraph (5).5If 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.6The appeal is to be by way of redetermination of—athe decision of NHS England to impose the condition; andbif 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.7If at the time the appeal is determined, P has not been included in the pharmaceutical list, and—athe First-tier Tribunal confirms the decision of NHS England; orbimposes 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 application8If 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.PART 7361Any 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).2Subject 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.3Where 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—afor 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;bunless 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.371A 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.2Before 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).3If 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).381If 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—aany Local Pharmaceutical Committee whose area includes all or part of A1;bany Local Medical Committee whose area includes all or part of A1;cany person on a pharmaceutical list or dispensing doctors list who, in the opinion of NHS England, may be affected by the determination;dany LPS chemist who, in the opinion of NHS England, may be affected by the determination;eany provider of primary medical services who, in the opinion of NHS England, may be affected by the determination;fwhere it is considering making a determination as a consequence of a routine application, the person making that application; andgany HWB whose area includes all or part of A1.2NHS England may also give notice of the proposed determination to such other persons as it considers appropriate to do so.3A notice under paragraph (1) or (2) must inform the person notified—athat 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;bof 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).4Once 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—ait 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; andbthe proceedings relating to that determination have reached their final outcome.391When 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—aprimary medical services by a provider of primary medical services;bpharmaceutical services by a person on a pharmaceutical list; orclocal pharmaceutical services by a provider of such services,is likely to be adversely affected by the consequences of the determination.2Once it has determined whether or not an area is or is part of a controlled locality, NHS England must—aif 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—idelineate precisely the boundary of the resulting controlled locality on a map,iipublish that map, andiiimake that map available as soon as is practicable to any HWB that has all or part of that controlled locality in its area;bgive notice of the determination to the persons mentioned in paragraph (3) informing them of—iits determination and the reasons for it,iitheir right of appeal, if the person has a right of appeal under regulation 45(1)(a)(i), andiiitheir 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.3The persons mentioned in this paragraph are—aif the determination resulted from an application from a Local Pharmaceutical Committee or Local Medical Committee pursuant to regulation 37(1), that Committee;bif 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; andcthe persons notified in accordance with regulation 38(1) and (2) in relation to the proposal to make the determination.4A HWB to which a map is made available under paragraph (2)(a)(iii) must—apublish that map alongside its pharmaceutical needs assessment map (once it has one); orbinclude 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).401This paragraph applies to all routine applications—afor inclusion in a pharmaceutical list as an NHS pharmacist; orbfrom an NHS pharmacist included in such a list—ito relocate to different pharmacy premises in the area of the relevant HWB, oriito 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.2If 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—ain 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—istarting on the date on which the proceedings relating to the grant of outline consent reached their final outcome, andiiending on the date on which A1 is made; orbwithin 1.6 kilometres of the location of proposed pharmacy premises (other than proposed distance selling premises), in respect of which—ia routine application under these Regulations or the 2012 Regulations, oriian 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.3For 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 2.4Paragraph (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.5The 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).411This paragraph applies to any routine application—afor inclusion in a pharmaceutical list as an NHS pharmacist; orbfrom an NHS pharmacist included in such a list—ito relocate to different pharmacy premises in the area of the relevant HWB, oriito 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 2.2If 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—athe location of the premises for which the applicant is seeking the listing; orbif 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.3Subject to regulation 43(2), the area within a 1.6 kilometre radius of a relevant location is a “reserved location” if—athe 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; andbNHS 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.4Before making a determination under paragraph (2) (referred to in this regulation and regulation 42 as “D1”), NHS England must—anotify 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); andbinvite 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).5NHS 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—afor the reasons relating to prejudice in—iregulation 44(3),iiregulation 44(3) of the 2012 Regulations, oriiiregulation 18ZA(2) of the 2005 Regulations; andbwithin 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.6For the purposes of paragraph (5), the “relevant premises” are—athe premises which are proposed for listing; orbif 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 2.421Where 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))—awhether 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—ino particular premises were proposed for listing in the application, butiiparticular premises have since been identified; orbthat, 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—ia reserved location, oriiin 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).2Before making D2, NHS England must—anotify 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); andbinvite 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.3NHS 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—athe relevant HWB; orba neighbouring HWB of the relevant HWB.4Where NHS England makes D2—aD1 lapses as soon as D2 is made; andbNHS 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 D2.5Where—aNHS England has made D2; andbthe 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.431Once NHS England has determined whether or not an area is a reserved location under regulation 41(2) or 42(1), it must—agive 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); andbas part of that notice, inform them of—iits determination and the reasons for it, andiiin 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).2Where—apart 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); andbthere 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.3A 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.4Once a reserved location takes effect, NHS England must—adelineate precisely the boundary of the reserved location on a map;bpublish that map; andcmake that map available as soon as is practicable to any HWB that has all or part of that reserved location in its area.441This paragraph applies to all routine applications—afor inclusion in a pharmaceutical list as an NHS pharmacist; orbfrom an NHS pharmacist included in such a list—ito relocate to different pharmacy premises in the area of the relevant HWB, oriito open, within the area of the relevant HWB, additional pharmacy premises at or from which to provide pharmaceutical services.2As 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.3If 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—athe relevant HWB; orba neighbouring HWB of the relevant HWB.4For 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 2.451A person with appeal rights (as provided for in this regulation) may appeal to the Secretary of State against the following decisions by NHS England—aa 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—ia person, as mentioned in regulation 38(4), who is making a routine application to which the determination relates, andiia person given notice of the determination who is mentioned in regulation 39(2)(b)(iii);ba 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;ca 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—ithe person making the application to which the determination relates, andiia person given notice of the determination who is mentioned in regulation 43(1)(b)(ii); andda determination under regulation 42(1), in respect of which the only people with appeal rights are—ithe person making the application to which the determination relates, andiia 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.2A notice of appeal under paragraph (1) is only valid if it includes a concise and reasoned statement of the grounds of appeal.3Schedule 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).PART 8461In 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—aproviders of primary medical services who provide pharmaceutical services at or from medical practice premises in that area; andbgeneral 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)).2Each dispensing doctor list must include—athe 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; andbany area in relation to which the dispensing doctor has outline consent (which may be in the area of a neighbouring HWB).3NHS England must remove a dispensing doctor from a dispensing doctor list if—ain 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;bin 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; orcall 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.4If—aa general practitioner who is the only member of a provider of primary medical services who is a dispensing doctor so elects; orball 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.5In the circumstances described in paragraph (4)—aNHS England must agree to that request;bthe arrangements that NHS England had with the individual dispensing doctor or doctors become arrangements with the provider of primary medical services; andcthe 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.6Where a provider of primary medical services is listed in a dispensing doctors list—athe provider must notify NHS England—iof 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, andiiif 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; andbas 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).471The 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—aare included in these Regulations, including—ithe terms of service set out in Schedule 6 (which accordingly has effect), andiiany obligation that is only applicable in prescribed cases, if the dispensing doctor is a person to whom the obligation is applicable;bwere 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);care 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; anddare—iincluded in regulations under section 225 of the 2007 Act (duties of services-providers to allow entry by Local Healthwatch organisations or contractors), andiimade 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.2NHS England must ensure that those terms of service—aif 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; orbif 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.481A patient (P) may at any time request in writing that a dispensing doctor (D) provides P with pharmaceutical services if—aone or more of the Conditions specified in paragraphs (2) to (4) is satisfied in relation to P; andbP is on either D's patient list or the patient list of a provider of primary medical services (E) by whom D is employed or engaged.2Condition 1 is that P satisfies NHS England that P would have serious difficulty in obtaining any necessary drugs or appliances from pharmacy premises by reason of distance or inadequacy of means of communication.3Condition 2 is that P is resident in a controlled locality at a distance of more than 1.6 kilometres from any pharmacy premises, other than distance selling premises, and—athere is in effect—ian outline consent that has been granted to D for the area in which P resides, andiia related premises approval for the premises at or from which D (or another general practitioner within the practice) would dispense to P; orbthe following—iimmediately before these Regulations came into force, there was a right (other than outline consent) in effect under the 2012 Regulations for D, E or another general practitioner employed or engaged by E to provide drugs or appliances to patients on D or E's patient list (a right which continues in effect under these Regulations, subject to regulation 60),iiP either—aahas not previously been included in a patient list whilst residing in the area of the relevant HWB,bbhas been so included but now resides at a different address in the area of the relevant HWB, orcchas been so included and has not changed address, but immediately before P's acceptance by D or E onto their patient list, P was being provided with pharmaceutical services by another general practitioner or provider of primary medical services in the area of the relevant HWB under arrangements with NHS England, andiiithere is in effect premises approval in relation to the premises at or from which D would dispense to P.4Condition 3 is that P is resident in a controlled locality and within a distance of 1.6 kilometres from pharmacy premises that are not distance selling premises, but—aP is resident in a reserved location; andbeither paragraph (3)(a) or (b) is satisfied in relation to P.5If D—ain response to the request, applies in writing to NHS England, enclosing P's request, NHS England must make arrangements with D for the provision of pharmaceutical services to P—iin a case to which Condition 1 applies, at or from D's medical practice premises, oriiin a case to which Condition 2 or 3 applies, at or from D's listed dispensing premises; orbdoes not respond to the request as mentioned in sub-paragraph (a) within 30 days, NHS England may, subject to paragraph (7), require D to undertake to provide pharmaceutical services to P—iin a case to which Condition 1 applies, at or from D's medical practice premises, oriiin a case to which Condition 2 or 3 applies, at or from D's listed dispensing premises,by a notification to that effect which gives D reasonable notice of when the requirement is to take effect.6NHS England must not, under paragraph (5)(b), require D to undertake to provide services to P, if D satisfies NHS England that—aD does not normally provide pharmaceutical services; orbP would not have serious difficulty in obtaining any necessary drugs or appliances from pharmacy premises by reason of distance or inadequacy of means of communication.7Where arrangements have been made between D and NHS England for the provision of pharmaceutical services, those arrangements take effect—ain a case to which paragraph (5)(a) applies, from the date of the patient's request in writing; orbin a case to which paragraph (5)(b) applies, from the date which NHS England specifies in the notice under that paragraph as the date on which the arrangements are to take effect, or if D appeals the decision under paragraph (5)(b), the date on which that appeal reaches its final outcome.8Under those arrangements, at or from the relevant medical practice premises or listed dispensing premises for those arrangements, the following may provide pharmaceutical services to the patient, for as long as the arrangements remain in effect—aif the arrangements are with a provider of primary medical services (including an individual who is such a provider), any general practitioner performing primary medical services on behalf of that provider; orbif the arrangements are with an individual general practitioner who performs primary medical services on behalf of a provider of primary medical services, the general practitioner or any other general practitioner who performs primary medical services on behalf of that provider.9To be valid, a notification under paragraph (5)(b) by NHS England must include an explanation of—athe reasons for the imposition of the requirement; andbD's right of appeal under regulation 63(1)(a).49A dispensing doctor who provides pharmaceutical services to patients on a patient list may provide necessary pharmaceutical services to a person who has been accepted by the dispensing doctor as a temporary patient.501In circumstances where NHS England has arrangements (whether they were made under these Regulations or were made under or continued by virtue of the 2012 Regulations) with a dispensing doctor (D) to provide pharmaceutical services to a person (P), if—apharmaceutical services have been provided to P because of the circumstances described in Condition 1 in regulation 48(2), but NHS England determines that Condition 1 no longer applies in relation to P;bthe area in which P is resident was but ceases to be a controlled locality, and the provision of pharmaceutical services to P arose out of P's residence in a controlled locality;cP was resident in but has moved out of a controlled locality, and the provision of pharmaceutical services to P arose out of P's residence in that controlled locality;dP is resident in a controlled locality but is not (any longer) resident at a distance of more than 1.6 kilometres from any pharmacy premises, other than distance selling premises, at or from which pharmaceutical services are being provided, and—iNHS England determines that Condition 3 in regulation 48(4) does not apply in respect of P, oriiNHS England determines that Condition 3 in regulation 48(4) does apply in respect of P, but P informs NHS England that P wishes to be provided with pharmaceutical services by a person on a pharmaceutical list rather than by D (other than as permitted by paragraph 7 of Schedule 6);eP is resident in a reserved location, and—ihad previously informed NHS England (or a Primary Care Trust) that P wished to be provided with pharmaceutical services by D, butiiP has since informed NHS England that P wishes instead to be provided with pharmaceutical services by a person on a pharmaceutical list rather than by D (other than as permitted by paragraph 7 of Schedule 6); orfP is resident in a location that ceases to be or be part of a reserved location as a consequence of a determination referred to in regulation 42 as D2,D must terminate the provision of pharmaceutical services to P, subject to any postponement of the discontinuation by NHS England in accordance with paragraphs (2) to (6).2NHS England may postpone the discontinuation—auntil any proceedings relating to the discontinuation, including proceedings arising out of the grant of a routine or excepted application that has led to the discontinuation, have reached their final outcome; orbwhere paragraph (3) or (4) applies.3This paragraph applies where—aNHS England grants a routine or excepted application, the result of which is the inclusion in a pharmaceutical list of pharmacy premises that are not already listed in relation to an NHS pharmacist;bthe pharmacy premises to which that application relates are not distance selling premises but—iare in a controlled locality, oriiare within 1.6 kilometres of a part of a controlled locality in which patients of a dispensing doctor reside and those patients are being provided with pharmaceutical services by that dispensing doctor; andcgranting the routine or excepted application, in the opinion of NHS England, results in a significant change to the arrangements that are in place for the provision of pharmaceutical services (including by a person on a dispensing doctor list) or local pharmaceutical services in any part of a controlled locality.4This paragraph applies where NHS England is required to terminate the provision of pharmaceutical services pursuant to paragraph (1)(f) but NHS England is satisfied that the determination that led to the decision to terminate has adversely affected D.5Where paragraph (3) or (4) applies, NHS England may postpone the discontinuation for such period as it thinks fit.6NHS England must postpone the discontinuation—awhile it is forming the opinion mentioned in paragraph (3)(c); orbfor such period as NHS England considers necessary in order to give the doctor reasonable notice (in any case to which paragraph (1) applies) of the discontinuation.7NHS England must notify any decision under this regulation to terminate arrangements to provide pharmaceutical services, subject to any postponement of the discontinuation, to—aD;bif there is any postponement of the discontinuation, the NHS pharmacist listed in relation to any pharmacy premises, the presence of which, or the choice of a patient to obtain services at or from which, led to the determination of NHS England;cany Local Pharmaceutical Committee whose area includes the listed dispensing premises at or from which D has been providing pharmaceutical services to P; anddany Local Medical Committee whose area includes the listed dispensing premises at or from which D has been providing pharmaceutical services to P.8Each notification under paragraph (7) must include—aa statement of the reasons for the decision; andbif the person notified is a person with rights of appeal under regulation 63(1)(b), an explanation of how those rights may be exercised.511A person or partnership with a patient list, or a person who performs services on behalf of a provider of primary medical services, who wishes to be granted the right to provide pharmaceutical services to patients on their own list or the provider's list (if the patients apply under regulation 48(1) on the basis of Condition 2 or 3) may apply in writing to NHS England for—aconsent (“outline consent”) to the provision of pharmaceutical services to patients who request those services and who reside in the area specified in the application;bapproval of any medical practice premises at or from which D wishes to dispense (“premises approval”).2Where D has outline consent that has taken effect and wishes to apply for premises approval in relation to—aadditional medical practice premises at or from which to provide pharmaceutical services to patients who reside in the area for which D has an outline consent; orbmedical practice premises at or from which D wishes to relocate to provide pharmaceutical services to patients who reside in the area for which D has an outline consent, but the move to new medical practice premises is not a relocation of the type provided for in regulation 55(2),the premises approval application need not have a related outline consent application, but in all other cases a premises approval application under paragraph (1)(b) must have a related outline consent application.3An application for premises approval must include details of the address of the premises and whether those premises are already listed in relation to a different area.4Except in so far as these Regulations provide to the contrary, NHS England is to determine applications for outline consent and premises approval in such manner (including with regard to procedures) as it sees fit.5NHS England must refuse an application under paragraph (1) (but not regulation 54, 55 or 58) for premises approval if the premises in respect of which approval is sought are within 1.6 kilometres of pharmacy premises that are not distance selling premises.6NHS England must refuse an application for outline consent to the extent that any part of the area specified in the application—ais not, or is not part of, a controlled locality; orbis within 1.6 kilometres of pharmacy premises that are not distance selling premises.7Where NHS England is minded to refuse an application for outline consent pursuant to paragraph (6)(a), it may defer that decision in order to make a determination under regulation 36(2).8Subject to paragraph (9), NHS England must refuse an application under paragraph (1) (but not regulation 54, 55 or 58) if granting it would, in its opinion, prejudice the proper provision of relevant NHS services in the area of—athe relevant HWB; orba neighbouring HWB of the relevant HWB.9If NHS England determines that an application for outline consent would, if it had been made for a smaller area within the area specified in the application, not prejudice the proper provision of relevant NHS services in the area of—athe relevant HWB; orba neighbouring HWB of the relevant HWB,it may grant the application in respect of that smaller area.10NHS England must refuse an application (A1) under paragraph (1)—afor outline consent to the extent that any part of the area specified in A1 is the same as the area or any part of the area specified in an application for outline consent which 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; orbfor premises approval (but not under regulation 54, 55 or 58) if the premises specified in A1 were specified in an application for premises approval, or relate to an application for outline consent where any part of the area specified in that application is the same as the area or any part of the area specified in an earlier application for outline consent, which was refused—iunder this regulation,iiunder regulation 51 of the 2012 Regulations (outline consent and premises approval: applications by doctors), oriiiby virtue of regulation 18(2) of the 2005 Regulations (refusal: outline consent and premises approval where patients are in a controlled locality),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 there has been a substantial and relevant change of circumstances affecting the controlled locality to which the application relates since those proceedings reached their final outcome.521Where NHS England receives an application for outline consent or premises approval (including an application for premises approval to which regulation 54 or 55 applies, but not an application for temporary premises approval to which regulation 58 or 61 applies), as soon as is practicable, it must give notice of that application to—aany Local Pharmaceutical Committee—iwhose area includes the medical practice premises or all or part of the area to which the application relates, oriiany part of whose area is within 2 kilometres of the medical practice premises to which the application relates;bany Local Medical Committee—iwhose area includes the medical practice premises or all or part of the area to which the application relates, oriiany part of whose area is within 2 kilometres of the medical practice premises to which the application relates;cany person—iincluded in a pharmaceutical list for the area of the relevant HWB, oriiwho is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,whose interests might, in the opinion of NHS England, be significantly affected if the application were granted;dany LPS chemist—iwith whom NHS England has made arrangements for the provision of any local pharmaceutical services in the area of the relevant HWB, andiiwhose interests might, in the opinion of NHS England, be significantly affected if the application were granted;eany Local Healthwatch organisation for the area of the relevant HWB, and any other patient, consumer or community group in that area which, in the opinion of NHS England, has a significant interest in the outcome of the application;fany provider of primary medical services, or any other person on the dispensing doctors list for the area of the relevant HWB if there is one (being a performer but not a provider of primary medical services), who in the opinion of NHS England has a significant interest in the outcome of the application;gany Local Health Board any part of whose area is within 2 kilometres of the medical practice premises to which the application relates; andhthe relevant HWB and any other HWB (HWB2) any part of whose area—iis within 2 kilometres of the medical practice premises to which the application relates, oriiin the case of an application for outline consent, is part of the area specified in the application;2NHS England may also give notice of the application to any other person who, in the opinion of NHS England, has a significant interest in the outcome of the application;3If a HWB is notified under paragraph (1)(h), NHS England must also give notice of the application to—aany person—iincluded in a pharmaceutical list for the area of HWB2, oriiwho is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,whose interests might, in the opinion of NHS England, be significantly affected if the application were granted;bany LPS chemist—iwith whom NHS England has made arrangements for the provision of any local pharmaceutical services in the area of HWB2, andiiwhose interests might, in the opinion of NHS England, be significantly affected if the application were granted,cany Local Healthwatch organisation for the area of HWB2, and any other patient, consumer or community group in that area which, in the opinion of NHS England, has a significant interest in the outcome of the application; anddany provider of primary medical services, or any other person on the dispensing doctors list for the area of HWB2 if there is one (being a performer but not a provider of primary medical services), who in the opinion of NHS England has a significant interest in the outcome of the application.4A person (P) notified under paragraphs (1) to (3) may make representations in writing about the application that is the subject of the notification to NHS England, provided P does so within 45 days of the date on which notice of the application was given to them.5If NHS England is considering, as a consequence of an application for outline consent or premises approval, making (including revising) a determination as to whether or not an area is or is not to be part of controlled locality, it must give notice under paragraph (1) at the same time that it gives notice under regulation 38(1).6A person (P) notified under paragraphs (1) to (3)—amust be informed of P's right to make representations under paragraph (4); andbneed not be given the same information as other persons notified under paragraphs (1) to (3) but, subject to sub-paragraphs (7) to (9), P must be provided with sufficient information, from the information supplied by the applicant, to enable P to make informed representations with regard to whether or not the application should be granted, having regard to P's interest in the matter.7P need not be provided with any information that is published as part of the relevant pharmaceutical needs assessment.8P must not be provided with any private addresses, private telephone numbers or dates of birth supplied by the applicant (A).9If A advises NHS England that—ainformation supplied by A is considered by A to be confidential to A; andbA does not consent to the information being disclosed as part of the notification,NHS England must withhold that information from P if it considers that the full disclosure principle does not require it to provide that information to P.10The “full disclosure principle” is that information that is relevant to the determination of an application should be available to any individual who has a significant interest in the outcome of the application, unless it is fair and proper for that information to be withheld from that individual.11If information is being withheld from P under paragraph (9), P must be informed of the nature of the information that is being withheld from P.531Once NHS England has determined an application for outline consent or premises approval, as soon as is practicable, it must give notice of that decision to—athe applicant; andbany person notified by it under regulation 52(1) to (3) in relation to the application.2Each notification under paragraph (1) must include a statement of the reasons for the decision and, if the person notified is a person with rights of appeal in relation to the decision under regulation 63(1)(c) or (d), an explanation of how those rights may be exercised.3When outline consent is granted, subject to paragraphs (11) and (13)(b), NHS England must determine when the outline consent is to take effect.4Subject to regulation 54, premises approval takes effect, if the application for it had a related outline consent application, when the related outline consent takes effect (but otherwise it does so in accordance with regulation 56).5Outline consent takes effect on the day the proceedings relating to the grant of it have reached their final outcome, unless on the day before that day within 1.6 kilometres of the relevant practice premises there are premises which are the subject of an outstanding pharmacy application.6For the purposes of this regulation, the “relevant practice premises” are the premises—awhich are the subject of a related premises approval application; orbif there is no related premises approval application, that are the medical practice premises of the dispensing doctor from which the dispensing doctor wishes to dispense to patients in the area in relation to which outline consent is sought.7In these Regulations, “outstanding pharmacy application” means—aan application which has not yet reached its final outcome—ifor inclusion in a pharmaceutical list (not necessarily that of the relevant HWB), oriifrom a person included in a pharmaceutical list—aato relocate to different premises in the area of the relevant HWB, orbbto open, within the area of that HWB, additional premises at or from which to provide pharmaceutical services,where the applicant is seeking the listing of pharmacy premises other than distance selling premises; orbcircumstances where an application of the type mentioned in paragraph (a) has been granted, and—ithe provision of pharmaceutical services at or from the premises for which listing was sought has not yet commenced, andiithe grant has not yet lapsed.8In a case where outline consent is not to take effect on the date on which it is granted, NHS England must give the dispensing doctor to whom outline consent was granted (D) written details of—athe outstanding pharmacy application; andbthe earliest date (referred to in this Part as the “provisional date”) on which an application can be made by D for a determination of when the outline consent is to come into effect.9That provisional date, subject to paragraph (10), is the day after the end of the period of one year beginning on the day of—athe determination by NHS England of D's application of outline consent; orbwhere that determination is the subject of an appeal, the day on which the appeal reaches its final outcome.10NHS England may at any time before the provisional date determine that the provisional date be changed to a later date, but only to a date which is not more than 3 months after the date originally determined in accordance with paragraph (8).11Outline consent lapses if, before the provisional date, pharmaceutical services are provided at or from the pharmacy premises to which the outstanding pharmacy application relates.12On or as soon as is reasonably practicable after the provisional date, NHS England must notify D that D may within 3 months of the provisional date request in writing that NHS England determine whether the outline consent is to come into effect.13Where NHS England receives a request under paragraph (12), it must, as soon as is reasonably practicable determine—aunless paragraph (b) applies, that the outline consent is to come into immediate effect; orbthat the outline consent has lapsed—iwhere on the date of the determination (which must be a day from Monday to Friday, except Good Friday, Christmas Day or a bank holiday) primary medical services are not being provided at or from the relevant practice premises, oriiby virtue of paragraph (11),and it must inform D accordingly.14NHS England must notify the applicant for outline consent of its determination under paragraph (10) or (13) and must include with the notification of its determination an explanation of—athe reasons for the determination; andbthe applicant's rights of appeal in relation to it under regulation 63(1)(e).541If outline consent has been granted but has not yet taken effect, before the provisional date the person or partnership (D) to whom it was granted may apply to NHS England to change the premises at or from which D wishes to dispense to other premises in the area of the relevant HWB.2NHS England may agree to the change (and so, where appropriate, grant premises approval to the new premises) if it is satisfied that the relocation is of the type provided for in regulation 55(2).3Where NHS England agrees to a change pursuant to paragraph (2), the premises approval takes effect when the related outline consent takes effect or, if later, on the date on which the change is agreed by NHS England.4NHS England must notify its decision in relation to the application under paragraph (1) to the persons to whom it notified the application who made representations in relation to it under regulation 52(4), and it must include with the notification of its decision an explanation of—athe reasons for the decision; andbif the person notified is a person with rights of appeal under regulation 63(1)(c) or (d), an explanation of how those rights may be exercised.551A dispensing doctor (D) who—ais providing pharmaceutical services at or from listed dispensing premises; andbwishes to relocate and dispense from new medical practice premises in relation to the area for which D has outline consent,may apply in writing to NHS England for premises approval for the new medical practice premises at or from which D wishes to dispense.2Subject to paragraph (3), NHS England must grant that application if it is of the type described in this paragraph, that is to say if NHS England is satisfied that—afor 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;bgranting the application would not result in a significant change to the arrangements that are in place for the provision of pharmaceutical services (including by a person on a dispensing doctor list) or of local pharmaceutical services—iin any part of the area of the relevant HWB, oriiin 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; andcNHS England is satisfied that granting the application would not cause significant detriment to proper planning in respect of the provision of pharmaceutical services in the area of the relevant HWB.3NHS England must, unless it has good cause not to do so, refuse an application under paragraph (1) if an application under—athat paragraph;bregulation 55(1) of the 2012 Regulations (premises approval: relocations of practice premises which are not significant after outline consent has taken effect); orcregulation 65(4)(a) of the 2005 Regulations (premises approval: additional and new premises after outline consent has taken effect),has been granted to D during the 12 months before the application was submitted under paragraph (1).4NHS England must notify its decision in relation to the application under paragraph (1) to the persons to whom it notified the application who made representations in relation to it under regulation 52(4), and it must include with the notification of its decision an explanation of—athe reasons for the decision; andbif the person notified is a person with rights of appeal under regulation 63(1)(c) or (d), an explanation of how those rights may be exercised.561Where—apremises approval is granted in relation to additional medical practice premises, or in relation to medical practice premises to which a dispensing doctor (D) is relocating; andbthe application for premises approval had no related application for outline consent,paragraph (2) applies.2In the circumstances described in paragraph (1), the approval takes effect—aon the date the determination of the application takes effect, and that date is—iif no appeal is made against the decision within the period for bringing an appeal, the date on which that period expires, oriiif the decision is appealed within that period, the date on which the appeal reaches its final outcome; orbif on the day before that day within 1.6 kilometres of the relevant medical practice premises there are premises which are the subject of an outstanding pharmacy application, on the date which is—ithe day after the end of a period of one year from the date on which that outstanding pharmacy application reaches its final outcome, oriisuch longer period (not exceeding 3 months) as NHS England may for good cause allow before the expiry of that year.3Premises approval to which paragraph (1) applies lapses if before the date on which it would otherwise take effect by virtue of paragraph (2), pharmaceutical services are provided at or from the pharmacy premises to which the outstanding pharmacy application relates.571Where a dispensing doctor (D) has outline consent but NHS England considers that the provision of pharmaceutical services by any NHS pharmacist, or of LP services by any LPS chemist, is likely to be adversely affected if D provides pharmaceutical services at or from medical practice premises which have been subject to a related application for premises approval (whether under regulation 51, 54 or 55), NHS England may by conditions—apostpone the taking effect of the related premises approval for such period as it thinks fit; orblimit the patients to whom D (or any successor to D) is able to provide pharmaceutical services at or from the medical practice premises in such manner, and for such periods, as it thinks fit.2NHS England must decide whether or not to impose conditions under paragraph (1)—aif there was a delay in the related outline consent taking effect because of an outstanding pharmacy application, when it determines that the outline consent is to come into effect; orbin any other case, when it determines the application for premises approval.3NHS England must notify any decision to impose, or not to impose, conditions under paragraph (1) to—aD;bany person with third party appeal rights in relation to the related application for premises approval;cany Local Pharmaceutical Committee whose area includes the medical practice premises to which the decision relates; anddany Local Medical Committee whose area includes the medical practice premises to which the decision relates.4A notification under paragraph (3) must include—aa statement of the reasons for the decision; andbif the person notified is a person with rights of appeal under regulation 63(1)(f), an explanation of how those rights may be exercised.581In the circumstances described in regulation 56(1), if the premises approval has not taken effect because of an outstanding pharmacy application which has not lapsed, NHS England may grant the applicant (D) temporary premises approval—aif it considers it is desirable to do so in order to secure the adequate provision of pharmaceutical services in the area for which D has outline consent;bfor a period of not exceeding 12 months, but which may be renewed for a further period not exceeding 3 months (and if the first period granted is less than 12 months, it may be renewed more than once for up to a total aggregate period of 15 months).2If NHS England grants temporary premises approval under paragraph (1), it must notify—aD;bthe applicant who made the outstanding pharmacy application;cany Local Pharmaceutical Committee whose area includes the medical practice premises for which temporary premises approval has been granted; anddany Local Medical Committee whose area includes the medical practice premises for which temporary premises approval has been granted;3A notification under paragraph (2) must include—aa statement of the reasons for the decision; andba statement of the duration of the temporary premises approval and any circumstances in which it might be extended.4If NHS England refuses an application to grant temporary premises approval under paragraph (1), NHS England must notify that decision to the applicant and include with that notification—aa statement of the reasons for the decision; andban explanation of how D's rights of appeal under regulation 63(1)(c)(iii) may be exercised.591A “practice amalgamation” occurs where 2 or more patient lists are combined as a result of the coming together, as a single provider of primary medical services (SP), of 2 or more providers of primary medical services.2If, following a practice amalgamation, the medical practice premises of SP are all premises that immediately prior to the amalgamation were listed dispensing premises, the premises approvals for those premises and the related outline consents become the premises approvals and outline consents of SP.3If, following practice amalgamation, paragraph (2) does not apply but one or more of the providers of primary medical services coming together as SP had, immediately prior to amalgamation, listed dispensing premises—aif any listed dispensing premises become medical practice premises of SP—ithe premises approvals for those premises, and the related outline consents, become approvals and consents of SP, andiiany applications for premises approval in respect of other medical practice premises of SP are to be treated under this Part as applications for additional premises;bif none of the listed dispensing premises become medical practice premises of SP—iSP may nominate one of its medical practice premises as premises in respect of which it may apply for premises approval and have that application treated as a relocation from listed dispensing premises of a dispensing doctor who was part of the coming together to form SP, andiiany applications for premises approval in respect of other medical practice premises of SP are to be treated under this Part as applications for additional premises.4Where a practice amalgamation is proposed, a dispensing doctor who intends to be part of the practice amalgamation may make an application on the basis of paragraph (3)(b) in anticipation of circumstances that are expected to arise following the practice amalgamation, and if the dispensing doctor does so—aany premises approval granted as a consequence becomes, when the practice amalgamates, a premises approval granted to SP; orbif the proposed amalgamation does not take place, or if the dispensing doctor who makes the application does not become party to a practice amalgamation that does take place, any premises approval granted on the basis of that application lapses.5If an application for premises approval arises because a practice amalgamation has taken or is due to take place, it must include the names of all the medical practitioners and any other providers of primary medical services who are participating in the amalgamation.601Outline consent lapses (in addition to as mentioned in regulation 53(11) and (13)(b)) if—ano arrangement has been made under regulation 48 with a patient pursuant to that outline consent within 6 months of the date on which it takes effect;b6 months have elapsed since any drug or appliance was dispensed under the arrangements made pursuant to that outline consent; orcfollowing a practice amalgamation, the amalgamated practice has no medical practice premises with premises approval and there are no outstanding applications to which regulation 59(3)(b) applies in respect of premises approval from the amalgamated practice.2If an area, or part of an area, for which a dispensing doctor (D) has outline consent becomes a location in relation to which it is no longer possible for D to provide pharmaceutical services to patients on a patient list, D ceases to have outline consent in relation to that location.3Premises approval lapses (in addition to as mentioned in regulation 56(3) and 59(4)(b)) if—athe premises are no longer medical practice premises of a dispensing doctor with outline consent;b6 months have elapsed, or such longer period as NHS England may for good cause allow, since any drug or appliance was dispensed under the arrangements made pursuant to regulation 48 at or from those premises;cthe provider of primary medical services whose premises, or (if different) the dispensing doctor in relation to whom they are listed, notifies NHS England on whose dispensing doctors list the premises are listed that all the medical practitioners with authority to dispense at or from those premises have ceased to do so;dthe dispensing doctor in relation to whom the premises are listed in the dispensing doctors list is no longer listed in that list; orethe related outline consent lapses.4A right which continues in effect by virtue of regulation 48(3)(b)(i) is to be treated as outline consent for the purposes of paragraphs (1) and (3).5For the purposes of—aparagraph (1)(a), no account is to be taken of a period when D is unable to make arrangements to provide pharmaceutical services; orbparagraph (1)(b) or (3)(b), no account is to be taken of a period when D is unable to provide pharmaceutical services,because of a condition imposed by virtue of one of the provisions mentioned in paragraph (6).6Those provisions are—aregulation 57;bregulation 57 of the 2012 Regulations (gradual introduction of premises approval); andcregulation 20(2) of the 2005 Regulations (imposition of conditions) or by virtue of regulation 57.611During an emergency requiring the flexible provision of pharmaceutical services, NHS England may require a dispensing doctor to provide pharmaceutical services (“temporary services”) to patients to whom the dispensing doctor is not otherwise entitled to provide pharmaceutical services—awhere, as a result of the temporary closure of pharmacy premises in the area of the relevant HWB, NHS England considers that, in order to secure continuing adequate provision of pharmaceutical services in that area during the emergency, it is necessary for it to require provision of those temporary services; andbfor 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.2NHS England must terminate arrangements to provide temporary services if the doctor notifies it that the doctor is unwilling to provide those services (and so wishes to revert to the doctor's overridden arrangements for the provision of pharmaceutical services).3NHS England may grant temporary premises approval—ain relation to additional premises that are not listed dispensing premises; orbto premises to which a doctor wishes to relocate temporarily from listed dispensing premises,because there is an emergency requiring the flexible provision of pharmaceutical services.4In the circumstances described in paragraph (3)—athe temporary premises approval must be 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; andbthe dispensing doctor may revert to the overridden premises approval before the end of the period specified by NHS England, on giving NHS England at least 24 hours notice.5NHS England may grant temporary premises approval if there is a temporary suspension in the provision of dispensing services at or from listed dispensing premises (P1) for a reason (for example, fire or flooding) that is beyond the control of the dispensing doctor (D) listed in relation to P1.6In the circumstances described in paragraph (5), NHS England may make a temporary amendment to the entry of D in the relevant dispensing list in order to allow D to provide the services that D 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.7A period specified under paragraph (6) must not be longer (initially) than 6 months, and NHS England may under that paragraph—aif it has good cause to do so, extend the period specified under that paragraph (but not beyond 12 months from the date on which D starts to provide the services in question from P2); orbcurtail the period specified,in appropriate circumstances.8For the period specified under paragraph (6), but subject to paragraph (9) and regulation 118, P2 instead of P1 are to be treated as listed in relation to D for the purposes of these Regulations (albeit that the premises actually listed in relation to D are P1).9D may revert to the overridden premises approval before the end of the period specified under paragraph (6), on giving NHS England at least 24 hours notice.10Planned refurbishment is not a “reason beyond the control” of D for the purposes of paragraph (5).11There is no right of appeal under these Regulations in respect of a decision of NHS England under this regulation.12If NHS England grants an application for temporary premises approval under this regulation, it must notify that decision to the persons who would have been notified about the application had the application been an application to which regulation 55 applies.621No person is to take part in determining any application for outline consent (including determining when it is to come into effect), premises approval or temporary premises approval, or in taking decisions under regulation 50, 53 or 57, who—ais a person who is included in a pharmaceutical list or is an employee of such a person;bassists in the provision of pharmaceutical services under Chapter 1 of Part 7 of the 2006 Act (pharmaceutical services and local pharmaceutical services – provision of pharmaceutical services);cis an LPS chemist, or provides or assists in the provision of local pharmaceutical services;dis a provider of primary medical services;eis a member of a provider of primary medical services that is a partnership or a shareholder in a provider of primary medical services that is a company limited by shares;fis employed or engaged by a primary medical services provider; orgis employed or engaged by an APMS contractor in any capacity relating to the provision of primary medical services,whether or not their involvement would give rise to a reasonable suspicion of bias.2No other person is to take part in determining any application, or taking any decision, referred to in paragraph (1) if because of an interest or association they have, or because of a pressure to which they may be subject, their involvement would give rise to a reasonable suspicion of bias.631A person with appeal rights (as provided for in this regulation) may appeal to the Secretary of State against the following decisions by NHS England—aa decision under regulation 48(5)(b) to require a dispensing doctor to undertake to provide pharmaceutical services, in respect of which the only person with appeal rights is the dispensing doctor;ba decision under regulation 50 requiring the termination of arrangements to provide pharmaceutical services, subject to any postponement of the discontinuation, in respect of which the only people with appeal rights are—ithe dispensing doctor who is being required to terminate arrangements, subject to any postponement of the discontinuation, andiiif there is any postponement of the discontinuation, the NHS pharmacist listed in relation to any pharmacy premises, the presence of which, or the choice of a patient to obtain services at or from which, led to the determination by NHS England;ca decision to refuse an application for—ioutline consent under regulation 51,iipremises approval under regulation 51, 54 or 55, oriiitemporary premises approval under regulation 58,in respect of which the only person with appeal rights is the applicant;da decision to grant an application for—ioutline consent under regulation 51, oriipremises approval under regulation 51, 54 or 55,in respect of which the only person with appeal rights is a person who has third party appeal rights;ea determination of—ia change to a provisional date under regulation 53(10), oriiwhether outline consent is to come into effect under regulation 53(13),in respect of which the only person with appeal rights is the person to whom the relevant outline consent was granted; andfa decision to impose, or a failure to impose, conditions under regulation 57, in respect of which the only people with appeal rights are—ithe dispensing doctor, andiian NHS pharmacist or LPS chemist who has third party appeal rights in relation to the related application for premises approval,provided they notify the Secretary of State with a valid notice of appeal within 30 days of the date on which the person bringing the appeal was notified of the decision that is being appealed.2A notice of appeal under paragraph (1) is only valid if it includes a concise and reasoned statement of the grounds of appeal.3For the purposes of paragraph (1)(d) or (f), a person (P1) has third party appeal rights if—aP1 was a person whom NHS England was required to notify about the relevant application for outline consent or premises approval by virtue of P1 being—iincluded in a pharmaceutical list,iientitled to be included in a pharmaceutical list because of the grant of a routine or excepted application but not (yet) included,iiian LPS chemist with whom NHS England has made arrangements for the provision of any local pharmaceutical services, oriv(except in relation to paragraph (1)(f)), a provider of primary medical services, or any other person on the dispensing doctors list for the area of the relevant HWB if there is one (being a performer but not a provider of primary medical services),and a person whose interests might, in the opinion of NHS England, be significantly affected by the decision;bP1 made representations in writing about the application under regulation 52(4); andcsubject to sub-paragraph (5), NHS England is satisfied, having regard to those representations in writing and any oral representations made at any oral hearing, that P1—imade a reasonable attempt to express P1's grounds for opposing the application adequately in P1's representations, andiihas grounds for opposing the application, which—aado not amount to a challenge to the legality or reasonableness of the relevant pharmaceutical needs assessment, or to the fairness of the process by which that assessment was undertaken, andbbare not vexatious or frivolous.4If NHS England considers that a person notified under regulation 52(1) to (3) is a person with third party appeal rights, it must notify that person of that fact when it notifies that person of a decision (D1) in respect of which that person may be able to exercise those rights.5A person to whom paragraph (3)(a) and (b) applies (P2) who is not notified by NHS England that they are person with third party appeal rights may appeal to the Secretary of State against the determination (D2) by NHS England that it is not satisfied as mentioned in sub-paragraph (3)(c), provided that P2—anotifies the Secretary of State within 30 days of the date on which that person was notified of NHS England’s decision that P2 wishes to appeal against both D1 and D2; andbincludes within that notification concise and reasoned statements of P2's grounds of appeal against both D1 and D2,and if the appeal against D2 is successful, P2 is a person with third party appeal rights in relation to D1 for the purposes of this regulation.6Schedule 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, 7, 10 and 12 and Schedule 2).PART 9641Paragraph (2) applies where—aan application in respect of distance selling premises is granted under these Regulations; orban application was granted under the 2005 Regulations or 2012 Regulations in respect of premises which were, for the purposes of the Regulations under which the application was granted, distance selling premises.2The inclusion in the pharmaceutical list of the person (X) listed in relation to—athose distance selling premises; orbif there has been a relocation of the retail pharmacy business or appliance contractor business at those distance selling premises to other premises, those other premises,is subject to the conditions set out in paragraph (3).3Those conditions are—aX must not offer to provide pharmaceutical services ... to persons who are present at (which includes in the vicinity of) the listed chemist premises;bthe means by which X provides pharmaceutical services ... must be such that any person receiving those services does so otherwise than at the listed chemist premises;cthe listed chemist premises must not be on the same site or in the same building as the premises of a provider of primary medical services with a patient list;din the case of pharmacy premises, the pharmacy procedures for the premises must be such as to secure—ithe uninterrupted provision of essential services, during the opening hours of the premises, to persons anywhere in England who request those services, andiithe 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 X or X's staff; andenothing ... in X's publicity material in respect of the listed chemist premises, in material published on behalf of X publicising services provided at or from the listed chemist premises or in any communication (written or oral) from X or X's staff to any person seeking the provision of essential services from X must represent, either expressly or impliedly, that—ithe essential services provided at or from the premises are only available to persons in particular areas of England, oriiX is likely to refuse, for reasons other than those provided for in X's terms of service, to provide drugs or appliances ordered on prescription forms or repeatable prescription forms which are presented by particular categories of patients (for example, because the availability of essential services from X is limited to other categories of patients).3ANotwithstanding the amendments to paragraph (3) which come into force on 1st October 2025, until the end of 31st March 2026 paragraph (3) remains in force as it had effect before those amendments were made, but only in so far as is necessary to give effect to paragraph (3B).3BAt distance selling premises listed in relation to X before 1st October 2025, X may until the end of 31st March 2026 provide directed services that consist of the supply or administration of a prescription only medicine used for vaccination or immunisation against coronavirus or influenza virus (but no other directed services).4NHS England may not vary or remove the conditions set out in paragraph (3).651If an application to which regulation 13(1)(b) of the 2005 Regulations (exemption from the necessary or expedient test) applied was granted, the inclusion in the pharmaceutical list of the person listed in relation to—athe premises that were listed as a consequence of that application; orbif there has been a relocation of the retail pharmacy business or appliance contractor business at those premises to other premises, those other premises,is subject to the condition set out in paragraph (2) (“the 100 hours condition”).2The condition is that the premises must be kept open for at least 100 hours per week for the provision of pharmaceutical services.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3ANHS England may remove a 100 hours condition in respect of premises of an NHS pharmacist and replace it with a direction under paragraph (4) or (5) or paragraph 25 or 26 of Schedule 4, but that direction, and any subsequent direction which replaces that direction (whether it is in respect of those premises or any premises to which that NHS pharmacist, or any NHS pharmacist that is in succession to that NHS pharmacist, relocates), must specify a total number of core opening hours of not less than 72.4Where, in the course of making a routine application or an excepted application to which regulation 24 or 26(2) applies—afor inclusion in a pharmaceutical list as mentioned in regulation 10(2)(a), or from a person already included in such a list to relocate to different pharmacy premises or to open, within the area of the relevant HWB, additional pharmacy premises—ian NHS pharmacist undertook to provide pharmaceutical services at or from the proposed pharmacy premises for a specified number of core opening hours each week which is more than 40 ...,iithe NHS pharmacist and NHS England agreed , or the NHS pharmacist undertook, that pharmaceutical services are to be provided at or from the proposed pharmacy premises during any additional opening hours specified , or any core hours specified that replace (at any distance in succession) a 100 hours condition, at set times and on set days, andiiithe application was granted having regard to any such undertaking or agreement,when it includes the premises in a pharmaceutical list, NHS England must direct that the person listed in relation to the premises is to provide pharmaceutical services at or from those premises for the specified number of core opening hours so undertaken, and ... at the set times and on the set days so agreed or undertaken; orbfor inclusion in a pharmaceutical list as mentioned in regulation 10(2)(b), or from a person already included in such a list to relocate to different appliance contractor premises or to open, within the area of the relevant HWB, additional appliance contractor premises—ian NHS appliance contractor undertook to provide pharmaceutical services at or from proposed appliance contractor premises for a specified number of core opening hours each week which is more than 30 (other than as a consequence of a 100 hours condition),iithe NHS appliance contractor and NHS England agreed that pharmaceutical services are to be provided at or from the appliance contractor premises during the additional opening hours specified (that is, the hours which are the difference between the total number of hours specified and 30) at set times and on set days, andiiithe application was granted having regard to that undertaking and that agreement,when it includes the premises in a pharmaceutical list, NHS England must direct that the person listed in relation to the premises is to provide pharmaceutical services at or from those premises for the specified number of core opening hours so undertaken, and during the additional opening hours at the set times and on the set days so agreed.5Where NHS England has—ainvited an NHS chemist to increase the total number of core opening hours during which the NHS chemist is to provide pharmaceutical services at or from listed chemist premises; andbthereafter agreed with the NHS chemist—ian increased number of core opening hours, andiiif the NHS chemist—aais an NHS pharmacist, that pharmaceutical services are to be provided at or from the pharmacy premises during any additional opening hours , or any core hours specified that replace (at any distance in succession) a 100 hours condition, at set times and on set days, andbbis an NHS appliance contractor, that pharmaceutical services are to be provided at or from the appliance contractor premises during any additional opening hours (that is, the hours which are the difference between the total number of hours specified and 30) at set times and on set days,NHS England must direct that the person listed in relation to the premises is to provide pharmaceutical services at or from those premises for the specified number of core opening hours so undertaken, and ... at the set times and on the set days so agreed or undertaken.6Except as provided for under paragraph (5) and subject to paragraph (7), NHS England may only vary a direction given under paragraph (4) or (5), or regulation 65(4) or (5) of the 2012 Regulations (core opening hours conditions), in accordance with paragraph 25 or 26 of Schedule 4 or paragraph 15 or 16 of Schedule 5.7A direction given under paragraph (4) or (5), or regulation 65(4) or (5) of the 2012 Regulations, must not be varied within 3 years of the direction being given.65A1In this regulation, “opening hours directions” means directions that have been given under regulation 65(4) or (5), or issued in accordance with paragraph 25 or 26 of Schedule 4 or paragraph 15 or 16 of Schedule 5, or given under or issued in accordance with earlier provisions which that regulation and those paragraphs have (at any distance in succession) replaced.2Opening hours directions given or issued in respect of premises included in a pharmaceutical list apply to any NHS chemist listed in relation to those premises, not just to the NHS chemist to whom they were given or issued.3Where, by virtue of regulation 24 or 26(2), an excepted application may be granted in circumstances where the applicant is undertaking to provide the same pharmaceutical services as those that are already being provided, but at or from premises that are not already included in a pharmaceutical list, that application must be refused where opening hours directions apply in respect of the premises from which the applicant is relocating the relevant business, unless—athe applicant, as part of their undertaking, undertakes to provide pharmaceutical services for any total number of core opening hours, and on any set days and at any set times, specified in those opening hours directions, taking into account any variation in respect of a rest break in accordance with paragraph 23(7)(bd) of Schedule 4; andbNHS England is, accordingly, required to give directions under regulation 65(4) in the same terms as those given in those opening hours directions, but in respect of the premises to which the applicant is relocating the relevant business and taking into account any variation in respect of a rest break in accordance with paragraph 23(7)(bd) of Schedule 4.4In circumstances where, in respect of any premises, there are opening hours directions that have replaced (at any distance in succession) a 100 hours condition, whether that condition applied in respect of those premises or other premises, any routine application to relocate from those premises must be refused unless—athe applicant undertakes to provide pharmaceutical services, at or from the premises to which the applicant is relocating the relevant business, for any total number of core opening hours, and on any set days and at any set times, specified in those opening hours directions; andbNHS England is, accordingly, required to give directions under regulation 65(4) in the same terms as those given in those opening hours directions but in respect of the premises to which the applicant is relocating the relevant business.661Where, immediately before these Regulations came into force, the inclusion in the pharmaceutical list of an NHS chemist (C1) was subject to a condition imposed in relation to listed chemist premises by virtue of regulation 13(3)(b) of the 2005 Regulations (exemption from the necessary or expedient test), including such a condition as varied in accordance with regulation 14 of the 2005 Regulations (variation of directed services in respect of exempted premises) or regulation 66(2) and (3) of the 2012 Regulations (conditions relating to providing directed services), it is a condition of the inclusion in the pharmaceutical list of the person listed in relation to those premises—aif, before these Regulations came into force, C1 had not been requested by a Primary Care Trust to provide the directed services specified as regards C1 for the purposes of that condition, that they must provide those directed services at or from those premises, where requested to do so by NHS England unless thereafter NHS England ceases to commission those services; orbif, before these Regulations came into force, C1 was providing, or had been requested by a Primary Care Trust to provide, the directed services specified as regards C1 for purposes of that condition, that they must provide those directed services at or from those premises unless NHS England does not continue to commission those services.2The person listed in relation to the premises may apply to NHS England to vary the directed services specified for the purposes of the condition imposed by virtue of paragraph (1), or to remove the condition, but only if at least 3 years have elapsed—asince the condition was imposed by virtue of the 2005 Regulations; andbduring that period neither a Primary Care Trust nor NHS England has requested that the services be provided at or from the premises in respect of which the condition was imposed,but otherwise NHS England may not vary or remove the condition imposed by virtue of paragraph (1).3If, pursuant to an application under paragraph (2), NHS England does vary the directed services specified for the purposes of the condition imposed by virtue of paragraph (1) in respect of any premises, it is a condition of the inclusion in the pharmaceutical list of the person listed in relation to those premises that they must—aprovide the directed services specified as regards C1 as a consequence of the application—iif NHS England commissions the services within 3 years of the date on which the condition is imposed by virtue of these Regulations, andiiunless thereafter NHS England ceases to commission the services; andbnot withhold agreement to a service specification for those services unreasonably.4Where, in the course of making a routine or excepted application under these Regulations or the 2012 Regulations, an NHS chemist undertook—ato provide the directed services mentioned in the application, if a Primary Care Trust or NHS England commissioned the services within 3 years of the date of either the grant of the application or, if later, the listing in relation to the applicant of the premises to which the application relates;bif the directed services were commissioned, to provide the services in accordance with an agreed service specification; andcnot to withhold agreement to a service specification unreasonably,the inclusion in the pharmaceutical list of the person (C2) listed in relation to the premises that were listed as a consequence of that application is subject to the condition set out in paragraph (5).5The condition is that, at or from those premises, C2 must—aprovide the directed services mentioned in the application (whether or not C2 was the applicant); andbnot withhold agreement to a service specification for those services unreasonably,if the Primary Care Trust or NHS England commissions the services from C2 within 3 years of the date of either the grant of the application or, if later, the listing in relation to the applicant of the premises to which the application relates, unless thereafter NHS England ceases to commission the services (if it has commissioned them) or does not continue to commission services (that is, if only the Primary Care Trust, and not NHS England, has commissioned them).6Where a Primary Care Trust or NHS England specifies that a requirement to provide directed services arising out of a condition imposed by virtue of this regulation is to take effect by a specified date, the requirement takes effect—aon that date; orbon the date on which provision of the directed service is commenced,whichever is the sooner.7NHS England may not vary or remove the condition imposed by virtue of paragraphs (3) to (5).671Except in the circumstances described in paragraph (3) or (5), where an NHS chemist (C) wishes, other than as a consequence of a change of ownership application or a consolidation application—ato withdraw from a pharmaceutical list, orbfor particular listed chemist premises no longer to be listed in relation to C,C must comply with paragraph (2).2C must notify NHS England of C's wish—aunless sub-paragraph (b) applies, at least 3 months in advance of the date on which pharmaceutical services are no longer to be provided;bat least—i6 months in advance of that date, in the case of premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies, orii30 days in advance of that date, if—aaa condition is imposed under regulation 35,bbC appeals that condition to the First-tier Tribunal,ccon appeal, the First-tier Tribunal confirms the imposition of that condition or imposes another condition, andddwithin 30 days of being informed of the decision of the First-tier Tribunal, C notifies NHS England that C wishes to withdraw from the pharmaceutical list within a shorter period of not less than 30 days,unless either it is impracticable for C to do so, in which case C must notify NHS England as soon as it is practicable for C to do so, or NHS England agrees to a shorter notification period.3If C has consented to—aparticular listed chemist premises no longer being listed in relation to C by NHS England; orbbeing removed from the pharmaceutical list for the area of a HWB,in the context of a relocation application, which is not part of a consolidation application, paragraph (4) applies.4In the circumstances described in paragraph (3), C must, where the relocation application is granted, when C gives notice to NHS England of C's intention to commence the provision of pharmaceutical services at or from the new premises (in accordance with paragraph 34 of Schedule 2), give notice to NHS England of when, before C commences the provision of pharmaceutical services at or from the new premises, C is to cease to provide pharmaceutical services at or from the existing premises.5If C has consented to—aparticular listed chemist premises no longer being listed by NHS England; orbbeing removed from a pharmaceutical list for the area of a HWB,in the context of a consolidation application, paragraph (6) applies.6In the circumstances described in paragraph (5), in the context of an application—ato which regulation 26A(3) applies, if it is granted—iC who is the person listed in relation to S2 for the purposes of regulation 26A(3)(b) must give notice of C’s intention to cease the provision of pharmaceutical services at the same time as C who is P1 for the purposes of regulation 26A(3) issues a notice in accordance with paragraph 34A of Schedule 2; butiiC who is P1 for the purposes of regulation 26A(3) need not issue a notice under this regulation;bto which regulation 26A(4) applies, if it is granted—iC who is the person listed in relation to S1 for the purposes of regulation 26A(4) must give notice of C’s intention to cease the provision of pharmaceutical services at the same time as C who is P2 for the purposes of regulation 26A(4) issues a notice in accordance with paragraph 34A of Schedule 2; butiiC who is P2 for the purposes of regulation 26A(4) need not issue a notice under this regulation.67A1An NHS chemist must, if the NHS chemist enters administration, notify NHS England of that fact.2For these purposes, “enters administration” has the meaning given in paragraph 1(2)(b) of Schedule B1 to the Insolvency Act 1986 (administration).681It is a condition of the inclusion of each NHS chemist (C) in a pharmaceutical list by NHS England that C makes every reasonable effort to communicate and co-operate with NHS England with a view to resolving any dispute between C and NHS England relating to C's compliance with the terms of service under which C provides pharmaceutical services for NHS England.2NHS England may not vary or remove the condition imposed by virtue of paragraph (1).PART 10691Subject to paragraph (3), before issuing a notice under regulation 70 or 71, NHS England must make every reasonable effort to communicate and co-operate with an NHS chemist (C) with a view to resolving any dispute between C and NHS England relating to C's compliance with C's terms of service.2Where an NHS pharmacist invites a Local Pharmaceutical Committee to participate in the attempts to resolve the dispute, NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the dispute.3Paragraphs (1) and (2) do not apply where NHS England is satisfied—athe dispute relates to a matter that has already been the subject of dispute resolution between NHS England (or a Primary Care Trust) and C and there are no new issues of substance that justify delay in issuing a notice under regulation 70 or 71; orbthat it is appropriate to proceed immediately to issuing a notice under regulation 70 or 71—ibecause listed chemist premises are not, or have not been, open during core opening hours or supplementary opening hours without good cause, NHS England having made reasonable efforts to communicate with C with a view to establishing what the cause was,iito protect the safety of any persons to whom C may provide pharmaceutical services, oriiito protect NHS England from material financial loss.701Where an NHS chemist (C) breaches a term of service and the breach is capable of remedy, NHS England may by a notice (“a remedial notice”) require C to remedy the breach.2To be valid, the remedial notice must include—athe nature of the breach;bthe steps C must take, to the satisfaction of NHS England, in order to remedy the breach;cthe period (“the notice period”) during which the steps must be taken; anddan explanation of how C's rights of appeal under regulation 77(1)(a) may be exercised.3The notice period must be not less than 30 days, unless NHS England is satisfied that a shorter period is appropriate—ato protect the safety of any persons to whom C may provide pharmaceutical services; orbto protect NHS England from material financial loss.4If the breach relates to a failure to provide, or a failure to provide to a reasonable standard, a service that C is required to provide, the remedial notice may provide that—aas regards the period during which there was a failure to provide, or a failure to provide to a reasonable standard, that service, NHS England is to withhold all or part of the remuneration due to C in respect of that period under the Drug Tariff or a determination as mentioned in regulation 91(6);bpending C taking the steps that C must take, to the satisfaction of NHS England, in order to remedy the breach, NHS England is to withhold all or part of the remuneration due to C under the Drug Tariff or a determination as mentioned in regulation 91(6), and in these circumstances—ias regards any period for which C remains in breach, any withholding that is attributable to that period is to be permanent, andiionce C has taken the steps that C must take, to the satisfaction of NHS England, any withholding that has taken place which is attributable to a period when C is no longer in breach is to be restored to C, provided that C submits a claim, in accordance with the Drug Tariff or a determination as mentioned in regulation 91(6), for restoration of the withheld remuneration attributable to that period.5The remedial notice may only provide for the withholding of all or part of the remuneration payable under a determination as mentioned in regulation 91(6) where the breach relates to a failure to provide, or a failure to provide to a reasonable standard, an enhanced service.6The period referred to in paragraph (4)(b)(i) may be a longer period than the notice period.7If NHS England refuses to restore all or part of any withheld remuneration which is claimed under paragraph (4)(b)(ii), it must notify C of that decision as soon as is practicable, and that notification must include—aa statement of the reasons for the decision; andban explanation of how C's rights of appeal under regulation 77(1)(b) may be exercised.8NHS England may rescind a remedial notice at any time.711Where an NHS chemist (C) breaches a term of service and the breach is not capable of remedy, NHS England may by a notice (“a breach notice”) require C not to repeat the breach.2To be valid, the breach notice must include—athe nature of the breach; andban explanation of how C's rights of appeal under regulation 77(1)(c) may be exercised.3If the breach relates to a failure to provide, or a failure to provide to a reasonable standard, a service that C is required to provide, the breach notice may provide that, as regards the period during which there was a failure to provide, or a failure to provide to a reasonable standard, that service, NHS England is to withhold all or part of the remuneration due to C under the Drug Tariff or a determination as mentioned in regulation 91(6) in respect of that period.4The breach notice may only provide for the withholding of all or part of the remuneration payable under a determination as mentioned in regulation 91(6) where the breach relates to a failure to provide, or a failure to provide to a reasonable standard, an enhanced service.5NHS England may rescind a breach notice at any time.71ANHS England must not issue a breach or remedial notice in respect of a breach of a term of service by a NHS chemist in the following circumstances—aas a consequence of a disease being, or in anticipation of a disease being imminently—ipandemic, andiia 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;bthe prioritisation is in order to assist in the management of the serious risk or potentially serious risk to human health;cas part of the announcement, NHS England with the agreement of the Secretary of State has issued advice to the effect that NHS chemists need not comply with a specified term of service—iin the area to which the announcement relates,iiin the circumstances specified in the announcement, andiiiduring the period specified in the announcement; anddthe NHS chemist—iis situated in the area to which the announcement relates, andiihas not complied with the term of service (it being the specified term of service) in the particular circumstances mentioned in sub-paragraph (c)(ii) and during the period mentioned in sub-paragraph (c)(iii).721A remedial notice or breach notice may only provide for the withholding of all or any part of the remuneration of an NHS chemist (C) if—aNHS England is satisfied that the breach to which the withholding relates is, or was, without good cause;bthe amount withheld is justifiable and proportionate, having regard to the nature and seriousness of the breach and the reasons for it;cNHS England includes in the notice its duly justified reasons for both the decision to withhold remuneration and the amounts that are, and (where applicable) are to be, withheld.2NHS England need not take into account the reasons for the breach, pursuant to paragraph (1)(b), if it has made every reasonable effort to communicate with C to discover the reasons but it has been unable to discover them.3Withholdings of payments provided for in remedial notices and breach notices are without prejudice to the arrangements in place for recovering overpayments under regulation 94 and the Drug Tariff.4For the purposes of regulations 70(4) and 71(3), remuneration determined by the Secretary of State, or by NHS England acting as determining authority pursuant to regulation 91(1), is remuneration due to C under the Drug Tariff.731NHS England may remove an NHS chemist (C) from a pharmaceutical list, or remove the listing of particular listed chemist premises in relation to C, if C—afails to take the steps set out in a remedial notice that C must take, to the satisfaction of NHS England, in order to remedy the breach, and NHS England is satisfied that it is necessary to remove C from the pharmaceutical list, or remove the listing of particular listed chemist premises in relation to C—ito protect the safety of any persons to whom C may provide pharmaceutical services, oriito protect NHS England from material financial loss; orbhas breached C's terms of service, and—iC has repeatedly been issued with remedial notices or breach notices (or both) in relation to the relevant term of service,iipreviously been issued with a remedial notice or breach notice in relation to the relevant term of service, and NHS England is satisfied that C is likely to persist in breaching the term of service without good cause, oriiiC has repeatedly been issued with remedial notices or breach notices (or both) in relation to different terms of service, and NHS England is satisfied that C is likely to persist in breaching C's terms of service without good cause.2For the purpose of paragraph (1), NHS England may only remove—aparticular chemist premises from C's listing in a pharmaceutical list if the relevant breaches all relate to those particular chemist premises; orbC from a particular pharmaceutical list if the relevant breaches all relate to listed chemist premises which are the only chemist premises listed in that pharmaceutical list in relation to C.3NHS England may only remove C, or chemist premises listed in relation to C, from a pharmaceutical list under paragraph (1) if—athe removal is justifiable and proportionate, having regard to the nature and seriousness of the breaches (or likely breaches) and the reasons for them; andbNHS England, when it notifies C of the decision, includes in the notice its duly justified reasons for the decision.4NHS England need not take into account the reasons for the breaches (or likely breaches), pursuant to paragraph (3)(a), if it has made every reasonable effort to communicate with C to discover the reasons but has been unable to discover them.5NHS England must not remove C, or chemist premises listed in relation to C, from a pharmaceutical list under paragraph (1) because—aC has simply ceased to provide pharmaceutical services at or from particular listed chemist premises (regulation 74 applies in those circumstances); orbof failure to provide, or to provide to a reasonable standard, a directed service, unless C is required to provide that service pursuant to a condition imposed by virtue of regulation 66(1) or (3) to (5) (and the removal is justifiable and proportionate etc.).6Where NHS England is considering removing C, or removing the listing of particular chemist premises listed in relation to C, from a pharmaceutical list under paragraph (1), it must—agive notice to C, at least 30 days in advance of taking the decision, that NHS England is minded to remove C or the premises from a pharmaceutical list;bas part of that notification, advise C that C may make—iwritten representations to NHS England with regard to that action, provided C notifies NHS England with those representations within 30 days beginning with the date of the notification by NHS England, andiioral representations to NHS England with regard to that action, provided—aaC notifies NHS England of C's wish to do so within 30 days beginning with the date of the notification by NHS England, andbbC (or a representative of C) attends the hearing that NHS England arranges for the purpose of hearing those representations, which NHS England must give C reasonable notice of; andcconsult any Local Pharmaceutical Committee whose area includes the particular listed chemist premises or C's only chemist premises on that pharmaceutical list.7If NHS England does decide to remove C, or to remove the listing of particular chemist premises listed in relation to C, from a pharmaceutical list under paragraph (1), it must, when it notifies C of that decision, include in that notification—aa statement of the reasons for the decision; andban explanation of how C's rights of appeal under regulation 77(1)(d) may be exercised.741Subject to paragraphs (2) and (4), if an NHS chemist (C)—adies;bin the case of an NHS pharmacist, ceases to carry on a retail pharmacy business; orcin the case of an NHS appliance contractor, ceases to carry on a business in the course of which C supplies appliances either by retail sale or in circumstances corresponding to retail sale,NHS England must remove C from the relevant pharmaceutical lists.2Paragraph (1)(a) or (b) shall not apply in the case of an NHS pharmacist, if—aa representative of C (as defined in section 72 of the 1968 Act (representative of pharmacist in case of death or disability)) is carrying on the retail pharmacy business of C that is included in the relevant pharmaceutical list (“the business”);bthe conditions specified in section 72(2) of the 1968 Act are fulfilled in relation to the representative and the business;cthe period applicable in accordance with section 72(3) of the 1968 Act has not expired; anddthe representative has agreed to be bound by, and continues to agree to be bound by, C's terms of service.3If NHS England determines that C has not, during the preceding 6 months, provided pharmaceutical services at or from chemist premises (“the particular premises”) listed in a particular pharmaceutical list—aif there are other chemist premises listed in that pharmaceutical list in relation to C, NHS England must remove the listing of the particular premises from that list; orbif there are no other chemist premises listed in that pharmaceutical list in relation to C, NHS England must remove C from that list.4When determining, for the purposes of paragraph (1) or (3), whether C has ceased to carry on a business or ceased to provide pharmaceutical services, no account is to be taken of any time spent by C—asuspended from a relevant pharmaceutical list;bin whole-time service in the armed forces of the Crown in a national emergency;cin compulsory whole-time service in the armed forces of the Crown (including service resulting from reserve liability); ordwhere C is liable for compulsory whole-time service in the armed forces of the Crown, in any equivalent service,and in a case of C ceasing to carry on a business, no account is to be taken of the first 6 months after C completes that whole-time service in the armed forces of the Crown or equivalent service.5Before taking a decision to remove C, or chemist premises listed in relation to C, from a pharmaceutical list under paragraph (1) or (3), NHS England must—agive notice to C (or, in appropriate circumstances, a person whom NHS England reasonably believes is representing C or is an executor of C) of the decision that NHS England is minded to take;bas part of that notification, advise C (or the representative or executor) that they may make—iwritten representations to NHS England with regard to that action, provided they notify NHS England with those representations within 30 days beginning with the date of the notification by NHS England, andiioral representations to NHS England with regard to that action, provided—aathey notify NHS England of their wish to do so within 30 days beginning with the date of the notification by NHS England, andbbC (or the representative or executor, or someone representing the representative or executor) attends the hearing that NHS England arranges for the purpose of hearing those representations, which NHS England must give C reasonable notice of; andcconsult any Local Pharmaceutical Committee whose area includes the chemist premises that NHS England is minded to remove from the pharmaceutical list.6If NHS England does decide to remove C, or chemist premises listed in relation to C, from a pharmaceutical list under paragraph (1) or (3), it must, when it notifies C of that decision, include in that notification—aa statement of the reasons for the decision; andban explanation of how C's rights of appeal under regulation 77(1)(d) may be exercised.751If, as a consequence of a change of ownership application or a consolidation application, an NHS chemist (C) is no longer to be the person listed in a pharmaceutical list in relation to particular pharmacy premises—aif there are other chemist premises listed in that pharmaceutical list in relation to C, NHS England must remove the listing of the particular premises in relation to C from that list; orbif there are no other chemist premises listed in that pharmaceutical list in relation to C, subject to regulation 76, NHS England must remove C from that pharmaceutical list.2If C is relocating from existing chemist premises listed in a particular pharmaceutical list to new chemist premises other than as a consequence of a consolidation application—aif—ithere are other chemist premises listed in that pharmaceutical list in relation to C, oriithere are no other chemist premises so listed, but the existing chemist premises and the new chemist premises are in the area of the same HWB,NHS England must remove the listing of the existing premises in relation to C from that pharmaceutical list with effect from the date that C is required to notify to NHS England under regulation 67(4); orbif—ithere are no other premises listed in that pharmaceutical list in relation to C, andiithe new chemist premises are in the area of another HWB,subject to regulation 76, NHS England must remove C from that pharmaceutical list with effect from the date that C is required to notify to NHS England under regulation 67(4).3If C has been providing pharmaceutical services on behalf of a suspended NHS chemist at or from chemist premises listed in a particular pharmaceutical list (“the temporary provision premises”), once the fixed period referred to in regulation 27(3) expires, if—aother chemist premises are listed by NHS England in that pharmaceutical list in relation to C, NHS England must remove the listing of the temporary provision premises in relation to C; orbapart from the temporary provision premises, there are no other chemist premises listed by NHS England in that pharmaceutical list in relation to C, NHS England must remove C from that pharmaceutical list.4Paragraph (5) applies if C—awishes, other than as provided for in paragraphs (1) to (3), to close particular listed chemist premises and so—ito withdraw from a pharmaceutical list, oriifor particular listed chemist premises no longer to be listed in relation to C; andbhas complied with regulation 67(2).5In the circumstances described in paragraph (4)—aif there are other chemist premises listed in the relevant pharmaceutical list in relation to C, NHS England must remove the listing of the particular premises in relation to C from that list; orbif there are no other chemist premises listed in the relevant pharmaceutical list in relation to C, subject to regulation 76, NHS England must remove C from that list.6If NHS England decides not to remove C from a pharmaceutical list under paragraph (5), it must, when it notifies C of that decision, include in that notification—aa statement of the reasons for the decision; andbwhere appropriate, an explanation of how any rights of appeal that C has under regulation 77(1)(e) may be exercised.761If NHS England would otherwise remove an NHS chemist (C) from a pharmaceutical list under regulation 75, but—ais investigating C in order to see whether there are grounds for exercising its powers in relation to C under section 151, 152 or 154 of the 2006 Act (which relate to disqualification of practitioners, contingent removal and suspension), or regulation 80;bhas decided to—iremove C from a pharmaceutical list under section 151 or 152 of the 2006 Act or regulation 80, oriicontingently remove C under section 152 of the 2006 Act,but C has not yet been removed or contingently removed; orchas suspended C under section 154 of the 2006 Act,it must not, without the consent of the Secretary of State, remove C from that pharmaceutical list under regulation 75 until the relevant investigation or proceedings have been concluded.2If C's name is kept on a pharmaceutical list pursuant to paragraph (1)—aas regards C, NHS England may exercise its functions under—iPart 11 of these Regulations, andiiChapter 6 of Part 7 of the 2006 Act (pharmaceutical services and local pharmaceutical services – disqualification); butbfor all other purposes, C is to be treated as having been removed from that pharmaceutical list under regulation 75.771An NHS chemist (C) may appeal against the following decisions by NHS England—athe issuing of a remedial notice under regulation 70, including—ithe specified steps that C must take that are in the notice,iithe duration of the notice period in the notice,iiiany decision to provide for a withholding of remuneration that is included in the notice, andivthe amount of any withholding;ba decision not to restore remuneration to C, as provided for in a remedial notice in accordance with regulation 70(4)(b)(ii), or to restore a smaller amount than the amount that C considers should be restored;cthe issuing of a breach notice under regulation 71, including—iany decision to provide for a withholding of remuneration that is included in the notice, andiithe amount of any withholding;da decision to remove C from a pharmaceutical list, or remove the listing of particular listed chemist premises in relation to C, under regulation 73(1) or 74(1) or (3);ea refusal to remove C from a pharmaceutical list under regulation 75(5), other than a decision to keep C on the pharmaceutical list for limited purposes pursuant to regulation 76,provided that C notifies the Secretary of State with a valid notice of appeal within 30 days of the date on which C was notified of the decision that is being appealed.2A notice under paragraph (1) is valid only if it includes a concise and reasoned statement of the grounds of appeal.3NHS England must not remove C or the listing of particular listed chemist premises in relation to C (as the case may be) from a pharmaceutical list under regulation 73(1) or 74(1) or (3)—aif no appeal is brought against the decision to remove, until the period for bringing the appeal has elapsed; orbif an appeal is brought against the decision to remove but it is unsuccessful, before the appeal is determined by the Secretary of State.4Schedule 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, 7, 8 and 12 and Schedule 2).PART 1178The schemes prescribed under section 151(7)(b) of the 2006 Act (disqualification of practitioners) are schemes in the course of which health or medical services are paid for out of public funds and provided—aother than as part of the health services referred to in section 151(7)(a)—iby port health authorities,iiby the armed forces of the Crown, oriiito persons in accommodation in which they are required in accordance with law to be detained (but not naval, military and air force prisons, which are covered by sub-paragraph (ii)); orbby or on behalf of the government of a country or territory outside the United Kingdom.791Where NHS England has imposed a condition on an NHS chemist (C) under regulation 35 (or thereafter under this regulation), or a Primary Care Trust has imposed a condition on C under regulation 35 or 79 of the 2012 Regulations (which relate to fitness conditions and conditions to combat fraud), NHS England may review the decision to impose the condition—aat its own volition; orbwhere requested to do so by C, but C may not make such a request—iin the case of the first such request, until at least 3 months have elapsed since C was included in the relevant pharmaceutical list, oriithereafter, until at least 6 months have elapsed since NHS England (or a Primary Care Trust) determined the outcome of the previous review.2If NHS England is undertaking the review of its own volition, it must inform C that it is doing so.3As part of any review under paragraph (1), NHS England must afford C an opportunity to make representations to it in writing.4As a result of the review, NHS England may remove the condition, leave the condition unchanged, vary the condition or impose a different condition, but any varied or different condition must be a condition with a view to—apreventing any prejudice to the efficiency of the services, or any of the services, which C has undertaken to provide; orbpreventing any act or omission within section 151(3)(a) of the 2006 Act (disqualification of practitioners).5NHS England must notify C of a decision under paragraph (4), and it must include with the notification an explanation of—athe reasons for the decision;bC's right of appeal against its decision on the review to the First-tier Tribunal (which C has by virtue of this sub-paragraph);cthe 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; anddthe continuing application of the condition that applied prior to the review, if there is an appeal, pending the outcome of the appeal.6If the outcome of the review is that the condition is to be varied or a different decision is to be imposed, that decision is to take effect—aif no appeal is brought against the decision, once the period for bringing an appeal has elapsed; orbif an appeal is brought against the decision, and the decision of NHS England is not changed by the First-tier Tribunal, once the First-tier Tribunal has determined the appeal (if the First-tier Tribunal takes a different decision to the decision taken by NHS England, that decision takes effect upon the taking of that decision, unless the First-tier Tribunal directs otherwise).80If, in the course of a review under regulation 79 or otherwise, NHS England determines that an NHS chemist has failed to comply with a condition imposed under—aregulation 35 or 79, or as varied under regulation 79; orbregulation 35 or 79 of the 2012 Regulations (which relate to fitness conditions and conditions to combat fraud), or as varied under regulation 79 of those Regulations,it may remove that NHS chemist from the relevant pharmaceutical list.81In unsuitability cases, NHS England must remove an NHS chemist (C) from a pharmaceutical list if—aC (or where C is a body corporate, any director or superintendent of C) has been convicted in the United Kingdom of murder;bC (or where C is a body corporate, any director or superintendent of C)—ihas been convicted in the United Kingdom of a criminal offence, other than murder, which was committed after 1st April 2005, andiihas been sentenced to a term of imprisonment of over 6 months; orcC is the subject of a national disqualification.821This paragraph applies where NHS England is considering—aremoving an NHS chemist (C) from a pharmaceutical list under section 151 or 152(3)(b) of the 2006 Act (which relate to disqualification of practitioners and contingent removal);bremoving C from a pharmaceutical list under regulation 80; orccontingently removing C from a pharmaceutical list under section 152(1) of the 2006 Act .2Where paragraph (1) applies, before reaching its decision, NHS England must—anotify C of the action NHS England is considering taking and its grounds for considering taking that action; andbas part of that notification—iinform C of any allegation against C, andiiadvise C that C may make—aawritten representations to NHS England with regard to that action, provided C notifies NHS England with those representations within 30 days beginning with the date of the notification by NHS England, andbboral representations to NHS England with regard to that action, provided C notifies NHS England of C's wish to do so within 30 days beginning with the date of the notification by NHS England and C (or a representative of C) attends the hearing that NHS England arranges for the purpose of hearing those representations, which NHS England must give C reasonable notice of; andcin an unsuitability case to which regulation 81(a) or (b) applies, if C is a body corporate, advise C that NHS England will not remove C from the relevant pharmaceutical list as a consequence of that regulation (without prejudice to any other action it may take), provided that—ithe director or superintendent ceases to be a director or superintendent of C within the period of 30 days that begins on the date of the notification by NHS England, andiiwithin that period, C notifies NHS England of the date on which the director or superintendent has ceased or is to cease to be a director or superintendent of C.3Once NHS England has taken its decision, it must notify C of its decision, and it must include with the notification (which may be combined, in appropriate cases, with a notification under regulation 79(5)) an explanation of—athe reasons for the decision;bif NHS England has decided to remove or contingently remove C from a pharmaceutical list—iC's rights of appeal in relation to that decision under section 158 of the 2006 Act (appeals), andiithe 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; andcif NHS England has decided to contingently remove C, the arrangements for review of the conditions under section 157(1) of the 2006 Act (review of decisions).4If NHS England has decided to remove or contingently remove C from a pharmaceutical list in accordance with this regulation, that decision is not to take effect—aif C does not appeal against the decision, until the period for bringing an appeal against the decision has elapsed; orbif C does appeal against the decision, unless the First-tier Tribunal has determined the appeal and confirmed the decision of NHS England (if the First-tier Tribunal takes a different decision to the decision taken by NHS England, that decision takes effect upon the taking of that decision, unless the First-tier Tribunal directs otherwise).831Where NHS England is considering suspending an NHS chemist (C) from a pharmaceutical list under section 154(1) or section 155(2) of the 2006 Act (which relate to suspension and suspension pending appeal), before reaching its decision, it must—anotify C of the action NHS England is considering taking and its grounds for considering taking that action; andbas part of that notification—iwhere NHS England is considering taking action under section 154(1), inform C of any allegation against C, andiiadvise C that C may make oral representations to NHS England with regard to the possible suspension on a specified day, provided C notifies NHS England of C's wish to do so within a specified period (of not less than 24 hours).2If, within the specified period—aC does not advise NHS England that C wishes to make oral representations to NHS England on the specified day, thereafter NHS England may suspend C with immediate effect; orbC does advise NHS England that C wishes to make oral representations to NHS England on the specified day, NHS England must not suspend C until after the oral hearing, but may then do so with immediate effect.3Once NHS England has taken its decision, it must notify C of its decision as soon as is practicable, and it must include with the notification of its decision an explanation of—athe reasons for the decision;bif NHS England has decided to suspend C under section 154(1), the arrangements for review of the suspension under section 157(1) of the 2006 Act (review of decisions).841This paragraph applies where NHS England—ais required to review a contingent removal or a suspension under section 157(1) of the 2006 Act (review of decisions); orbdecides to review a contingent removal or a suspension that it could be required to review under that section (if section 157(2) were satisfied).2Where paragraph (1) applies, as part of the review, NHS England must afford the NHS chemist who has been contingently removed or is suspended (C) the opportunity to make—awritten representations to NHS England, provided C notifies NHS England with those representations within 30 days beginning with the date of the notification by NHS England; andboral representations to NHS England with regard to that action, provided—iC notifies NHS England of C's wish to do so within 30 days beginning with the date of the notification by NHS England, andiiC (or a representative of C) attends the hearing that NHS England arranges for the purpose of hearing those representations, which NHS England must give C reasonable notice of.3Once NHS England has taken its decision under section 157(3) of the 2006 Act, it must notify C of its decision, and it must include with the notification of its decision an explanation of—athe reasons for the decision;bif C has a right of appeal in relation to the decision—ithe right of appeal that C has in relation to that decision under section 158 of the 2006 Act (appeals), andiithe 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; andcif C has been or remains suspended or contingently removed, the arrangements for review of the suspension or the conditions under section 157(1) of the 2006 Act.851If an NHS chemist is suspended from a pharmaceutical list, in addition to NHS England’s powers to terminate suspensions under section 157(3)(b) of the 2006 Act (review of decisions) on a review, NHS England may terminate the suspension at any time, in appropriate circumstances.2If NHS England terminates a suspension under paragraph (1), it must notify the NHS chemist that it has done so.861NHS England must ensure that the records it maintains relating to the fitness of NHS chemists and LPS chemists to be NHS chemists or LPS chemists are only accessible to persons whom NHS England employs in circumstances where NHS England is satisfied that they—ashould have access to the information on a need-to-know basis; andbfully understand the confidential nature of the information and the purposes for which they are being permitted access to it.2Where functions of NHS England relating to the fitness of NHS chemists or LPS chemists are carried out on behalf of NHS England by an agent of NHS England—athe reference in paragraph (1) to persons whom NHS England employs includes reference to persons whom the agent employs to perform functions under the agency arrangement (about whom the agent must be satisfied on NHS England’s behalf as mentioned in sub-paragraphs (a) and (b) of paragraph (1)); andbNHS England must ensure that the terms of the agency arrangement are such that the information the agent holds relating to the fitness of NHS chemists and LPS chemists to be NHS chemists or LPS chemists as a consequence of the arrangement is not further processed by the agent in a manner which is incompatible with the confidential nature of the information and the purposes for which it has been obtained.871Section 159(8)(a) of the 2006 Act (national disqualification) is to have effect as if the reference to “two years” were a reference to “five years”, if the First-tier Tribunal determines, when it imposes the national disqualification, that the conduct of the person on whom the national disqualification has been imposed has been such that there is no realistic prospect of a review being successful if held within five years.2Section 159(8)(b) of the 2006 Act is to have effect as if the reference to “one year” were a reference to “three years”, if the First-tier Tribunal determines, on a review, that the conduct of the person on whom the national disqualification has been imposed has been such that there is no realistic prospect of a further review being successful if held within three years.3Section 159(8) of the 2006 Act is to have effect as if the references to “two years” and “one year”—ain a case where—ia national disqualification has been imposed as a consequence of a criminal conviction, andiion appeal, the conviction has been quashed or the penalty imposed by the court has been reduced; orbin a case where—ia national disqualification has been imposed as a consequence of an adverse decision of a licensing body, andiion appeal, the decision of the licensing body has been quashed or the penalty imposed by it has been reduced,were a reference to a period equal to the period between the date on which that appeal was determined and the date on which the national disqualification was imposed or last reviewed.881Where NHS England—arefuses an application from a person (P) by virtue of regulation 33;bgrants an application subject to conditions imposed on P by virtue of regulation 35;cimposes or varies a condition imposed on P by virtue of regulation 79;dremoves P from a pharmaceutical list by virtue of section 151 or 152(3)(b) of the 2006 Act (which relate to disqualification of practitioners and contingent removal);econtingently removes P from a pharmaceutical list by virtue of section 152 of the 2006 Act, or varies or imposes a different condition on P by virtue of that section; orfsuspends P under section 154 or 155 of the 2006 Act (which relate to suspension and suspension pending appeal),NHS England must notify the persons listed in paragraph (2) that it has done so.2Those persons are—athe Secretary of State;bwhere known to NHS England, any other primary care organisation that—ihas included P, or a body corporate of which P is a director or superintendent, in a relevant list, oriiis considering including P, or a body corporate of which P is a director or superintendent, in a relevant list;cthe Scottish Ministers;dthe Welsh Ministers;ethe Northern Ireland Executive;fthe General Pharmaceutical Council;gany Local Pharmaceutical Committee for the area of the relevant HWB (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);hin a case that is or may be a fraud case, the NHS CFA; andiany person who may and does request to be notified of an adverse fitness decision as regards P.3A person (Q) comes within paragraph (2)(i) if Q establishes to the satisfaction of NHS England (or before the appointed day the relevant Primary Care Trust) that Q—ahas employed or engaged, is employing or engaging or is considering employing or engaging P, or a director or superintendent of P, in a professional capacity; orbis a member of a partnership of which P has been or is a member, or which is considering inviting P to be a member.4A notification under paragraph (1) must include—awhere P is an individual or a partnership—iP's, or each member of the partnership's, name, address and date of birth, andiiP's, or each member of the partnership's, registration number in the Register of Pharmacists; andbwhere P is a body corporate—iP's name, company registration number and the address of P's registered office, andiithe registration number in the Register of Pharmacists of P's superintendent and of any director of P who is a registered pharmacist;ca copy of the notification of the decision that was sent to P; anddthe name of and contact details for a person at NHS England who is in a position to respond to further enquiries.5NHS England must notify P of whom it has notified under paragraph (1) and include, when it does so, the content of that notification.6If, in response to an enquiry from a person notified under paragraph (1), NHS England notifies that person with further documentation (including documentation in an electronic form) that relates to P, NHS England must also notify P with—athat documentation; andbdetails of the person to whom it has been sent.7If NHS England is notified by the First-tier Tribunal of a national disqualification, or the outcome of the review of a national disqualification, it must notify that information to the persons it notified about its own decision in relation to P under paragraph (2)(b) and (g) to (i).8If—ahaving notified a person under paragraph (1) of a suspension or a condition (including a condition imposed on contingent removal); orbafter a Primary Care Trust notified a person under regulation 88(1) of the 2012 Regulations (wider notifications of fitness decisions) of a suspension or a condition (including a condition imposed on contingent removal),NHS England terminates the suspension or removes the condition, NHS England must notify that person with the notification given to P of the decision to terminate the suspension or remove the condition.PART 12891The Drug Tariff referred to in section 127(4) of the 2006 Act (arrangements for additional pharmaceutical services) is the aggregate of—athe determinations of remuneration made by the Secretary of State, acting as a determining authority, under section 164 of the 2006 Act (remuneration for persons providing pharmaceutical services), but not of the remuneration of dispensing doctors;bthe determinations of remuneration made by NHS England, acting as a determining authority, pursuant to regulation 91(1); andcany other instruments that the Secretary of State is required by virtue of these Regulations or the 2006 Act to publish, or does publish, together with those determinations,in the publication known as the Drug Tariff, which the Secretary of State shall publish in such format as the Secretary of State thinks fit.2Determinations under section 164 of the 2006 Act by the Secretary of State or NHS England may be made by reference to—athe drugs and appliances dispensed or expected to be dispensed in accordance with NHS prescriptions during a reference period determined by the Secretary of State;blists of published prices produced by suppliers of the drugs or appliances that are available from them on NHS prescription;cscales, indices or other data that relate to volume and price that are produced by suppliers of the drugs or appliances that are available from them on NHS prescription; anddany other scales, indices or other data (including formulae) by reference to which the Secretary of State considers it appropriate to make such a determination, and in these circumstances, the Secretary of State may provide that remuneration is to be determined by reference to data which is—iin the form current at the time of the determination; andiiin any subsequent form taking effect after that time.3Amendments may be made to the Drug Tariff at such intervals as the Secretary of State thinks fit, but must be published in a consolidated version of the Drug Tariff that has the amendments included in it.4The consultation that the Secretary of State must undertake under section 165(1) of the 2006 Act (section 164: supplementary) prior to the inclusion of, or change to, a price of a drug or appliance which is to form part of a calculation of remuneration shall be by way of consultation on the process for determining the price to be included or changed, not on the proposed price itself (unless it is impossible to carry out an effective consultation in any other way).5The Drug Tariff is to include the arrangements for the claiming of payments by NHS chemists and the making of payments to NHS chemists under it (whether the amounts are determined by the Secretary of State or NHS England), and—aclaims by NHS chemists for payments under the Drug Tariff must be made in accordance with those arrangements;bpayments under the Drug Tariff must be made—iby NHS England (or a person exercising its functions), andiiin accordance with those arrangements, subject as appropriate to any deduction that may or must be made in accordance either with those arrangements or with any provision of, or made under, the 2006 Act (including the Drug Tariff); andcthe arrangements may include arrangements for auditing, monitoring or analysing the making of payments.901The data which the Secretary of State and NHS England may take into account prior to making a determination under section 164 of the 2006 Act (remuneration for persons providing pharmaceutical services) may include information obtained pursuant to paragraph (3) by—athe Secretary of State or a person appointed by the Secretary of State under this paragraph; orbNHS England or a person appointed by NHS England under this paragraph,and a person appointed under this paragraph is referred to in this regulation as “a nominee”.2Before appointing a person to be a nominee, the Secretary of State or NHS England must consult, as they consider appropriate, organisations representative of the NHS chemists to whose remuneration the possible determination arising out of the data would relate.3An NHS chemist must, within 30 days of a request to do so, provide—athe Secretary of State or a nominee of the Secretary of State with information (for example invoices) which the Secretary of State considers to be relevant to the matters the Secretary of State may take into account prior to making a determination under section 164 of the 2006 Act; orbNHS England or a nominee of NHS England with information (for example invoices) which NHS England considers to be relevant to the matters NHS England may take into account prior to making a determination under section 164 of the 2006 Act.4A nominee may handle and process information obtained under paragraph (3).5The Secretary of State may require—ainformation obtained by a nominee of the Secretary of State under paragraph (3)(a) to be obtained; andbinformation processed or handled by a nominee of the Secretary of State under paragraph (4) to be processed or handled,in such manner as the Secretary of State may reasonably specify.6NHS England may require—ainformation obtained by a nominee of NHS England under paragraph (3)(b) to be obtained; andbinformation processed or handled by a nominee of NHS England under paragraph (4) to be processed or handled,in such manner as NHS England may reasonably specify.7The Secretary of State and NHS England may share with each other information which they or their nominees have obtained under this regulation (for purposes related to the determination of pharmaceutical remuneration).911NHS England is appointed by the Secretary of State as a determining authority in relation to the following remuneration to be paid to NHS chemists for providing pharmaceutical services—athe remuneration listed in Schedule 8 (which has effect); andbremuneration in respect of advanced services.2Before making determinations as provided for by paragraph (1), NHS England must consult—athe Secretary of State in such manner as the Secretary of State may reasonably request; andba body appearing to it to be representative of persons to whose remuneration the determination would relate.3In making determinations as provided for by paragraph (1), NHS England must—aco-operate with the Secretary of State over seeking to ensure that resource use in respect of pharmaceutical remuneration is compatible with any objectives agreed between the Secretary of State and NHS England in respect of the total resource to be available for pharmaceutical remuneration;bensure that those determinations are compatible with the Secretary of State's arrangements for the claiming and making of payments, and making deductions from payments, that are included in the Drug Tariff (which may relate to pharmaceutical remuneration determined by NHS England as well as to pharmaceutical remuneration determined by the Secretary of State);censure that those determinations are signed by a member of the senior management of NHS England, and for these purposes a person is a member of the senior management of NHS England if that person plays a significant role in—ithe making of decisions about how the whole or a substantial part of its activities are to be managed or organised, oriithe actual managing or organising of the whole or a substantial part of those activities; anddact in a manner that ensures that any amendments which, as a consequence, need to be made to the Drug Tariff, are made in a manner that is compatible with the Secretary of State's arrangements for the publication of the Drug Tariff (or the arrangements of a person publishing the Drug Tariff on the Secretary of State's behalf).4The Secretary of State must, before making a determination which could by virtue of paragraph (1) be made by NHS England, notify NHS England of the Secretary of State's intention to make the determination.5Before determining any remuneration payable in respect of an enhanced service, NHS England must consult—aif the service is to be provided on the basis of a service specification that sets standard conditions nationally (including with regard to remuneration), the body that is, for the time being, the body consulted under section 165(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of NHS pharmacists; orbotherwise, any Local Pharmaceutical Committee for the area in which the service is to be provided.6Where NHS England makes a determination of the remuneration payable in respect of an enhanced service, it must publish the determination in such manner as it thinks appropriate for bringing it to the attention of persons included in the relevant pharmaceutical lists.7The arrangements for claiming and paying any remuneration in respect of an enhanced service thus determined must allow for the making for any deduction that may or must be made from that remuneration by virtue of any provision of, or made under, the 2006 Act (for example, a deduction that may or must be made by virtue of regulations 70 to 72).91A1In the case of the drugs or medicines to which paragraph (2) applies, determining authorities must ensure that determinations under section 164 of the 2006 Act (remuneration of persons providing pharmaceutical services) in respect of pharmaceutical remuneration that relates to the supply or administration of those drugs or medicines either—ado not provide for or permit any reimbursement to be paid for the cost of the drug or medicine (and so the basic price of the drug or medicine, for Drug Tariff purposes, is zero); orbonly provide for or permit nominal reimbursement to be paid for the cost of the drug or medicine.2This paragraph applies to—aa drug or medicine which is used for vaccinating or immunising people against coronavirus ..., if the conditions set out in paragraph (3) are satisfied; ...aaa drug or medicine which is used for vaccinating or immunising people against respiratory syncytial virus, if the conditions set out in paragraph (3) are satisfied;aba drug or medicine which is used for vaccinating or immunising people against measles, mumps and rubella, if the conditions set out in paragraph (3) are satisfied; ...aca drug or medicine which is used for vaccinating or immunising people against pertussis (whooping cough), if the conditions set out in paragraph (3) are satisfied; ...ada drug or medicine which is used for vaccinating or immunising children against influenza, if the conditions set out in paragraph (3) are satisfied; ...aea drug or medicine which is used for vaccinating or immunising people against human papillomavirus, if the conditions set out in paragraph (3) are satisfied; orban antiviral drug or medicine which is used for preventing or treating coronavirus (“a coronavirus antiviral”), if the conditions set out in paragraph (4) are satisfied.3The conditions set out in this paragraph are—athe Secretary of State (references to whom in this regulation encompass both the Secretary of State for Health and Social Care and other Secretaries of State) has purchased the vaccines for supply as part of the health service;bthe Secretary of State has made arrangements for all or part of the Secretary of State’s stock of the vaccines, purchased as mentioned in sub-paragraph (a), to be supplied to NHS pharmacists and LPS chemists, whether directly or via an intermediary, at no cost to the NHS pharmacists or LPS chemists;cNHS England has made arrangements for the administration of the vaccines from the stock mentioned in sub-paragraph (b) as part of a directed service; anddthe ... vaccine in question is from that stock and administered as part of that service.3AThe references in paragraph (3) to vaccines or the vaccine in question are references to the drugs or medicines in respect of which the conditions set out in paragraph (3) are to be satisfied by virtue of paragraph (2)(a) to (ae).4The conditions set out in this paragraph are—athe Secretary of State has purchased coronavirus antivirals of a particular type for supply as part of the health service;bthe Secretary of State has made arrangements for all or part of the Secretary of State’s stock of that particular type of coronavirus antiviral, purchased as mentioned in sub-paragraph (a), to be supplied to NHS pharmacists and LPS chemists, whether directly or via an intermediary, at no cost to the NHS pharmacists or LPS chemists; andcthe coronavirus antiviral in question—iis from that stock, oriiis not from that stock but is nevertheless of the particular type of coronavirus antiviral that is available at no cost to NHS pharmacists and LPS chemists under the arrangements mentioned in sub-paragraph (b).5For the purposes of paragraph (4), the Secretary of State may characterise the particular type of coronavirus antivirals that are available at no cost to NHS pharmacists and LPS chemists solely by reference to the presentation of the drug or medicine (as well as by reference to its active ingredient, strength or any, or a combination of any, other distinguishing characteristics).6For the avoidance of doubt, determinations under section 164 of the 2006 Act that, in accordance with this regulation—ado not provide for or permit reimbursement to be paid for the cost of a drug or medicine (and so the basic price of the drug or medicine, for Drug Tariff purposes, is zero); orbonly provide for or permit nominal reimbursement to be paid for the cost of a drug or medicine,may nevertheless provide for or permit remuneration to be paid for any service provided by a NHS pharmacist or LPS chemist, in the course of which the drug or medicine is supplied or administered.7In this regulation, “nominal reimbursement” means, in the case of a drug or medicine that has been provided at no cost to a NHS pharmacist or LPS chemist, payment of an amount that is paid in place of the amount that the NHS pharmacist or LPS chemist would ordinarily make from the difference between—athe amount that they paid for the drug or medicine when they purchased it; andbthe amount that they are paid by NHS England in respect of the cost of that drug or medicine (most commonly the basic price listed in the Drug Tariff), if they supply or administer that drug or medicine under arrangements for the provision of pharmaceutical or local pharmaceutical services.8For the purposes of paragraph (2)(ad), a drug or medicine is to be treated as a drug or medicine which is used for vaccinating or immunising children if (despite not being solely used for that purpose) it is mainly used for that purpose but it is also used for vaccinating or immunising people who have attained the age of 16 years.921As regards the pharmaceutical services provided by dispensing doctors—aif a drug, appliance or related additional service is provided by a dispensing doctor in circumstances where the dispensing doctor could provide it under pharmaceutical services or related arrangements for the provision of primary medical services, the remuneration in respect of providing that drug, appliance or service is to be the remuneration payable in respect of that drug, appliance or service under the related arrangements; andbin all other cases, the remuneration payable to a dispensing doctor in respect of those pharmaceutical services is to be the remuneration payable under a GMS contract to a GMS practice in respect of those services by virtue of directions under section 87 of the 2006 Act (GMS contracts: payments), whether or not the dispensing doctor is a GMS practice.2Claims for remuneration in respect of pharmaceutical services by or on behalf of a dispensing doctor are to be made to the NHS BSA (which calculates the amount of the payment on behalf of NHS England) in such manner as the NHS BSA determines.3The making of payments by NHS England pursuant to a claim made in accordance with paragraph (2) is to be in accordance with the arrangements—athat the dispensing doctor has with NHS England for the provision of primary medical services to the patients to whom the dispensing doctor provides pharmaceutical services; orbif the dispensing doctor has no such 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,subject as appropriate to any deduction that may or must be made in accordance either with those arrangements or with any provision of, or made under, the 2006 Act (including the determinations mentioned in paragraph (1)).931A determination of remuneration under section 164 of the Act (remuneration for persons providing pharmaceutical services) is to have effect—ain relation to remuneration in respect of a period beginning on or as from a date specified in the determination, on or as from that date; orbif no such date is specified, in relation to remuneration in respect of the period beginning on the date that the determination is published.2A date before the date a determination is published may only be specified under paragraph (1)(a) if, taking the determination as a whole, it is not detrimental to the persons to whose remuneration it relates.941Where NHS England considers that a payment has been made to an NHS chemist pursuant to the arrangements mentioned in regulation 89(5) or 91(7) in circumstances where it was not due, it must (except to the extent that the Secretary of State, on the application of NHS England, directs otherwise) draw the overpayment to the attention of the NHS chemist, and—awhere the NHS chemist admits the overpayment; orbif the NHS chemist does not admit there has been an overpayment, where the final outcome of an investigation or appeal is that there has been an overpayment,the amount overpaid shall be recoverable by deduction from other remuneration payable to the NHS chemist in respect of pharmaceutical services or as a civil debt.2Where NHS England considers that a payment has been made to a dispensing doctor or provider of primary medical services pursuant to the arrangements mentioned in regulation 92(2) in circumstances where it was not due, it must (except to the extent that the Secretary of State, on the application of NHS England, directs otherwise) seek to recover that overpayment under those arrangements.3Recovery under this regulation of an overpayment is to be without prejudice to the investigation of any related breach of the relevant NHS chemist's or dispensing doctor's terms of service.95Subject to any provision of regulations made under Part 9 of the 2006 Act (charging) to the contrary and without prejudice to regulation 92(1)(a), any drug, appliance or container supplied under arrangements made by NHS England for the provision of pharmaceutical services must be supplied free of charge (although a prescription charge may be payable).961Where any person is entitled to repayment of a charge paid under the Charges Regulations presents an NHS pharmacist with a valid claim for the repayment within 3 months of the date on which the charge was paid, the NHS pharmacist must make the repayment.2For the purposes of paragraph (1), a claim for repayment is only valid if duly made—ain such form and manner as the Secretary of State has determined for an application for such a repayment under regulation 18(2)(b) of the Charges Regulations (repayment of charges); orbon an equivalent form issued in Scotland, Wales or Northern Ireland.971An NHS chemist who is presented with or receives an order under paragraph 5(2) or (3) of Schedule 4, or paragraph 4(2) or (3) of Schedule 5, is eligible to claim a payment from NHS England, in accordance with the Drug Tariff, if—athe NHS chemist has refused, in accordance with paragraph 9 of Schedule 4 or paragraph 8 of Schedule 5, to provide a drug or appliance and has informed NHS England of this action as soon as practicable; orbhas provided a drug or appliance pursuant to paragraph 5(2) or (3) of Schedule 4, or paragraph 4(2) or (3) of Schedule 5 but has reason to believe (whether or not this was the case at the time that the drug or appliance was dispensed) that the order was not a genuine order on NHS prescription and has informed NHS England of this belief as soon as is practicable,and in either case has sent the order (or, in the case of an electronic prescription, details of it) to NHS England.2Where NHS England establishes that an order about which it has been notified in accordance with paragraph (1) was not a genuine order, NHS England must make such payment as is due to the NHS chemist under the Drug Tariff.3In this regulation, “order” includes a purported order.981If an NHS chemist (C) is suspended from a pharmaceutical list, NHS England must make payments to C, in accordance with the determination that is to be made by the Secretary of State under this paragraph in relation to such payments.2A determination under paragraph (1) may be amended from time to time by a further determination under that paragraph.3Before making a determination under paragraph (1), the Secretary of State must consult such organisations as appear to the Secretary of State to be representative of NHS chemists.4A determination under paragraph (1) must be published in the Drug Tariff.5A determination under paragraph (1) may include provision that payments in accordance with the determination are not to exceed a specified amount in a specified period.6If a payment has been made pursuant to a determination under paragraph (1) to C when it was not due, it must (except to the extent that the Secretary of State, on the application of NHS England, directs otherwise) draw the overpayment to the attention of C, and—awhere C admits the overpayment; orbif C does not admit there has been an overpayment, where the final outcome of an investigation or appeal is that there has been an overpayment,the amount overpaid shall be recoverable by deduction from other remuneration payable to C in respect of pharmaceutical services (for example, from subsequent payments under the determination or from payments for pharmaceutical services where C resumes the provision of pharmaceutical services) or as a civil debt.7C may appeal to the Secretary of State against the following decisions by NHS England—aa refusal to make payments to C under the determination under paragraph (1);bthe level of any payments made to C under the determination under paragraph (1); orca deduction from remuneration under paragraph (6),provided that C notifies the Secretary of State with a valid notice of appeal within 30 days of the date on which C was notified of the decision that is being appealed.8A notice under paragraph (7) is valid only if it includes a concise and reasoned statement of the grounds of appeal.9Schedule 3 has effect in relation to appeals to the Secretary of State under paragraph (7) (as it does in relation to appeals against decisions under Parts 2 to 5, 7, 8 to 10 and Schedule 2).PART 13991NHS England may designate relevant areas, premises or descriptions of premises for the purposes of paragraph 2 of Schedule 12 to the 2006 Act (LPS schemes – designation of priority neighbourhoods or premises).2Any designation made is to be of an area in which, or premises or descriptions of premises at or from which, local pharmaceutical services are to be provided under a proposed or approved LPS scheme (referred to in this regulation as the “relevant scheme”), but a designation is not necessary in respect of every such scheme.3Any designation made must—abe made in writing and be dated;binclude a map showing the location of the area, premises or description of premises designated; andcinclude an outline of the services to be provided under the relevant scheme.4NHS England must give notice of the designation to—athe HWB (HWB1) for the area to which the designation relates, or (as the case may be) for the area in which the premises or descriptions of premises are situated;bany Local Pharmaceutical Committee whose area includes the premises, descriptions of premises, or all or part of the area to which the designation relates;cany Local Medical Committee whose area includes the premises, descriptions of premises, or all or part of the area to which the designation relates;dany NHS chemist whose listed chemist premises—iare in the area of HWB1, oriiare in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the designation;eany person who is entitled because of the grant of a routine or excepted application to be included in a pharmaceutical list—ifor the area of HWB1, oriifor the area of a neighbouring HWB, if their interests are likely, in the opinion of NHS England, to be affected by the designation,but who is not (yet) included;fany LPS chemist whose chemist premises—iare in the area of HWB1, oriiare in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the designation;gany dispensing doctor whose listed dispensing premises—iare in the area of HWB1, oriiare in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the designation; andhany Local Healthwatch organisation for the area of HWB1.5A designation under this regulation, and any designation by a Primary Care Trust under regulation 4 of the 2006 Regulations (designation of priority neighbourhoods or premises), may be varied by NHS England where—aif it relates to an area, the LP services to be provided under the relevant scheme are to be provided in or from part only of that area;bif it relates to premises, the LP services to be provided under the relevant scheme are to be provided at or from part only of those premises;cif it relates to a description of premises, the LP services to be provided under the relevant scheme are to be provided at or from parts only of the premises described.6Where a designation is varied under paragraph (5), that designation must—asatisfy the requirements of paragraph (3) (the date of the designation becoming the date on which it is varied); andbbe notified in accordance with paragraph (4).7NHS England must—apublish—iall its (current) designations, including designations it has varied, under this regulation, andiiall the (current) designations of Primary Care Trusts, including their varied designations, under regulation 4 of the 2006 Regulations; andbensure that each HWB has access to those designations which is sufficient to enable the HWB to carry out its functions under these Regulations.1001NHS England must regularly review—aall its designations, including designations it has varied, under regulation 99; andball the designations of Primary Care Trusts, including their varied designations, under regulation 4 of the 2006 Regulations (designation of priority neighbourhoods or premises),and in any event must review each of those designations before the end of 6 months beginning with either the date of the designation or (if later) the date it concluded its last review of the designation.2When conducting a review under paragraph (1), NHS England must take into account any responses it or a Primary Care Trust received when the designation was last notified.3In a case where a designation is not varied or cancelled as a result of a review, NHS England must give notice of the outcome of the review to the persons who would have been notified under regulation 99(6)(b) if the designation had been varied.1011NHS England may at any time cancel—aany of its designations, including designations it has varied, under regulation 99; andbany of the designations of Primary Care Trusts, including their varied designations, under regulation 4 of the 2006 Regulations (designation of priority neighbourhoods or premises).2NHS England must cancel a designation—aif required to do so by a direction given by the Secretary of State under section 168A of the 2006 Act (exercise of functions);bwithin 12 months of the date of the decision to make the designation, disregarding any subsequent decision to vary the designation, if in the case of designation for a proposed LPS scheme, no proposal to enter into an LPS scheme has been received by NHS England (or before the appointed day by a Primary Care Trust) for approval;cif, in the case of a designation for a proposed LPS scheme, the only (or only remaining) proposal to enter into an LPS scheme that relates to the designation has been refused;dif there has been a significant change to the area in which, or to the premises at or from which, LP services are to be provided, other than a change which leads to a variation of the designation under regulation 99(5); oreif or when an LPS contractor commences the provision of LP services at or from the designated location.3NHS England must give notice of the cancellation to the persons who would have been notified under regulation 99(6)(b) if the designation had instead been varied.4If a designation has been cancelled under this regulation or regulation 6 of the 2006 Regulations (cancellation of designations by a Primary Care Trust), NHS England may only designate the same area, premises or description of premises under regulation 99 within 6 months of that cancellation if the reason for the cancellation was the refusal by NHS England or a Primary Care Trust of a proposal to enter into an LPS scheme.1021Each LPS scheme must specify—athe LP services to be provided under the scheme, which must include the dispensing of drugs; andbthe address of the premises at or from which those services are to be provided (“the scheme premises”).2If the provider of services under an LPS scheme is a health service body, the scheme must state that it is an NHS contract.3Each LPS scheme must contain the terms, or terms which make provision that has the same effect as the terms, set out in Schedule 7.102A1Any term that is part of an LPS scheme as a consequence of action taken under regulation 102 or by agreement between the parties is temporarily not part of that scheme, in the particular circumstances mentioned in sub-paragraph (c)(ii) and during the period mentioned in sub-paragraph (c)(iii), in the following circumstances—aas a consequence of a disease being, or in anticipation of a disease being imminently—ipandemic, andiia 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;bthe prioritisation is in order to assist in the management of the serious risk or potentially serious risk to human health;cas part of the announcement, NHS England with the agreement of the Secretary of State has issued advice to the effect that LPS contractors are not to comply with a specified type of term of LPS schemes—iin the area to which the announcement relates,iiin the circumstances specified in the announcement, andiiiduring the period specified in the announcement; anddthe LPS contractor is situated in the area to which the announcement relates and compliance with the term (it being of the specified type) would, but for the effect of this paragraph, be a requirement of the LPS scheme of the LPS contractor.2NHS England must not take enforcement action, as provided for in an LPS scheme, in respect of a breach of a term of the LPS scheme in the following circumstances—aas a consequence of a disease being, or in anticipation of a disease being imminently—ipandemic, andiia 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;bthe prioritisation is in order to assist in the management of the serious risk or potentially serious risk to human health;cas part of the announcement, NHS England with the agreement of the Secretary of State has issued advice to the effect that LPS contractors need not comply with a specified type of term of an LPS scheme—iin the area to which the announcement relates,iiin the circumstances specified in the announcement, andiiiduring the period specified in the announcement; anddthe LPS contractor—iis situated in the area to which the announcement relates, andiihas not complied with the term (it being of the specified type) in the particular circumstances mentioned in sub-paragraph (c)(ii) and during the period mentioned in sub-paragraph (c)(iii).1031Subject to paragraph (3), an LPS contractor (C) is to be treated as a health service body for the purposes of section 9 of the 2006 Act (NHS contracts) unless—aas regards an LPS scheme established by a Primary Care Trust before the appointed day, either—ibefore the LPS scheme was entered into, the proposed provider (or providers) under the scheme objected to that by a notice in writing to the Primary Care Trust, oriibefore the appointed day, the LPS scheme was varied under regulation 10(4) of the 2006 Regulations (health service body status), as a consequence of which the scheme ceased to be treated as an NHS contract; orbbefore the LPS scheme is entered into, the proposed provider (or providers) under the scheme object to that by a notice in writing to NHS England.2Where C is to be treated as a health service body for the purposes of section 9 of the 2006 Act, subject to paragraph (3), any variation of the LPS scheme which changes a party to the scheme does not affect the health service body status of the provider (or providers) of goods and services under the scheme.3C may at any time request a variation of an LPS scheme so as to provide that the scheme is to become, or is to cease to be, an NHS contract, and if C does so—aif—iC is the only other party to the scheme, NHS England must agree to the variation, oriiif all the parties to the scheme other than NHS England are together making the request, NHS England must agree to the variation; andbthe procedure in paragraph 26 of Schedule 7 is to apply.4Where, pursuant to paragraph (3), NHS England agrees to a variation of an LPS scheme, C is (as the case may be)—ato be treated as a health service body; orbsubject to paragraph (6), to cease to be treated as a health service body,for the purposes of section 9 of the 2006 Act from the date on which the variation takes effect.5Subject to paragraph (6), a person who has been both a provider under an LPS scheme and treated as a health service body for the purposes of that scheme is to cease to be treated as a health service body for the purposes of that scheme where—athe scheme is varied so that person is no longer a provider under that scheme; orbthe scheme, or the agreement that is part of the scheme to which that person is a party, is terminated.6Where a person ceases to be treated as a health service body pursuant to—aparagraph (4)(b), where C or NHS England—ihas referred any matter to the NHS dispute resolution procedure before C ceases to be a health service body, oriirefers any matter to the NHS dispute resolution procedure, in accordance with paragraph 21(1)(a) of Schedule 7, after C ceases to be a health service body,C is to continue to be treated as a health service body (and accordingly the scheme or agreement is to continue to be regarded as an NHS contract) for the purposes of the consideration and determination of the dispute;bparagraph (5)(b), C is to continue to be treated as a health service body for the purposes of the resolution of any dispute that falls to be resolved in accordance with the terms of the terminated agreement or scheme notwithstanding its termination.1041NHS England may make payments of financial assistance in respect of the development of LPS schemes.2If a proposal for an LPS scheme is submitted to NHS England, it must consider whether or not to select that proposal for development, unless the proposal is vexatious or frivolous.1051NHS England may only be a party to an LPS scheme with the following—aan individual who does not fall within paragraph (2);ba partnership (other than a limited liability partnership) where each partner does not fall within paragraph (2);ca body corporate where—ithe body corporate, andiiany director, chief executive, superintendent or company secretary of the body corporate,do not fall within paragraph (2).2A person (P) falls within this paragraph if—aP is the subject of a national disqualification;bSubject to paragraph (3), P is disqualified or suspended (other than by an interim suspension order or a direction pending investigation) from practising by a licensing or regulatory body anywhere in the world;cP has, within 5 years of the date on which either P would be due to start participating in the LPS scheme, or (if earlier) commits to participating in the scheme, been refused admission to a relevant list for a reason that amounts to inefficiency, fraud or unsuitability (as understood by reference to the conditions in section 151(2) to (4) of the 2006 Act) (disqualification of practitioners), unless P has subsequently been included in a relevant list;dP has been convicted in the United Kingdom of murder;eP has been convicted in the United Kingdom of a criminal offence other than murder—iwhich was committed on or after 1st April 2006, andiifor which P has been sentenced to a term of imprisonment of over 6 months;fsubject to paragraph (4), P has elsewhere than the United Kingdom been convicted of an offence which, if committed in England or Wales—iwould constitute murder, oriiwould constitute a criminal offence, andaawhich was committed on or after 1st April 2006, andbbfor which P has been sentenced to a term of imprisonment of over 6 months;gP has been convicted of an offence referred to in—iSchedule 1 to the Children and Young Persons Act 1933 (offences against children and young persons with respect to which special provisions of the Act apply), oriiSchedule 1 to the Criminal Procedure (Scotland) Act 1995 (offences against children under the age of 17 years to which special provisions apply),which was committed on or after 1st April 2006;hP—ihas been made bankrupt and has not been discharged from the bankruptcy,iiis a person in relation to whom a moratorium period under a debt relief order under Part 7A of the Insolvency Act 1986 (debt relief orders) applies,iiiis the subject of a bankruptcy restrictions order, an interim bankruptcy restrictions order, a debt relief restrictions order or an interim debt relief restrictions order under Schedule 4A or 4ZB to the Insolvency Act 1986 or Schedule 2A of the Insolvency (Northern Ireland) Order 1989 (which relate to bankruptcy and debt relief restrictions orders and undertakings),ivif P is a body corporate, has been wound up under Part 4 of the Insolvency Act 1986;vhas made a composition or arrangement with, or granted a trust deed for, P's creditors and P has not been discharged in respect of it;iin respect of P there is—ian administrator, administrative receiver or receiver appointed, oriian administration order under Schedule B1 to the Insolvency Act 1986 (administration);jP has, within 5 years of the date on which either P would be due to start participating in the LPS scheme or (if earlier) commits to participating in the scheme, been removed—ifrom the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners, the Charity Commission, the Charity Commission for Northern Ireland or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity—aafor which the person was responsible or to which the person was privy, orbbwhich the person by their conduct contributed to or facilitated, oriiunder—aasection 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990 (powers of Court of Session to deal with management of charities), orbbsection 34(5)(e) or (ea) of the Charities and Trustee Investment (Scotland) Act 2005 (powers of the Court of Session),from being concerned with the management or control of any body;kP has, within 5 years of the date on which either P would be due to start participating in the LPS scheme or (if earlier) commits to participating in the scheme, been subject to—ia disqualification order or disqualification undertaking under the Company Directors Disqualification Act 1986 or the Company Directors Disqualification (Northern Ireland) Order 2002 , oriian order made under section 429(2) of the Insolvency Act 1986 (disabilities on revocation of a county court administration order); orlP has, in the case of an individual, refused to comply with a request from NHS England for P to be medically examined on the grounds that NHS England is concerned that P is incapable of adequately providing services under the scheme.3A person does not fall within paragraph (2)(b) if NHS England is satisfied that the disqualification or suspension imposed by a licensing or regulatory body outside the United Kingdom does not make P unsuitable to be—aa party to an LPS scheme; orbin the case of an LPS scheme made with a body corporate, a director, chief executive, superintendent or company secretary of a party to an LPS scheme.4A person does not fall within paragraph (2)(f) where NHS England is satisfied that the conviction does not make P unsuitable to be—aa party to an LPS scheme; orbin the case of an LPS scheme with a body corporate, a director, chief executive, superintendent or company secretary of a party to an LPS scheme.1061A person (P) proposing to become a party to an LPS scheme with NHS England must supply to NHS England, with their proposal, the information listed in paragraph (2) about the following relevant persons—aif P is an individual, about P;bif P a partnership, about each partner;cif P is a body corporate, about—ithe body corporate, andiiany director, chief executive, superintendent or company secretary of the body corporate.2That information is whether a relevant person (R)—ahas any criminal convictions in the United Kingdom;bhas accepted a police caution in the United Kingdom;chas been convicted elsewhere than in the United Kingdom of an offence which would, if committed in England or Wales, constitute a criminal offence;dhas been subject to an order under section 246(2) or (3) of the Criminal Procedure (Scotland) Act 1995 (admonition and absolute discharge) discharging R absolutely;ehas accepted a conditional offer under section 302 of the Criminal Procedure (Scotland) Act 1995 (fixed penalty: conditional offer by procurator fiscal);fhas agreed to pay a penalty under section 115A of the Social Security Administration Act 1992 (penalty as alternative to prosecution);gis the subject of any proceedings which might lead to a conviction and which have not yet been notified to NHS England;hhas been subject to any investigation into R's professional conduct by a licensing or regulatory body, the outcome of which was adverse;iis, to R's knowledge, the subject of an investigation into R's professional conduct by a licensing or regulatory body;jis, to R's knowledge, or where the outcome was adverse has been, the subject of an investigation into R's professional conduct in respect of any current or previous employment;kis, to R's knowledge, the subject of an investigation by another primary care organisation, which might lead to removal from a relevant list;lis, to R's knowledge, or where the outcome was adverse has been, the subject of an investigation by the NHS CFA in relation to fraud;mon fitness grounds—ihas had an application for inclusion in a relevant list refused,iihas been conditionally included in a relevant list,iiihas been removed or contingently removed from a relevant list,ivis suspended from a relevant list,and if so, the name of the relevant primary care organisation; ornis or ever has been the subject of a national disqualification,and if so, P must give details of the relevant investigation or proceedings, including the nature of the investigation or proceedings, where and when (if known) they took place, and any outcome.3If information mentioned in paragraph (2) has already been provided to NHS England on a previous occasion pursuant to regulations under Part 7 of the 2006 Act, P need not provide that information again to NHS England, but if P is relying on this paragraph, P must, when supplying their proposal—aconfirm to NHS England that NHS England already has all the information required under paragraph (2); orbif there is any missing information required under that paragraph—iconfirm to NHS England what information NHS England already has, andiiprovide the missing information.4If NHS England determines that P may not become a party to the LPS scheme by virtue of regulation 105, NHS England must notify P of its determination, the reasons for its determination, and of P's right of appeal under paragraph (5).5P may appeal against a determination mentioned in paragraph (4) to the First-Tier Tribunal, provided P does so within 30 days of the date on which P was notified of the determination.107If NHS England decides to select a proposal for an LPS scheme for development, it must give notice of that decision and provide such details of the proposed LPS scheme as it considers appropriate to—athe HWB (HWB1) for the area in which are situated the premises at or from which local pharmaceutical services are to be provided under the proposal;bany Local Pharmaceutical Committee for the area in which are situated the premises at or from which local pharmaceutical services are to be provided under the proposal;cany Local Medical Committee for the area in which are situated the premises at or from which local pharmaceutical services are to be provided under the proposal;dany NHS chemist whose listed chemist premises—iare in the area of HWB1, oriiare in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the proposal;eany person who is entitled because of the grant of a routine or excepted application to be included in a pharmaceutical list—ifor the area of HWB1, oriifor the area of a neighbouring HWB, if their interests are likely, in the opinion of NHS England, to be affected by the proposal,but who is not (yet) included;fany LPS chemist whose scheme premises—iare in the area of HWB1, oriiare in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the proposal;gany dispensing doctor whose listed dispensing premises—iare in the area of HWB1, oriiare in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the proposal; andhany Local Healthwatch organisation for the area of HWB1.1081Before NHS England becomes a party to an LPS scheme with any person, it must determine whether that person is to be given a right of return to a pharmaceutical list if that person makes an application under regulation 28 and satisfies the conditions for a grant of an application under that regulation.2If an LPS scheme is varied so as to—arelocate the provision of local pharmaceutical services under the scheme to different scheme premises; orbchange a party (other than NHS England) to the scheme,NHS England must review any right of return granted under this regulation or regulation 15 of the 2006 Regulations (right of return to pharmaceutical lists) arising under that scheme in order to determine whether or not the right of return is to be varied or rescinded.3If an LPS scheme is varied as mentioned in paragraph (2)(b), the right of return of the person who is no longer a party to the LPS scheme is extinguished (whether or not the right of return is maintained in respect of the new provider under the LPS scheme).4NHS England may review any right of return granted under this regulation or regulation 15 of the 2006 Regulations (right of return to pharmaceutical lists) in order to determine whether or not the right of return is to be varied or rescinded—aat any time an LPS scheme is varied other than in order to give effect to an amendment to these Regulations (in addition to those occasions on which it is required to review a right of return under paragraph (2)); orbif asked to do so by an LPS contractor.5NHS England must publish the principles by reference to which it makes determinations under this regulation and may amend those principles from time to time.6Where NHS England makes, varies or rescinds a determination under this regulation, it must give notice of that decision to—athe HWB (HWB1) for the area in which are situated the scheme premises for the relevant LPS scheme;bany Local Pharmaceutical Committee for the area in which are situated the scheme premises for the relevant LPS scheme;cany Local Medical Committee for the area in which are situated the scheme premises for the relevant LPS scheme;dany NHS chemist whose listed chemist premises—iare in the area of HWB1, oriiare in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the decision;eany person who is entitled because of the grant of a routine or excepted application to be included in a pharmaceutical list—ifor the area of HWB1, oriifor the area of a neighbouring HWB, if their interests are likely, in the opinion of NHS England, to be affected by the decision,but who is not (yet) included;fany LPS chemist whose scheme premises—iare in the area of HWB1, oriiare in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the decision;gany dispensing doctor whose listed dispensing premises—iare in the area of HWB1, oriiare in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the decision; andhany Local Healthwatch organisation for the area of HWB1.1091Where a provider (P) of piloted services under an LPS pilot scheme is or has become a health service body for the purposes of section 9 of the 2006 Act (NHS contracts), subject to paragraph (2), any variation of the LPS pilot scheme which changes a party to the scheme does not affect the health service body status of the provider of piloted services under that scheme.2If P is a health service body for the purposes of an LPS pilot scheme, P may at any time request a variation by NHS England of the scheme so as to provide that the scheme is to cease to be an NHS contract, and if P does—aNHS England must agree to the variation; andbsubject to paragraph (4), P is to cease to be a health service body for the purposes of section 9 of the 2006 Act from the date on which the variation takes effect.3Subject to paragraph (4), a person who has been both the provider of piloted services under an LPS pilot scheme and a health service body for the purposes of that scheme is to cease to be a health service body for the purposes of that scheme where the scheme—ais varied so that person is no longer the provider of piloted services under that scheme; orbis terminated.4Where a person ceases to be a health service body for the purposes of an LPS pilot scheme agreement pursuant to—aparagraph (2)(b), where P or NHS England—ihas referred any matter to the NHS dispute resolution procedure before P ceases to be a health service body, oriirefers any matter to the NHS dispute resolution procedure, in accordance with the terms of the scheme, after it ceases to be a health service body,P is to continue to be regarded as a health service body (and accordingly the scheme is to continue to be regarded as an NHS contract) for the purposes of the consideration and determination of the dispute;bparagraph (3)(b), P is to continue to be a health service body for the purposes of the resolution of any dispute that falls to be resolved in accordance with the terms of the terminated scheme notwithstanding its termination.5Piloted services and pharmaceutical services must not be provided at or from the same premises.110On the date (D1) on which an LPS pilot scheme terminates because of a term of that scheme provided for in directions under section 138 of, or paragraph 7(1) of Schedule 11 to, the 2006 Act (which relate to terms of LPS pilot schemes) which requires that the scheme is to terminate—afor a reason that relates to the fitness of P to be a provider of piloted services, P does not have a right of return to a pharmaceutical list; orbeither—ibecause listed chemist premises, other than distance selling premises, of an NHS pharmacist have opened less than a kilometre by the nearest practical route available to the public on foot from the premises specified in the LPS pilot scheme,iifor a reason relating to the requisite amount of items dispensed at those premises during a financial year,iiibecause NHS England (or before it the Primary Care Trust that was party to the scheme) or P has given the other party to the scheme a period of notice of not less than 6 months of their intention to terminate the scheme, orivbecause all LPS pilot schemes terminate on that date,NHS England must include those premises, and if P is not already so included P, in the pharmaceutical list for the area of the HWB in which the premises are situated with effect from D1.1111Nothing in these Regulations prevents NHS England from making a temporary amendment to an LPS scheme or an LPS pilot scheme which NHS England is satisfied is necessary or expedient because of an emergency requiring the flexible provision of pharmaceutical services.2In the circumstances described in paragraph (1), NHS England may make a temporary variation to an LPS scheme or an LPS pilot scheme, but—aonly for a specified period (which must be no longer than the specified period of the emergency given by the Secretary of State), which NHS England may extend or curtail in appropriate circumstances; andbthe provider under the scheme may revert to their overridden arrangements before the end of the period specified by NHS England, on giving NHS England at least 24 hours notice.3There is no right of appeal under these Regulations in respect of a decision to make or not to make, or to extend or curtail the duration of, a temporary amendment under this regulation.112Where NHS England has concerns about the fitness of an LPS chemist, or a pharmacist or pharmacy technician employed by an LPS chemist, to provide local pharmaceutical services, it must where appropriate pass on those concerns and any relevant supporting evidence to the General Pharmaceutical Council.1131The Secretary of State directs the First-tier Tribunal to exercise the functions of the Secretary of State under the terms of an LPS scheme which—agive effect to paragraphs 21, 22 and 29 of Schedule 7; andbrelate to the determination of appeals to the Secretary of State, but only in so far as those functions require a determination by the Secretary of State—ias to whether a person falls within paragraph 29(2) of Schedule 7 during the existence of the scheme, oriiin respect of a decision by NHS England under paragraph 29(3) or (4) of Schedule 7.2The Secretary of State directs the First-tier Tribunal to exercise the functions of the Secretary of State under the terms of an LPS pilot scheme that relate to the determination of appeals to the Secretary of State, but only in so far as those functions require a determination by the Secretary of State in respect of the fitness of a provider of piloted services to be a provider of piloted services.1141In respect of the area of each HWB, NHS England must prepare, maintain and publish a list of the LPS chemists (if there are any) who provide local pharmaceutical services at or from premises situated in that area.2The lists must include—athe addresses of the premises at or from which the local pharmaceutical services are provided;bthe days on which and times at which, at or from those premises, the LPS chemist is to provide those services;ca description of the services the LPS chemist is to provide.3NHS England must ensure that each HWB has access to the lists of LPS chemists that it holds which is sufficient to enable the HWB to carry out its functions under these Regulations.PART 14115Where, in accordance with the provisions of these Regulations, or the 2012 Regulations or the 2005 Regulations as they continue to have effect by virtue of Schedule 9, or the 2006 Act, NHS England—aremoves a person from a pharmaceutical list, dispensing doctor list or list of LPS chemists; orbremoves the listing of premises in relation to a person on a pharmaceutical list or dispensing doctor list,it must notify the person of the change to its list that has taken place.116An application to an NHS chemist for pharmaceutical services, or an application to an LPS chemist for local pharmaceutical services, may be made (other than by the chemist concerned)—aon behalf of a child by either parent, or in the absence of both parents, the guardian or other person who has care of the child;bon behalf of any person, other than a child under the age of 18 years of age who is—iin the care of an authority to whose care that person has been committed under the Children Act 1989 , by a person duly authorised by that authority, oriiin the care of a voluntary organisation, by that organisation or a person duly authorised by them;con behalf of any adult who is incapable of making such an application or authorising such an application to be made on their behalf, by a relative or the primary carer (who may be an adult or an organisation) of that person; ordon behalf of any other person by a duly authorised person.1171The NHS Litigation Authority must exercise the following functions of the Secretary of State—athe functions relating to receiving and determining any appeal in relation to which Schedule 3 has effect, including all of the functions of the Secretary of State under that Schedule (which include determining whether certain persons have rights of appeal);bthe functions relating to being contacted about, and providing, information under—iregulation 33(2),iiregulation 86(2), andiiiparagraph 23(1)(b) of Schedule 2;cthe function of providing consent under regulation 76(1);dthe function of receiving notifications under regulation 88(2)(a);ethe functions relating to receiving and determining an appeal under—iparagraph 25(7) to (9) of Schedule 4,iiparagraph 26(9) to (11) of Schedule 4,iiiparagraph 15(7) to (9) of Schedule 5, andivparagraph 16(9) to (11) of Schedule 5;fsubject to paragraph (2), the functions under the terms of LPS schemes that give effect to the following provisions—iparagraph 21 of Schedule 7,iiparagraph 22 of Schedule 7, andiiiparagraph 23 of Schedule 7;gthe functions under the terms of LPS pilot schemes which relate to receiving and determining appeals by providers of piloted services with regard to the determination of premises opening hours;hsubject to paragraph (2), the functions under the terms of LPS pilot schemes which relate to dispute resolution; andithe functions relating to—ireceiving and determining any appeal which, by virtue of Schedule 9, the Secretary of State is required to determine, andiidispute resolution which, by virtue of Schedule 9, the Secretary of State is required to perform,under the 2005 Regulations, the 2012 Regulations or the terms of an LPS scheme, including the incidental functions of the Secretary of State relating to such appeals or dispute resolution (for example, determining whether certain persons have rights of appeal and applying the continuity principles as appropriate).2The NHS Litigation Authority must not, pursuant to paragraph (1)(f) or (h), exercise the Secretary of State's functions that the First-tier Tribunal is required to exercise by virtue of regulation 113.3The NHS Litigation Authority is to exercise the powers of the Secretary of State under section 2 of the 2006 Act (Secretary of State's general power) to do anything that is calculated to facilitate, or is conducive or incidental to, the discharge of any function of the Secretary of State that the NHS Litigation Authority is exercising by virtue of paragraph (1), but only to the extent that it is necessary for the proper exercise of that function.118Where, during an emergency requiring the flexible provision of pharmaceutical services, or a period specified under regulation 29(3), 61(6) or 111(2), arrangements for the provision of pharmaceutical services or local pharmaceutical services are overridden by temporary arrangements—aany proceedings with regard to the overridden arrangements are unaffected by that overriding (although they may need to be stayed during the emergency or the specified period for other reasons); andbif as a result of those proceedings the overridden arrangements require amendment before the end of the temporary arrangements, when the emergency or the specified period ends, the reversion to overridden arrangements is to be to the original overridden arrangements as amended as a result of those proceedings.119The transitional provisions set out in Schedule 9 have effect.119A1This paragraph applies where—apursuant to paragraph 5A(4)(a) of Schedule 4, paragraph 4A(4)(a) of Schedule 5, paragraph 3A(2)(a) of Schedule 6 or paragraph 3A(4)(a) of Schedule 7, an NHS chemist, an LPS chemist or a dispensing doctor is required to endorse a prescription or an associated batch issue; andbthe Secretary of State (or the NHS BSA acting on the Secretary of State’s behalf) is only able, or is also able, to process a claim for pharmaceutical reimbursement in respect of the product being provided if the claim is made using a separate token (“a dispensing token”), which is in a form approved by the Secretary of State for the purposes of making such claims (and for prescription charge purposes).2Where paragraph (1) applies—ato the extent required or permitted by the Drug Tariff, a dispensing token recording the provision of the product is treated as being, as regards that product, the prescription for product reimbursement purposes;bif the manner for recording the provision of the product in the dispensing token is provided for in the Drug Tariff, the recording of the provision of the product in the dispensing token must be in the manner provided for in the Drug Tariff; andcthe manner of the endorsement of the original prescription or associated batch issue (where provided for in the Drug Tariff) may vary, depending on whether or not it is to be used for product reimbursement purposes.3Where, by virtue of paragraph (2)(a), a dispensing token is treated as being the prescription for product reimbursement purposes—aparagraph 7(6) of Schedule 4 applies as if the reference to paragraph 5A(4)(a) of that Schedule included a reference, in the alternative, to paragraph (2)(a);bparagraph 6(3B) of Schedule 5 applies as if the reference to paragraph 4A(4)(a) of that Schedule included a reference, in the alternative, to paragraph (2)(a);cparagraph 4B of Schedule 6 applies as if the reference to paragraph 3A(2)(b) of that Schedule included a reference, in the alternative, to paragraph (2)(a); anddparagraph 5(6) of Schedule 7 applies as if the reference to paragraph 3A(4)(a) of that Schedule included a reference, in the alternative, to paragraph (2)(a).4For the purposes of this regulation, “pharmaceutical reimbursement” has the meaning given in paragraph 19(3) of Schedule 7.120The amendments to and revocations of enactments set out in Schedule 10 have effect.1211The Secretary of State must, in accordance with paragraphs (2) to (4)—acarry out reviews of these Regulations;bset out the conclusions of each review in a report; andcpublish each report.2Each report must in particular—aset out the objectives intended to be achieved by these Regulations;bassess the extent to which those objectives have been achieved;cassess whether those objectives remain appropriate; anddif those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision.3The first report under this regulation must be published before the end of 31st March 2018.4Each subsequent report must be published before the end of the period of five years beginning on the day on which the previous report was published.Signed by authority of the Secretary of State for Health.Earl Howe Parliamentary Under-Secretary of State,

Department of Health

SCHEDULE 1 Regulation 4(1)1A statement of the pharmaceutical services that the HWB has identified as services that are provided—ain the area of the HWB and which are necessary to meet the need for pharmaceutical services in its area; andboutside the area of the HWB but which nevertheless contribute towards meeting the need for pharmaceutical services in its area (if the HWB has identified such services).2A statement of the pharmaceutical services that the HWB has identified (if it has) as services that are not provided in the area of the HWB but which the HWB is satisfied—aneed to be provided (whether or not they are located in the area of the HWB) in order to meet a current need for pharmaceutical services, or pharmaceutical services of a specified type, in its area;bwill, in specified future circumstances, need to be provided (whether or not they are located in the area of the HWB) in order to meet a future need for pharmaceutical services, or pharmaceutical services of a specified type, in its area.3A statement of the pharmaceutical services that the HWB has identified (if it has) as services that are provided—ain the area of the HWB and which, although they are not necessary to meet the need for pharmaceutical services in its area, nevertheless have secured improvements, or better access, to pharmaceutical services in its area;boutside the area of the HWB and which, although they do not contribute towards meeting the need for pharmaceutical services in its area, nevertheless have secured improvements, or better access, to pharmaceutical services in its area;cin or outside the area of the HWB and, whilst not being services of the types described in sub-paragraph (a) or (b), or paragraph 1, they nevertheless affect the assessment by the HWB of the need for pharmaceutical services in its area.4A statement of the pharmaceutical services that the HWB has identified (if it has) as services that are not provided in the area of the HWB but which the HWB is satisfied—awould, if they were provided (whether or not they were located in the area of the HWB), secure improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in its area,bwould, if in specified future circumstances they were provided (whether or not they were located in the area of the HWB), secure future improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in its area.5A statement of any NHS services provided or arranged by a local authority, NHS England, an integrated care board, an NHS trust or an NHS foundation trust to which the HWB has had regard in its assessment, which affect—athe need for pharmaceutical services, or pharmaceutical services of a specified type, in its area; orbwhether 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.6An explanation of how the assessment has been carried out, and in particular—ahow it has determined what are the localities in its area;bhow it has taken into account (where applicable)—ithe different needs of different localities in its area, andiithe different needs of people in its area who share a protected characteristic; andca report on the consultation that it has undertaken.7A map that identifies the premises at or from which pharmaceutical services are provided in the area of the HWB.SCHEDULE 2 Regulation 10(7)PART 111The information mentioned below in this paragraph must be included in all routine and excepted applications.2The name of the relevant HWB.3The type of application being made (for example, the application is for inclusion in a pharmaceutical list and a change of ownership application), including a statement of whether the application is a routine or an excepted application.4The name and address of the applicant (A).5If A is an individual or a partnership carrying on a retail pharmacy business, A or each partner's registration number in the GPhC register.6If A is a body corporate carrying on a retail pharmacy business, the name and registration number in the GPhC register of A's superintendent.7If A is seeking the listing of premises not already listed in relation to A (whether or not A is already listed)—aeither—ithe address of the premises, oriiif the address is not known and it is a routine application, A's best estimate of where the proposed premises will be;bwhether the applicant is currently in possession of the premises;cthe proposed core opening hours in respect of the premises; anddthe total proposed opening hours for the premises (having regard to both the proposed core opening hours and any supplementary opening hours).8If A is seeking to provide directed services—adetails of the directed services to be provided;bconfirmation that A is accredited to provide the services, where that accreditation is a prerequisite for the provision of those services;cconfirmation that the premises are accredited in respect of the provision of the services, where that accreditation is a prerequisite for the provision of those services; andda floor plan showing the consultation area where A proposes to offer directed services (where relevant, unless one cannot be provided for reasons that are good cause).9A is not entitled to ask for a routine application to be considered, in the alternative, as an excepted application, or for an excepted application to be considered, in the alternative, as a routine application.10An estimate of the location of premises is only a “best estimate” for the purposes of sub-paragraph (7)(a)(ii) if NHS England is satisfied that—ait is the best estimate that A can reasonably make at the time of the application of the location of the premises; andbits reasons for granting or refusing the application would be essentially the same if the applicant located, if the application was granted, at any location within the range of possible locations covered by the estimate.21The information mentioned below in this paragraph must be included in all routine and excepted applications for inclusion in a pharmaceutical list.2If the applicant (A) is an individual or a partnership—aA's or each partner's full name;bA's or each partner's sex;cA's or each partner's date of birth;dA's or each partner's private address and telephone number;ea declaration that A or each partner is a registered pharmacist, if A is seeking entry in the list mentioned in regulation 10(2)(a);fif A is a partnership, a declaration that A is, or is entitled to be, lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act (general provisions), if A is seeking entry in the list mentioned in regulation 10(2)(a); andgif A is already included in Part 3 of the GPhC register in respect of any premises, A's registration number in that Part of the GPhC register, if A is seeking entry in the list mentioned in regulation 10(2)(a).3If A is a body corporate—aA's registered name and any other name under which A trades;bA's company registration number;cA's registered office and any fixed line telephone number relating to that office;dthe private address and date of birth of A's superintendent (if A is seeking entry in the list mentioned in regulation 10(2)(a));ethe name and date of birth of each director of A (who is not A's superintendent), and if any director of A (who is not A's superintendent) is a registered pharmacist, that director's registration number in the GPhC register;fa declaration that A is, or is entitled to be, lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act, if A is seeking entry in the list mentioned in regulation 10(2)(a); andgif A is already included in Part 3 of the GPhC register in respect of any premises, A's registration number in that Part of the GPhC register, if A is seeking entry in the list mentioned in regulation 10(2)(a).4If the services that A undertakes to provide consists of or includes the supply of appliances, the appliances A undertakes to supply.31Subject to paragraph 5, the information mentioned below in this paragraph must be included in all routine and excepted applications for inclusion in a pharmaceutical list, as regards any person (P) who is—athe individual who is making the application;ba partner in the partnership that is making the application; orca director or (if A is seeking entry in the list mentioned in regulation 10(2)(a)) superintendent of the body corporate that is making the application.2Details of whether P—ahas been convicted of any criminal offence in the United Kingdom;bhas been bound over following a criminal conviction in the United Kingdom;chas accepted a police caution in the United Kingdom;dhas, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging P absolutely (without proceeding to conviction); orehas accepted and agreed to pay either a procurator fiscal fine under section 302 of the Criminal Procedure (Scotland) Act 1995 (fixed penalty: conditional offer by procurator fiscal) or a penalty under section 115A of the Social Security Administration Act 1992 (penalty as alternative to prosecution).3Details of whether P has at any time been convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England (at the time of the application), could lead to a criminal conviction in England.4Details of any criminal proceedings to which P is currently subject—ain the United Kingdom; orbelsewhere than the United Kingdom if the originating events, if they took place in England, could lead to a criminal conviction in England.5If P is, to P's knowledge, or has been subject to any investigation into, or proceedings relating to, P's fitness to practise by a licensing body—aif the investigation or proceedings have not yet reached their final outcome, details of that investigation or proceedings; orbif the investigation or proceedings have reached a final outcome that was adverse, details of the final outcome of that investigation or proceedings.6If P is, to P's knowledge, or has been subject to any investigation into, or proceedings relating to, P's professional conduct by an employer—aif the investigation or proceedings have not yet reached their final outcome, details of that investigation or proceedings; orbif the investigation or proceedings have reached a final outcome that was adverse, details of the final outcome of that investigation or proceedings.7If P is a pharmacist, details of P's—apharmaceutical qualifications (including where obtained); andbpersonal work history for the previous 7 years from the date on which the application is submitted, together with a declaration by P (where it can be made, in the case of sub-paragraphs (ii) and (iii)) that—ithe details provided are a complete and accurate account of that personal work history,iiP has not been dismissed in that time, and if P cannot make this declaration, the reasons for being unable to do so must be covered in P’s personal work history,iiiP has not had a break of more than 6 months from work in that time, and if P cannot make this declaration, the reasons for being unable to do so must be covered in P’s personal work history, andivif P is an NHS chemist, or is a partner in or a director or superintendent of a NHS chemist, P or the NHS chemist in which P is a partner or of which P is a director or superintendent, has complied with the requirements of paragraph 31 of Schedule 4 and paragraph 21 of Schedule 5 that are applicable to P.8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9If P is, to P's knowledge, or has been subject to any investigation or proceedings that could lead or could have led to P's removal from a relevant list for a reason relating to unsuitability, fraud or efficiency of service provision, details of that investigation or those proceedings, and of any final outcome to that investigation or those proceedings.10If P is, to P's knowledge, or has been where the outcome was adverse, the subject of any investigation by the NHS CFA (or any body that preceded it which had, or outside England which has, primary responsibility for investigating fraud in the health service) in relation to fraud.11If P has been refused inclusion in, or conditionally included in, or contingently removed or suspended from, any relevant list for a reason relating to unsuitability, fraud or efficiency of service provision, details of same.12If P is in the process of applying to be included in another relevant list and proceedings relating to the application have not yet reached their final outcome (including where an application has been deferred), details of that application and the reasons for—aany deferment of that application; orbrefusal or conditional inclusion where the refusal or conditional inclusion has not yet reached its final outcome.13If P—ais the person making the application; andbqualified as a pharmacist in Switzerland or an EEA State other than the United Kingdom,details that demonstrate that P has the level of knowledge of English which, in the interests of P 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.41Subject to paragraph 5, the information mentioned below in this paragraph must be included in all routine and excepted applications for inclusion in a pharmaceutical list by a body corporate (C1)—aas regards C1; orbas regards any other body corporate (C2) of which a director or superintendent of C1—iis a director or superintendent or has been a director or superintendent in the 6 months prior to the date of the application, oriihas been a director or superintendent for more than 6 months prior to the date of the application, where they were a director or superintendent of C2 at the time of the originating events to which the information relates.2Details of any convictions that C1 or C2 has for offences committed in the United Kingdom that are not spent convictions.3Details of whether C1 or C2 (being corporate bodies registered within the United Kingdom) has at any time been convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England (at the time of the application), could lead to a criminal conviction in England.4Details of any criminal proceedings to which C1 or C2 is currently subject—ain the United Kingdom; orbelsewhere than in the United Kingdom if the originating events, if they took place in England, could lead to a criminal conviction in England.5Details of any investigation to which C1 or C2—ais, to its knowledge, subject by the General Pharmaceutical Council in relation to an entry in Part 3 of the GPhC register; orbhas been subject by the General Pharmaceutical Council, the Royal Pharmaceutical Society of Great Britain or the Pharmaceutical Society of Northern Ireland in relation to an entry in the register required to be kept under section 75 of the 1968 Act (registration of premises), the outcome of which was adverse.6If C1 or C2, to its knowledge, is or has been subject to any investigation or proceedings that could lead or could have led to its removal from a relevant list, details of that investigation or those proceedings, and of any final outcome to that investigation or those proceedings.7If C1 or C2 is, to its knowledge, or has been where the outcome was adverse, the subject of any investigation by the NHS CFA (or any body that preceded it which had, or outside England which has, primary responsibility for investigating fraud in the health service) in relation to fraud.8If C1 or C2 has been refused inclusion in, or conditionally included in (other than by reason of a condition imposed under Part 9), a relevant list, details of that refusal or conditional inclusion.9If C1 or C2 is in the process of applying to be included in another relevant list and proceedings relating to the application have not yet reached their final outcome (including where an application has been deferred), details of that application and the reasons for—aany deferment of that application; orbany refusal or conditional inclusion, where the refusal or conditional inclusion has not yet reached its final outcome.10Details of any case in which an application by C1 or C2 has lapsed by virtue of regulation 35(8).51If information mentioned in paragraph 3 or 4 has already been provided to NHS England (or a home Primary Care Trust) on a previous occasion pursuant to regulations under Part 7 of the 2006 Act, an applicant need not provide that information again to NHS England in relation to the current application.2An applicant relying on paragraph (1) must, when making its application—aconfirm to NHS England that NHS England already has all the information required under paragraphs 3 and 4; orbif there is any missing information required under those paragraphs—iconfirm to NHS England what information NHS England already has, andiiprovide the missing information.3Unless sub-paragraph (4) applies, information is only to be considered missing for the purposes of sub-paragraph (2)(b) if, having regard to the fact that the fitness of the applicant to be included in a pharmaceutical list has already been established (or if the applicant’s fitness is under investigation, that investigation is being taken forward separately), it is nevertheless material to the consideration of the application.4Information is to be considered missing for the purposes of sub-paragraph (2)(b) if it has previously been provided to NHS England or a Primary Care Trust by the applicant, but more than 7 years prior to the date of the application.5If a declaration that is required to be included in an application has never previously been provided to NHS England or has previously been provided but it is no longer up to date—aan up to date declaration, together with any information that the applicant needs to provide in support of that declaration; orbany information that needs to be provided because the applicant is unable to make that declaration,is to be considered as missing information for the purposes of sub-paragraph (2)(b).5A1Where, in the case of a body corporate making an application for inclusion in a pharmaceutical list, there is a change to the superintendent of the body corporate before the applicant is included in a pharmaceutical list or the application cannot be further proceeded with, the applicant must update the application as soon as is reasonably practicable with—athe details about that superintendent that the applicant would have been required to submit under paragraph 3; andbthe details about any other body corporate that the applicant would have been required to submit under paragraph 4 because of that superintendent being that other body corporate’s superintendent,had the superintendent been in post at the time the application was submitted.2If—athe application has been determined by NHS England but—ithere are proceedings relating to the application that have not yet reached their final outcome, oriiin the case of an application that has been granted, there are no such proceedings but the applicant has not yet been included in a pharmaceutical list; andbNHS England is satisfied, on the basis of the information provided or required to be provided under sub-paragraph (1), that there are grounds for refusing the application under regulation 33 or imposing a condition under regulation 35,NHS England may redetermine the application, but only for the purpose of refusing it under regulation 33 or imposing a condition under regulation 35 (so there may still be a purpose to any proceedings that have not yet reached their final outcome).6If, as regards a routine or excepted application—a. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .b. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .the premises which the applicant (A) is seeking to be listed in relation to A are already listed chemist premises or are adjacent to or in close proximity to such premises, A must include with the application details that explain why A believes the application should not be refused pursuant to regulation 31.71If an applicant (A) is making a routine application and is seeking to satisfy NHS England that granting that application would meet a need for pharmaceutical services, or secure improvements to or better access to pharmaceutical services, in circumstances where—athat need, those improvements or that better access has or have been identified in the pharmaceutical needs assessment of the relevant HWB (or Primary Care Trust), A must include in that application details that explain how A intends to meet that need, or secure those improvements or that better access (in whole or in part); orbthat need, those improvements or that better access has or have not been identified in the pharmaceutical needs assessment of the relevant HWB (or Primary Care Trust), A must include in that application, details that explain A's belief that regulation 18(1)(b) is satisfied in relation to that application.2Where an applicant includes information in an application pursuant to paragraph (a) but not paragraph (b) of sub-paragraph (1), NHS England must not consider whether regulation 18(1)(b) applies in relation to that application when it determines that application.8If the applicant (A) is making an excepted application, A must include in that application details that explain—aA's belief that the application satisfies the criteria included in one of the regulations in Part 4 which need to be satisfied if section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) are not to apply in relation to that application; andbif the regulation includes reasons for which the application must be refused, why the application should not be refused for those reasons.91An applicant (A) must provide the following undertakings—aan undertaking to notify NHS England within 7 days of any material changes to the information provided in the application that occur before—ithe application is withdrawn,iiwhile the application remains the subject of proceedings, the proceedings relating to the application reach their final outcome and any appeal through the courts has been disposed of, oriiiif the application is granted, A commences the provision of the services to which the application relates,whichever is the latest of these events to take place;ban undertaking to notify NHS England if A is included, or applies to be included, in any other relevant list of another primary care organisation before—ithe application is withdrawn,iiwhile the application remains the subject of proceedings, the proceedings relating to the application reach their final outcome and any appeal through the courts has been disposed of, oriiiif the application is granted, A commences the provision of the services to which the application relates,whichever is the latest of these events to take place;cif A is seeking inclusion in a pharmaceutical list or (if A is already listed in that list) the listing of premises in relation to A that are not already listed in relation to A, an undertaking—ito comply with all the obligations that are to be their terms of service under regulation 11 if the application is granted, andiiin particular, in relation to any proposed pharmacy premises, to provide all the services and perform all the activities at or from those premises that are required under the terms of service to be provided or performed as or in connection with essential services; anddif A is seeking to provide directed services an undertaking—ithat A will provide the directed services mentioned in the application, if NHS England does commission the services at or from A within 3 years of the date of either the grant of the application or, if later, the listing in relation to the applicant of the premises to which the application relates,iiif the services are commissioned by NHS England, that A will provide the services in accordance with an agreed service specification, andiiiA's agreement to a service specification will not be unreasonably withheld.2In relation to a consolidation application, if NHS England intends to commission from the applicant enhanced services provided at or from the closing premises, and notifies the applicant of that intention, the applicant is required to provide the undertaking referred to in sub-paragraph (1)(d) in relation to those services, whether or not the applicant is on notice of that intention at the time the applicant makes the consolidation application.10Where, pursuant to this Part, a person is required to provide details, that obligation is only discharged if the information or documentation provided is sufficient to satisfy NHS England, with good cause, that no relevant information or documentation is missing, having regard to the uses that NHS England may need to make of the information or documentation when carrying out its functions.PART 2111As regards any routine or excepted application, if NHS England considers that relevant information or documentation is missing—ait may request the missing relevant information or documentation from the applicant; andbthe applicant must, within the period reasonably specified by NHS England in the request under paragraph (a)—iprovide any information or documentation reasonably requested,iinotify NHS England that there is to be a delay in providing the requested information or documentation, for specified reasons, and specify a date by which the applicant undertakes to provide the information or documentation, oriiiif the applicant considers that any information or documentation has been unreasonably requested, notify NHS England of that and seek a review by NHS England of the reasonableness of the request.2If an applicant refuses to comply with a request under sub-paragraph (1)(a)—awithin the period—ireasonably specified by NHS England under paragraph (1)(b), oriiending on the date specified by the applicant in accordance with paragraph (1)(b)(ii), if NHS England is satisfied that a delay beyond the period it specified, and the length of the delay, are for good cause,unless paragraph (b) applies, the application is to be treated as withdrawn;bin circumstances where the applicant has, in accordance with sub-paragraph (1)(b)(iii), sought a review by NHS England of the reasonableness of the request, if the review determines that any or all of the information or documentation requested—imust after all, be provided, the application is to be treated as withdrawn unless the information or documentation that must still be provided is provided within a new period reasonably specified by NHS England for the provision of that information or documentation,iineed not be provided by the applicant, the request of NHS England is to be treated as withdrawn to the extent that it relates to information or documentation that need not be provided.3NHS England may request information or documentation under this paragraph at any time after it receives an application and before its determination of that application, but it must consider whether or not it needs to request information or documentation under this paragraph prior to notifying an application (where it is required to do so) under Part 3.121If, when an applicant (A) submits an application, A fails to provide with the application—athe undertakings referred to in paragraph 9 that are relevant to the application, NHS England must, if the application is notifiable prior to notifying the application under Part 3, request that A provide the relevant undertakings within a specified period; orbany fee payable in respect of that application by virtue of directions under section 131 of the 2006 Act (power to charge), NHS England must, if the application is notifiable prior to notifying the application under Part 3, request that A provide the fee (or any missing part of the fee) within a specified period.2If A fails to comply with a request under sub-paragraph (1) within a period reasonably specified by NHS England under that sub-paragraph, the application is to be treated as withdrawn.13Where an applicant (A) is relying on paragraph 5(1), NHS England must ensure that the information that it holds about A is aggregated in such a way that it is able to make a reasonable determination as to whether the application should be refused or deferred under regulation 33 or 34.141NHS England, having received—aa routine application, consideration of which may or must be deferred under regulation 14(1) to (3), 16(1) to (4), 19(1) to (4), 21(1) to (4) or 38(4); orba notifiable application, consideration of which may be deferred under regulation 32 or 34,must consider, prior to notifying that application under Part 3 and as soon as is practicable, whether or not to defer consideration of that application under those provisions.2If consideration of the application is deferred prior to notification, once NHS England no longer has grounds for deferring the application, it must proceed as soon as is practicable with the notification of the application, unless the application has been withdrawn or NHS England is required to treat it as withdrawn.15NHS England, having received a notifiable application for inclusion in a pharmaceutical list from a person who is not already included in that list, may without notifying that application under Part 3 (or if no notification is required, as soon as is practicable) decide to refuse that application under regulation 30.16NHS England, having received a notifiable application for inclusion in a pharmaceutical list from a person who is not already included in that list, may without notifying that application under Part 3 decide to refuse that application under regulation 33(1).17NHS England, having received a routine application where the applicant is seeking the listing of pharmacy premises, must consider, prior to notifying that application under Part 3 and as soon as is practicable, whether or not the application needs to be refused under regulation 40(2).PART 318An application is a “notifiable application” for the purposes of this Schedule if—ait is a routine application; orbit is an excepted application pursuant to regulation 24, 25, 26(2) or 26A,and NHS England has not decided to dispense with the notification pursuant to paragraphs 15 to 17.191As soon as is practicable (having regard to its functions under Part 2), NHS England must give notice of a notifiable application to—aany Local Pharmaceutical Committee—iwhose area includes the premises or location to which the application relates, oriiany part of whose area is within 2 kilometres of the premises or location to which the application relates;bany Local Medical Committee—iwhose area includes the premises or location to which the application relates, oriiany part of whose area is within 2 kilometres of the premises or location to which the application relates;cany person—iincluded in a pharmaceutical list for the area of the relevant HWB, oriiwho is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,whose interests might, in the opinion of NHS England, be significantly affected if the application were granted;dany LPS chemist—iwith whom NHS England has made arrangements for the provision of any local pharmaceutical services in the area of the relevant HWB, andiiwhose interests might, in the opinion of NHS England, be significantly affected if the application were granted;eany Local Healthwatch organisation for the area of the relevant HWB, and any other patient, consumer or community group in that area which, in the opinion of NHS England, has a significant interest in the outcome of the application;fif the applicant is seeking to locate premises in, or within 1.6 kilometres of, a controlled locality in the area of the relevant HWB—iany provider of primary medical services, oriiany other person on the dispensing doctors list for the area of the relevant HWB if there is one (being a performer but not a provider of primary medical services),who, in the opinion of NHS England, has a significant interest in the outcome of the application;gany Local Health Board any part of whose area is within 2 kilometres of the premises or location to which the application relates; andhthe relevant HWB and any other HWB any part of whose area is within 2 kilometres of the premises or location to which the application relates.2NHS England may also give notice of the notifiable application to any other person who, in the opinion of NHS England, has a significant interest in the outcome of the application.3If any part (PA) of the area of a notified HWB (HWB2) other than the relevant HWB is within 2 kilometres of the premises or location to which the application relates, NHS England must also give notice of the application to—aany Local Pharmaceutical Committee—iwhose area includes PA, andiithat is not given notice of the application under paragraph (1)(a);bany Local Medical Committee—iwhose area includes PA, andiithat is not given notice of the application under paragraph (1)(b);cany person—iincluded in a pharmaceutical list for the area of HWB2, oriiwho is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,whose interests might, in the opinion of NHS England, be significantly affected if the application were granted;dany LPS chemist—iwith whom NHS England has made arrangements for the provision of any local pharmaceutical services in the area of HWB2, andiiwhose interests might, in the opinion of NHS England, be significantly affected if the application were granted;eany Local Healthwatch organisation for the area of HWB2, and any other patient, consumer or community group in that area which, in the opinion of NHS England, has a significant interest in the outcome of the application; andfif the applicant is seeking to locate premises within 1.6 kilometres of a controlled locality in the area of HWB2—iany provider of primary medical services, oriiany other person on the dispensing doctors list for the area of HWB2 if there is one (being a performer but not a provider of primary medical services),who, in the opinion of NHS England, has a significant interest in the outcome of the application.4Those notified under sub-paragraphs (1) to (3) may make representations in writing about the application that is the subject of the notification to NHS England, provided they do so within 45 days of the date on which notice of the application was given to them , or within 30 days in the case of applications pursuant to regulation 26A.5A relevant HWB that is notified under sub-paragraph (1)(h) in relation to a consolidation application must make representations in writing about the application under sub-paragraph (4) which (in addition to any other matter about which they may wish to make representations) indicate whether, if the application were granted, in the opinion of the relevant HWB the proposed removal of premises from its pharmaceutical list would or would not create a gap in pharmaceutical services provision that could be met by a routine application—ato meet a current or future need for pharmaceutical services; orbto secure improvements, or better access, to pharmaceutical services.201If NHS England is considering, as a consequence of a notifiable application, making (including revising) a determination as to whether or not an area is or is not to be part of a controlled locality, it must give notice under this Part at the same time that it gives notice under regulation 38(1).2If, as a consequence of a notifiable application, NHS England is required, by virtue of regulation 41 to determine whether or not an area is a reserved location, NHS England must consider giving notice under this Part at the same time that it gives notice under regulation 41(4).211A person notified under paragraph 19 (P)—amust be informed—iof P's right to make representations under paragraph 19(4);iiof the circumstances in which notified persons would be permitted, pursuant to paragraph 25, to make oral representations at any oral hearing relating to the application, andiiiif NHS England intends to consider the application together and in relation to any other application, of that intention;bneed not be given the same information as other persons notified under paragraph 19 but, subject to sub-paragraphs (2) to (4), P must be provided with sufficient information, from the information supplied by the applicant, to enable P to make informed representations with regard to whether or not the application should be granted, having regard to P's interest in the matter.2P need not be provided with any information that is published as part of the relevant pharmaceutical needs assessment.3P must not be provided with—ainformation supplied by the applicant (A) under paragraphs 2 to 4, or which A is exempt from supplying by virtue of paragraph 5; andbany private addresses, private telephone numbers or dates of birth supplied by A.4If A advises NHS England that—ainformation supplied by A is considered by A to be confidential to A; andbA does not consent to the information being disclosed as part of the notification,NHS England must withhold that information from P if it considers that the full disclosure principle does not require it to provide that information to P.5The “full disclosure principle” is that information that is relevant to the determination of an application should be available to any individual who has a significant interest in the outcome of the application, unless it is fair and proper for that information to be withheld from that individual.6If information is being withheld from P under paragraph (4), P must be informed of the nature of the information that is being withheld from P.PART 4221Except in so far as these Regulations provide to the contrary, NHS England is to determine or defer routine and excepted applications in such manner (including with regard to procedures) as it sees fit.2NHS England may determine a routine or excepted application without hearing any oral representations, if it considers that oral representations are unnecessary.3Where appropriate, NHS England may if it thinks fit consider 2 or more applications together and in relation to each other, but where it does so, it must give notice to the applicants of its intention to do so (if it has not already done so under Part 3).231In the case of a routine or excepted application by a person (A) for inclusion in a pharmaceutical list who is not already included in it, NHS England must, prior to determining the application—acheck with the NHS CFA whether A, and if A is a body corporate whether any director or superintendent of A, has any record of, or is under investigation for, fraud;bcheck with the Secretary of State whether the Secretary of State holds any information about A, and if A is a body corporate about any director or superintendent of A, that is relevant to its consideration of whether—ithe application should be refused or deferred under regulations 33 or 34, oriiconditions should be imposed under regulation 35;c. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2In such a case, having considered whether—athe application should be refused or deferred under regulations 33 or 34; orbconditions should be imposed under regulation 35,if it is minded to impose conditions under regulation 35, it must notify A at least 7 days in advance of determining that it is to impose such conditions and consider any representations (which may be at an oral hearing) that A makes prior to the determination with regard to the notification.241Where NHS England receives a routine or excepted application, consideration or determination of which may be deferred, if it does decide to defer consideration or determination of that application (whether before or after the application is notified, in the case of a notifiable application), it must—anotify the applicant (A) of its decision and the reasons for it; andbwhere possible, notify A of the period for which the application is being deferred (if necessary by reference to a future event rather than a period of time).2If the application is—aa routine application, consideration of which may be deferred under regulation 14(1)(a), 16(1)(a), 19(2)(a) or 21(1)(a), it must proceed as soon as is practicable to invite other applications under regulation 14(1)(b), 16(1)(b), 19(2)(b) or 21(1)(b), in such manner as it sees fit;ba routine application, consideration of which may be deferred under regulation 14(2), 16(3), 19(3) or 21(3), it must make arrangements that enable it to consider the other applications at the same time as A's application, as soon as is practicable;ca routine application, consideration of which may be deferred under regulation 14(3), 16(4), 19(4) or 21(4), it must, once the appeal relating to the other application has reached its final outcome, notify A of that outcome and that A must within a specified period (of not less than 30 days)—iupdate A's application, andiinotify NHS England as to whether or not A still wishes to proceed with the application;da routine application, consideration of which may be deferred under regulation 16(2) or 21(2), it must keep under regular review the issue of whether the future circumstances that gave rise to the deferral have arisen;ea routine application, consideration of which may be deferred under regulation 32, it must—isend A a copy of the designation that led to the decision,iireview that decision once the designation that led to the decision has been cancelled or is varied in a manner which means the application may no longer be deferred under regulation 32,iiinotify A of the cancellation or variation, andivrequire A within a specified period (of not less than 30 days)—aato update A's application, andbbto notify NHS England as to whether or not A still wishes to proceed with the application;fa routine or excepted application, consideration of which may be deferred under regulation 34, once the outcome of the cause for the deferral is known, NHS England must notify A that A must within a specified period (of not less than 30 days)—iupdate A's application, andiinotify NHS England as to whether or not A still wishes to proceed with the application; andga routine application, consideration of which must be deferred under regulation 38(4), it must proceed, as soon as is practicable, with the determination of whether the relevant area is or is not to be part of a controlled locality.3If A informs NHS England within the period specified under sub-paragraph (2)(c), (e)(iv) or (f) that A does not wish to proceed with the application, or fails to respond in the required manner to the notification within the specified period, the application is to be treated as withdrawn.251If NHS England does decide to hear oral representations, it must—agive the applicant and any additional presenters not less than 14 days notice of the time and place at which the oral representations are to be heard; andbin the case of the applicant, advise the applicant of who apart from the applicant (including other applicants, where the hearing relates to more than one application), has been invited to make representations at the hearing.2For these purposes, a person (P) is an “additional presenter” if—athe application to which the oral hearing relates is a notifiable application;bP was given notice of the application under Part 3 and made representations about the application in accordance with paragraph 19(4), which—iindicated that, if there were to be an oral hearing in relation to the application, P would wish to make oral representations at that hearing, andiiidentified a matter about which NHS England considers it would be desirable to hear further evidence from P at the oral hearing; andcNHS England is satisfied that P made a reasonable attempt to express P's views on the application adequately in P's written representations.3If NHS England decides at or after an oral hearing that an application is to be deferred, it may (but need not) hold a further oral hearing once the period for which the application is deferred expires.261No person is to take part in determining or deferring any routine or excepted application who—ais a person who is included in a pharmaceutical list or is an employee of such a person;bassists in the provision of pharmaceutical services under Chapter 1 of Part 7 of the 2006 Act (pharmaceutical services and local pharmaceutical services – provision of pharmaceutical services);cis an LPS chemist, or provides or assists in the provision of local pharmaceutical services;dis a provider of primary medical services;eis a member of a provider of primary medical services that is a partnership or a shareholder in a provider of primary medical services that is a company limited by shares;fis employed or engaged by a primary medical services provider; orgis employed or engaged by an APMS contractor in any capacity relating to the provision of primary medical services,whether or not their involvement would give rise to a reasonable suspicion of bias.2No other person is to take part in determining or deferring a particular routine or excepted application if because of an interest or association they have, or because of a pressure to which they may be subject, their involvement would give rise to a reasonable suspicion of bias.27As regards any routine or excepted application—aNHS England must endeavour to determine it as soon as is practicable; andbunless consideration of it is deferred in accordance with these Regulations or there is other good cause for delay, in the case of—ia notifiable application, NHS England must determine it within 4 months of the date on which it received from the applicant all the information and documentation the applicant is required to submit in relation to it, oriian application which is not a notifiable application, NHS England must determine it within 30 days of the date on which it received from the applicant all the information and documentation the applicant is required to submit in relation to it.PART 5281As regards any routine application, once it has determined the application, NHS England must, as soon as is practicable, give notice of its decision to—athe applicant;bany Local Pharmaceutical Committee—iwhose area includes the premises or location to which the application relates, oriiany part of whose area is within 2 kilometres of the premises or location to which the application relates;cany Local Medical Committee—iwhose area includes the premises or location to which the application relates, oriiany part of whose area is within 2 kilometres of the premises or location to which the application relates;dany person—iincluded in a pharmaceutical list for the area of the relevant HWB, oriiwho is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,whose interests might, in the opinion of NHS England, be significantly affected by the decision;eany LPS chemist—iwith whom NHS England has made arrangements for the provision of any local pharmaceutical services in the area of the relevant HWB, andiiwhose interests might, in the opinion of NHS England, be significantly affected by the decision;fany Local Healthwatch organisation for the area of the relevant HWB, and any other patient, consumer or community group in its area which, in the opinion of NHS England, has a significant interest in the decision;gif the applicant is seeking to locate premises in or within 1.6 kilometres of a controlled locality in the area of the relevant HWB—iany provider of primary medical services, oriiany other person on the dispensing doctors list for the area of the relevant HWB if there is one (being a performer but not a provider of primary medical services),who, in the opinion of NHS England, has a significant interest in the decision;hany person—iwhom NHS England notified under paragraph 19(2), andiiwho made representations in writing about the application under paragraph 19(4);iany Local Health Board any part of whose area is within 2 kilometres of the premises or location to which the decision relates; andjthe relevant HWB and any other HWB any part of whose area is within 2 kilometres of the premises or location to which the decision relates.2If any part (PA) of the area of a notified HWB (HWB2) other than the relevant HWB is within 2 kilometres of the premises or location to which the application relates, NHS England must also, as soon as is practicable, give notice of the decision to—aany Local Pharmaceutical Committee—iwhose area includes PA, andiithat is not given notice of the application under paragraph (1)(b);bany Local Medical Committee—iwhose area includes PA, andiithat is not given notice of the application under paragraph (1)(c);cany person—iincluded in a pharmaceutical list for the area of HWB2, oriiwho is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,whose interests might, in the opinion of NHS England, be significantly affected by the decision;dany LPS chemist—iwith whom NHS England has made arrangements for the provision of any local pharmaceutical services in the area of HWB2, andiiwhose interests might, in the opinion of NHS England, be significantly affected by the decision;eany Local Healthwatch organisation for the area of HWB2, and any other patient, consumer or community group in its area which, in the opinion of NHS England, has a significant interest in the decision; andfif the applicant is seeking to locate premises within 1.6 kilometres of a controlled locality in the area of HWB2—aaany provider of primary medical services, orbbany other person on the dispensing doctors list for the area of HWB2 if there is one (being a performer but not a provider of primary medical services),who, in the opinion of NHS England, has a significant interest in the decision.3As regards any excepted application, once it has determined the application, NHS England must, as soon as is practicable, give notice of its decision to—ain the case of an application pursuant to regulation 23, the applicant;bin the case of an application pursuant to regulation 24, 25, 26(2) or 26A—ithe applicant,iiany Local Pharmaceutical Committee whose area includes the premises or location to which the application relates,iiiany Local Medical Committee whose area includes the premises or location to which the application relates,ivthe relevant HWB, and if the applicant is relocating to different premises in the area of another HWB, the other HWB, andvany (other) person whom NHS England notified under paragraph 19 and who made representations in writing about the application under paragraph 19(4);cin the case of an application pursuant to regulation 26(1) or 27 to 29—ithe applicant,iiany Local Pharmaceutical Committee whose area includes the premises or location to which the application relates,iiiany Local Medical Committee whose area includes the premises or location to which the application relates,ivany person—aaincluded in a pharmaceutical list for the area of the relevant HWB, orbbwho is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,whose interests might, in the opinion of NHS England, be significantly affected by the decision;vany LPS chemist—aawith whom NHS England has made arrangements for the provision of any local pharmaceutical services in the area of the relevant HWB, andbbwhose interests might, in the opinion of NHS England, be significantly affected by the decision,viany Local Healthwatch organisation for the area of the relevant HWB, and any other patient, consumer or community group in its area which, in the opinion of NHS England, has a significant interest in the decision,viiany Local Health Board any part of whose area is within 2 kilometres of the pharmacy premises to which the decision relates, andviiithe relevant HWB and any other HWB any part of whose area is within 2 kilometres of the premises or location to which the decision relates.4If, in the case of an application pursuant to regulation 26(1) or 27 to 29, any part (PA) of the area of a HWB (HWB3) notified under sub-paragraph (3)(c) other than the relevant HWB is within 2 kilometres of the premises or location to which the application relates, NHS England must also, as soon as is practicable, give notice of the decision to—aany Local Pharmaceutical Committee—iwhose area includes PA, andiithat is not given notice of the application under paragraph (3)(c)(ii);bany Local Medical Committee—iwhose area includes PA, andiithat is not given notice of the application under paragraph (3)(c)(iii);cany person—iincluded in a pharmaceutical list for the area of HWB3, oriiwho is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,whose interests might, in the opinion of NHS England, be significantly affected by the decision;dany LPS chemist—iwith whom NHS England has made arrangements for the provision of any local pharmaceutical services in the area of HWB3, andiiwhose interests might, in the opinion of NHS England, be significantly affected by the decision; andeany Local Healthwatch organisation for the area of HWB3, and any other patient, consumer or community group in its area which, in the opinion of NHS England, has a significant interest in the decision.5Where NHS England has decided to consider 2 or more applications together pursuant to paragraph 22(3), it must give notice to each applicant of the decision taken with regard to each other application considered together with their application.6Each notification of a decision under this paragraph must include a statement by NHS England of the reasons for the decision.29 Subject to paragraph 29A, NHS England must send with a notice of decision under paragraph 28 in respect of the grant of an application a template of a notice of commencement, for the applicant to send to it under paragraph 34, in which the applicant is to provide the following information (some of which NHS England may have included in the template that it sends)—athe address of the premises to which the application relates;bthe services that are to be provided at or from those premises;cthe date of the grant of the application;da declaration with regard to when the applicant intends to commence the provision of those services at or from those premises;ein the case of pharmacy premises, the registration number for those premises with the General Pharmaceutical Council; andfa signature on behalf of the applicant and the date of the notice.29A1This paragraph applies as regards a notice of decision under paragraph 28 in respect of a consolidation application that is granted, in relation to the person who is—aP1 for the purposes of regulation 26A (P1), if regulation 26A(3) applied to that application; orbP2 for the purposes of regulation 26A (P2), if regulation 26A(4) applied to that application.2NHS England must send with the notice of decision sent to P1 or P2 a template of a notice of consolidation, for P1 or P2 to send to it under paragraph 34A, in which P1 or P2 is to provide the following information (some of which NHS England may have included in the template that it sends)—athe date of the grant of the application;bthe address of the premises at or from which pharmaceutical services are no longer to be provided (“the closing premises”);cthe date on which pharmaceutical services are to cease being provided at or from the closing premises;dthe address of the premises at or from which pharmaceutical services are to continue to be provided (“the continuing premises”);ethe registration number of the continuing premises with the General Pharmaceutical Council;fconfirmation that reasonable steps have been taken to advise any patients who have nominated the person listed in relation to the closing premises as their nominated dispensing contractor that their nomination will transfer to the person listed in relation to the continuing premises, if the Electronic Prescription Service is available through those premises, unless they change their nomination;gthe date on which the consolidation is to take effect;ha signature on behalf of P1 or P2 (whichever has been sent the template) and the date of the notice.301A person with third party rights (as provided for in this paragraph) may appeal to the Secretary of State against a decision of NHS England to grant a notifiable application, or an application to which regulation 26(1), 27 or 28 applies, provided that the person notifies the Secretary of State with a valid notice of appeal within 30 days of the date on which that person was notified of NHS England’s decision under paragraph 28.2For the purposes of this Schedule, a person (P1) is a person with third party rights if—aP1 is a person to whom sub-paragraph (3) applies; orbP1 was entitled to receive notification of the decision to grant the application by virtue of paragraph 28(5).3P1 is a person to whom this sub-paragraph applies if—aP1 was a person whom NHS England was required to notify about the decision on the application by virtue of P1 being a person whose interests might, in the opinion of NHS England, be significantly affected by the decision, and also being—iincluded in a pharmaceutical list,iientitled to be included in a pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,iiian LPS chemist, oriveither—aaa provider of primary medical services, orbbanother person on the dispensing doctor list for the area of the relevant HWB if there is one (P1 being a performer but not a provider of primary medical services),but only if the application is in respect of premises in a controlled locality and it was granted partly on the basis that, having regard to regulation 44(3), in the opinion of NHS England granting the application would not prejudice the proper provision of relevant NHS services in the area of the relevant HWB or of a neighbouring HWB of the relevant HWB;bin the case of a notifiable application, P1 made representations in writing about the application under paragraph 19(4); andcin the case of a notifiable application but subject to sub-paragraph (6), NHS England is satisfied, having regard to those representations in writing and any oral representations made in accordance with paragraph 25, that P1—imade a reasonable attempt to express P1's grounds for opposing the application adequately in P1's representations, andiihas grounds for opposing the application, which—aado not amount to a challenge to the legality or reasonableness of a pharmaceutical needs assessment, or to the fairness of the process by which a HWB or Primary Care Trust undertook that assessment, andbbare not vexatious or frivolous.4If NHS England considers that a person notified under paragraph 28 is a person with third party appeal rights, it must notify that person of that fact when it notifies that person of the determination.5A notice of appeal under sub-paragraph (1) is only valid if it includes a concise and reasoned statement of the grounds of appeal.6A person to whom sub-paragraph (3)(a) and (b) applies (P2) who is not notified by NHS England that they are person with third party appeal rights may appeal to the Secretary of State against the determination (D1) by NHS England that it is not satisfied as mentioned in sub-paragraph (3)(c), provided that P2—anotifies the Secretary of State within 30 days of the date on which that person was notified of NHS England’s decision under paragraph 28 (D2) that P2 wishes to appeal against D1 and D2; andbincludes within that notification concise and reasoned statements of P2's grounds of appeal against both D1 and D2,and if the appeal against D1 is successful, P2 is a person with third party appeal rights in relation to D2 for the purposes of this Schedule.311As regards any routine application, sub-paragraph (2) applies where—athe applicant (A) is seeking the listing of premises not already listed in relation to A (whether or not A is already included in the pharmaceutical list); andbprior to the determination of the application, A was only able to provide a best estimate of where the proposed listed chemist premises would be (not the address of those premises).2Where this sub-paragraph applies, it is a condition of the grant of that application that A notifies to NHS England the address of the premises to be listed within 6 months of—athe date on which A was sent the notice of decision under paragraph 28 (having regard also to paragraph 10(2) of Schedule 3);bif the grant of the application is appealed to the Secretary of State by a person with third party appeal rights, the date on which the appeal is determined by the Secretary of State; orcin a case of an application which is subject to a condition imposed by virtue of paragraph 33(2), the date on which that condition becomes spent,whichever is the latest.3A notification under sub-paragraph (2) is only valid if NHS England is satisfied that the premises are at a location that is within the range of possible locations covered by the estimate referred to in sub-paragraph (1)(b).3AFor the purposes of paragraph (3), premises are not within the range of possible locations covered by the estimate referred to in sub-paragraph (1)(b) if the granted application would have been refused pursuant to regulation 31 if the address of those premises had been included in that application instead of the estimate.4If NHS England receives a purported notification under sub-paragraph (2), it must, within 14 days of receiving that purported notification—anotify A of whether or not it is satisfied that it is a valid notification;bif it is satisfied that it is a valid notification, notify the address to the persons notified of the decision to grant the application; andcif NHS England is not satisfied that it is a valid notification, it must include with that notification—ithe reasons for its decision, andiian explanation of how A's rights of appeal under paragraph 36(1)(b) may be exercised.5NHS England may not vary or remove a condition imposed by virtue of this paragraph.6If A breaches a condition imposed by virtue of this paragraph, the grant of the application lapses.321As regards any routine application, sub-paragraph (2) applies where—athe applicant (A) is seeking the listing of premises not already listed in relation to A (whether or not A is already included in the pharmaceutical list); andbprior to the determination of the application, A provided the address of where the proposed listed chemist premises would be.2Where this sub-paragraph applies, A may notify to NHS England a different address (“new address”) as the address to which the application relates within—a4 months of the date on which A was sent the notice of decision under paragraph 28 (having regard also to paragraph 10(2) of Schedule 3); orbif the grant of the application is appealed to the Secretary of State by a person with third party appeal rights, 4 months of the date on which the appeal is determined by the Secretary of State.3A notification under sub-paragraph (2) is only valid if NHS England is satisfied that accepting the notification as valid would neither—aresult in a significant change to the arrangements that are in place (having regard to the grant of A's application) for the provision of local pharmaceutical services or of pharmaceutical services other than those provided by a person on a dispensing doctor list—iin any part of the area of the relevant HWB, oriiin a controlled locality that is part of the area of a neighbouring HWB of the relevant HWB, where that controlled locality is within 1.6 kilometres of the new address; norbcause significant detriment to proper planning in respect of the provision of pharmaceutical services in the area of the relevant HWB.3AA notification under sub-paragraph (2) is not valid if the granted application would have been refused pursuant to regulation 31 if the address of those premises had been included in that application instead of the address mentioned in sub-paragraph (1)(b).4If NHS England receives a purported notification under sub-paragraph (2), it must, within 14 days of receiving that purported notification—anotify A of whether or not it is satisfied that it is a valid notification, together with the reasons for its decision;bif NHS England is not satisfied that it is a valid notification, it must include with that notification—ithe reasons for its decision, andiian explanation of how A's rights of appeal under paragraph 36(1)(b) may be exercised.cif it is satisfied that it is a valid notification, notify the new address to the persons notified of the decision to grant the application, and must include with that notification—ithe reasons for its decision, andiiif the person has a right of appeal under sub-paragraph (5), an explanation of how that right of appeal may be exercised.5A person (X) who—ais notified under sub-paragraph (4)(c); andbwas entitled to be notified of the decision to grant the application—iby virtue of paragraph 28(5), oriias a person whom NHS England was required to notify about the application by virtue of X being—aaan LPS chemist,bbincluded in a pharmaceutical list, orccentitled to be included in a pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,and a person whose interests might, in the opinion of NHS England, be significantly affected by the decision;may appeal against a decision by NHS England to accept the purported notification as a valid notification, provided X notifies the Secretary of State with a valid notice of appeal within 30 days of the date on which X was notified under sub-paragraph (4)(c).6A notice of appeal under sub-paragraph (5) is only valid if it includes a concise and reasoned statement of the grounds of appeal.331Where NHS England grants a routine application because doing so—awill meet a future need for pharmaceutical services, or pharmaceutical services of a specified type in its area; orbwill secure future improvements or better access to pharmaceutical services, or pharmaceutical services of a specified type, in its area,sub-paragraph (2) applies.2Where this sub-paragraph applies, NHS England may grant the application subject to a condition that pharmaceutical services are not provided at or from the listed chemist premises to which the application relates (or at or from any premises to which the business relocates) until—asome or all of the future circumstances, as a consequence of which the application was granted, have arisen; orba specified date (having regard to when some or all of the future circumstances, as a consequence of which the application was granted, are likely to arise).3NHS England may vary or remove a condition imposed by virtue of sub-paragraph (2), but if it varies the condition, the revised condition (which becomes a condition imposed by virtue of sub-paragraph (2)) must be a condition that it also meets the requirements of that paragraph.4The condition imposed by virtue of sub-paragraph (2) becomes spent once—awhere a date has been specified, that date passes; orbwhere the condition relates to future circumstances arising, NHS England notifies the successful applicant (P) that the future circumstances have arisen.5P may by a notice request a determination from NHS England as to whether the future circumstances have arisen at any time (but only once in any 60 days), and NHS England must give notice of that determination within 30 days of that request.341 Except where paragraph 34A applies, as regards any application—afor inclusion in a pharmaceutical list by a person who is not already included in it; orbby a person who is included in a pharmaceutical list and who is seeking—ito open, within the area of the relevant HWB, additional premises at or from which to provide the same or different pharmaceutical services,iito relocate to different premises, and at or from those premises to provide the same or different pharmaceutical services, oriiito provide, at or from the person's listed chemist premises, services that are in addition to those already listed in relation to that person,if the application is granted, paragraph (2) applies.2Subject to paragraph 35, NHS England may only change a pharmaceutical list to give effect to that decision if the successful applicant (P) gives NHS England a valid notice of commencement, in the correct form, informing NHS England that P is to commence the provision of the services in respect of which the application was made and at or from the premises to which the application related ....3A notice of commencement is in the correct form if it—aincludes the information required under paragraph 29; andbis in the same format as the version of the notice sent by NHS England with the notice of decision under paragraph 28.3AA notice of commencement is invalid unless it is given to NHS England no fewer than 30 days prior to the date on which the provision of services is to commence, unless prior to the notified date NHS England has agreed with P a shorter period of prior notice.3BP must notify NHS England in writing as soon as reasonably practicable of any change to the date included in a notice of commencement as the date on which the provision of services is to commence, and must do so in advance of the date on which the provision of services is to commence.3CA notice of commencement is invalid if the date included in it (on or after 25th May 2023), whether when the notice is given or after a change in accordance with sub-paragraph (3B), as the date on which the provision of services is to commence is more than 60 days after the end of the period within which the notice, if it is to be valid, must be sent, as determined in accordance with sub-paragraph (4).4A notice of commencement is invalid unless it is sent to NHS England within—aif, prior to NHS England determining the application—iP undertook to commence the provision of the services in respect of which the application was made within a period of less than 6 months, andiithat undertaking was not withdrawn,that period;b 12 months of—iunless paragraph (a) applies, the date on which P was sent the notice of NHS England’s decision under paragraph 28 granting the application,iiif the grant was appealed by a person with third party appeal rights, the date on which that appeal is determined by the Secretary of State,iiiif, in the course of granting the application, a decision is taken to impose a condition in accordance with regulation 35 and that condition is appealed by P, the date on which that appeal is determined by the First-tier Tribunal (unless regulation 35(8) applies),ivif the grant of the application was subject to a condition imposed by virtue of paragraph 31, the date on which—aaP validly notifies to NHS England under a condition imposed by virtue of paragraph 31 of the address of the premises, orbbif P appeals successfully against a decision of NHS England that a notification under a condition imposed by virtue of paragraph 31 is invalid, that appeal is determined by the Secretary of State,vif P, pursuant to paragraph 32—aanotifies NHS England of a new address,bbNHS England does not accept the validity of the notification, andccP appeals successfully against that decision,the date on which that appeal is determined by the Secretary of State, orviif the grant of the application was subject to a condition imposed by virtue of paragraph 33, the date on which the condition imposed by virtue of that paragraph becomes spent or is removed on appeal, orwhichever is the latest; orcsuch longer period—inot exceeding a further 3 months as NHS England may allow, oriiif—aathe grant is appealed by a person with third party appeal rights,bba decision to accept a notification pursuant to paragraph 32 is appealed by a third party,ccP appeals successfully against a notice under paragraph 35, orddif P appeals successfully against a decision not to allow a longer period under sub-paragraph (i),as the Secretary of State may allow when the appeal is determined,and so once a valid notice of commencement can no longer be sent in relation to an application (having regard also to paragraph 10(2) of Schedule 3), the grant of that application lapses.5A notice of commencement ceases to have effect if the Secretary of State receives a valid notice of appeal—afrom a person with third party appeal rights relating to the grant to which the notice of commencement relates; orbfrom a third party, in a case to which sub-paragraph (4)(c)(ii)(bb) applies.6In any case where a longer period allowed by virtue of sub-paragraph (4)(c)—abegan in the 3 months prior to the coming into force of the Coronavirus Regulations, that longer period is extended so that it ends on the day that is 6 months after the day on which the Coronavirus Regulations came into force; andbended in the 6 months prior to the coming into force of the Coronavirus Regulations, that longer period is treated as having not ended and is extended so that it ends on the day that is 6 months after the day on which the Coronavirus Regulations came into force.7In this paragraph, “the Coronavirus Regulations” means the National Health Service (Coronavirus) (Charges and Further Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020.34A1This paragraph applies as regards a consolidation application that is granted, in relation to the person who is—aP1 for the purposes of regulation 26A (P1), if regulation 26A(3) applied to that application; orbP2 for the purposes of regulation 26A (P2), if regulation 26A(4) applied to that application.2NHS England may only change a pharmaceutical list to give effect to that decision if P1 or P2 gives NHS England a valid notice of consolidation, in the correct form, informing NHS England of the date on which the consolidation is to take effect in the next 14 days.3A notice of consolidation under this paragraph is in the correct form if it—aincludes the information required under paragraph 29A; andbis in the same format as the version of the notice sent by NHS England with the notice of decision under paragraph 28.4A notice of consolidation is invalid unless it is sent to NHS England within—a6 months of the date on which the applicant was sent the notice of NHS England’s decision under paragraph 28 granting the application;bsuch longer period—inot exceeding a further 3 months as NHS England may allow, oriiif—aathe grant is appealed by a person with third party appeal rights, orbbP1 or P2 appeals successfully against a decision not to allow a longer period under paragraph (i),as the Secretary of State may allow when the appeal is determined,5A notice of consolidation ceases to have effect if the Secretary of State receives a valid notice of appeal from a person with third party appeal rights relating to the grant to which the notice of consolidation relates.6Once, having regard to sub-paragraph (4), a valid notice of consolidation can no longer be sent in relation to the grant of a consolidation application, the grant of that application lapses.351NHS England, having granted a routine application—afor inclusion in a pharmaceutical list by a person (P) not already included; orbif P is already included in a particular pharmaceutical list, for inclusion in that list also in relation to premises not already listed in relation to P,may, if the grant has not lapsed and is not under appeal to the Secretary of State, give notice to P requiring P to commence the provision of pharmaceutical services by a date specified in the notice.2If NHS England gives notice under sub-paragraph (1) but afterwards a valid notice of appeal is given against the grant, the notice under sub-paragraph (1) lapses.3A notice under sub-paragraph (1) may not specify a date that is—aearlier than 30 days from the date of the notice under that paragraph; orblater than 9 months after the date on which the grant of the application was notified to P.4NHS England may change its pharmaceutical list to give effect to that notice—aon the specified date, unless the decision to give notice under sub-paragraph (1) is appealed; orbif the notice under paragraph (1) is appealed and the appeal is unsuccessful or discontinued—iif the appeal is discontinued, 30 days after P discontinues the appeal,iiif the appeal is unsuccessful, 30 days after the appeal is determined, oriiion the specified date,whichever is the latest.361As regards any routine or excepted application, other than an application pursuant to regulation 29, the applicant (A) may appeal to the Secretary of State against a decision by NHS England—ato refuse the application on grounds set out in Parts 3 to 5 or 7 of these Regulations;bthat a notification pursuant to a condition imposed by virtue of paragraph 31 is invalid;cto refuse to accept that a notification under paragraph 32(2) is a valid notification;dto impose or vary a condition imposed pursuant to paragraph 33;eto refuse to allow A an extension period under paragraph 34(4)(c)(i) or 34A(4)(b)(i); orfto give notice under paragraph 35,provided A notifies the Secretary of State with a valid notice of appeal within 30 days of the date on which A was notified of the decision that is being appealed.2A notice of appeal under sub-paragraph (1) is only valid if it includes a concise and reasoned statement of the grounds of appeal.SCHEDULE 3 Regs 10(8), 45(3), 63(6), 77(4), 98(9)PART 111If the Secretary of State has received a notification under paragraph 30(6) of Schedule 2 from a person (P1), the Secretary of State must determine (prior to a notification under Part 2 or a determination under paragraph 2) whether P1 is to have third party appeal rights on the basis that—aP1 is a person to whom paragraph 30(3)(a) and (b) of Schedule 2 applies; andbin relation to P1, NHS England should have been satisfied as mentioned in paragraph 30(3)(c) of Schedule 2.2If the Secretary of State has received a notification under regulation 63(5) from a person (P2), the Secretary of State must determine (prior to a notification under Part 2 or a determination under paragraph 2) whether P2 is to have third party appeal rights on the basis that—aP2 is a person to whom regulation 63(3)(a) and (b) applies; andbin relation to P2, NHS England should have been satisfied as mentioned in regulation 63(3)(c).3Once the Secretary of State has made a determination under paragraph (1) or (2), the Secretary of State must notify NHS England and P1 or P2 of that determination and the reasons for it.2If the Secretary of State, after considering a valid notice of appeal under regulation 45, 63 or 77, or paragraph 30, 32(5) or 36 of Schedule 2 against a decision, is of the opinion that the notice—acontains no valid grounds of appeal (for example, because it amounts to a challenge to the legality or reasonableness of a HWB's or Primary Care Trust's pharmaceutical needs assessment, or to the fairness of the process by which the HWB or a Primary Care Trust undertook that assessment); orbcontains no reasonable grounds for appeal (for example, where it is vexatious or frivolous),the Secretary of State may determine the appeal by dismissing it (without proceeding to notify the appeal under Part 2).PART 231Unless the Secretary of State determines the appeal under paragraph 2, or the appeal relates to an application pursuant to regulation 23, the Secretary of State must send a copy of a valid notice of appeal sent under paragraph 30, 32(5) or 36 of Schedule 2 to—aNHS England;bin the case of an appeal against the grant of an application, any person who was entitled to receive notification of the decision by virtue of paragraph 28(5) of Schedule 2;cin the case of an appeal in relation to a notifiable application, including against decisions as mentioned in paragraphs 32(4) and 36(1)(b) to (f) of Schedule 2—ithe applicant (unless they are the person bringing the appeal),iiany person who was notified in relation to that application under paragraph 19 of Schedule 2 who made representations in writing about the application under paragraph 19(4) of that Schedule (unless they are also the person bringing the appeal), anddin the case of an appeal in relation to an application pursuant to regulation 26(1), 27 or 28 (including against decisions as mentioned in paragraph 36(1)(d) to (f) of Schedule 2), any person notified in relation to the decision on that application under paragraph 28(3)(c) or (4).2Any person to whom a notice of appeal is sent under sub-paragraph (1) may make representations in writing about the appeal, provided they do so within 30 days of the date on which they are sent the notice of appeal by the Secretary of State.41A valid notice of appeal under regulation 45(1)(b) does not need to be notified to others.2The Secretary of State must send a valid notice of appeal—aagainst a determination under regulation 36(2) to the persons given notice of the proposed determination under regulation 38(1) or (2); orbagainst a determination under regulation 41(2) or 42(1) to—ithe person making the routine application to which the determination relates, andiiany person given notice of the determination who is mentioned in regulation 43(1)(b)(ii),unless they are the person bringing the appeal.3Any person to whom a notice of appeal was sent under sub-paragraph (2) may make representations in writing about the appeal, provided they do so within 30 days of the date on which they were sent the notice of appeal by the Secretary of State.51A valid notice of appeal under regulation 63(1)(a) does not need to be notified to others.2The Secretary of State must send a valid notice of appeal against—aa decision mentioned in regulation 63(1)(b) to the persons, other than the appellant, given notice of the decision under regulation 50(7); orba decision or determination mentioned in regulation 63(1)(c) to (f) to—ithe person who made the original application for outline consent or premises approval,iiany person who was notified in relation to that application under regulation 52(1) to (3) who made representations in writing about the application under regulation 52(4), andiiiif the appeal is against a refusal to grant temporary premises approval, the applicant who made the relevant outstanding pharmacy application,unless they are person bringing the appeal.3Any person to whom a notice of appeal was sent under sub-paragraph (2) may make representations in writing about the appeal, provided they do so within 30 days of the date on which they were sent the notice of appeal by the Secretary of State.6A valid notice of appeal under regulation 77 or 98 does not need to be notified to others.PART 371Except in so far as these Regulations provide to the contrary, the Secretary of State is to determine the appeal to which a valid notice of appeal under regulation 45, 63 or 77, or under paragraph 30, 32(5) or 36 of Schedule 2, relates in such manner (including with regard to procedures) as the Secretary of State sees fit.2The Secretary of State may determine the appeal without hearing any oral representations, if the Secretary of State considers that oral representations are unnecessary.3Where appropriate, the Secretary of State may, if the Secretary of State thinks fit, consider 2 or more appeals together and in relation to each other, but where the Secretary of State does so, the Secretary of State must give notice of the Secretary of State's intention to do so to—aNHS England;bthe appellants; andcany other person notified in relation to the appeals under Part 2.4Where an application for inclusion in a pharmaceutical list has been updated in accordance with paragraph 5A of Schedule 2, the Secretary of State may, on an application from NHS England, defer the Secretary of State’s decision in relation to the application on any ground that NHS England could have relied on for deferring the application pursuant to regulation 34 until—athe reason for the deferral no longer exists; orbthe outcome of the cause of the deferral is known and NHS England has—idecided, in the light of that outcome, whether or not to redetermine the application, andiiredetermined the application, if it is to be redetermined.5Where NHS England redetermines an application in accordance with paragraph 5A(2) of Schedule 2 and refuses it, the Secretary of State may direct that the proceedings relating to the appeal are to be brought to an end without a determination of the matter under paragraph 9.81If the Secretary of State does decide to hear oral representations, the Secretary of State must give not less than 14 days notice of the time and place at which the oral representations are to be heard to—aNHS England;bthe person who made the original application to which the appeal relates;cif a person other than that applicant is bringing the appeal, the person bringing the appeal;dany Local Pharmaceutical Committee whose area includes all or part of the area, or in whose area is the location or are the premises, to which the decision relates;eany Local Medical Committee whose area includes all or part of the area, or in whose area is the location or are the premises, to which the decision relates; andfany additional presenters,and they (or their duly authorised representatives) are to be the only persons entitled to make oral representations at the hearing.2For these purposes, a person (P) is an “additional presenter” if—aP was notified of the appeal under Part 2 and has made written representations in accordance with paragraph 3(2), 4(3) or 5(3) ...; andbthe Secretary of State is satisfied that P made a reasonable attempt to express P's views on the appeal adequately in P's written representations.91On determining an appeal relating to a valid notice under paragraph 30 or 36, the Secretary of State may—aif the appeal is an appeal to which paragraph 30 or 36(1)(a) of Schedule 2 applies (that is, against a decision to grant or refuse a routine or excepted application)—iconfirm the decision of NHS England,iiquash the decision and redetermine the application, oriiiquash the decision and remit the matter to NHS England for it to redetermine the application, where the Secretary of State considers that there should be a (further) notification under paragraph 19 of Schedule 2, subject to such directions as the Secretary of State considers appropriate; orbif the appeal is an appeal to which paragraph 32(5) or 36(1)(b) to (f) applies—iconfirm the decision of NHS England, oriisubstitute for that decision any decision that NHS England could have taken when it took that decision.2If the Secretary of State grants or confirms the grant of a routine application, the Secretary of State may direct NHS England—ato impose a condition under paragraph 33, in circumstances where NHS England could have imposed such a decision if it had granted the application; orbto take such action under regulation 50(4) or (5) as the Secretary of State thinks fit.3On determining an appeal relating to a valid notice under regulation 45, the Secretary of State may—aconfirm the decision or determination of NHS England;bsubstitute for that decision or determination any decision or determination that NHS England could have taken when it took that decision or made that determination; orcquash the decision or determination of NHS England and remit the matter to it for it to redetermine the decision or determination, subject to such directions as the Secretary of State considers appropriate.4On determining an appeal relating to a valid notice under regulation 63, the Secretary of State may—ain the case of decision or determination mentioned in regulation 63(1)(a), (b), (e) or (f)—iconfirm the decision or determination of NHS England,iisubstitute for that decision or determination any decision or determination that NHS England could have taken when it took that decision or made that determination, oriiiquash the decision or determination of NHS England and remit the matter to it for it to redetermine the decision or determination, subject to such directions as the Secretary of State considers appropriate; orbif the appeal is against a decision to grant or refuse an application for outline consent or premises approval—iconfirm the decision of NHS England,iiquash the decision of NHS England and redetermine the application, oriiiquash the decision of NHS England and remit the matter to it for it to redetermine the application, subject to such directions as the Secretary of State considers appropriate.5On determining an appeal relating to a valid notice under regulation 77, the Secretary of State may—aconfirm the decision of NHS England; orbsubstitute for that decision any decision that NHS England could have taken when it took that decision.6If the Secretary of State grants or confirms the grant of an application for—aoutline consent, the Secretary of State may direct NHS England to take such action under regulation 53(3) as the Secretary of State thinks fit; orbpremises approval, the Secretary of State may direct NHS England to take such action under regulation 57 as the Secretary of State thinks fit.101Once the Secretary of State has determined the appeal, the Secretary of State must notify the following—aNHS England;bthe person who made the original application to which the appeal relates;cif a person other than that person brought the appeal, the person who brought the appeal; anddany person who made written representations relating to the application pursuant to the notification under Part 2,and must include with that notification a statement of the reasons for the Secretary of State's decision and the Secretary of State's findings of fact.1AIf the Secretary of State has—agranted or confirmed the grant of a consolidation application; orballowed or refused an appeal against a decision as mentioned in paragraph 36(1)(b) in respect of an extension period under paragraph 34A(4)(b)(i),the Secretary of State must notify the relevant HWB (under this sub-paragraph or sub-paragraph (1)(d)), and must include with that notification a statement of the reasons for the Secretary of State’s decision and the Secretary of State’s findings of fact.2If the Secretary of State has granted or confirmed the grant of a routine or excepted application—aNHS England must send to the applicant a template of the notice of commencement referred to in paragraph 29 or a notice of consolidation referred to in paragraph 29A; andbthe time periods in paragraphs 31, 32, 34 and 34A thereafter apply as if the references to the applicant being sent notices of NHS England’s decision were reference to the applicant being notified by the Secretary of State under sub-paragraph (1).3If the Secretary of State has granted or confirmed the grant of—aa routine application, NHS England must proceed as soon as is practicable to take such action under regulation 50(4) or (5) as it thinks fit, subject to any directions of the Secretary of State under paragraph 9(2)(b);ban application for outline consent, NHS England must proceed as soon as is practicable to make a determination under regulation 53(3), subject to any directions of the Secretary of State under paragraph 9(6)(a); orcan application for premises approval, NHS England must proceed as soon as is practicable take such action under regulation 57 as it thinks fit, subject to any directions of the Secretary of State under paragraph 9(6)(b).11For the purposes of these Regulations, the Secretary of State's decision becomes NHS England’s decision on the matter (but no further appeal to the Secretary of State on that decision is possible), unless the Secretary of State's decision is overruled by a court.SCHEDULE 4 Regulation 11(1)(a)(i)PART 111To the extent that this Schedule imposes a requirement on an NHS pharmacist in respect of an activity which could only, or would normally, be undertaken by a natural person—aif the NHS pharmacist is a registered pharmacist—ithat NHS pharmacist must comply with that requirement, oriiif the NHS pharmacist employs or engages natural persons in connection with the provision of pharmaceutical services, the NHS pharmacist must either comply with that requirement or secure compliance with that requirement by—aawhere conformity with the standards generally accepted in the pharmaceutical profession so requires, a registered pharmacist (who is not suspended), orbbin other cases, by the natural persons (including registered pharmacists) whom the NHS pharmacist employs or engages in connection with the provision of pharmaceutical services; orbif the NHS pharmacist is not a natural person, that NHS pharmacist must secure compliance with that requirement by—iwhere conformity with the standards generally accepted in the pharmaceutical profession so requires, a registered pharmacist (who is not suspended), oriiin other cases, the natural persons (including registered pharmacists) whom the NHS pharmacist employs or engages in connection with the provision of pharmaceutical services.2Where in this Schedule reference is made to an NHS pharmacist—abeing the subject of any activity, and it is an activity to which a natural person could only, or would normally, be subject; orbforming a view,that reference is to be construed as a referring, as appropriate, to the NHS pharmacist (if a natural person) or to the NHS pharmacist's staff.3References in this Schedule to an NHS pharmacist are to be construed in accordance with sub-paragraphs (1) and (2).2Where this Schedule imposes a requirement on the director or superintendent of a body corporate that is on a pharmaceutical list, a breach of that requirement is to be deemed to be a breach by the body corporate of its terms of service.PART 23For the purposes of these Regulations, “essential services” means—athe services described in this Part; andbthe activities described in this Part to be carried out in connection with those services.4An NHS pharmacist must, to the extent that paragraphs 5 to 9 require and in the manner described in those paragraphs, provide proper and sufficient drugs and appliances to persons presenting prescriptions for drugs or appliances ordered by health care professionals in pursuance of their functions in the health service, the Scottish health service or the Northern Ireland health service.51In this Part, “signed” includes signature with a prescriber's advanced electronic signature.2Subject to the following provisions of this Part, where—aany person presents to an NHS Pharmacist (P) a non-electronic prescription form which contains—ian order for drugs, not being Scheduled drugs, or for appliances, not being restricted availability appliances, signed by a prescriber,iian order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances), signed by a prescriber and including the reference “SLS”, oriiian order for a restricted availability appliance, signed by a prescriber and including the reference “SLS”; ...bsubject to sub-paragraph (4), P receives as a nominated dispensing contractor from the Electronic Prescription Service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) to (iii) and—iany person requests the provision of drugs or appliances in accordance with that prescription, oriiP has previously arranged with the patient that P will dispense that prescription on receipt; or cany person—ipresents P with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iii), andiirequests the provision of drugs or appliances in accordance with the related electronic prescription form,P must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as P supplies in the normal course of business.3Subject to the following provisions of this Part, where—aany person presents to P a non-electronic repeatable prescription which contains—ian order for drugs, not being Scheduled drugs or controlled drugs within the meaning of the Misuse of Drugs Act 1971 , other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a prescriber,iian order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, not being a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001, signed by a prescriber and including the reference “SLS”,iiian order for appliances, not being restricted availability appliances, signed by a prescriber, orivan order for a restricted availability appliance, signed by a prescriber, and including the reference “SLS”,and also presents an associated batch issue; ...bP receives as a nominated dispensing contractor from the Electronic Prescription Service an electronic repeatable prescription which contains an order of a kind specified in paragraph (a)(i) to (iv) and—iany person requests the provision of drugs or appliances in accordance with that repeatable prescription, oriiP has previously arranged with the patient that P will dispense that repeatable prescription on receipt; or cany person—ipresents P with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iv), andiirequests the provision of drugs or appliances in accordance with the related electronic repeatable prescription,P must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as P supplies in the normal course of business.4P must not provide under an electronic prescription form a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedules 2 to 5 to the Misuse of Drugs Regulations 2001.5For the purposes of this paragraph, a non-electronic repeatable prescription for drugs or appliances shall be taken to be presented even if the person who wishes to obtain the drugs or appliances does not present that prescription, where—aP has that prescription in P's possession; andbthat person presents, or P has in P's possession, an associated batch issue.5A1This sub-paragraph applies where—aany person requests a drug or appliance from an NHS pharmacist (P) in accordance with a prescription form or repeatable prescription; andba SSP has effect in respect of—ithe requested drug or appliance, oriidrugs or appliances of a specified description, and the requested drug or appliance is of that description.2Where sub-paragraph (1) applies, P must consider whether it is reasonable and appropriate to supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.3Where sub-paragraph (1) applies, P may provide a different product or quantity of product to the product or quantity of product ordered on the prescription form or repeatable prescription, where—aP is able to do so with reasonable promptness;bto do so is in accordance with the SSP; andcthe supply of a different product or quantity of product to that ordered by the prescriber is by or under the direct supervision of a registered pharmacist who is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is reasonable and appropriate.4Where P, in accordance with sub-paragraph (3), provides a different product or quantity of product to that ordered by the prescriber—athe registered pharmacist mentioned in sub-paragraph (3)(c) must endorse the prescription or the associated batch issue accordingly (if the manner for making the endorsement is provided for in the Drug Tariff, in the manner provided for in the Drug Tariff), and the prescription or associated batch issue as thus endorsed is treated as being the prescription for product reimbursement purposes (even though the supply is not in pursuance of that prescription); andbif the patient to or for whom the product is provided is on a patient list, and the supply—iby virtue of regulation 226A(5)(c)(iii) of the Human Medicines Regulations 2012 (sale etc. by a pharmacist in accordance with a serious shortage protocol), is of a prescription only medicine that is different to but has a similar therapeutic effect to the product ordered by the prescriber, oriiis of any other type, and the Secretary of State and the person who is, for the time being, the person consulted under section 165(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of NHS pharmacists, acting jointly, have issued and publicised in such manner as they see fit a recommendation to the effect that, for clinical reasons, in the case of supplies of that type, providers of primary medical services should be notified of a supply to a patient on its patient list that is in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription,P must notify the provider of primary medical services on whose patient list the patient is of the supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.5Where—asub-paragraph (1) applies;ba registered pharmacist is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; andcP is able to supply the product or quantity of product ordered by the prescriber within a reasonable timescale but not with reasonable promptness,the requirements to act with reasonable promptness in paragraph 5(2) and (3) are to be read as requirements to act within a reasonable timescale.5B1Subject to the following provisions of this Part, where—aan NHS Pharmacist (P) receives, via a secure service approved by NHS England for this purpose, an electronic message that amounts to an order for the supply of a drug in accordance with a PTP or a PTPGD ; andba person who is entitled to be supplied with that drug in pursuance of that order requests the provision of the drug in accordance with that order,P must, with reasonable promptness, provide the drug so ordered.1AWhere P considers—aon the basis of a request for the supply of a drug in accordance with a PTP or a PTPGD that has been approved by NHS England as a basis for supply as part of pharmaceutical services;bhaving made the appropriate checks; andchaving regard to what is reasonable and appropriate,that a person is entitled to be supplied with the drug in accordance with the PTP or PTPGD as part of pharmaceutical services, P must, with reasonable promptness, provide the drug requested.2If a person who is entitled as mentioned in sub-paragraph (1)(b) or (1A) asks P to do so—aP must give an estimate of the time when the drug will be ready; andbif they are not ready by then, P must give a revised estimate of the time when they will be ready (until they are ready).3Sub-paragraph (1) does not apply where arrangements are in place for the provision of the drug (whether by P or otherwise) ordered pursuant to the PTP or PTPGD as part of a directed service which includes arrangements for the provision of such a drug ordered in accordance with such a PTP or PTPGD.4Sub-paragraph (1A) does not apply where arrangements are in place for the provision of the drug (whether by P or otherwise) requested in accordance with the PTP or PTPGD as part of a directed service which includes arrangements for the provision of such a drug requested in accordance with such a PTP or PTPGD.5C1Subject to the following provisions of this Part, where—aan NHS Pharmacist (P) receives a LPIV; andba person who is entitled to be supplied by P with a prescription item ordered on the LPIV requests the provision of the item in accordance with that LPIV,P must, with reasonable promptness, provide the prescription item so ordered.2If a person who is entitled as mentioned in sub-paragraph (1)(b) asks P to do so—aP must give an estimate of the time when the prescription item will be ready; andbif they are not ready by then, P must give a revised estimate of the time when the item will be ready (until it is ready).3Sub-paragraph (1) does not apply where arrangements are in place for the provision of the item (whether by P or otherwise) ordered on the LPIV as part of a directed service which includes arrangements for the provision of such an item ordered on such a LPIV.61This paragraph applies where, in a case of urgency, a prescriber requests an NHS pharmacist (P) to provide a drug or appliance.2P may provide the drug or appliance requested before receiving a prescription form or repeatable prescription in respect of that drug or appliance, provided that—ain the case of a request for a drug, the drug is neither—ia Scheduled drug, noriia controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under the Regulations); andbin the case of a request for a drug or an appliance, the prescriber undertakes to—igive P a non-electronic prescription form or non-electronic repeatable prescription in respect of the drug or appliance within 72 hours of the request being made, oriitransmit an electronic prescription to the Electronic Prescription Service within 72 hours of the request being made.71If a person specified in sub-paragraph (2) asks an NHS pharmacist (P) to do so—aP must give an estimate of the time when the drugs or appliances will be ready; andbif they are not ready by then, P must give a revised estimate of the time when they will be ready (until they are ready).2A person specified in this sub-paragraph is a person—apresenting a non-electronic prescription form or non-electronic repeatable prescription; orbrequesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription.3Before providing any drugs or appliances in accordance with a prescription form or a repeatable prescription, P must ask any person who makes or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription that the person named on the prescription form or the repeatable prescription does not have to pay the charges specified in regulation 3(1) or (2) of the Charges Regulations (supply of drugs and appliances by chemists) by virtue of either—aentitlement to exemption under regulation 10(1) of the Charges Regulations (exemptions); orbentitlement to remission of charges under regulation 5 of the Remission of Charges Regulations (entitlement to full remission and payment),to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of sub-paragraph (a), (c), (d), (e), (f) or (g) of regulation 10(1) of the Charges Regulations or in respect of entitlement to remission by virtue of regulation 5(1)(e) or (2) of the Remission of Charges Regulations, and at the time of the declaration P already has such evidence available to P.3ZAFor the purposes of sub-paragraph (3), satisfactory evidence includes evidence derived from a check, known as a real time exemption check, of electronic records that are managed by the NHS BSA for the purposes (amongst other purposes) of providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under the Charges Regulations.3AIn any case where no satisfactory evidence, as required by sub-paragraph (3), is produced to P, P must ensure before the drugs or appliances are provided that the person who was asked to produce that evidence is advised, in appropriate terms, that checks are routinely undertaken to ascertain entitlement to—aexemption under the Charges Regulations; orbremission of charges under the Remission of Charges Regulations,where such entitlement has been claimed, as part of the arrangements for preventing or detecting fraud or error in relation to such claims.4If, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by sub-paragraph (3), is produced to P, P shall endorse the form on which the declaration is made to that effect.5In the case of an electronic prescription, P must ensure that the following information is duly entered into the records managed by NHS England that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as a real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (3))—ain a case where exemption from or remission of charges is claimed for all or some of the items included in the prescription, a record of—ithe exemption category specified in regulation 10(1) of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which it is claimed applies to the case, andiiwhether or not satisfactory evidence was produced to P as required by sub-paragraph (3);bin any case where a charge is due, confirmation that the relevant charge was paid; andcin a case of a prescription for or including contraceptive substances, confirmation that no charge was payable in respect of those substances.6Sub-paragraphs (3) to (5) apply to the provision of a drug or appliance in accordance with a SSP as they apply to the provision of a drug or appliance in accordance with a prescription form or a repeatable prescription (or an associated batch issue), and for these purposes, the prescription for product reimbursement purposes, as mentioned in paragraph 5A(4)(a), is treated as being the prescription in accordance with which the drug or appliance is provided (even though the supply is not in pursuance of that prescription).7A1Subject to sub-paragraph (3), an NHS pharmacist (P1) must not sub-contract the performance of any of its core dispensing functions.2For the purposes of this paragraph and paragraph 7B, “core dispensing functions” means the assembly or part-assembly of any prescription item (including bagging and the application of dispensing labels) with a view to the supply of that prescription item in accordance with a prescription, a SSP, a LPIV, a PTP or a PTPGD.3Sub-paragraph (1) does not apply to—aa contract for services between P1 and—ia health care professional (for example, a locum) or a provider of locums, oriia corporate body that is—aais a subsidiary undertaking of P1, orbba subsidiary undertaking of a parent undertaking of which P1 is also a subsidiary undertaking,for the performance by that health care professional, a locum provided by the provider of locums, or the corporate body of core dispensing functions at P1’s pharmacy premises;barrangements whereby a retail pharmacy business that is not P1 is nevertheless carrying on a retail pharmacy business at P1’s premises as a temporary arrangement related to the purchase of those premises; orcthe performance of any of P1’s core dispensing functions under valid hub and spoke arrangements.4For the purposes of this paragraph and paragraphs 7B and 7C, “hub and spoke arrangements” are arrangements between P1 and another retail pharmacy business (P2) which—aare for the purpose of P2 supporting P1with regard to the fulfilment of orders—isubmitted to P1 on prescription forms or LPIVs, oriifor the provision of prescription items by P1 in accordance with PTPs or PTPGDs; andbprovide for the assembly or part-assembly of those orders (including in accordance with a SSP) at premises of P2 with a view to the supply of the prescription items at or from the pharmacy premises of P1 to or for the use of the patients for whom they were ordered.5For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 7B and 7C, P1 must—ahave given notice in writing to NHS England of P1’s intention to sub-contract core dispensing functions—inot less than 28 days before the date on which the proposed arrangements are intended to commence, oriiby a date agreed with NHS England before which the proposed arrangements are to commence; andbhave taken reasonable steps, before entering into the arrangements, to satisfy itself of P2’s fitness to carry out core dispensing functions on behalf of P1.6A notice under sub-paragraph (5)(a) must include the particulars which have been approved by NHS England for the purposes of making such notifications.7For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 7B and 7C, they must have the following features—athey must provide, and ensure, that any prescription item that is assembled or part-assembled under the arrangements is supplied to or for the use of the patient for whom it is dispensed at or from the pharmacy premises of P1 (and so the arrangements must not allow P2 to fulfil the order directly);bin the case of an order for a medicine on a prescription form or LPIV, they must ensure that what is done, in the course of fulfilling the order, is done in a manner that ensures compliance with the requirements that are to be complied with for the supply from P2 to P1 of the medicine to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012 (assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses);cin the case of orders for prescription items that are not orders for medicines on a prescription form or a LPIV (“non-regulation-222A orders”)—ithey must relate to fulfilling both orders for medicines on prescription forms and non-regulation-222A orders, and accordingly P1 cannot only sub-contract to P2 core dispensing functions in respect of non-regulation-222A orders, andiithey must ensure that what is done, in the course of fulfilling the non-regulation-222A order, is done in a manner that would ensure compliance with the requirements that would need to be complied with for the supply from P2 to P1 of the prescription item, if it were instead of a medicine ordered on a prescription form or a LPIV, to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012;dthey must provide, and ensure, that P2 does not sub-contract any of the core dispensing functions that P2 performs on behalf of P1;ethey must provide for the discontinuation of the arrangements, as set out in paragraph 7B (in addition to any patient safety or commercial grounds P1 or P2 may have for discontinuing the arrangements); andfthey must not be or have become invalid by virtue of paragraph 7B.8If P1 has hub and spoke arrangements in place, P1 must also have in place, as part of P1’s business continuity plan required by paragraph 29D, business continuity arrangements which ensure that P1 is able to meet all P1’s obligations to provide dispensing services in the event of any temporary or permanent discontinuation or disruption of the hub and spoke arrangements.9P1 must give notice in writing to NHS England of any—atemporary discontinuation of hub and spoke arrangements that amounts to a suspension of those arrangements; orbpermanent discontinuation of hub and spoke arrangements,either before that discontinuation occurs or as soon as is reasonably practicable after it occurs, unless it is in response to a notice of objection from NHS England.7B1At any stage after receipt of a notice under paragraph 7A(5)(a), NHS England may request from P1 (as defined in paragraph 7A(1)) further information relating to the proposed or commenced hub and spoke arrangements that is relevant to one or more of the objection criteria, and if NHS England makes such a request, P1 must supply the requested information to NHS England promptly.2For the purposes of this paragraph, the objection criteria are—athe proposed or commenced hub and spoke arrangements do not have the features required by paragraph 7A(7), including where they have had them but they have lapsed;bin the case of commenced hub and spoke arrangements, they have the features required by paragraph 7A(7) but there has been a breach of those requirements;cthe proposed hub and spoke arrangements would put, or the commenced hub and spoke arrangements put, the safety of any persons to whom P1 provides pharmaceutical services at serious risk;dthe proposed hub and spoke arrangements would put, or the commenced hub and spoke arrangements put, NHS England at risk of material financial loss;ein the case of commenced hub and spoke arrangements, those arrangements have led to P1 repeatedly breaching P1’s terms of service, or to P1 breaching its terms of service in circumstances where P1 is likely to continue to do so repeatedly;fP2’s (as defined in paragraph 7A(4)) fitness to carry out core dispensing functions is impaired; orgin the opinion of NHS England, there are reasonable grounds for believing one or more of the objection criteria in paragraphs (a) to (f) are established.3NHS England may, before the commencement of proposed hub and spoke arrangements, issue a notice of objection to the proposed arrangements, based on one or more of the objection criteria and if it does so—aP1 must not commence the arrangements unless or until the notice of objection is withdrawn by NHS England; andbany arrangements that are commenced, in breach of this sub-paragraph, are invalid.4NHS England may, after the commencement of hub and spoke arrangements, issue a notice of objection to the arrangements, based on one or more of the objection criteria, and if it does so—athose arrangements become invalid; andbP1 must discontinue the arrangements promptly.5NHS England may withdraw a notice of objection issued under sub-paragraph (4), which has the effect of the arrangements to which the notice related no longer being invalid.6NHS England must, in a notice of objection, give its reasons for issuing the notice.7Subject to sub-paragraph (9), before issuing a notice under sub-paragraph (4), NHS England must make every reasonable effort to communicate and co-operate with P1 with a view to resolving the matter without the notice being issued.8Where P1 invites a Local Pharmaceutical Committee to participate in the attempts to resolve the matter referred to in sub-paragraph (7), NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the matter.9Sub-paragraphs (7) and (8) do not apply where NHS England is satisfied—aits concerns relate to a matter that has already been the subject of dispute resolution between NHS England and P1 and there are no new issues of substance to delay issuing the notice; orbthat it is appropriate to proceed immediately to issuing a notice—ito protect the safety of any persons to whom P1 may provide pharmaceutical services, oriito protect NHS England from material financial loss.10After issuing a notice of objection under sub-paragraph (3), or issuing a notice of objection under sub-paragraph (4) which was not delayed by virtue of sub-paragraph (7) or (8), NHS England must, where requested to do so by P1, make every reasonable effort to communicate and co-operate with P1 with a view to resolving the matter in a manner that may lead to the notice of objection being withdrawn.11Where P1 invites a Local Pharmaceutical Committee to participate in the attempts to resolve the matter referred to in sub-paragraph (10), NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the matter.12Sub-paragraphs (10) and (11) do not apply where NHS England is satisfied its concerns that led to the notice of objection being issued relate to a matter that has already been the subject of dispute resolution between NHS England and P1 and there are no new issues of substance to be resolved.7C1This paragraph applies to “relevant data”, which is data that relates to a patient and which is shared for the purpose of fulfilling an order under hub and spoke arrangements (as defined in paragraph 7A(4)) which is a non-regulation-222A order (as defined in paragraph 7A(7)(c)).2For the purposes of section 8(c) (lawfulness of processing: public interest etc) of, and paragraph 2(2)(a), (c) and (d) of Schedule 1 (special categories of personal data etc – health or social care purpose) to, the Data Protection Act 2018, sub-paragraph (3) applies to the processing of any relevant data—aby P1 or P2 (as defined in paragraph 7A(1) and (4)) which relates to a patient; andbwhich is necessary for the purposes of—ifulfilling an order of a type mentioned in paragraph 7A(4)(a) under valid hub and spoke arrangements, oriidischarging any related professional obligations to the patient (including obligations relating to the keeping of records).3That processing is—anecessary for the performance of a task carried out in the public interest; andbif the data is personal data concerning health, necessary for the purposes of preventative medicine, medical diagnosis or for the provision of health care or treatment.4Any person (P3) who—ais employed or engaged by P1 or P2; andbin the course of being so employed or engaged is required to undertake the processing of data described in sub-paragraph (2),owes a duty of confidentiality in respect of that data (whether or not they would do so but for this sub-paragraph).5The duty in paragraph (4)—ais a duty of confidentiality which, if not owed by a health care professional, is owed under an enactment or rule of law for the purposes of section 11(1)(b) of the Data Protection Act 2018 (special categories of personal data etc: supplementary); andbis such that, if the processing is necessary for the purposes described in sub-paragraph (2)(b), P3 is able, lawfully, to process that data by virtue of this paragraph.6For the purposes of sub-paragraph (2)(b)(ii), a professional obligation to a patient is to be regarded as such notwithstanding that discharging the obligation may—aalso be an obligation that arises in some other way (for example, arising from a duty of care); orbbe done by a person who is not a health care professional.7Sub-paragraphs (2) and (3) do not apply where, in reliance or purported reliance on valid hub and spoke arrangements, a person processes any data which relates to a patient but, in the course of the doing of anything that relates to the fulfilling of the order to which that data relates, there is a breach of—athe requirements to be fulfilled if what is done is to be treated as part of valid hub and spoke arrangements; orba duty of confidentiality owed in respect of the data by a health care professional or under an enactment or rule of law as mentioned in sub-paragraph (5)(a).8Words and expressions used in both—asub-paragraphs (1) to (7); andbParts 1 and 2 (preliminary and general processing) of, and paragraphs 2(2)(a), (c) and (d) of Schedule 1 to, the Data Protection Act 2018,bear the meanings they bear in those provisions of the Data Protection Act 2018.81Where an NHS pharmacist (P) is presented with, or receives from the Electronic Prescription Service, a prescription form or a repeatable prescription, P must only provide the drugs or appliances so ordered—aif the prescription form or repeatable prescription is duly signed and completed as described in paragraph 5(2) or (3); andbin accordance with the order on the prescription form or repeatable prescription,subject to any regulations in force under the Weights and Measures Act 1985 and the following provisions of this Part.2Drugs or appliances so ordered shall be provided either by or under the direct supervision of a registered pharmacist.2ASubject to sub-paragraphs (2B) to (2E) and without prejudice to sub-paragraphs (10) and (11), for the purposes of sub-paragraph (1)(b), a drug is provided in accordance with the order on a prescription form or repeatable prescription if (in addition to where the provision is exactly in accordance with the order)—aa different quantity is provided to that ordered on the prescription form or repeatable prescription in order to allow for the provision of the drug in its manufacturer’s original outer packaging; andbthe provision is otherwise in accordance with the order.2BIn the case of an order for a prescription only medicine, sub-paragraph (2A) only applies if sub-paragraph (8) applies or one of the following applies—athe provision is in accordance with regulation 217B(1) to (3) of the Human Medicines Regulations 2012 (original pack dispensing), and accordingly, regulation 217B(1) to (3) of those Regulations is expressly applied to such supplies; orbthe medicine must be provided in the manufacturer’s original outer packaging in order to comply with regulation 217C of the Human Medicines Regulations 2012 (original pack dispensing: medicinal products containing a relevant substance).2CIn the case of an order for a drug that is not a prescription only medicine, sub-paragraph (2A) only applies if sub-paragraph (8) applies or the provision of a different quantity to that ordered on the prescription is in circumstances where—athe different quantity is no more than 10% greater or no more than 10% less than the quantity ordered; andbthe registered pharmacist carrying out or directly supervising the provision does not consider, in the exercise of their professional skill and judgement, that the provision of a different quantity to that ordered may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber.2DWhere P may, pursuant to sub-paragraph (2A) and sub-paragraph (2B)(a) or (2C)(a) and (b), provide a different quantity of a drug to that ordered on a prescription form or a repeatable prescription, P must consider, in the exercise of their professional skill and judgement, whether it is reasonable and appropriate to do so, having regard to the benefits to patients where they are provided with drugs in their manufacturer’s original outer packaging.2ESub-paragraphs (2B)(a) and (2C)(a) and (b) do not apply to the provision of any drug which is—afor the time being specified in Schedules 2 to 4 of the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain provisions under the Regulations); orba special medicinal product for the purposes of regulation 167 of the Human Medicines Regulations 2012 (supply to fulfil special patient needs).3Where the registered pharmacist referred to in sub-paragraph (2) is employed or engaged by P, the registered pharmacist must not be someone—awho is disqualified from inclusion in a relevant list; orbwho is suspended from the GPhC register.4If the order is for , or a product to be provided in accordance with a SSP is, an appliance of a type requiring measuring and fitting (for example a truss), P must make all necessary arrangements for a registered pharmacist—ato measure the person named on the prescription form or repeatable prescription for the appliance; andbto fit the appliance.5If the order is for , or a product to be provided in accordance with a SSP is, a drug or appliance included in the Drug Tariff, the British National Formulary (including any Appendix published as part of that Formulary), the Dental Practitioner's Formulary, the European Pharmacopoeia or the British Pharmaceutical Codex, the drug or appliance provided must comply with any relevant standard or formula specified therein.6If the order—ais an order for a drug; butbis not an order for a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under the Regulations),and does not prescribe its quantity, strength or dosage, P (in this context, a registered pharmacist) may provide the drug in such strength and dosage as in the exercise of their professional skill, knowledge and care P considers to be appropriate and, subject to sub-paragraph (7), in such quantity as P considers to be appropriate for a course of treatment for a period not exceeding 5 days.7Where an order to which sub-paragraph (6) applies is for—aan oral contraceptive substance;ba drug, which is available for supply as part of pharmaceutical services only together with one or more other drugs; orcan antibiotic in a liquid form for oral administration in respect of which pharmaceutical considerations require its provision in an unopened package,which is not available for provision as part of pharmaceutical services except in such packages that the minimum size available contains a quantity appropriate to a course of treatment for a period of more than 5 days, P may provide the minimum size available package.8Where any drug to which this paragraph applies (that is, a drug that is not one to which the Misuse of Drugs Act 1971 applies, unless it is a drug for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001), ordered by a prescriber on a prescription form or repeatable prescription, is available for provision by P in a pack in a quantity which is different to the quantity which has been so ordered, and that drug is—asterile;beffervescent or hygroscopic;ca liquid preparation for addition to bath water;da coal tar preparation;ea viscous preparation; orfpacked at the time of its manufacture in a special container,P must provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.9In this paragraph, “special container” means any container with an integral means of application or from which it is not practicable to dispense an exact quantity.10Subject to sub-paragraph (11), where a drug is ordered by a prescriber on a prescription form or a repeatable prescription , or is to be provided in accordance with a SSP, in a quantity that is, or is a multiple of a quantity that is, readily available in a pack size manufactured for a UK marketing authorisation holder for the drug, P must provide the drug in an original pack (or in original packs) of that size which has been assembled by a manufacturer of the drug for such a UK marketing authorisation holder, unless—ait is not possible for P to obtain such a pack (or packs) with reasonable promptness in the normal course of business; orbit is not practicable for P to provide such a pack (or packs) in response to the order (for example, because of patient needs or the method of administration of the drug).11In the case of oral liquid methadone, P (in practice, a registered pharmacist) must decide whether it would be most appropriate to provide—aeach dose in a separate container;ban original pack (or original packs); orcthe oral liquid methadone in some other way,and P must then provide it in packaging that accords with that decision.12P must only provide a Scheduled drug in response to an order by name, formula or other description on a prescription form or repeatable prescription if—ait is ordered as specified in sub-paragraph (13); orbin the case of a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances), it is ordered in the circumstances prescribed in that Schedule.13A Scheduled drug that is a drug with an appropriate non-proprietary name may be provided in response to an order on a prescription form or repeatable prescription for a drug (“the prescribed drug”) that is not a Scheduled drug but which has the same non-proprietary name as the Scheduled drug if—athe prescribed drug is ordered by that non-proprietary name or by its formula;bthe prescribed drug has the same specification as the Scheduled drug (so the Scheduled drug may be dispensed generically); andcthe Scheduled drug is not in a pack which consists of a drug in more than one strength, and providing it would involve the supply of part only of the pack.14If a Scheduled drug is a combination of more than one drug, it can only be ordered as specified in sub-paragraph (13) if the combination has an appropriate non-proprietary name, whether or not the drugs in the combination each have such names.15P must provide any drug which P is required to provide under paragraph 5 or 5C , or provides under paragraph 5A or 5B, in a suitable container.16Where P provides a drug or appliance under paragraph 5A, P must include in the dispensing label on the packaging of the product, for the patient’s benefit, information to the effect that the product is being supplied in accordance with a SSP, identifying the particular SSP.17Sub-paragraphs (5) to (10) apply to the provision of a drug in accordance with a LPIV, a PTP or a PTPGD as they apply to the provision of a drug in accordance with a prescription form or a repeatable prescription (or an associated batch issue).18Where P provides a drug under paragraph 5B, P must include a dispensing label on the packaging of the product and include in the label (in addition to the particulars required or permitted by Part 2 of Schedule 26 to the Human Medicines Regulations 2012), for the patient’s benefit, information to the effect that the product is being supplied in accordance with a PTP or a PTPGD, identifying the particular PTP or PTPGD.91An NHS pharmacist (P) may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—aP reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example because P reasonably believes it has been stolen or forged);bit appears to P that there is an error on the prescription form or on the repeatable prescription or, in the case of a non-electronic repeatable prescription, its associated batch issue (including a clinical error made by the prescriber) or that, in the circumstances, providing the drugs or appliances would be contrary to P's (in practice, a registered pharmacist's) clinical judgement;cP or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or by any person accompanying that person;dthe person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or any other person accompanying that person, commits or threatens to commit a criminal offence; orethe prescription form or repeatable prescription is incomplete because it does not include the information relating to the identification of the prescriber that NHS England (or a person exercising its functions) requires in order to perform its functions relating to—ithe remuneration of persons providing pharmaceutical services, andiiany apportionment of, or any arrangements for recharging in respect of, that remuneration,unless P (or the person who employs or engages P) is to receive no pharmaceutical remuneration of any kind in respect of the drug or appliance.2P must refuse to provide a drug ordered on a prescription form or repeatable prescription where the order is for a prescription only medicine which the prescriber was not entitled to prescribe.2AP may refuse to provide a drug or appliance ordered on an electronic prescription if the access that P has to the Electronic Prescription Service is not such as to enable P to dispense that prescription promptly (or at all) , but where P does so, P must take all reasonable steps to ensure that the product ordered by the prescriber is supplied within a reasonable timescale, which may include (depending on what steps or combination of steps the circumstances require)—aproviding details of other NHS pharmacists or LPS chemists whose premises are situated in the same area and who may be able to provide the product ordered by the prescriber;burgent supply without a prescription in accordance with paragraph 6;carranging for the urgent provision of a non-electronic prescription form by the prescriber.2BP must refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—aa SSP has effect in respect of—ithe requested drug or appliance, oriidrugs or appliances of a specified description, and the requested drug or appliance is of that description; andbalternative provision has already taken place in accordance with the SSP.2CP may refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—aa SSP has effect in respect of—ithe requested drug or appliance, oriidrugs or appliances of a specified description, and the requested drug or appliance is of that description;ba registered pharmacist is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; andcP is unable to provide the drug or appliance within a reasonable timescale,but if P does refuse to do so, P must provide the patient or the person requesting the drug or appliance on behalf of a patient with appropriate advice, as necessary, about reverting to the prescriber for the prescriber to review the patient’s treatment.3P must refuse to provide drugs or appliances ordered on a repeatable prescription where—aP has no record of that prescription (other than on the first occasion on which the prescription is presented);bP does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to P;cit is not signed by a prescriber;dto do so would not be in accordance with any intervals specified in the prescription;eit would be the first time a drug or appliance had been provided pursuant to the prescription and the prescription was signed (whether electronically or otherwise) more than 6 months previously;fthe repeatable prescription was signed (whether electronically or otherwise) more than one year previously;gthe expiry date on the repeatable prescription has passed; orhP has been informed by the prescriber that the prescription is no longer required.4Where a patient requests the supply of drugs or appliances ordered on a repeatable prescription (other than on the first occasion that the patient makes such a request), P must only provide the drugs or appliances ordered if P is satisfied—athat the patient to whom the prescription relates—iis taking or using, and is likely to continue to take or use, the drug or appliance appropriately, andiiis not suffering from any side effects of the treatment which indicates the need or desirability of reviewing the patient's treatment;bthat the medication regimen of, or manner of utilisation of the appliance by, the patient to whom the prescription relates has not altered in a way which indicates the need or desirability of reviewing the patient's treatment; andcthere have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient's treatment.5P may refuse to fulfil an order or a request for a drug that is or is purportedly in accordance with a LPIV, a PTP or a PTPGD where—aP reasonably believes it is not a genuine order or valid request for the person who requests, or on whose behalf is requested, the provision of the drug;bproviding it would be contrary to P’s clinical judgement;cP or other persons are subjected to or threatened with violence by the person who requests the provision of the drug, or by any person accompanying that person; ordthe person who requests the provision of the drug, or any person accompanying that person, commits or threatens to commit a criminal offence.6P must refuse to provide, pursuant to a LPIV, a PTP or a PTPGD, an order or a request for a drug that is or is purportedly in accordance with the LPIV, the PTP or PTPGD where P is not satisfied that it is in accordance with the LPIV, the PTP or PTPGD .7P may refuse to provide a prescription item ordered on a prescription form or repeatable prescription where—amore than one prescription item has been ordered on the prescription form or repeatable prescription;bat least one of those prescription items is a listed HRT prescription item and at least one of those prescription items is not; andcthe person named on the prescription form or repeatable prescription is claiming entitlement to exemption under regulation 10(1)(j) of the Charges Regulations (exemptions) in respect of any of those prescription items which is a listed HRT prescription item.101In connection with the services provided under paragraph 4, an NHS pharmacist (P) must—aensure that appropriate advice is given to patients about any drugs or appliances provided to them—ito enable them to utilise the drugs or appliances appropriately, andiito meet the patient's reasonable needs for general information about the drugs or appliances;bprovide appropriate advice to patients to whom they provide drugs or appliances on—ithe safe keeping of the drugs or appliances, andiireturning unwanted drugs or appliances to the pharmacy premises for safe destruction;cwhen providing drugs to patients in accordance with a repeatable prescription, provide appropriate advice in particular on the importance of only requesting those items which they actually need;dwhen providing appliances to patients in accordance with a prescription form or repeatable prescription—iprovide appropriate advice in particular on the importance of only requesting those items which they actually need, andiifor those purposes, have regard to the details contained in the records maintained under paragraph (f) in respect of the provision of appliances and prescribing pattern relating to the patient in question;daensure that appropriate advice about the benefits of repeat dispensing is given to any patient who—ihas a long term, stable medical condition (that is, a medical condition that is unlikely to change in the short to medium term), andiirequires regular medicine in respect of that medical condition,including, where appropriate, advice that encourages the patient to discuss repeat dispensing of that medicine with a prescriber at the provider of primary medical services whose patient list the patient is on;eprovide a patient with a written note (which may be in an electronic form) of any drug or appliance which is owed, and inform the patient when it is expected that the drug or appliance will become available;fkeep and maintain records—iof drugs and appliances provided, in order to facilitate the continued care of the patient;iiin appropriate cases, of advice given and any interventions or referrals made (including clinically significant interventions in cases involving repeatable prescriptions), andiiiof notes provided under sub-paragraph (e);g. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .hif P takes possession of a non-electronic repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue;iif P provides a drug or appliance under an electronic prescription, provide the patient, if the patient so requests, with a written record of the drugs or appliances ordered on that prescription and, in the case of an electronic repeatable prescription, of the number of occasions on which it can be dispensed;jmaintain records of repeatable prescriptions in such a form as to provide a clear audit trail of supplies under the repeatable prescription (including dates and quantities supplied);kdestroy any surplus batch issues relating to drugs or appliances—iwhich are not required, oriiwhere a patient is refused the drugs or appliances pursuant to paragraph 9;lensure that where a person is refused drugs or appliances pursuant to paragraphs 9(1)(b), (2), (3) or (4), the patient is referred back to the prescriber for further advice;mwhere a patient is provided with drugs or appliances under a repeatable prescription, notify the prescriber of any clinically significant issues arising in connection with the prescription and keep a record of that notification;nnotify the prescriber of any refusal to provide drugs or appliances pursuant to paragraph 9(4);owhen providing appliances, provide a patient with a written note of P's name, address and telephone number; andpwhen providing specified appliances, comply with the additional requirements set out in paragraph 12.2Where, on presentation of a prescription form or repeatable prescription in connection with the dispensing services under paragraph 4, P is unable (having regard to any relevant SSP) to provide an appliance, or stoma appliance customisation is required and P is unable to provide that, P shall—aif the patient consents, refer the prescription form or repeatable prescription to another NHS pharmacist or to an NHS appliance contractor; andbif the patient does not consent to a referral, provide the patient with contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to P.111An NHS pharmacist (P) must, if requested to do so by any person—a. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .bwhere the Electronic Prescription Service is temporarily unavailable through P's pharmacy premises, provide that person with contact details of at least 2 NHS pharmacists in the area at or from whose premises the service is available, if these details are known to P.2... P must, if requested to do so by any person, enter in that person's PDS patient details—awhere the person does not have a nominated dispensing contractor, a nominated dispensing contractor; orbwhere the person does have a nominated dispensing contractor—ia replacement dispensing contractor, oriia further dispensing contractor,chosen by that person.3Sub-paragraph (2)(b)(ii) does not apply if the number of nominated dispensing contractors for that person would thereby exceed the maximum number permitted by the Electronic Prescription Service.4Regulation 116(a) to (c) applies to a request under this paragraph as it applies to an application to an NHS chemist for pharmaceutical services.5If P is a nominated dispensing contractor for a person (X) but the nomination was made before P became the person listed in a pharmaceutical list in relation to the pharmacy premises nominated in X's PDS patient details, P must within 6 months of P becoming the person so listed—aexplain to X that the ownership of the pharmacy premises has changed; andbask X whether X wishes to maintain the nomination in respect of those pharmacy premises.6If P dispenses an electronic prescription or makes an urgent supply without a prescription, P must send the form duly completed by or on behalf of the patient, if one is required under regulation 3(3)(b) or (c), (5C) or (5E) of the Charges Regulations in respect of that prescription (which may be the associated EPS token), to the NHS BSA.121This paragraph sets out the additional requirements referred to in paragraph 10(1)(p) relating to the provision of specified appliances.2An NHS pharmacist (P) who dispenses specified appliances in the normal course of business must provide a home delivery service in respect of those appliances and, as part of that service—aP must offer to deliver the specified appliance to the patient's home;bif the patient accepts that offer, the delivery must be made with reasonable promptness and at such time as is agreed with the patient;cthe specified appliance must be delivered in a package which displays no writing or other markings which could indicate its content; anddthe manner of delivery of the package and any supplementary items required by sub-paragraph (3) must not convey the type of appliance being delivered.3In any case where a specified appliance is provided (whether by home delivery or otherwise), P must provide a reasonable supply of appropriate supplementary items (such as disposable wipes and disposal bags) and—amust ensure that the patient may, if the patient wishes, consult a person to obtain expert clinical advice regarding the appliance; orbif P believes it is appropriate to do so, must—irefer the patient to a prescriber, oriioffer the patient an appliance use review service.4If P is unable to provide an appliance use review service in accordance with sub-paragraph (3)(b)(ii), P must give the patient the contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to arrange for the service to be provided, if these details are known to P.5Where P provides a telephone care line in respect of the dispensing of any specified appliance, P must ensure that during out of hours periods—aadvice is made available to patients through that telephone care line; orb telephone or website contact details for providers of NHS services that may be consulted for advice regarding specified appliances during those periods, are made available to patients through that telephone care line.6For the purposes of this paragraph—“expert clinical advice”, in relation to a specified appliance, means advice which is given by a person who is suitably trained and who has relevant experience in respect of the appliance;“out of hours periods”, in relation to pharmacy premises, means the periods outside the core opening hours and any supplementary opening hours of the premises.13An NHS pharmacist must, to the extent paragraph 14 requires and in the manner described in that paragraph, accept and dispose of unwanted drugs presented to the NHS pharmacist for disposal.141Subject to paragraph (2), where a person presents to an NHS pharmacist (P) any drugs provided for a patient in, and which have been kept in—aa private household; orba children's home; orca residential care home, that is to say an establishment which exists wholly or mainly for the provision of residential accommodation, together with board and personal care, for persons in need of personal care because of—iold age,iimental or physical disability,iiipast or present dependence on alcohol or drugs,ivany past illnesses, orvpast or present mental disorder,P must accept the drugs and dispose of them in accordance with sub-paragraph (3).2P is not required to accept any drugs for disposal unless NHS England has made arrangements for the collection and disposal of drugs of that description.3On receipt of the drugs, P must—awhere required to do so by NHS England or by a waste disposal contractor retained by NHS England, separate solid drugs or ampoules, liquids and aerosols from each other;bstore the drugs in containers provided by NHS England, or by a waste disposal contractor retained by NHS England, for the purpose of storing drugs of that description; andccomply with any other statutory requirements in respect of storing or the disposal of drugs of that description (meeting those requirements are therefore an essential service for the purposes of these Regulations),and shall co-operate with any suitable arrangements that NHS England has in place for regular collection of the drugs from P's pharmacy premises by or on behalf of NHS England.15In connection with the services provided under paragraph 13, an NHS pharmacist (P) must—aensure that P (including P's staff) is aware of the risks associated with the handling of waste drugs and the correct procedures to be used to minimise those risks; andbensure that P (including P's staff) has readily available, and close to any place where waste drugs are stored, appropriate protective equipment, including gloves, overalls and materials to deal with spillages.16An NHS pharmacist must, to the extent paragraphs 17 and 18 require, and in the manner set out in those paragraphs, promote public health messages to members of the public.171Where a person using a pharmacy—apresents a non-electronic prescription form or non-electronic repeatable prescription to an NHS pharmacist (P) or requests the provision of drugs or appliances in accordance with an electronic prescription; andbit appears to P that the person—ihas diabetes,iiis at risk of coronary heart disease, especially those with high blood pressure, oriiismokes or is overweight,P must, as appropriate, provide advice to that person with the aim of increasing that person's knowledge and understanding of the health issues which are relevant to that person's personal circumstances.2Advice given under sub-paragraph (1) may be backed up, as appropriate—aby the provision of written material (for example leaflets); andbby referring the person to other sources of information or advice.3P must, in appropriate cases, keep and maintain a record of advice given pursuant to this paragraph, and that record must be in a form that facilitates—aauditing of the provision of pharmaceutical services by P; andbfollow-up care for the person who has been given the advice.18An NHS pharmacist (P) must, at the request of NHS England, ensure that—aP (including P's staff) participates, in the manner reasonably requested by NHS England, in up to 6 campaigns in each financial year to promote ... health messages to users of P's pharmacy;bwhere requested to do so by NHS England, P records the number of people to whom P (including P's staff) has provided information as part of one of those campaigns ; andcwhere requested to do so by NHS England, P sends to NHS England by means of an electronic communication of the type specified in the request—ithe number recorded pursuant to sub-paragraph (b), andiiinformation which is reasonably requested by NHS England, and which is in an anonymised form if it would otherwise identify any person to whom information was provided as part of the campaign, for the purposes of evaluating the effectiveness of the campaign and policy development.19An NHS pharmacist must, to the extent paragraph 20 requires and in the manner set out in that paragraph, provide information to users of the NHS pharmacist's pharmacy about other health and social care providers and support organisations.201Where it appears to an NHS pharmacist (P), having regard to the need to minimise inappropriate use of health and social care services and of support services, that a person using P's pharmacy—arequires advice, treatment or support that P cannot provide; butbanother provider, of which P is aware, of health or social care services or of support services is likely to be able to provide that advice, treatment or support,P must provide contact details of that provider to that person and must, in appropriate cases, refer that person to that provider.2Where, on presentation of a prescription form or repeatable prescription, P is unable to provide an appliance or stoma appliance customisation because the provision of the appliance or customisation is not within P's normal course of business, P must—aif the patient consents, refer the prescription form or repeatable prescription to another NHS pharmacist or to an NHS appliance contractor; andbif the patient does not consent to a referral, provide the patient with contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to P.3Where appropriate, a referral under this paragraph may be made by means of a written referral note.4P must, in appropriate cases, keep and maintain a record of any information given or referral made under this paragraph and that record must be in a form that facilitates—aauditing of the provision of pharmaceutical services by P; andbfollow-up care for the person who has been given the information or in respect of whom the referral has been made.21An NHS pharmacist must, to the extent paragraph 22 requires and in the manner set out in that paragraph, provide advice and support to people caring for themselves or their families.221Where it appears to an NHS pharmacist (P), having regard to the need to minimise the inappropriate use of health and social care services, that a person (X) using P's pharmacy would benefit from advice from P to help X manage a medical condition (including, in the case of a carer, to help X in assisting in the management of another person's medical condition), P must provide advice to X as regards managing the medical condition, including, as appropriate, advice—aon treatment options, including advice on the selection and use of appropriate drugs which are not prescription only medicines; andbon changes to the patient's lifestyle.2P must, in appropriate cases, keep and maintain a record of any advice given under sub-paragraph (1), and of any drugs supplied when the advice was given, and that record shall be in a form that facilitates—aauditing of the provision of pharmaceutical services by P; andbfollow-up care for the person to whom or in respect of whom the advice has been given.22A1Before dispensing any item on a prescription form or supplying it in accordance with a serious shortage protocol, an NHS pharmacist (P) must provide a home delivery option to eligible patients in respect of the item where, as a consequence of a disease being or in anticipation of a disease being imminently—apandemic; andba serious risk or potentially a serious risk to human health,NHS England with the agreement of the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are advised to stay away from pharmacy premises in the area specified, in the circumstances specified and for the duration of the period specified in the announcement.2If P’s pharmacy premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from P’s pharmacy, P must ascertain from—aan eligible patient—iwho has contacted P about the home delivery of prescription items, oriiwho is a person whom P considered, on the basis of the nature of an item on a prescription form, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; orba person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted P about the home delivery of prescription items,whether or not the item could be supplied by a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which P must provide.3Where paragraph (2) does not apply, if P’s pharmacy premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from P’s pharmacy, the home delivery option that P must provide must comprise—aP delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);bP arranging for an item dispensed by P to be delivered by another NHS pharmacist or by an LPS contractor to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; orcif P is unable to deliver the item or arrange for its delivery by another NHS pharmacist or by an LPS contractor, P arranging for the dispensing or supply of the item by another NHS pharmacist or by an LPS contractor who would be able to deliver the dispensed item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.4Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at P’s pharmacy premises for the purposes of receiving dispensing services.5Notwithstanding the foregoing provisions of this Part, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, P may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.6Where arrangements are in place which enable an NHS pharmacist to make a delivery as mentioned in sub-paragraph (3)(a) or (b) as part of a directed service, the NHS pharmacist must deliver the item as part of that directed service.7This paragraph does not apply to an NHS pharmacist in respect of distance selling premises.22AA1Before dispensing a notified item on a prescription form or supplying it in accordance with a serious shortage protocol, a PTP or a PTPGD, an NHS pharmacist (P) must provide a home delivery option to eligible patients in respect of that item.2For the purposes of this paragraph, a “notified item” is an item that, as a consequence of a disease being or in anticipation of a disease being imminently—apandemic; andba serious risk or potentially a serious risk to human health,is the subject of an announcement made by NHS England, with the agreement of the Secretary of State, to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are entitled to be provided with a home delivery option in respect of that item, if it is supplied to them as part of pharmaceutical services.3Where P is to, or may be required to, dispense a notified item on a prescription form or supply it in accordance with a serious shortage protocol, a PTP or a PTPGD, P must ascertain from—aan eligible patient—iwho has contacted P about the home delivery of a notified item, oriiwho is a person whom P considered, on the basis of an order or request for a notifiable item, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; orba person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted P about the home delivery of a notified item,whether or not the item could be supplied via a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which P must provide.4Where paragraph (3) does not apply, the home delivery option that P must provide must comprise—aP delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);bP arranging for an item dispensed by P to be delivered by another NHS pharmacist or by an LPS contractor to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; orcif P is unable to deliver the item or arrange for its delivery by another NHS pharmacist or by an LPS contractor, P arranging for the dispensing or supply of the item by another NHS pharmacist or by an LPS contractor who would be able to deliver the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.5Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at P’s pharmacy premises for the purposes of being supplied with the notifiable item.6Notwithstanding the foregoing provisions of this Part, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, P may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.7Where arrangements are in place which enable an NHS pharmacist to make a delivery as mentioned in sub-paragraph (4)(a) or (b) as part of a directed service, the NHS pharmacist must deliver the item as part of that directed service.8This paragraph does not apply to an NHS pharmacist in respect of distance selling premises.22BAn NHS pharmacist (P) must, to the extent that paragraph 22C requires and in the manner set out in that paragraph, provide advice, assistance and support to and in respect of a health service patient—arecently discharged from hospital who is referred to P for advice, assistance and support in respect of the patient’s medication regimen by the staff of the hospital in which the patient stayed; orbwho is otherwise referred to P for advice, assistance and support in respect of the patient’s medication regimen by the staff of an NHS trust or NHS foundation trust as part of arrangements linked to the transfer of care between different providers of NHS services.22C1An NHS pharmacist (P) must have procedures in place (as part of its standard operating procedures) for checking at appropriate intervals on days on which P’s pharmacy premises are open for business whether P has received any referrals, which are in the form and manner approved for this purpose by NHS England, for the services set out in this paragraph (“DMS referrals”).2If P receives a DMS referral in respect of a health service patient (X) requesting from P stage 1 of the service (as well as stages 2 and 3), P must, as soon as possible but in any event within 72 hours of receiving the DMS referral (excluding hours of days on which the pharmacy premises are not open for business), as stage 1 of the service—areview the actions requested, and act on those requested actions, to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so;buse the information that P has or is able to access about X’s medication regimen before the discharge or transfer to compare it (so far as is possible) with X’s medication regimen on discharge or transfer;ccheck any prescriptions for X that P may be asked to dispense (including electronic repeatable prescriptions) or has part dispensed in order to assess whether, in P’s clinical judgement, any changes are appropriate or there are any other issues of concern;dwhere necessary, discuss changes that may be appropriate or raise any issues of concern identified, to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so with—ithe staff of the hospital or other provider of NHS services that made the referral, andiiany provider of primary medical services on whose patient list X is; andekeep and maintain records of the DMS referrals received and of any actions taken, as appropriate (in particular, to support delivery of stages 2 and 3 of the service).3This sub-paragraph applies—aif P receives—iin respect of X an electronic prescription for a medicinal product or is presented by X with a non-electronic prescription form, a non-electronic repeatable prescription or an EPS token in respect of a medicinal product, andiiis on notice as a result of a DMS referral requesting from P stage 2 of the service (whether or not it is the referral mentioned in sub-paragraph (2)) that the prescription is the first prescription for a medicinal product to be dispensed by P to X following X’s discharge from hospital or the transfer of X’s care between different providers of NHS services; orbin the following circumstances—iP receives in respect of a health service patient (Y) an electronic prescription for a medicinal product or is presented by Y with a non-electronic prescription form, a non-electronic repeatable prescription or an EPS token in respect of a medicinal product,iiP is on notice as a result of a DMS referral requesting from P stage 2 of the service (and potentially stage 3) that it is the first prescription for a medicinal product to be dispensed to Y following Y’s discharge from hospital or the transfer of Y’s care between different providers of NHS services (a different NHS pharmacist having provided stage 1 of the service in respect of Y), andiiiP is on notice that Y, or where appropriate a carer of Y, wishes P to provide the services described in sub-paragraphs (4) and (5) to or in respect of Y.4Where sub-paragraph (3) applies, P must, as stage 2 of the service, prior to or as part of the process of dispensing the prescription—areview (or further review) the medication regimen of X or Y, using the information that P has or is able to access about that medication regimen, including from the prescription, in order to assess whether, in P’s clinical judgement, appropriate account has been taken of any changes to X’s or Y’s medication regimen during X’s or Y’s stay in hospital or prior to the transfer of X’s or Y’s care between different providers of NHS services;bif any issues of concern are identified, raise these to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so with any provider of primary medical services on whose patient list X or Y is; andckeep and maintain records of any actions taken as part of this stage of the process, as appropriate (in particular, to support delivery of stage 3 of the service).5At the point at which P, in P’s clinical judgement is to, or would normally, discuss the prescription as mentioned in paragraph (3)(a)(i) or (b)(i) with X or Y, or where appropriate with a carer of X or Y, P must, as stage 3 of the service—aengage in a discussion with X or Y, or where appropriate a carer of X or Y, in a manner which is in accordance with P’s duty of confidentiality to X or Y and which is—ito assess their understanding of what medicinal products X or Y should be taking, andiito offer to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so advice, assistance and support in respect of X’s or Y’s medication regimen;bdraw to X’s or Y’s attention (where appropriate via a carer of X or Y)—iP’s disposal service in respect of unwanted drugs, andiiany other pharmaceutical services that P, in the exercise of P’s clinical judgement, considers X or Y may benefit from following X’s or Y’s stay in hospital or the transfer of X’s or Y’s care between different providers of NHS services;cif any issues of concern are identified, raise these to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so with any provider of primary medical services on whose patient list X or Y is; anddkeep and maintain records, as appropriate—iof the discussion pursuant to paragraphs (a) and (b), and of any raising of concerns and any actions taken, andiifor service evaluation purposes.6If the DMS referral requesting that P provides services under this paragraph includes circumstances in which P is not to provide, or is to cease to provide, services under this paragraph, P is not to, or is to cease to, provide services under this paragraph in those circumstances (for example, X’s or Y’s admission or re-admission to hospital).PART 3231Subject to paragraph 23A, an NHS pharmacist (P) must ensure that pharmaceutical services are provided at or from P's pharmacy premises—afor 40 hours each week;bfor not less than 100 hours each week, in the case of premises in respect of which a 100 hours condition applies;cif NHS England or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at or from the premises for fewer than 40 hours per week, provided that the person listed in relation to them provides those services at set times and on set days, at the times and on the days so set;dif a Primary Care Trust, or on appeal the Secretary of State, has (under previous Regulations) directed that pharmaceutical services are to be provided at or from the premises for more than 40 hours per week, and at set times and on set days, at the times and on the days so set , subject to any variation in respect of a rest break in accordance with sub-paragraph (7)(bd); oreif NHS England or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at or from the premises for more than 40 hours each week, but only on set times and on set days as regards the additional opening hours , or the core opening hours where paragraph 26(4A) applied to the issuing of the direction—ifor the total number of hours each week required by virtue of that direction, andiias regards the additional opening hours for which the person listed in relation to the premises is required to provide pharmaceutical services by virtue of that direction, at the days on which and times at which that person is required to provide pharmaceutical services during those additional opening hours, as set out in that direction , subject to any variation in respect of a rest break in accordance with sub-paragraph (7)(bd),but NHS England may, in appropriate circumstances, agree a temporary suspension of services for a set period, where it has received 3 months notice of the proposed suspension.2The hours during which pharmacy premises must be open by virtue of sub-paragraph (1) are referred to in these Regulations as “core opening hours”.3P must notify NHS England of other hours during which P's pharmacy premises are to be open, which are hours in addition to P's core opening hours (and which are referred to in these Regulations as “supplementary opening hours”).4Unless P is a distance selling chemist, at P's pharmacy premises P must exhibit—aa notice specifying the days on which and times at which the premises are open for the provision of drugs and appliances (including times at which P is providing pharmaceutical services during supplementary opening hours); andbat times when the premises are not open, a notice based on information provided by NHS England, where practicable legible from outside the premises, specifying—ithe addresses of other NHS pharmacists and the days on which and times at which drugs and appliances may be obtained from those addresses, andiithe addresses of LPS chemists in the area, the type of local pharmaceutical services which those LPS chemists provide, and the days on which and times at which their premises are open.5P must, on request, submit a return to NHS England setting out—athe days on which and times at which pharmaceutical services are provided at or from P's pharmacy premises (including times at which P is providing pharmaceutical services during supplementary opening hours); andbthe pharmaceutical services which P ordinarily provides at or from those premises.6Where P changes—athe supplementary opening hours of P's pharmacy premises; orbthe pharmaceutical services which P ordinarily provides at or from those premises,P must supply NHS England with a return informing it of the change before the change takes place.7Where P has notified to NHS England (or, before the appointed day, a Primary Care Trust) the days on which and times at which pharmaceutical services are to be provided at or from P's pharmacy premises (for example, in a return under sub-paragraph (5) or (6) or in an application for inclusion in a pharmaceutical list)—aP must ensure that pharmaceutical services are provided at or from the premises to which the notification relates on the days and at the times set out in the notification (unless the notification has been superseded by a return, or a further return, under sub-paragraph (6)); ...baP must not change the days on which or the times at which pharmaceutical services are to be provided at or from those premises during core opening hours, except for making a change that—iamounts to the inclusion of a rest break which is no longer than one hour, or a change to such a rest break—aaon a Monday to Saturday, which starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours, orbbon a Sunday, andiidoes not change the total number of P’s core opening hours on a particular day,otherwise than as provided for, and in accordance with the procedures set out in, paragraphs 25 and 26;bbP must not change P’s supplementary opening hours in a way that reduces the time for which P’s pharmacy is open before or after a rest break on a Monday to Saturday to less than 3 hours (if P wants to change the supplementary opening hours affected by this requirement, P must also change the time of the rest break);bcP must not change—ithe total number of P’s supplementary opening hours in a way that either reduces or leaves the same the total number of P’s supplementary opening hours, oriiunless the change relates to an increase of the total number of supplementary opening hours, the days on which or the times at which pharmaceutical services are to be provided at or from P’s premises during supplementary opening hours,for a period of at least 5 weeks after the day on which that notification was received by NHS England, unless NHS England agrees otherwise; andbdP must not change the days on which or the times at which pharmaceutical services are to be provided at or from those premises during core opening hours, in the case of making a change that—iamounts to the inclusion of a rest break which is no longer than one hour, or a change to such a rest break—aaon a Monday to Saturday, which starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours, orbbon a Sunday, andiidoes not change the total number of P’s core opening hours on a particular day,for a period of at least 5 weeks after the day on which that notification was received by NHS England, unless NHS England agrees otherwise.7AParagraphs (ba) and (bd) of sub-paragraph (7) do not apply to changes to core opening hours of premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies, and accordingly the core opening hours of such premises may only be changed in accordance with paragraph 25 or 26.8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10Where there is a temporary suspension in the provision of pharmaceutical services by P because of illness or another reason beyond the control of P, P is not in breach of sub-paragraphs (1) and (7), or of paragraph 23A(5)(a), provided that—aP notifies NHS England of that suspension as soon as practicable, in the manner required by paragraph 29D(2)(a) and wherever possible before the start of the suspension; aaP uses all reasonable endeavours to implement the business continuity plan that P is required to have by virtue of paragraph 29D; andbP uses all reasonable endeavours to resume provision of pharmaceutical services as soon as is practicable.11Planned refurbishment of pharmacy premises is not a “reason beyond the control of P” for the purposes of sub-paragraph (10).12For the purposes of calculating the number of hours that pharmacy premises are open during a week that includes Christmas Day, Good Friday, Easter Sunday or a bank holiday, it is to be deemed that the pharmacy premises were open on that day at the times at which they would ordinarily have been open on that day of the week.13For the purposes of this Part, “additional opening hours”, where they are required, are hours during which P is required to provide pharmaceutical services pursuant to sub-paragraph (1)(e) which are in addition to the hours during which P would be required to provide pharmaceutical services, if P were subject instead to the condition set out in sub-paragraph (1)(a).23A1Where NHS England is satisfied that people in a particular area are experiencing, or are likely to experience, significant difficulty in accessing pharmaceutical services on a temporary basis for an identified period, NHS England may establish a local hours plan with the NHS pharmacists in that area that are willing to participate in a local hours plan for that area.2NHS England must, prior to establishing a local hours plan, consult any local pharmaceutical committee for the area that comprises or includes the area of the plan, unless NHS England decides that it is not practicable to do so.3NHS England must notify any local pharmaceutical committee for the area that comprises or includes the area of a local hours plan that it establishes of the contents of that plan and any changes to it, including where further NHS pharmacists join or any NHS pharmacists cease to participate in the plan.4The local hours plan is to be of a specified duration, determined by NHS England, and is to contain the temporary opening hours agreed between NHS England and each of the participating NHS pharmacists (each participating NHS pharmacist agrees their own but not other participants’ temporary opening hours).5NHS pharmacists that have agreed to participate in a local hours plan—amust ensure that pharmaceutical services are provided at or from their pharmacy premises during the agreed temporary opening hours; andbmay cease to participate in the plan and return to their core and supplementary opening hours, provided that, subject to sub-paragraph (8), they have given the notice period for doing so that they have each agreed with NHS England as part of the plan.6NHS England may revise a local hours plan from time to time, including by allowing further NHS pharmacists to join, but any change to the plan that is a change to the temporary opening hours of an NHS pharmacist that is participating in the plan, or of their notice period as referred to in sub-paragraph (5)(b), must be agreed with that NHS pharmacist.7A local hours plan ceases to have effect on the expiry of its specified duration, determined by NHS England in accordance with sub-paragraph (4), unless NHS England revises the specified duration, in which case the new specified duration becomes the specified duration of the plan, and further revisions are then also permissible pursuant to this sub-paragraph.8If NHS England revises the specified duration of a local hours plan, an NHS pharmacist may cease to participate in the plan on the date that was the plan’s expiry date, having given prior notice of their intention to do so, which may be of a shorter period than their agreed notice period where—athe NHS pharmacist does not wish to participate in the plan beyond the expiry date that has been extended;bthe timing of the revision means it is not possible, or not reasonably practicable, for prior notice to be given for the agreed notice period; andcthe NHS pharmacist gives notice of their intention to cease to participate in the plan on the date that was the plan’s expiry date as soon as it is reasonably practicable for them to do so.9While a local hours plan has effect, the core and supplementary opening hours that have temporarily been suspended may be changed in accordance with paragraphs 23(6) and (7), 25 and 26.241Subject to paragraph 26(2A) and except where paragraph 26(2ZB) applies, where NHS England issues a direction for setting any days or times for opening hours under this Part, or determines them without issuing a direction, it must in doing so seek to ensure that the days and times at which pharmacy premises are open for the provision of pharmaceutical services in the area in which the premises that are the subject of the direction are located are such as—ato maintain as necessary the existing level of service provision for the people in that area or other likely users of the pharmacy premises; orbto maintain a sustainable level of adequate service provision for the people in that area or other likely users of the pharmacy premises, in circumstances where maintaining the existing level of service provision is either unnecessary or not a realistically achievable outcome.2In considering the matters mentioned in sub-paragraph (1), NHS England—amust treat any local pharmaceutical services being provided in its area as if they were pharmaceutical services being so provided; andbmay have regard to any pharmaceutical services that are being provided in its area during supplementary opening hours.3NHS England may only direct that an NHS pharmacist (P) may provide pharmaceutical services at or from premises for less than 40 hours in any week if it is satisfied that the provision of pharmaceutical services in its area is likely to be adequate to meet the need for such services at times when P is not providing pharmaceutical services.4Except in the case of premises that have (at any time) been subject to a direction under regulation 65 or regulation 65 of the 2012 Regulations (core opening hours conditions), NHS England may only direct that P must provide pharmaceutical services at or from premises for more than 40 hours in any week where it is satisfied that P is to receive reasonable remuneration in respect of the additional opening hours for which P is required to provide pharmaceutical services (and any additional remuneration payable in accordance with a determination made as mentioned in regulation 91(6) in respect of those hours is “reasonable remuneration” for these purposes).5Sub-paragraph (4) does not apply in circumstances where the direction is in respect of any premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies.251Where it appears to NHS England, after consultation with or having considered the matter at the request of the Local Pharmaceutical Committee for the area in which the premises are situated, that the days on which or times at which pharmacy premises are or are to be open for the provision of pharmaceutical services will not, or no longer, meet the needs of—apeople in its area; orbother likely users of the pharmacy premises,for the pharmaceutical services available at or from those premises, it must carry out an assessment as to whether to issue a direction requiring the NHS pharmacist (P) whose premises they are to provide pharmaceutical services at or from the pharmacy premises at set times and on set days (which may include Christmas Day, Good Friday and bank holidays).2Before concluding the assessment under sub-paragraph (1) NHS England must—agive notice to P of any proposed changes to the days on which or times at which the pharmacy premises are to be open; andballow P 30 days within which to make written representations to NHS England about the proposed changes.3When it determines the outcome of its assessment, NHS England must—aissue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs (4) and (5);bconfirm any existing direction in respect of the times at which P must provide pharmaceutical services at or from the pharmacy premises, provided that the existing direction (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations) would meet the requirements of sub-paragraphs (4) and (5); orceither—irevoke, without replacing it, any existing direction in respect of the times at which P must provide pharmaceutical services at or from the pharmacy premises (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), oriiin a case where there is no existing direction, issue no direction,in which case, by virtue of whichever of paragraph 23(1)(a) or (b) applies, the pharmacy will need to be open for 40 hours each week or for at least 100 hours each week.4Where NHS England issues a direction under sub-paragraph (3) in respect of pharmacy premises that are to be required to be open—afor more than 40 hours each week, it must set out in that direction—ithe total number of hours each week for which P must provide pharmaceutical services at or from the pharmacy, andiias regards the additional opening hours, the days on which and the times at which P is required to provide those services during those hours,but it must not set out in that direction the days on which or times at which P is to provide pharmaceutical services during hours which are not additional opening hours; orbfor less than 40 hours each week, it shall set out in that direction the days on which and times at which pharmaceutical services are to be provided at or from the pharmacy premises.5NHS England must not issue a direction under sub-paragraph (3) that has the effect simply of requiring pharmacy premises to be open for 40 hours each week on set days and at set times (that is, the direction must have the effect of requiring pharmacy premises to be open for either more or less than 40 hours each week).6NHS England must notify P of any direction issued or any other action taken under sub-paragraph (3), and where it sets new days on which or times at which P is to provide pharmaceutical services at or from pharmacy premises, it must include with the notification a statement of—athe reasons for the change; andbP's right of appeal under paragraph (7).7P may, within 30 days of receiving notification under sub-paragraph (6), appeal in writing to the Secretary of State against any direction issued or any other action taken under sub-paragraph (3) which sets new days on which or times at which P is to provide pharmaceutical services.8The Secretary of State may, when determining an appeal, either confirm the action taken by NHS England or take any action that NHS England could have taken under paragraph (3).9The Secretary of State shall notify P of the determination and shall in every case include with the notification a statement of the reasons for the determination.10If the days on which or times at which P is to provide pharmaceutical services at or from pharmacy premises have been changed in accordance with this paragraph, P must introduce the changes—aif P has not appealed under sub-paragraph (7), not later than 8 weeks after the date on which P receives notification under sub-paragraph (6); orbif P has appealed under sub-paragraph (7), not later than 8 weeks after the date on which P receives notification under sub-paragraph (9).11This paragraph does not apply where regulation 65(5) to (7) applies.261An NHS pharmacist (P) may apply to NHS England for it to change the days on which or times at which P is obliged to provide pharmaceutical services during core opening hours at or from P's pharmacy premises in a way that—areduces the total number of hours for which P is obliged to provide pharmaceutical services at or from those premises each week ...; orbkeeps that total number of hours the same.1AOn or after 23rd June 2025, if P makes an application under paragraph (1)(b), P must state in the application whether P wishes the application to be determined on the basis of paragraph 24(1) or sub-paragraph (2ZB).2 Except where sub-paragraph (2A) applies, where P makes an application under sub-paragraph (1)(a), as part of that application P must provide NHS England with such information as NHS England may reasonably request in respect of the matters that NHS England must seek to ensure pursuant to paragraph 24(1).2ZAWhere P makes an application under sub-paragraph (1)(b), as part of that application P must provide NHS England with such information as NHS England may reasonably request in respect of the matters that NHS England must seek to ensure pursuant to sub-paragraph (2ZB) or paragraph or paragraph 24(1) (depending on the basis of the application).2ZBIn the case of an application under sub-paragraph (1)(b) which is based on the matters that NHS England must seek to ensure pursuant to this sub-paragraph, where NHS England—aissues a direction under sub-paragraph (4) for setting any days or times for opening hours; orbdetermines the application under sub-paragraph (4) without issuing a direction,it must in doing so seek to ensure that the people who are accustomed to accessing pharmaceutical services at the pharmacy premises are likely to benefit from the changes because, overall, they would be more likely to access those services at those premises during the proposed core opening hours than during the existing core opening hours.2AIn the case of an application for a direction under sub-paragraph (4) that has the effect of reducing, in the case of any premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies, the total number of core opening hours to 72 or above, but without changing any or all of the following—athe core opening hours on a Monday to Saturday at times between 5pm and 9pm;bthe core opening hours on a Sunday at times between 11am and 4pm, other than by way of the inclusion of, or a change to, a rest break which—iis no longer than one hour, andiistarts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours; andcthe total number of core opening hours on a Sunday,NHS England must grant that application, and paragraph 24(1) does not apply to such an application.2BIn the case of a valid application for a direction under sub-paragraph (4) to which sub-paragraph (2A) applies, if—athe date included in the application as the date on which P wishes to change P’s core opening hours is five weeks or more after the day on which the application is received by NHS England; andbNHS England has not determined the application by that date,pending the determination of the application, P’s core opening hours are the core opening hours that P requested in the application.3NHS England must determine the application within 60 days of receiving it (including any information required of P in accordance with sub-paragraph (2) or (2ZA)).4When it determines the application, NHS England must—aissue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs (4A), (5) and (6) and which has the effect of either granting the application under this paragraph or granting it only in part;bconfirm any existing direction in respect of the times at which P must provide pharmaceutical services at or from the pharmacy premises, provided that the existing direction (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations) would meet the requirements of sub-paragraphs (5) and (6); orceither—irevoke, without replacing it, any existing direction in respect of the times at which P must provide pharmaceutical services at or from the pharmacy premises (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), where this has the effect of granting the application under this paragraph or granting it only in part, oriiin a case where there is no existing direction, issue no direction....4ANHS England must not issue a direction under sub-paragraph (4), or revoke without replacing it an existing direction under that sub-paragraph, if doing so would have the effect of reducing, in the case of any premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies, any or all of the following—athe total number of core opening hours to below 72;bthe core opening hours on a Monday to Saturday at times between 5pm and 9pm;cthe core opening hours on a Sunday at times between 11am and 4pm, other than by way of the inclusion of, or a change to, a rest break which—iis no longer than one hour, andiistarts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours; anddthe total number of core opening hours on a Sunday,and an application seeking such a change is not a valid application for the purposes of sub-paragraph (2B).4BOn and after 25th May 2023, NHS England must not issue a direction under sub-paragraph (4), or revoke without replacing it an existing direction under that sub-paragraph, pursuant to an application made before 25th May 2023 for a direction pursuant to this paragraph as it had effect before 25th May 2023, if doing so would have the effect of reducing, in the case of any premises in respect of which a 100 hours condition applies, any or all of the following—athe core opening hours on a Monday to Saturday at times between 5pm and 9pm;bthe core opening hours on a Sunday at times between 11am and 4pm, other than by way of the inclusion of, or a change to, a rest break which—iis no longer than one hour, andiistarts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours; andcthe total number of core opening hours on a Sunday.5Where NHS England issues a direction under sub-paragraph (4) in respect of pharmacy premises that are to be required to be open—afor more than 40 hours each week, it must set out in that direction—ithe total number of hours each week for which P must provide pharmaceutical services at or from the pharmacy premises, andiias regards any additional opening hours, the days on which and the times at which P is required to provide those services during those hours,but except in a case to which sub-paragraph (4A) applies, it must not set out in that direction days on which or times at which P is to provide pharmaceutical services during hours which are not additional opening hours; orbfor less than 40 hours each week, it shall set out in that direction the days on which and times at which pharmaceutical services are to be provided at or from the pharmacy premises.6NHS England must not issue a direction under sub-paragraph (4) that has the effect simply of requiring pharmacy premises to be open for 40 hours each week on set days and at set times (that is, the direction must have the effect of requiring pharmacy premises to be open for either more or less than 40 hours each week).7Where NHS England is considering taking action under sub-paragraph (4)(a) or (c)(i), it shall consult the Local Pharmaceutical Committee for the area in which the pharmacy premises are situated before determining the application.8NHS England must notify P of any direction issued or any other action taken under sub-paragraph (4), and where this has the effect of refusing an application under this paragraph or granting it in part, it must send P a statement setting out—athe reasons for the refusal or, as the case may be, for granting the application only in part; andbP's right of appeal under sub-paragraph (9).9P may, within 30 days of receiving a notification pursuant to sub-paragraph (8), appeal in writing to the Secretary of State against any action under sub-paragraph (4) which has the effect of refusing an application under this paragraph or granting it only in part.10The Secretary of State may, when determining an appeal, either confirm the action taken by NHS England or take any action that NHS England could have taken under sub-paragraph (4).11The Secretary of State must notify the pharmacist of the determination and must include with the notification a statement of the reasons for the determination.12If the days on which or times at which P is to provide pharmaceutical services at or from pharmacy premises have been changed in accordance with this paragraph, P must introduce the changes—aif P has not appealed under sub-paragraph (9), not earlier than 30 days after the date on which P receives notification under sub-paragraph (4); orbif P has appealed under sub-paragraph (9), not earlier than 30 days after the date on which P receives notification under sub-paragraph (11).13This paragraph does not apply where regulation 65(5) to (7) applies.271Notwithstanding the provisions of this Part, during an emergency requiring the flexible provision of pharmaceutical services, NHS England may, on application from an NHS pharmacist (“P”), permit P a temporary change to the days on which or times at which P is obliged to provide pharmaceutical services at or from pharmacy premises, or permit temporary closure of those premises, if—aP gives at least 24 hours notice of the change or closure; andbthe reasons given by P for the request are, in the opinion of NHS England, adequate reasons.2NHS England need not approve the request in advance of the change or closure, but if it does not do so and decides subsequently that P's reasons are not, in its opinion, adequate reasons, then the days on which or times at which P is obliged to provide pharmaceutical services at or from the premises are to revert to the overridden days or times, from the day after the date on which that decision is given to P.27A1Notwithstanding the foregoing provisions of this Part, the core or supplementary opening hours of an NHS pharmacist (P) may be changed by NHS England where, as a consequence of a disease being, or in anticipation of a disease being imminently—apandemic; andba serious risk or potentially a serious risk to human health,NHS England with the agreement of the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, NHS England may, in the area to which the announcement relates and in the circumstances specified in the announcement, notify NHS pharmacists of changes to core and supplementary opening hours for the period specified in the announcement.2Where paragraph (1) applies, where NHS England notifies P of changes to P’s core or supplementary hours at P’s pharmacy premises, those are P’s core and supplementary opening hours for the period that NHS England specifies in the notification (unless NHS England notifies P of further changes to P’s opening hours).27B1Notwithstanding the forgoing provisions of this Part, in order to assist in the management of a serious risk or potentially serious risk to human health which arises as a consequence of a disease being, or in anticipation of a disease being imminently, pandemic, an NHS pharmacist (P) may, with the agreement of NHS England, limit for a specified period (within P’s core and supplementary opening hours) the pharmaceutical services provided at or from P’s pharmacy premises to relevant immunisation services.2If NHS England has made an announcement to the effect that there are particular arrangements under this paragraph that it is prepared to agree, and P limits P’s provision of pharmaceutical services to relevant immunisation services in a manner that is consistent with that announcement, it is to be assumed (in the absence of a contrary notification from NHS England to P) that P has the agreement of NHS England to those arrangements.3In this paragraph, “relevant immunisation services” means directed services that provide for the administration of a medicinal product for vaccination or immunisation against coronavirus or influenza virus in accordance with—aa patient group direction that meets the conditions of regulation 233 of the Human Medicines Regulations 2012 (exemption for supply etc under a PGD by a person conducting a retail pharmacy business); orba protocol that meets the conditions of regulation 247A of the Human Medicines Regulations 2012 (protocols relating to coronavirus and influenza vaccinations and immunisations),and for these purposes, “coronavirus” has the meaning given in section 1(1) of the Coronavirus Act 2020.PART 4281An NHS pharmacist (P) must, in connection with the pharmaceutical services provided by P, participate, in the manner reasonably required by NHS England, in an acceptable system of clinical governance and for the promotion of healthy living.2For these purposes a system of clinical governance and for the promotion of healthy living is “acceptable” if it is considered acceptable by NHS England and comprises the following components—aa patient and public involvement programme, which includes—i. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iia requirement that the pharmacist publicises the essential services and any advanced services, other than an advanced service in respect of the supply of drugs in accordance with regulation 225 of the Human Medicines Regulations 2012 (emergency sale etc by pharmacist: at patient’s request), that are available at or from the pharmacist's pharmacy,iiia requirement that where a pharmacist publicises the essential services or any directed services that are available at or from the pharmacist's pharmacy (whether the pharmacist is producing their own publicity material or advertising services in material published by another person), the pharmacist does so in a manner which makes clear that the services are funded as part of the health service,iv. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vP's monitoring arrangements for drugs or appliances owed to patients but which are out of stock,via requirement that P co-operates appropriately with any reasonable inspection or review that NHS England or any relevant statutory authority wishes to undertake, ...viiP's monitoring arrangements in respect of P's compliance with the Equality Act 2010; and viiiundertaking at least once in each financial year an approved community engagement exercise in relation to the promotion of healthy living.ban audit programme, which in each financial year includes at least one clinical audit specified by P, and whichever of the following that NHS England specifies—ia clinical audit carried out in a manner which is compatible with NHS England’s arrangements for the receiving and processing of data from the audit, oriia policy based audit (to support the development of the commissioning policies of NHS England) carried out in a manner which is compatible with NHS England’s arrangements for the receiving and processing of data from the audit;ca risk management programme, which includes—iarrangements for ensuring that all stock is procured and handled in an appropriate way,iiarrangements for ensuring that all equipment used in the provision of pharmaceutical services is maintained appropriately,iiian approved incident reporting system, together with arrangements for analysing and responding to critical incidents,ivarrangements, including record keeping arrangements, for dealing appropriately and timeously with any communications concerning patient safety from the Secretary of State and NHS England,vappropriate standard operating procedures, including standard operating procedures in respect of the discharge medicines service dispensing drugs and appliances, repeatable prescriptions and providing advice and support to people caring for themselves or their families,viappropriate waste disposal arrangements (in addition to those required under Part 2) for clinical and confidential waste,viia clinical governance lead person for each pharmacy, appointed as such by the pharmacist (or who is the pharmacist), who is knowledgeable about both the pharmacy procedures of that pharmacy and the other NHS services that are available in the locality of that pharmacy,viiiappropriate safeguarding procedures for service users,ixP's monitoring arrangements in respect of P's compliance with the Health and Safety at Work etc. Act 1974 ;caat the request of NHS England, a pandemic response programme, which includes—iconducting an infection control risk assessment, in the approved manner,iiappropriate infection control measures at P’s pharmacy premises, having regard to that infection control risk assessment and to any approved particulars designed to support, in a proportionate manner, the safety of service users and pharmacy staff in particular in circumstances where services users or pharmacy staff may be, or are known or suspected to be, suffering from the pandemic disease,iiiarrangements, which may be approved arrangements, for communicating with potential service users about service availability and service provision at or from P’s pharmacy premises during the pandemic,ivarrangements for appropriate updating of the standard operating procedures mentioned in sub-paragraph (c)(v) and any business continuity plan of P, andvarrangements for appropriate updating of the premises standards programme mentioned in sub-paragraph (g) (including in response to any new approved particulars under sub-paragraph (g)(ii) that are in response to the pandemic),but prior to making such a request (or revising the terms of such a request), NHS England must consult the body that is, for the time being, the body consulted under section 165(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of NHS pharmacists;da clinical effectiveness programme, which includes arrangements for ensuring that appropriate advice is given by P—iin respect of the provision of drugs in accordance with a repeatable prescription,iiin respect of the provision of appliances in accordance with a prescription form or repeatable prescription, oriiito people caring for themselves or their families,and arrangements for ensuring that P, when giving advice to any patient on a matter mentioned in paragraph (d)(ii), has regard to the details contained in the records maintained under paragraph 10(1)(f) in respect of the provision of appliances and the prescribing pattern relating to the patient in question;ea staffing and staff management programme, which includes—iarrangements for appropriate induction for staff (including locums),iiappropriate training for all staff in respect of any role they are asked to perform,iiiarrangements for the checking of qualifications ... of all staff engaged in the provision of NHS services,iiiaa requirement that P undertakes an approved workforce survey annually, in an approved manner,ivarrangements for identifying and supporting the development needs of all staff engaged in the provision of NHS services, including continuing professional development for registered pharmacists and registered pharmacy technicians, and any necessary accreditation , certification or declarations of competence in respect of any role they are asked to perform,varrangements for addressing poor performance (in conjunction with NHS England as appropriate), andviarrangements (which must include a written policy) for ensuring that all staff and locums who, arising out of their employment with the pharmacist—aamake what is a protected disclosure within the meaning given in section 43A of the Employment Rights Act 1996 (meaning of protected disclosure) have the rights afforded in respect of such disclosures by that Act, andbbprovide information in good faith and not for purposes of personal gain to the General Pharmaceutical Council or to NHS England which includes an allegation of a serious nature which they reasonably believe to be substantially true, but disclosure of it is not a protected disclosure within the meaning given in section 43A, have the right not to be subjected to any detriment or to dismissal as a consequence of that act;fan information governance programme, which provides for—icompliance with approved procedures for information management and security, andiisubmission of an annual self assessment of compliance (to an approved level) with those procedures via approved data submission arrangements which allow NHS England to access that assessment; andga premises standards programme, which includes—ia system for maintaining cleanliness at the pharmacy which is designed to ensure, in a proportionate manner, that the risk to people at the pharmacy of health care acquired infection is minimised, andiiarrangements for compliance, in the areas of the pharmacy in which patients receive NHS services, with any approved particulars that are designed to ensure, in a proportionate manner, that those areas are an appropriate environment in which to receive health care and for the promotion of healthy living,and for the purposes of this sub-paragraph, “approved” means approved by NHS England.28A1An NHS pharmacist must ensure that at pharmacy premises, other than distance selling premises, there is a consultation room which is—aclearly designated as a room for confidential conversations;bdistinct from the general public areas of the pharmacy premises; andca room where both a person accessing pharmaceutical services and a person performing pharmaceutical services are able to be seated together and communicate confidentially.2Where, in the opinion of NHS England, pharmacy premises other than distance selling premises included on a pharmaceutical list on the relevant day are too small for a consultation room—athe NHS pharmacist in respect of those premises may, with the agreement of NHS England, comply with paragraph 28B instead of sub-paragraph (1); andbfor these purposes, references to distance selling premises in paragraph 28B are to be treated as a reference to the premises about which NHS England has formed the opinion that they are too small for a consulting room.3An NHS pharmacist in respect of premises that were on a pharmaceutical list on the relevant day but no advanced services were provided at or from those premises during the year before the relevant day need not comply with sub-paragraphs (1) or (2) in respect of those premises before 1st April 2023.4In this paragraph, “the relevant day” means the day of the coming into force of regulation 15(1) of the National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020.28BAn NHS pharmacist in respect of distance selling premises must ensure that there are arrangements in place at those premises which enable a person performing pharmaceutical services to communicate confidentially with a person accessing pharmaceutical services—aby telephone or another live audio link; andbvia a live video link.28CAn NHS pharmacist (P) in respect of distance selling premises must ensure that P has a website for use by the public for the purpose of accessing pharmaceutical services from those premises, on which there is an interactive page, clearly promoted to any user of the website when they first access it, which provides public access to a reasonable range of up to date materials that promote healthy lifestyles by addressing a reasonable range of health issues.29An NHS pharmacist must provide pharmaceutical services and exercise any professional judgement in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession.29A1An NHS pharmacist (P) must have access to summary care records at P’s pharmacy premises, and must ensure that the access that P has to summary care records at those premises is constant and reliable during core and supplementary opening hours, in so far as that is within the control of P.2P must access the summary information in a patient’s summary care record whenever P is providing pharmaceutical services to the patient, to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so.3In this paragraph, a “summary care record” and “summary information” mean a summary care record and summary information within the meanings given in—aregulation 68 of the GMS Regulations (summary care records); andbregulation 61 of the PMS Regulations (summary care records).29BAn NHS pharmacist (P) must have access to the EPS at P’s pharmacy premises, and must ensure that the access that P has to the EPS at those premises is constant and reliable during core and supplementary opening hours, in so far as that is within the control of P.29C1An NHS pharmacist (P) must ensure that pharmacy staff at pharmacy premises (including locums) have access to, and are able to send and receive messages via NHS.net Connect from, a premises specific NHS.net Connect account.2P must ensure that at least two members of the pharmacy staff have live, linked NHS.net Connect accounts to the premises specific NHS.net Connect account (unless fewer than two members of the pharmacy staff are engaged in the provision of NHS services).3P must ensure that there is a comprehensive and accurate pharmacy profile in respect of P’s pharmacy premises in the NHS England directory of services, and P must verify and where necessary update the information contained in that profile at least once each quarter of the financial year.4P must ensure that there is a comprehensive and accurate pharmacy profile in respect of P’s pharmacy premises on the NHS.uk website, and P must verify and where necessary update the information contained in that profile at least once each quarter of the financial year.5As regards the Central Alerting System (CAS) operated by the Medicines and Healthcare products Regulatory Agency (MHRA)—aP must register P’s premises specific NHS.net Connect address with MHRA as an address at which P is content to accept notifications as part of the CAS (unless they are content with the address already in the system);bif P changes P’s premises specific NHS.net Connect address, P must immediately notify MHRA of P’s new premises specific NHS.net Connect address, in accordance with paragraph (a); andcP must monitor P’s premises specific NHS.net Connect account with sufficient frequency to ensure the safe and effective supply of medicinal products at or from P’s pharmacy premises, and must act on the alerts P receives as part of the CAS, as appropriate.29D1An NHS Pharmacist (P) must have at all times an up to date business continuity plan for P’s pharmacy premises, which is available at those premises, to deal with the temporary suspension because of illness or another reason beyond the control of P of the provision of pharmaceutical services at or from those premises that—ais proportionate to the needs of the people who are anticipating or are accustomed to receiving pharmaceutical services from P; andbincludes the components set out in sub-paragraph (2).2The components are—aarrangements for notifying NHS England, in the approved manner—iabout the prospect of a temporary suspension, whenever such a suspension becomes likely, andiiabout a temporary suspension and its anticipated duration, wherever possible before the start of the suspension;barrangements for updating the pharmacy profile mentioned in paragraph 29C(3) about the suspension, including in due course about the resumption of the provision of pharmaceutical services at or from the pharmacy premises;cif P provides directed services that provide people with urgent care services, arrangements for ensuring, to the extent practicable, that people are not referred to P’s pharmacy premises for those services during the temporary suspension;darrangements, where practicable and to an extent that is reasonable having regard to the needs of the people who are anticipating or are accustomed to receiving pharmaceutical services from P, for notifying other providers of pharmaceutical and local pharmaceutical services and providers of primary medical services about the suspension and its anticipated duration;earrangements for displaying information about the suspension and its anticipated duration—iin the case of distance selling pharmacies, on the website for the distance selling pharmacy, clearly promoted to any user of the website when they first access it, oriiin any other case, on a notice at P’s pharmacy premises visible from outside the premises, which also provides information, where appropriate in the approved manner and to an extent that is reasonable having regard to the needs of the people who are anticipating or are accustomed to receiving pharmaceutical services from P, about the availability of pharmaceutical or local pharmaceutical services at or from other pharmacy premises nearby; andfarrangements, where practicable, for the continuity of care for the people who are anticipating or are accustomed to receiving pharmaceutical services from P, including for any people who—ihave booked appointments, oriiattend the pharmacy premises regularly for the supervised administration of medicines.3For the purposes of sub-paragraph (2), “approved” means approved by NHS England.4In the event of the temporary suspension, or the likely temporary suspension, of pharmaceutical services provision at or from P’s pharmacy premises, P must use all reasonable endeavours to implement P’s business continuity plan, and in the case of a likely temporary suspension, in a manner proportionate to that likelihood.301An NHS pharmacist (P) (including P's staff) must not give, promise or offer to any person any gift or reward (whether by way of a share of or dividend on the profits of P's business or by way of discount or rebate or otherwise) as an inducement to or in consideration of a person (X)—apresenting an order for drugs or appliances on a prescription form or repeatable prescription, non-electronic prescription form or non-electronic repeatable prescription;bnominating P as X's dispensing contractor (or one of them) in X's PDS patient details; orcreceiving from P any directed services.2Promising, offering or providing an auxiliary aid in relation to the supply of drugs or a home delivery service is not a gift or reward for the purposes of sub-paragraph (1).3Nothing in sub-paragraph (1) prohibits P from providing to a patient to whom P is providing any directed services any gift which—ais supplied as part of the provision of any directed service to that patient;bis directly related to that directed service;cis supplied in order to encourage or promote health or well-being or the adoption by the patient or the patient's family of a healthy lifestyle; anddin the case of a gift which—iis not a medicine, has a monetary value not exceeding £10, oriiis a medicine, is supplied as part of the provision of a minor ailments service.4P (including P's staff) must not give, promise or offer to any relevant person any gift or reward (including by way of a share of, or dividend on, the profits of P's business, or by way of a discount or rebate) as an inducement to or in consideration of the relevant person recommending to any person that they—apresent to P an order for drugs or appliances on a prescription form or repeatable prescription;bnominate P as their dispensing contractor (or one of them) in their entry in their PDS patient details; orcask P to provide them with any directed service.5For the purpose of sub-paragraph (4), “relevant person” means any person who performs or provides NHS services, whether on their own behalf or on behalf of another, and includes—aany NHS body or provider of primary medical services; andbany person employed or engaged by any of the persons mentioned in paragraph (a).6In the case of the provision of appliances, P (including P's staff) must not accept or receive any gift or reward in respect of only—aproviding contact details of alternative NHS pharmacists or NHS appliance contractors pursuant to paragraph 10(2)(b), 12(4) or 20(2)(b); orbreferring a prescription form or repeatable prescription to another NHS pharmacist or NHS appliance contractor pursuant to paragraph 10(2)(a) or 20(2)(a) and providing no additional service in connection with the item on that prescription.311An NHS pharmacist (P) and, where P is a body corporate, every director and superintendent of P must, within 7 days of its occurrence, inform NHS England in writing if they—aare convicted of any criminal offence in the United Kingdom;bare bound over following a criminal conviction in the United Kingdom;caccept a police caution in the United Kingdom;dhave, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging them absolutely (without proceeding to conviction);ehave accepted and agreed to pay either a procurator fiscal fine under section 302 of the Criminal Procedure (Scotland) Act 1995 (fixed penalty: conditional offer by procurator fiscal) or a penalty under section 115A of the Social Security Administration Act 1992 (penalty as alternative to prosecution);fhave been convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England, could lead to a criminal conviction in England;gare charged in the United Kingdom with a criminal offence, or are charged elsewhere than in the United Kingdom with an offence where the originating events, if they took place in England, could lead to a criminal conviction in England;hare notified by any licensing, regulatory or other body of the outcome of any investigation into their professional conduct, and there is a finding against them;ibecome the subject of any investigation into their professional conduct by any licensing, regulatory or other body;jbecome the subject of any investigation into their professional conduct in respect of any current or previous employment, or are notified of the outcome of any such investigation and any finding against them;kbecome the subject of any investigation by the NHS CFA in relation to fraud;lbecome the subject of any investigation by another primary care organisation which might lead to their removal from a relevant list; ormare removed, contingently removed or suspended from, refused inclusion in or conditionally included in any relevant list for a reason relating to unsuitability, fraud or efficiency of service provision,and must give details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome.2If a person to whom paragraph (1) applies (X) is, or was at the time of the originating events, a director or superintendent of a body corporate, X must in addition inform NHS England within 7 days if any such body corporate—ais convicted of any criminal offence in the United Kingdom;bis convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England, could lead to a criminal conviction in England;cis charged in the United Kingdom with a criminal offence, or is charged elsewhere than in the United Kingdom with an offence where the originating events, if they took place in England, could lead to a criminal conviction in England;dis notified by any licensing, regulatory or other body of the outcome of any investigation into its provision of professional services, and there is a finding against the body corporate;ebecomes the subject of any investigation into its provision of professional services by any licensing, regulatory or other body;fbecomes the subject of any investigation by the NHS CFA in relation to any fraud or is notified of the outcome of such an investigation where it is adverse;gbecomes the subject of any investigation by another primary care organisation which might lead to its removal from any relevant list; orhis removed, contingently removed or suspended from, refused inclusion in or conditionally included in any relevant list for a reason relating to unsuitability, fraud or efficiency of service provision,and must give the name and registered office of the body corporate and details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome.3P or X must consent to a request being made by NHS England to any employer or former employer or licensing or regulatory body in the United Kingdom or elsewhere, for information relating to a current investigation, or an investigation where the outcome was adverse.321An NHS pharmacist (P) must give notice to NHS England within 30 days (or if this is impracticable, as soon as practicable thereafter) of—aany occurrence requiring a change in the information recorded about P in the pharmaceutical list which P has not otherwise notified to NHS England in accordance with these Regulations;bif P is an individual, any change to P's private address;cif P is a body corporate, any change to the name, registration number, registered office or telephone number relating to that office of the body corporate; anddany occurrence requiring P's addition to or removal from an EPS list or a change in the information recorded about P in that list.2P must give NHS England, if it so requests, the name of any pharmacist employed or engaged by P who is responsible for dispensing a particular prescription.3If P is a body corporate, it must give notice to NHS England within 30 days (or if this is impracticable, as soon as practicable thereafter) of any changes to—athe names of its directors; andbthe name or address of its superintendent.4If P is a body corporate and appoints a superintendent or director who was not listed on P's application for inclusion on a pharmaceutical list, P must, within 30 days of the person's appointment, supply to NHS England the information mentioned in paragraph 3 and 4 of Schedule 2 about that person.5If P or a director or superintendent of P (if P is a body corporate) is on, or is a director or superintendent of a body corporate which is on, a relevant list other than a pharmaceutical list held by NHS England, they must supply in writing to NHS England—ain the case of a director or superintendent of a body corporate, the name and registered office of the body corporate on the other relevant list; andbparticulars of the other relevant list.6P or the director or superintendent of P (if P is a body corporate) must inform NHS England if they, or a body corporate of which they are a director or superintendent, apply to be included in a relevant list of another primary care organisation, and of the outcome of any such application.32A1An NHS pharmacist (P) must, to the extent reasonable—afacilitate remote access to the pharmaceutical services provided at or from P’s pharmacy premises, where users wish to access those services under arrangements that make those services available using remote access; andbestablish, maintain and keep under review procedures to facilitate remote access to those services under arrangements that make those services available using remote access.33An NHS pharmacist must co-operate with NHS England in the discharge by NHS England of the duty under section 1F(1) of the 2006 Act (duty as to education and training).341An NHS pharmacist must have in place arrangements, which comply with the requirements of the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 , for the handling and consideration of any complaints.2In this paragraph, “complaint” means a complaint about a matter connected with the provision of pharmaceutical services by the NHS pharmacist.351An NHS pharmacist (P) must allow persons authorised in writing by NHS England to enter and inspect P's pharmacy premises at any reasonable time, for the purposes of—aascertaining whether or not P is complying with the requirements of this Schedule;bauditing, monitoring and analysing—ithe provision made by P, in the course of providing pharmaceutical services, for patient care and treatment, including any arrangement made with a person in respect of provision of appliances, andiithe management by P of the pharmaceutical services P provides,where the conditions in sub-paragraph (2) are satisfied.2The conditions are that—areasonable notice of the intended entry has been given;bthe Local Pharmaceutical Committee for the area where the pharmacy premises are situated have been invited to be present at the inspection, where this is requested by P;cthe person authorised in writing (X) carries written evidence of X's authorisation, which X produces on request; anddX does not enter any part of the premises used solely as residential accommodation without the consent of the resident.3P must, at the request of NHS England or of X, allow it or X access to any information which it or X reasonably requires—afor the purposes mentioned in sub-paragraph (1); orbin the case of NHS England, in connection with its functions that relate to pharmaceutical services.4P must, at the request of NHS England, send to NHS England by means of an electronic communication of the type specified in the request any information to which a person authorised in writing by NHS England would have access during an inspection of P’s pharmacy premises pursuant to sub-paragraph (1), if—aP has that information in a form which means it may be sent by that form of electronic communication; orbit is reasonable for NHS England to request that P convert that information into a form which means that it may be sent by that form of electronic communication (and NHS England does so request).5P must, at the request of NHS England or a person authorised in writing by NHS England to make the request, send to NHS England or that person by means of an electronic communication, a duly completed questionnaire, which is—ain a format approved by NHS England; andbfor the purpose of enabling NHS England, or a person authorised in writing by NHS England, to determine whether or when it is necessary or expedient for a person authorised in writing by NHS England to undertake an inspection of P’s premises pursuant to sub-paragraph (1).6Before information is requested pursuant to sub-paragraph (5), NHS England must consult the person who is, for the time being, the person consulted under section 165(1)(a) of the 2006 Act, in respect of pharmaceutical remuneration of NHS pharmacists on the terms of the request.SCHEDULE 5 Regulation 11(2)(a)(i)11To the extent that this Schedule imposes a requirement on an NHS appliance contractor in respect of an activity which could only, or would normally, be undertaken by a natural person—aif the NHS appliance contractor is a natural person—ithat person must comply with that requirement, oriiif the NHS appliance contractor employs or engages other natural persons in connection with the provision of pharmaceutical services, the NHS appliance contractor must either comply with that requirement or secure compliance with that requirement by the other natural persons whom the NHS appliance contractor employs or engages; orbif the NHS appliance contractor is not a natural person, that NHS appliance contractor must secure compliance with that requirement by the natural persons whom the NHS appliance contractor employs or engages in connection with the provision of pharmaceutical services.2Where in this Schedule reference is made to an NHS appliance contractor—abeing the subject of any activity, and it is an activity to which a natural person could only, or would normally, be subject; orbforming a view,that reference is to be construed, as referring, as appropriate to the NHS appliance contractor (if a natural person) or to the NHS appliance contractor's staff.3References in this Schedule to an NHS appliance contractor are to be construed in accordance with sub-paragraphs (1) and (2).2Where this Schedule imposes a requirement on the director of a body corporate that is included in a pharmaceutical list, a breach of that requirement is to be deemed to be a breach by the body corporate of its terms of service.3An NHS appliance contractor must, to the extent that paragraphs 4 to 8 require and in the manner described in those paragraphs, provide proper and sufficient appliances to persons presenting prescriptions for appliances ordered by health care professionals in pursuance of their functions in the health service, the Scottish health service or the Northern Ireland health service.41In this Part, “signed” includes signature with a prescriber's advanced electronic signature.2Subject to the following provisions of this Schedule, where—aany person presents to an NHS appliance contractor (C) a non-electronic prescription form which contains—ian order for an appliance, not being a restricted availability appliance, signed by a prescriber, oriian order for a restricted availability appliance, signed by a prescriber and including the reference “SLS”; ...bC receives as a nominated dispensing contractor from the Electronic Prescription Service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) and (ii) and—iany person requests the provision of an appliance in accordance with that prescription, oriiC has previously arranged with the patient that C will dispense that prescription on receipt; or cany person—ipresents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) or (ii), andiirequests the provision of an appliance in accordance with the related electronic prescription form,C must, with reasonable promptness, provide the appliance so ordered if C supplies it in the normal course of business.3Subject to the following provisions of this Schedule, where—aany person presents to C a non-electronic repeatable prescription which contains—ian order for appliances, not being restricted availability appliances, signed by a prescriber, oriian order for a restricted availability appliance, signed by a prescriber and including the reference “SLS”,and also presents an associated batch issue; ...bC receives as a nominated dispensing contractor from the Electronic Prescription Service an electronic repeatable prescription which contains an order of a kind specified in paragraph (a)(i) or (ii) and—iany person requests the provision of appliances in accordance with that prescription, oriiC has previously arranged with the patient that the supplier will dispense that prescription on receipt; or cany person—ipresents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) or (ii), andiirequests the provision of appliances in accordance with the related electronic repeatable prescription,C must, with reasonable promptness, provide such of the appliances so ordered as C supplies in the normal course of business.4For the purposes of this paragraph, a non-electronic repeatable prescription for appliances shall be taken to be presented even if the person who wishes to obtain the appliances does not present that prescription, where—aC has that prescription in the supplier's possession; andbthat person presents, or C has in C's possession, an associated batch issue.4A1This sub-paragraph applies where—aany person requests an appliance from an NHS appliance contractor (C) in accordance with a prescription form or repeatable prescription; andba SSP has effect in respect of—ithe requested appliance, oriiappliances of a specified description, and the requested appliance is of that description.2Where sub-paragraph (1) applies, C must consider whether it is reasonable and appropriate to supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.3Where sub-paragraph (1) applies, C may provide a different product or quantity of product to the product or quantity of product ordered on the prescription form or repeatable prescription, where—aC is able to do so with reasonable promptness;bto do so is in accordance with the SSP; andcC is of the opinion that supplying a different product or quantity of product to that ordered by the prescriber is reasonable and appropriate.4Where C, in accordance with sub-paragraph (3), provides a different product or quantity of product to that ordered by the prescriber—aC must endorse the prescription or the associated batch issue accordingly (if the manner for making the endorsement is provided for in the Drug Tariff, in the manner provided for in the Drug Tariff), and the prescription or associated batch issue as thus endorsed is treated as being the prescription for product reimbursement purposes (even though the supply is not in pursuance of that prescription); andbif—ithe patient to or for whom the product is provided is on a patient list, andiithe supply is of a type in relation to which the Secretary of State and the person who is, for the time being, the person consulted under section 165(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of NHS appliance contractors, acting jointly, have issued and publicised in such manner as they see fit a recommendation to the effect that, for clinical reasons, in the case of supplies of that type, providers of primary medical services should be notified of a supply to a patient on its patient list that is in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription,C must notify the provider of primary medical services on whose patient list the patient is of the supply in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription.5Where—asub-paragraph (1) applies;bC is of the opinion that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; andcC is able to supply the product or quantity of product ordered by the prescriber within a reasonable timescale but not with reasonable promptness,the requirements to act with reasonable promptness in paragraph 4(2) and (3) are to be read as requirements to act within a reasonable timescale.51This paragraph applies where, in a case of urgency, a prescriber requests an NHS appliance contractor (C) to provide an appliance.2C may provide the appliance requested before receiving a prescription form or repeatable prescription in respect of that appliance, provided that the prescriber undertakes to—agive C a non-electronic prescription form or non-electronic repeatable prescription in respect of the appliance within 72 hours of the request being made; orbtransmit an electronic prescription to the Electronic Prescription Service within 72 hours of the request being made.61If a person specified in sub-paragraph (2) asks an NHS appliance contractor (C) to do so—aC must give an estimate of the time when the appliance will be ready; andbif it is not ready by then, P must give a revised estimate of the time when it will be ready (until it is ready).2A person specified in this sub-paragraph is a person—apresenting a non-electronic prescription form or non-electronic repeatable prescription; orbrequesting the provision of appliances in accordance with an electronic prescription form or an electronic repeatable prescription.3Before providing an appliance in accordance with a prescription form or repeatable prescription—aC must ask any person who makes or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription that the person named on the prescription form or repeatable prescription does not have to pay the charges specified in regulation 3(1) or (2) of the Charges Regulations (supply of drugs and appliances by chemists) by virtue of either—ientitlement to exemption under regulation 10(1) of the Charges Regulations (exemptions), oriientitlement to remission of charges under regulation 5 of the Remission of Charges Regulations (entitlement to full remission and payment),to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of sub-paragraph (a), (c), (d), (e), (f) or (g) of regulation 10(1) of the Charges Regulations or in respect of entitlement to remission by virtue of regulation 5(1)(e) or (2) of the Remission of Charges Regulations, and at the time of the declaration C already has such evidence available to C;bif, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by paragraph (a), is produced to C, C must endorse the form on which the declaration is made to that effect; andcin the case of an electronic prescription form or an electronic repeatable prescription, C must ensure that the following information is duly entered into the records managed by NHS England that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (a))—iin a case where exemption from or remission of charges is claimed, a record of—aathe exemption category specified in regulation 10(1) of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which it is claimed applies to the case; andbbwhether or not satisfactory evidence was produced to C as required by sub-paragraph (a), andiiin any case where a charge is due, confirmation that the relevant charge was paid.3AFor the purposes of sub-paragraph (3), satisfactory evidence includes evidence derived from a check, known as a real time exemption check, of electronic records that are managed by the NHS BSA for the purposes (amongst other purposes) of providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under the Charges Regulations.3BSub-paragraphs (3) and (3A) apply to the provision of an appliance in accordance with a SSP as they apply to the provision of an appliance in accordance with a prescription form or a repeatable prescription (or an associated batch issue), and for these purposes the prescription for product reimbursement purposes, as mentioned in paragraph 4A(4)(a), is treated as being the prescription in accordance with which the appliance is provided (even though the supply is not in pursuance of that prescription).71Where an NHS appliance contractor (C) is presented with, or receives from the Electronic Prescription Service, a prescription form or a repeatable prescription, C must only provide the appliances so ordered—aif the prescription form or repeatable prescription is duly signed and completed as described in paragraph 4; andbin accordance with the order on the prescription form or repeatable prescription,subject to any regulations in force under the Weights and Measures Act 1985 and the following provisions of this Schedule.2If the order is for, or a product to be provided in accordance with a SSP is, an appliance of a type requiring measuring and fitting (for example a truss), C must make all necessary arrangements for—ameasuring the person named on the prescription form for the appliance; andbfitting the appliance.3If the order is for, or a product to be provided in accordance with a SSP is, an appliance included in the Drug Tariff, the British National Formulary (including any Appendix published as part of that Formulary), the Dental Practitioner's Formulary, the European Pharmacopoeia or the British Pharmaceutical Codex, the appliance provided must comply with the standard or formula specified therein.4Where C provides an appliance under paragraph 4A, C must include with it in a written note, for the patient’s benefit, information to the effect that the product is being supplied in accordance with a SSP, identifying the particular SSP.81An NHS appliance contractor (C) may refuse to provide an appliance ordered on a prescription form or repeatable prescription where—aC reasonably believes that it is not a genuine order for the person named on the prescription form or repeatable prescription (for example because C reasonably believes it has been stolen or forged);bit appears to C that there is an error on the prescription form or on the repeatable prescription or, in the case of a non-electronic repeatable prescription, its associated batch issue (including a clinical error made by the prescriber) or that, in the circumstances, providing the appliance would be contrary to C's clinical judgement;cC or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription form or repeatable prescription or requesting the provision of appliances in accordance with an electronic prescription form or repeatable prescription, or by any person accompanying that persondthe person presenting the prescription form or requesting the provision of appliances in accordance with an electronic prescription form or repeatable prescription, or any other person accompanying that person, commits or threatens to commit a criminal offence; orethe prescription form or repeatable prescription is incomplete because it does not include information relating to the identification of the prescriber that NHS England (or a person exercising its functions) requires in order to perform its functions relating to—ithe remuneration of persons providing pharmaceutical services, andiiany apportionment of, or any arrangements for recharging in respect of, that remuneration,unless C (or the person who employs or engages C) is to receive no pharmaceutical remuneration of any kind in respect of the appliances.1AC may refuse to provide an appliance ordered on an electronic prescription if the access that C has to the Electronic Prescription Service is not such as to enable C to dispense that prescription promptly (or at all).1BC must refuse to provide an appliance ordered on a prescription form or a repeatable prescription where—aa SSP has effect in respect of—ithe requested appliance; oriiappliances of a specified description, and the requested appliance is of that description; andbalternative provision has already taken place in accordance with the SSP.1CC may refuse to provide an appliance ordered on a prescription form or a repeatable prescription where—aa SSP has effect in respect of—ithe requested appliance, oriiappliances of a specified description, and the requested appliance is of that description;bC is of the opinion that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; andcC is unable to provide the appliance within a reasonable timescale,but if C does refuse to do so, C must provide the patient or the person requesting the appliance on behalf of a patient with appropriate advice, as necessary, about reverting to the prescriber for the prescriber to review the patient’s treatment.2C must refuse to provide appliances ordered on a repeatable prescription where—aC has no record of that prescription (other than on the first occasion on which the prescription is presented);bC does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to the supplier;cit is not signed by a prescriber;dto do so would not be in accordance with any intervals specified in the prescription;eit would be the first time an appliance had been provided pursuant to the prescription and the prescription was signed (whether electronically or otherwise) more than 6 months previously;fthe repeatable prescription was signed (whether electronically or otherwise) more than one year previously;gthe expiry date on the repeatable prescription has passed; orhC has been informed by the prescriber that the prescription is no longer required.3Where a patient requests the supply of appliances ordered on a repeatable prescription (other than on the first occasion that the request is made), C must only provide the appliance ordered if C is satisfied that—athe patient to whom the prescription relates—iis using and is likely to continue to use the appliance appropriately, andiiis not suffering from any side effects of the treatment which indicate the need or desirability of reviewing the patient's treatment;bthe manner of utilisation of the appliance by the patient to whom the prescription relates has not altered in a way which indicates the need or desirability of reviewing the patient's treatment; andcthere have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient's treatment.91In connection with the services provided under paragraph 3, an NHS appliance contractor (C) must—aensure that appropriate advice is given to patients about any appliances provided to them—ito enable them to utilise the appliances appropriately, andiito meet the patient's reasonable needs for general information about the appliances;bprovide appropriate advice to patients to whom they provide appliances on the safe keeping of the appliances;cwhen providing appliances to patients in accordance with a prescription form or repeatable prescription—iprovide appropriate advice in particular on the importance of only requesting those items which they actually need, andiifor those purposes, have regard to the details contained in the records maintained under paragraph (f) in respect of the provision of appliances and prescribing pattern relating to the patient in question;dprovide a patient with a written note of any appliance which is owed, and inform the patient when it is expected that the appliance will become available;eprovide a patient with a written note of C's name, address and telephone number;fkeep and maintain records—iof appliances provided, in order to facilitate the continued care of the patient,iiin appropriate cases, of advice given and any interventions or referrals made (including clinically significant interventions in cases involving repeatable prescription), andiiiof notes provided under paragraph (d);gundertake appropriate training in respect of repeat dispensing having regard to any recommendations in respect of such training set out in the Drug Tariff;hif C takes possession of a non-electronic repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue;iif C provides an appliance under an electronic prescription, provide the patient, if the patient so requests, with a written record of the appliances ordered on that prescription and, in the case of an electronic repeatable prescription, of the number of occasions on which it can be dispensed;jmaintain records of repeatable prescriptions in such a form as to provide a clear audit trail of supplies under the repeatable prescription (including dates and quantities supplied);kdestroy any surplus batch issues relating to appliances—iwhich are not required, oriiwhere a patient is refused an appliance pursuant to paragraph 8;lensure that where a person is refused appliances pursuant to paragraph 8(1)(b), (2) or (3), the patient is referred back to the prescriber for further advice;mwhere a patient is provided with appliances under a repeatable prescription, notify the prescriber of any clinically significant issues arising in connection with the prescription and keep a record of that notification;nnotify the prescriber of any refusal to provide appliances pursuant to paragraph 8(4); andowhen providing specified appliances, comply with the additional requirements set out in paragraph 11.2Where, on presentation of a prescription form or repeatable prescription in connection with the dispensing of appliances under paragraph 4, C is unable to provide an appliance, or stoma appliance customisation is required and C is unable to provide that, C must—aif the patient consents, refer the prescription form or repeatable prescription to another NHS appliance contractor or to an NHS pharmacist; orbif the patient does not consent to a referral, provide the patient with contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to C.101An NHS appliance contractor (C) must, if requested to do so by any person—aexplain to that person the Electronic Prescription Service, whether or not it is a service which is available through C's appliance contractor premises; andbwhere the Electronic Prescription Service is not available through C's appliance contractor premises, provide that person with the names of at least 2 NHS appliance contractors through whom the Electronic Prescription Service is available, if these details are known to C.2Where the Electronic Prescription Service is available through C's appliance contractor premises, C must, if requested to do so by any person, enter in that person's PDS patient details—awhere the person does not have a nominated dispensing contractor, a nominated dispensing contractor; orbwhere the person does have a nominated dispensing contractor—ia replacement dispensing contractor, oriia further dispensing contractor,chosen by that person.3Sub-paragraph (2)(b)(ii) does not apply if the number of nominated dispensing contractors would thereby exceed the maximum number permitted by the Electronic Prescription Service.4Regulation 116(a) to (c) applies to a request under this paragraph as it applies to an application to an NHS chemist for pharmaceutical services.5If C is a nominated dispensing contractor for a person (X) but the nomination was made before C became the person listed in a pharmaceutical list in relation to the appliance contractor premises nominated in X's PDS patient details, C must within 6 months of C becoming the person so listed—aexplain to X that the ownership of the appliance contractor premises has changed; andbask X whether X wishes to maintain the nomination in respect of those appliance contractor premises.6If C dispenses an electronic prescription or makes an urgent supply without a prescription, C must send the form duly completed by or on behalf of the patient, if one is required under regulation 3(3)(b), (5C) or (5E) of the Charges Regulations in respect of that prescription (which may be the associated EPS token), to the NHS BSA.111This paragraph sets out the additional requirements referred to in paragraph 9(1)(o) relating to the provision of specified appliances.2An NHS appliance contractor (C) who dispenses specified appliances in the normal course of business must provide a home delivery service in respect of those appliances and, as part of that service—aC must offer to deliver the specified appliance to the patient's home;bif the patient accepts that offer, the delivery must be made with reasonable promptness and at such time as is agreed with the patient;cthe specified appliance must be delivered in a package which displays no writing or other markings which could indicate its content; anddthe manner of delivery of the package and any supplementary items required by sub-paragraph (3) must not convey the type of appliance being delivered.3In any case where a specified appliance is provided (whether by home delivery or otherwise), C must provide a reasonable supply of appropriate supplementary items (such as disposable wipes and disposal bags) and—amust ensure that the patient may, if the patient wishes, consult a person to obtain expert clinical advice regarding the appliance; orbif C believes it is appropriate to do so, must—irefer the patient to a prescriber; oriioffer the patient an appliance use review service.4If C is unable to provide an appliance use review service in accordance with sub-paragraph (3)(b)(ii), C must give the patient the contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to arrange for the service to be provided, if these details are known to C.5Where C provides a telephone care line in respect of the dispensing of any specified appliance, C must ensure that during out of hours periods—aadvice is made available to patients through that telephone care line; orb telephone or website contact details for providers of NHS services that may be consulted for advice regarding specified appliances during those periods, are made available to patients through the telephone care line.6For the purposes of this paragraph—“expert clinical advice”, in relation to a specified appliance, means advice which is given by a person who is suitably trained and who has relevant experience in respect of the appliance;“out of hours periods”, in relation to the appliance contractor premises, means the periods outside the core opening hours and any supplementary opening hours of the premises.121Where, on presentation of a prescription form or repeatable prescription, an NHS appliance contractor (C) is unable to provide an appliance or stoma appliance customisation because the provision of the appliance or customisation is not within C's normal course of business, C must—aif the patient consents, refer the prescription form or repeatable prescription to another NHS appliance contractor or to an NHS pharmacist; andbif the patient does not consent to a referral, provide the patient with contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to C.2C must, in appropriate cases, keep and maintain a record of any information given or referral made under sub-paragraph (1) and that record must be in a form that facilitates—aauditing of the provision of pharmaceutical services by C; andbfollow-up care for the person who has been given the information or in respect of whom the referral has been made.131An NHS appliance contractor (C) must ensure that pharmaceutical services are provided at or from C's appliance contractor premises—afor not less than 30 hours each week;bfor not less than 100 hours per week, in the case of which a 100 hours condition (originally imposed under the 2005 Regulations) applies;cif NHS England or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at or from the premises for fewer than 30 hours per week, provided that the person listed in relation to them provides those services at set times and on set days, at the times and on the days so set;dif a Primary Care Trust, or on appeal the Secretary of State, has (under previous Regulations) directed that pharmaceutical services are to be provided at or from the premises for more than 30 hours per week, and at set times and on set days, at the times and on the days so set; oreif NHS England or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at or from the premises for more than 30 hours each week, but only on set times and on set days as regards the additional opening hours—ifor the total number of hours each week required by virtue of that direction, andiias regards the additional opening hours for which the person listed in relation to the premises is required to provide pharmaceutical services by virtue of that direction, at the days on which and times at which that person is required to provide pharmaceutical services during those additional opening hours, as set out in that direction,but NHS England may, in appropriate circumstances, agree a temporary suspension of services for a set period, where it has received 3 months notice of the proposed suspension.2The hours during which appliance contractor premises must be open by virtue of sub-paragraph (1) are referred to in these Regulations as “core opening hours”.3C must exhibit a notice specifying the days on which and times at which the appliance contractor premises are open for the provision of appliances.4C must, on request, submit a return to NHS England setting out—athe days on which and times at which pharmaceutical services are provided at or from C's appliance contractor premises (including times at which C is providing pharmaceutical services when C is not obliged to do so by virtue of sub-paragraph (1), which are referred to in these Regulations as “supplementary opening hours”); andbthe pharmaceutical services which C ordinarily provides at or from those premises.5Where C changes—athe supplementary opening hours of C's appliance contractor premises; orbthe pharmaceutical services which C is ordinarily to provide at or fromthose premises,C must supply NHS England with a return informing it of the change.6Where C has notified to NHS England (or, before the appointed day, a Primary Care Trust) the days on which and the times at which pharmaceutical services are to be provided at or from C's appliance contractor premises (for example, in a return under sub-paragraph (4) or (5) or in an application for inclusion in a pharmaceutical list)—aC must ensure that pharmaceutical services are provided at or from the premises to which the notification relates on the days and at the time set out in that notification (unless the notification has been superseded by a return, or further return, under sub-paragraph (5)); andbC must not change—ithe days on which or the times at which pharmaceutical services are to be provided at or from those premises during core opening hours that are neither additional opening hours nor in total less than 30 (but if those core opening hours are additional opening hours, or are in total less than 30, regulation 65(5) to (7) and paragraphs 15 and 16 apply,iithe total number of any supplementary opening hours (regulation 65(5) to (7) and paragraphs 15 and 16 apply to changes to the total number of core opening hours),iiithe days on which or the times at which pharmaceutical services are to be provided at or from those premises during supplementary opening hours, orivthe pharmaceutical services which P is ordinarily to provide at or from those premises,for a period of at least 3 months after that notification was received by NHS England (or, before the appointed day, a Primary Care Trust), unless NHS England agrees otherwise.7Subject to sub-paragraph (8), where C is prevented by illness or other reasonable cause from complying with C's obligations under sub-paragraph (1), C must, where practicable, make arrangements with one or more NHS appliance contractors, NHS pharmacists or LPS chemists whose premises are situated in the same area for the provision of pharmaceutical services or local pharmaceutical services during that time.8C may only make an arrangement with an LPS chemist under sub-paragraph (7) where that LPS chemist provides local pharmaceutical services which are of a similar description as, and a similar extent to, the pharmaceutical services which C ordinarily provides.9Where there is a temporary suspension in the provision of pharmaceutical services by C for a reason beyond the control of C, C is not in breach of sub-paragraphs (1) and (6), provided that—aC notifies NHS England of that suspension as soon as practical; andbC uses all reasonable endeavours to resume provision of pharmaceutical services as soon as is practicable.10Planned refurbishment of appliance contractor premises is neither a “reasonable cause” for the purposes of sub-paragraph (7) nor a “reason beyond the control of C” for the purposes of sub-paragraph (9).11For the purposes of calculating the number of hours that premises are open during a week that includes Christmas Day, Good Friday, Easter Sunday or a bank holiday, it is to be deemed that the premises were open on that day at the times at which they would ordinarily have been open on that day of the week.12In this Schedule, the “additional opening hours”, when they are required, are those hours during which C would not be providing pharmaceutical services, were C subject to the condition set out in sub-paragraph (1)(a) and not the condition set out in sub-paragraph (1)(e).141Where NHS England issues a direction setting any days or times under this Schedule, it must in doing so seek to ensure that the hours at which premises are open for the provision of pharmaceutical services are such as to ensure that pharmaceutical services are provided on such days and at such times as are necessary to meet the needs of people in its area, or other likely users of the premises, for pharmaceutical services.2In considering the matters mentioned in sub-paragraph (1), NHS England—amust treat any local pharmaceutical services being provided in its area at the days and times in question as if they were pharmaceutical services being so provided; andbmay have regard to any pharmaceutical services that are being provided in its area in circumstances where the person providing the services is not obliged to provide those services.3NHS England may only direct that an NHS appliance contractor (C) may provide pharmaceutical services at or from appliance contractor premises for less than 30 hours in any week if it is satisfied that the arrangements for the supply of appliances in its area are likely to be adequate to meet the need for such services at times when C is not providing pharmaceutical services.4Except in the case of premises that have (at any time) been subject to a direction under regulation 65 or regulation 65 of the 2012 Regulations (core opening hours conditions), NHS England may only direct that C must provide pharmaceutical services at or from premises for more than 30 hours in any week if it is satisfied that C is to receive reasonable remuneration in respect of the additional opening hours for which C is required to provide pharmaceutical services (and any additional remuneration payable in accordance with a determination made as mentioned in regulation 91(6) in respect of those hours is “reasonable remuneration” for these purposes).151Where it appears to NHS England, after consultation with or having considered the matter at the request of the Local Pharmaceutical Committee for the area in which the premises are situated, that the days on which or times at which appliance contractor premises are or are to be open for the provision of pharmaceutical services will not, or no longer, meet the needs of—apeople in its area; orbother likely users of the appliance contractor premises,for the pharmaceutical services available at or from those premises, it must carry out an assessment as to whether to issue a direction requiring the NHS appliance contractor (C) to provide pharmaceutical services at or from the premises at set times and on set days (which may include Christmas Day, Good Friday and bank holidays).2Before concluding the assessment under sub-paragraph (1) NHS England must—agive notice to C of any proposed changes to the days on which or times at which the appliance contractor premises are to be open; andballow C 30 days within which to make written representations to NHS England about the proposed changes.3After considering any representations made in accordance with sub-paragraph (2)(b), NHS England must—aissue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs (4) and (5);bconfirm any existing direction in respect of the times at which C must provide pharmaceutical services at or from the appliance contractor premises, provided that the existing direction (whether issued under regulation 65, this Schedule, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations) would meet the requirements of sub-paragraphs (4) and (5);ceither—irevoke (without replacing it) any existing direction in respect of the times at which C must provide pharmaceutical services at or from the premises (whether issued under regulation 65, this Schedule, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), oriiin a case where there is no existing direction, issue no direction,in which case, by virtue of whichever of paragraph 13(1)(a) or (b) applies, the appliance contractor premises will need to be open for not less than 30 hours each week or not less than 100 hours each week.4Where NHS England issues a direction under sub-paragraph (3) in respect of appliance contractor premises that are to be required to be open—afor more than 30 hours each week, it must set out in that direction—ithe total number of hours each week for which C must provide pharmaceutical services at or from the premises, andiias regards the additional opening hours for which C is to provide pharmaceutical services, the days on which and the times at which C is required to provide those services during those additional opening hours,but it must not set out in that direction the days on which or times at which C is to provide pharmaceutical services during hours which are not additional opening hours; orbfor less than 30 hours each week, it must set out in that direction the days on which and times at which pharmaceutical services are to be provided at or from those premises.5NHS England must not issue a direction under sub-paragraph (3) that has the effect simply of requiring premises to be open for 30 hours each week on set days and at set times (that is, the direction must have the effect of requiring premises to be open for either more or less than 30 hours each week).6NHS England must notify C in writing of any direction issued or any other action taken under sub-paragraph (3), and where it sets new days on which or times at which the NHS appliance contractor is to provide pharmaceutical services at or from the premises, it must include with the notification a statement of—athe reasons for the change; andbC's right of appeal under paragraph (7).7C may, within 30 days of receiving notification under sub-paragraph (6), appeal in writing to the Secretary of State against any direction issued or any other action taken under sub-paragraph (3) which sets new days on which or times at which C is to provide pharmaceutical services.8The Secretary of State may, when determining an appeal, either confirm the action taken by NHS England or take any action that NHS England could have taken under paragraph (3).9The Secretary of State must notify C of the determination and must in every case include with the notification a statement of the reasons for the determination.10If the days on which or times at which C is to provide pharmaceutical services at or from appliance contractor premises have been changed in accordance with this paragraph, C must introduce the changes—aif C has not appealed under sub-paragraph (7), not later than 8 weeks after the date on which C receives notification under sub-paragraph (6); orbif C has appealed under sub-paragraph (7), not later than 8 weeks after the date on which C receives notification under sub-paragraph (9).11This paragraph does not apply where regulation 65(5) to (7) applies.161An NHS appliance contractor (C) may apply to NHS England for it to change the days on which or times at which C is obliged to provide pharmaceutical services at or from C's premises, in a way that—areduces the total number of hours for which C is obliged to provide pharmaceutical services each week (but not any of those required under a 100 hours condition); orbkeeps that total number of hours the same.2Where C makes an application under sub-paragraph (1), as part of that application C must provide NHS England with such information as NHS England may reasonably request in respect of any changes to the needs of the people in its area, or other likely users of the premises, for pharmaceutical services that are material to the application.3NHS England must determine an application under sub-paragraph (1) within 60 days of receiving it (including any information required of C in accordance with sub-paragraph (2)).4In determining the application, NHS England must—aissue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs (5) and (6) and which has the effect of either granting the application under this paragraph or granting it only in part;bconfirm any existing direction in respect of the times at which C must provide pharmaceutical services at or from the premises, provided that the existing direction (whether issued under regulation 65, this Schedule, the 2005 Regulations or the 1992 Regulations) would meet the requirements of sub-paragraphs (5) and (6); orceither—irevoke (without replacing it) any existing direction in respect of the times at which C must provide pharmaceutical services at or from the premises (whether issued under regulation 65, this Schedule, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), where this has the effect of granting the application under this paragraph or granting it only in part, oriiin a case where there is no existing direction, issue no direction,in which case, by virtue of whichever of paragraph 13(1)(a) or (b) applies, the appliance contractor premises will need to be open for not less than 30 hours each week or not less than 100 hours each week.5Where NHS England issues a direction under sub-paragraph (4) in respect of appliance contractor premises that are to be required to be open—afor more than 30 hours each week, it must set out in that direction—ithe total number of hours each week for which C must provide pharmaceutical services at or from the premises, andiias regards the additional opening hours for which C is to provide pharmaceutical services, the days on which and the times at which C is required to provide those services during those additional opening hours,but it must not set out in that direction the days on which or times at which C is to provide pharmaceutical services during hours which are not additional opening hours; orbfor less than 30 hours each week, it must set out in that direction the days on which and times at which pharmaceutical services are to be provided at or from those premises.6NHS England must not issue a direction under sub-paragraph (4) that has the effect simply of requiring appliance contractor premises to be open for 30 hours each week on set days and at set times (that is, the direction must have the effect of requiring appliance contractor premises to be open for either more or less than 30 hours each week).7Where NHS England is considering taking action under sub-paragraph (4)(a) or (c)(i), it must consult the Local Pharmaceutical Committee for the area where the premises are situated before determining the application.8NHS England must notify C of any direction issued or any other action taken under sub-paragraph (4), and where this has the effect of refusing an application under this paragraph or granting it in part, it must send C a statement setting out—athe reasons for the refusal or, as the case may be, for granting the application only in part; andbC's right of appeal under sub-paragraph (9).9C may, within 30 days of receiving a notification pursuant to sub-paragraph (8), appeal in writing to the Secretary of State against any action under sub-paragraph (4) which has the effect of refusing an application under this paragraph or granting it only in part.10The Secretary of State may, when determining an appeal, either confirm the action taken by NHS England or take any action that NHS England could have taken under sub-paragraph (4).11The Secretary of State must notify C of the determination and must in every case include with the notification a statement of the reasons for the determination.12If the days on which or times at which C is to provide pharmaceutical services at or from appliance contractor premises have been changed in accordance with this paragraph, C must introduce the changes—aif C has not appealed under sub-paragraph (9), not earlier than 30 days after the date on which C receives notification under sub-paragraph (4); orbif C has appealed under sub-paragraph (9), not earlier than 30 days after the date on which C receives notification under sub-paragraph (11).13This paragraph does not apply where regulation 65(5) to (7) applies.171Notwithstanding the provisions of paragraphs 13 to 16, during an emergency requiring the flexible provision of pharmaceutical services, NHS England may, on application from an NHS appliance contractor (C), permit C a temporary change to the days on which or times at which C is obliged to provide pharmaceutical services at or from appliance contractor premises, or permit temporary closure of those premises, if—aC gives at least 24 hours notice of the change or closure; andbthe reasons given by C for the request are, in the opinion of NHS England, adequate reasons.2NHS England need not approve the request in advance of the change or closure, but if it does not do so and decides subsequently that C's reasons are not, in its opinion, adequate reasons, then the days on which or times at which C is obliged to provide pharmaceutical services at or from the premises are to revert to the overridden days and times, from the day after the date on which that decision is given to C.181An NHS appliance contractor (C) must, in connection with the pharmaceutical services provided by C, participate, in the manner reasonably required by NHS England, in an acceptable system of clinical governance.2For these purposes a system of clinical governance is “acceptable” if it is considered acceptable by NHS England and comprises the following components—aa patient and public involvement programme, which includes—i. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iia requirement that C publicises the NHS services that are available at or from C's appliance contractor premises,iiia requirement that C undertakes an approved patient satisfaction survey annually, in an approved manner,ivC's monitoring arrangements in respect of appliances owed to patients but which are out of stock,van approved complaints system (which meets the requirements of paragraph 24),via requirement that C co-operates appropriately with visits by an authorised representative of any relevant Local Healthwatch organisation and takes appropriate action following the outcome of such visits,viia requirement that C co-operates appropriately with any reasonable inspection or review that NHS England or any relevant statutory authority wishes to undertake, andviiiC's monitoring arrangements in respect of C's compliance with the Equality Act 2010 ;ba clinical audit programme (normally of 5 days) twice in each financial year;ca risk management programme, which includes—iarrangements for ensuring that all stock is procured and handled in an appropriate way,iiarrangements for ensuring that all equipment used in the provision of pharmaceutical services is maintained appropriately,iiian approved incident reporting system, together with arrangements for analysing and responding to critical incidents,ivappropriate standard operating procedures, including standard operating procedures in respect of dispensing appliances, repeatable prescriptions and providing advice and support to people caring for themselves or their families,vappropriate waste disposal arrangements for clinical and confidential waste,viidentifying a clinical governance lead person in respect of each of C's appliance contractor premises,viiC's monitoring arrangements of C's compliance with the Health and Safety at Work etc. Act 1974 ;da clinical effectiveness programme, which includes arrangements for ensuring that appropriate advice is given by C—iin respect of the provision of appliances in accordance with a prescription form or repeatable prescription, oriito people caring for themselves or their families,and arrangements for ensuring that C, when giving advice to any patient on a matter mentioned in paragraph (d)(i), has regard to the details contained in the records maintained under paragraph 9(1)(f) in respect of the provision of appliances and prescribing pattern relating to the patient in question;ea staffing and staff management programme, which includes—iarrangements for appropriate induction for staff (including locums),iiappropriate training for all staff in respect of any role they are asked to perform,iiiarrangements for the checking of qualifications ... of all staff engaged in the provision of NHS services,ivarrangements for identifying and supporting the development needs of all staff engaged in the provision of NHS services, including continuing professional development for registered pharmacists, registered nurses and registered pharmacy technicians and any necessary accreditation in respect of the provision of directed services, andvarrangements for addressing poor performance (in conjunction with NHS England as appropriate); andfan information governance programme, which provides for—icompliance with approved procedures for information management and security, andiisubmission of an annual self assessment of compliance (to an approved level) with those procedures via approved data submission arrangements which allow NHS England to access that assessment.3For the purposes of sub-paragraph (2), “approved” means approved by NHS England.19An NHS appliance contractor must provide pharmaceutical services and exercise any professional judgment in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession.201An NHS appliance contractor (C) (including C's staff) must not give, promise or offer to any person any gift or reward (whether by way of a share of or dividend on the profits of the business or by way of discount or rebate or otherwise) as an inducement to or in consideration of a person (X)—apresenting an order for appliances on a prescription form or repeatable prescription; orbnominating C as X's dispensing contractor (or one of them) in X's PDS patient details.2Promising, offering or providing a home delivery service is not a gift or reward for the purposes of sub-paragraph (1).3C (including C's staff) must not accept or receive any gift or reward in respect of only—aproviding contact details of alternative NHS pharmacists or NHS appliance contractors pursuant to paragraph 9(2)(b), 11(4) or 12(1)(b); orbreferring a prescription form or repeatable prescription to another NHS appliance contractor or NHS pharmacist pursuant to paragraph 9(2)(a) or 12(1)(a) and providing no additional service in connection with the item on that prescription.211An NHS appliance contractor (C) and, where C is a body corporate every director of C must, within 7 days of its occurrence, inform NHS England in writing if they—aare convicted of any criminal offence in the United Kingdom;bare bound over following a criminal conviction in the United Kingdom;caccept a police caution in the United Kingdom;dhave, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging them absolutely (without proceeding to conviction);ehave accepted and agreed to pay either a procurator fiscal fine under section 302 of the Criminal Procedure (Scotland) Act 1995 (fixed penalty: conditional offer by procurator fiscal) or a penalty under section 115A of the Social Security Administration Act 1992 (penalty as alternative to prosecution);fhave been convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England, could lead to a criminal conviction in England;gare charged in the United Kingdom with a criminal offence, or are charged elsewhere than in the United Kingdom with an offence where the originating events, if they took place in England, could lead to a criminal conviction in England;hare notified by any licensing, regulatory or other body of the outcome of any investigation into their professional conduct, and there is a finding against them;ibecome the subject of any investigation into their professional conduct by any licensing, regulatory or other body;jbecome subject to an investigation into their professional conduct in respect of any current or previous employment, or are notified of the outcome of any such investigation and any finding against them;kbecome the subject of any investigation by NHS CFA in relation to fraud;lbecome the subject of any investigation by another primary care organisation, which might lead to their removal from a relevant list; ormare removed, contingently removed or suspended from, refused inclusion in or conditionally included in any relevant list for a reason relating to unsuitability, fraud or efficiency of service provision,and must give details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome.2If a person to whom paragraph (1) applies (X) is, or was at the time of the originating events, a director of a body corporate, X must in addition inform NHS England within 7 days if any such body corporate—ais convicted of any criminal offence in the United Kingdom;bis convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England, could lead to a criminal conviction in England;cis charged in the United Kingdom with a criminal offence, or is charged elsewhere than in the United Kingdom with an offence where the originating events, if they took place in England, could lead to a criminal conviction in England;dis notified by any licensing, regulatory or other body of the outcome of any investigation into its provision of professional services, and there is a finding against the body corporate;ebecomes the subject of any investigation into its provision of professional services by any licensing, regulatory or other body;fbecomes the subject of any investigation by the NHS CFA in relation to any fraud or is notified of the outcome of such an investigation where it is adverse;gbecomes the subject of any investigation by another primary care organisation which might lead to its removal from any relevant list; orhis removed, contingently removed or suspended from, refused inclusion in or conditionally included in any relevant list for a reason relating to unsuitability, fraud or efficiency of service provision,and X must give the name and registered office of the body corporate and details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome.3C or X must consent to a request being made by NHS England to any employer or former employer or licensing or regulatory body in the United Kingdom or elsewhere, for information relating to a current investigation, or an investigation where the outcome was adverse.221An NHS appliance contractor (C) must give notice to NHS England within 30 days (or if this is impracticable, as soon as practicable thereafter) of—aany occurrence requiring a change in the information recorded about C in the pharmaceutical list which C has not otherwise notified to NHS England in accordance with these Regulations;bif C is an individual, any change of C's private address;cif C is a body corporate, any change to the name, registered number, registered office, telephone number relating to that office of the body corporate; anddany occurrence requiring C's addition to or removal from the EPS list or a change in the information recorded about C in that list.2C must give NHS England, if it so requests, the name of any pharmacist employed or engaged by C who is responsible for dispensing a particular prescription.3If C is a body corporate, it must give notice to NHS England within 30 days (or if this in impracticable, as soon as practicable thereafter) of any changes to the names and addresses of each of its directors.4If C is a body corporate and appoints a director who was not listed on C's application for inclusion on a pharmaceutical list, C must, within 30 days of the person's appointment, supply to NHS England the information mentioned in paragraphs 3 and 4 of Schedule 2 about that person.5If C or a director of C (if C is a body corporate) is on, or is a director of a body corporate which is on, a relevant list other than a pharmaceutical list held by NHS England, they must supply in writing to NHS England—ain the case of a director of a body corporate, the name and registered office of the body corporate on the other relevant list; andbparticulars of the other relevant list.6C or a director C (if C is a body corporate) must inform NHS England if they, or a body corporate of which they are a director, apply to be included in a relevant list other than a pharmaceutical list held by NHS England, and of the outcome of any such application.23An NHS appliance contractor must co-operate with NHS England in the discharge by NHS England of the duty under section 1F(1) of the 2006 Act (duty as to education and training).241An NHS appliance contractor must have in place arrangements, which comply with the requirements of the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 , for the handling and consideration of any complaints.2In this paragraph, “complaint” means a complaint about a matter connected with the provision of pharmaceutical services by the NHS appliance contractor.251An NHS appliance contractor (C) must allow persons authorised in writing by NHS England to enter and inspect any premises C uses for the provision of pharmaceutical services at any reasonable time, for the purposes of—aascertaining whether or not C is complying with the requirements of this Schedule;bauditing, monitoring and analysing—ithe provision made by C, in the course of providing pharmaceutical services, for patient care and treatment, including any arrangement made with a person in respect of provision of appliances, andiithe management by C of the pharmaceutical services C provides,where the conditions in sub-paragraph (2) are satisfied.2The conditions are that—areasonable notice of the intended entry has been given;bthe Local Pharmaceutical Committee for the area where the premises are situated have been invited to be present at the inspection, where this is requested by C;cthe person authorised in writing (X) carries written evidence of X's authorisation, which X produces on request; anddX does not enter any part of the premises used solely as residential accommodation without the consent of the resident.3C must, at the request of NHS England or of X, allow it or X access to any information which it or X reasonably requires—afor the purposes mentioned in sub-paragraph (1); orbin the case of NHS England, in connection with its functions that relate to pharmaceutical services.SCHEDULE 6 Regulation 47(1)(a)(i)11Where this Schedule imposes a requirement on a dispensing doctor in respect of an activity which the dispensing doctor has duly authorised another person to undertake, if that other person undertakes that activity instead of the dispensing doctor—athat other person must comply with that requirement; andbthe dispensing doctor must secure compliance with that requirement by that other person.2Where reference is made in this Schedule to a dispensing doctor—abeing the subject of an activity, and in fact a person duly authorised by the dispensing doctor is the subject of that activity; orbforming a view, and in fact a person duly authorised by the dispensing doctor is to form that view,that reference is to be construed as referring, as appropriate, to that duly authorised person.3References in this Schedule to a dispensing doctor are to be construed in accordance with sub-paragraphs (1) and (2).21In this paragraph, “signed” includes signature with a prescriber's advanced electronic signature.2Subject to the following provisions of this Schedule, where—aany person presents to a dispensing doctor (D) a non-electronic prescription form which contains—ian order for drugs, not being Scheduled drugs, or for appliances, not being restricted availability appliances, signed by a prescriber other than D,iian order for drugs specified in Schedule 2 to the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances), signed by a prescriber other than D, and including the reference “SLS”, oriiian order for restricted availability appliances, signed by a prescriber other than D and including the reference “SLS”; ...bsubject to sub-paragraph (4), D receives as a nominated dispensing contractor from the Electronic Prescription Service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) to (iii) and—iany person requests the provision of drugs or appliances in accordance with that prescription, oriiD has previously arranged with the patient that D will dispense that prescription on receipt; or cany person—ipresents D with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iii), andiirequests the provision of drugs or appliances in accordance with the related electronic prescription form,and D is authorised or required by virtue of Part 8 to provide the drugs or appliances so ordered, D must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as D supplies in the normal course of business.3Subject to the following provisions of this Schedule, where—aany person presents to D a non-electronic repeatable prescription which contains—ian order for drugs, not being Scheduled drugs or controlled drugs within the meaning of the Misuse of Drugs Act 1971 , other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a prescriber other than D,iian order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, not being a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001, signed by a prescriber other than D and including the reference “SLS”,iiian order for appliances, not being restricted availability appliances, signed by a prescriber other than D, orivan order for a restricted availability appliance, signed by a prescriber other than D, and including the reference “SLS”,and also presents an associated batch issue; ...bD receives as a nominated dispensing contractor an electronic repeatable prescription from the Electronic Prescription Service which contains an order of a kind specified in paragraph (a)(i) to (iv) and—iany person requests the provision of drugs or appliances in accordance with that repeatable prescription, oriiD has previously arranged with the patient that D will dispense that repeatable prescription on receipt; or cany person—ipresents D with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iv), andiirequests the provision of drugs or appliances in accordance with the related electronic repeatable prescription,and D is authorised or required by virtue of Part 8 to provide the drugs or appliances so ordered, D must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as D supplies in the normal course of business.4D must not provide under an electronic prescription form a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedules 2 to 5 to the Misuse of Drugs Regulations 2001.5For the purposes of this paragraph, a non-electronic repeatable prescription for drugs or appliances shall be taken to be presented even if the person who wishes to obtain the drugs or appliances does not present that prescription, where—aD has that prescription in D's possession; andbthat person presents, or D has in D's possession, an associated batch issue.6Drugs and appliances provided under this paragraph must be provided in a suitable container.3In circumstances where paragraph 2 does not apply and subject to the following provisions of this Schedule, where a dispensing doctor (D) is authorised or required by virtue of Part 8 to provide a drug or appliance to a person—aD must record any order for the provision of any drugs or appliances which are needed for the treatment of the patient, before the drugs or appliances are dispensed (unless it is personally administered)—ion a prescription form completed in accordance with the term of the contract under which primary medical services are provided to the patient which gives effect to paragraph 39 of Schedule 6 to the GMS Regulations (other contractual terms – prescribing) or an equivalent provision applying in relation to that contract,iiif paragraph 39A of Schedule 6 to the GMS Regulations (other contractual terms – electronic prescriptions) or an equivalent provision applies in relation to the contract under which primary medical services are provided to the patient, on an electronic prescription form, oriiiin the case of a personally administered vaccine in respect of which the NHS BSA does not require an individual prescription form in order to process payment, on the form provided by the NHS BSA for the purposes of claiming payments for administering that vaccine (as well, potentially, as claiming other payments), and in the manner required by the NHS BSA (which may be as part of an aggregate total);bD must provide those drugs or appliances in a suitable container (unless it is personally administered);cD must provide for the patient a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances) only where the conditions in paragraph 42(2) of Schedule 6 to the GMS Regulations (other contractual terms – a restrictions on prescribing by medical practitioners) are satisfied; anddD must provide for the patient a restricted availability appliance only if the patient is a person, or it is for a purpose, specified in the Drug Tariff.3A1This sub-paragraph applies where, in relation to an order for a drug or an appliance on a prescription form or a repeatable prescription—aa SSP has effect in respect of—ithe requested drug or appliance, oriidrugs or appliances of a specified description, and the requested drug appliance is of that description.2Where sub-paragraph (1) applies and D provides a different product or quantity of product to the product or quantity of product ordered on the prescription form or repeatable prescription, in accordance with the SSP—aD must endorse the prescription or the associated batch issue accordingly (if the manner for making the endorsement is provided for in the Drug Tariff, in the manner provided for in the Drug Tariff); andbthe prescription or associated batch issue as thus endorsed is treated as being the prescription for product reimbursement purposes (even though the supply is not in pursuance of that prescription).3Where D provides a drug or appliance under this paragraph, D must include in the dispensing label on the packaging of the product, for the patient’s benefit, information to the effect that the product is being supplied in accordance with a SSP, identifying the particular SSP.3B1Subject to the following provisions of this Schedule, where—aa dispensing doctor (D) receives, via a secure service approved by NHS England for this purpose, an electronic message that amounts to an order for the supply of a drug in accordance with a PTP or a PTPGD; andba person who is entitled to be supplied with that drug by D (Part 8 and this Schedule having that effect) in pursuance of that order requests the provision of the drug in accordance with that order,D must, with reasonable promptness, provide the drug so ordered.1AWhere D considers—aon the basis of a request for the supply of a drug in accordance with a PTP or a PTPGD that has been approved by NHS England as a basis for supply as part of pharmaceutical services;bhaving made the appropriate checks; andchaving regard to what is reasonable and appropriate,that a person is entitled to be supplied with the drug by D (Part 8 and this Schedule having that effect) in accordance with the PTP or PTPGD as part of pharmaceutical services, D must, with reasonable promptness, provide the drug requested.2If a person requesting the provision of the drug asks D to do so—aD must give an estimate of the time when the drug will be ready; andbif they are not ready by then, D must give a revised estimate of the time when they will be ready (until they are ready).3Where D provides a drug under sub-paragraph (1) or (1A), D must include a dispensing label on the packaging of the product and include in the label (in addition to the particulars required or permitted by Part 1 of Schedule 26 to the Human Medicines Regulations 2012), for the patient’s benefit, information to the effect that the product is being supplied in accordance with a PTP or a PTPGD, identifying the particular PTP or PTPGD.4Sub-paragraph (1) does not apply where arrangements are in place for the provision of the drug ordered pursuant to the PTP or PTPGD as part of a directed service which includes arrangements for the provision of such a drug ordered in accordance with such a PTP or PTPGD.5Sub-paragraph (1A) does not apply where arrangements are in place for the provision of the drug requested in accordance with the PTP or PTPGD as part of a directed service which includes arrangements for the provision of such a drug requested in accordance with such a PTP or PTPGD.3C1Subject to the following provisions of this Schedule, where—aa dispensing doctor (D) receives a LPIV; andba person who is entitled to be supplied by D (Part 8 and this Schedule having that effect) with a prescription item ordered on the LPIV requests the provision of the item in accordance with that LPIV,D must, with reasonable promptness, provide the prescription item so ordered.2If a person who is entitled as mentioned in sub-paragraph (1)(b) asks D to do so—aD must give an estimate of the time when the prescription item will be ready; andbif they are not ready by then, D must give a revised estimate of the time when the item will be ready (until it is ready).3Sub-paragraph (1) does not apply where arrangements are in place for the provision of the item ordered on the LPIV as part of a directed service which includes arrangements for the provision of such an item ordered on such a LPIV.4Before providing any drugs or appliances in accordance with paragraph 3 or 3A, or in the circumstances set out in paragraph 5—aa dispensing doctor (D) must ask any person who makes or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription that the patient does not have to pay the charges specified in regulation 4(1) of the Charges Regulations (supply of drugs and appliances by doctors) by virtue of either—ientitlement to exemption under regulation 10(1) of the Charges Regulations (exemptions), oriientitlement to remission of charges under regulation 5 of the Remission of Charges Regulations (entitlement to full remission and payment),to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of regulation 10 of the Charges Regulations or in respect of entitlement to remission by virtue of regulation 5 of the Remission of Charges Regulations, and at the time of the declaration D has such evidence available to D;bif, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by sub-paragraph (a), is produced to D, D must endorse the form on which the declaration is made to that effect; andcin the case of an electronic prescription, D must ensure that the following information is duly entered into the records managed by NHS England that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as a real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (a))—iin a case where exemption from or remission of charges is claimed for all or some of the items included in the prescription, a record of—aathe exemption category specified in regulation 10(1) of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which it is claimed applies to the case, andbbwhether or not satisfactory evidence was produced to D as required by sub-paragraph (a),iiin any case where a charge is due, confirmation that the relevant charge was paid, andiiiin a case of a prescription for or including contraceptive substances, confirmation that no charge was payable in respect of those substances.4ZA1For the purposes of—aPart 5 of Schedule 3 to the GMS Regulations (other contractual terms – sub-contracting);bPart 5 of Schedule 2 to the PMS Regulations (other required terms – subcontracting); andcany contractual arrangements with an APMS practice that restrict the sub-contracting of rights or duties under the arrangements in relation to clinical matters,core dispensing functions are clinical matters (whether or not they would be considered as such but for this sub-paragraph) and accordingly, the specific requirements in this Schedule in respect of sub-contracting those functions are in addition to the general requirements in those Schedules in respect of sub-contracting them.2For the purposes of this paragraph and paragraph 4ZB, “core dispensing functions” means the assembly or part-assembly of any prescription item (including bagging and the application of dispensing labels) with a view to the supply of that prescription item in accordance with a prescription, an SSP, a LPIV, a PTP or a PTPGD.3A dispensing doctor (and by extension a provider of primary medical services as mentioned in regulation 47(2)(b), referred to together for the purposes of this paragraph and paragraphs 4ZB and 4ZC as (D)) must not sub-contract the performance of any of its core dispensing functions, but this does not apply to—aa contract for services between D and a health care professional (for example, a locum), or a provider of locums, for performance by that professional, or by locums provided by that provider of locums, personally of core dispensing functions at D’s listed dispensing premises; orbthe performance of any of D’s core dispensing functions under valid hub and spoke arrangements.4For the purposes of this paragraph and paragraphs 4ZB and 4ZC, “hub and spoke arrangements” are arrangements between D and a retail pharmacy business (P) which—aare for the purpose of P supporting D with regard to the fulfilment of orders—isubmitted to D on prescription forms or LPIVs, oriifor the provision of prescription items by D in accordance with PTPs or PTPGDs; andbprovide for the assembly or part-assembly of those orders (including in accordance with an SSP) at premises of P with a view to the supply of the prescription items at or from the listed dispensing premises of D to or for the use of the patients for whom they were ordered.5For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 4ZB and 4ZC, any prior notification that D is required to give to NHS England or an ICB before the commencement of arrangements by virtue of which D sub-contracts the core dispensing functions must include the following particulars—athe name, pharmacy premises address and General Pharmaceutical Council premises registration number of P;bthe duration of the proposed arrangements;ca description of the core dispensing functions to be covered by arrangements; andda description of the manner in which P proposes to meet D’s obligations under the terms of service in respect of the core dispensing functions to be covered by the arrangements.6For the hub and spoke arrangements to be valid for purposes of this paragraph and paragraphs 4ZB and 4ZC, if D is not otherwise (apart from by virtue of this sub-paragraph) required to give prior notification to NHS England or an ICB before the commencement of the sub-contracting of clinical services such as core dispensing functions—ait must give that prior notice in the case of hub and spoke arrangements, and in a manner that puts NHS England or the ICB for its location on reasonable notice of the commencement of the arrangements; andbthe notification that it does give must include the particulars specified in sub-paragraph (5)((a) to (d).7For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 4ZB and 4ZC, they must have the following features—athey must provide, and ensure, that any prescription item that is assembled or part-assembled under the arrangements is supplied to or for the use of the patient for whom it is dispensed at or from the listed dispensing premises of D (and so the arrangements must not allow P to fulfil the order directly);bin the case of an order for a medicine on a prescription form or LPIV, they must ensure that what is done, in the course of fulfilling the order, is done in a manner that ensures compliance with the requirements that are to be complied with for the supply from P to D of the medicine to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012 (assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses);cin the case of orders for prescription items that are not orders for medicines on a prescription form or a LPIV (“non-regulation-222A orders”)—ithey must relate to fulfilling both orders for medicines on prescription forms and non-regulation-222A orders, and accordingly D cannot only sub-contract to P core dispensing functions in respect of non-regulation-222A orders, andiithey must ensure that what is done, in the course of fulfilling the non-regulation-222A order, is done in a manner that would ensure compliance with the requirements that would need to be complied with for the supply from P to D of the prescription item, if it were instead of a medicine ordered on a prescription form or a LPIV, to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012;dthey must provide, and ensure, that P does not sub-contract any of the core dispensing functions that P performs on behalf of D;ethey must provide for the discontinuation of the arrangements, as set out in paragraph 4ZB (in addition to any patient safety or commercial grounds D or P may have for discontinuing the arrangements); andfthey must not be or have become invalid by virtue of paragraph 4ZB.8If D has hub and spoke arrangements in place, D must also have in place business continuity arrangements which ensure that D is able to meet all D’s obligations to provide dispensing services in the event of any temporary or permanent discontinuation or disruption of the hub and spoke arrangements.9D must give notice in writing to NHS England of any—atemporary discontinuation of hub and spoke arrangements that amounts to a suspension of those arrangements; orbpermanent discontinuation of hub and spoke arrangements,either before that discontinuation occurs or as soon as is reasonably practicable after it occurs, unless it is in response to a notice of objection from NHS England.4ZB1NHS England may at any time request from D (as defined in paragraph 4ZA(3)) information relating to hub and spoke arrangements that is relevant to the termination criteria (whether or not the arrangements have commenced), and if NHS England makes such a request, D must supply the requested information to NHS England promptly.2For the purposes of this paragraph, the termination criteria are—athe hub and spoke arrangements do not have the features required by paragraph 4ZA(7), including where they have had them but they have lapsed;bthe hub and spoke arrangements have the features required by paragraph 4ZA(7) but there has been a breach of those requirements;cthe hub and spoke arrangements put the safety of any persons to whom D provides pharmaceutical services at serious risk;dthe hub and spoke arrangements put NHS England at risk of material financial loss;ethe hub and spoke arrangements have led to D repeatedly breaching D’s terms of service, or to D breaching its terms of service in circumstances where D is likely to continue to do so repeatedly;fP’s (as defined in paragraph 4ZA(4)) fitness to carry out core dispensing functions is impaired; orgin the opinion of NHS England, there are reasonable grounds for believing one or more of the termination criteria in paragraphs (a) to (f) are established.3NHS England may, after the commencement of hub and spoke arrangements, issue a notice of objection to the arrangements, based on one or more of the termination criteria, and if it does so—athose arrangements become invalid on the termination date specified in the notice of objection; andbD must discontinue the arrangements on or by the date specified in the notice for their termination.4NHS England may withdraw a notice of objection issued under sub-paragraph (3), which has the effect of the arrangements to which the notice related no longer being invalid.5NHS England must, in a notice of objection, give its reasons for issuing the notice.6Subject to sub-paragraph (7), before issuing a notice of objection, NHS England must make every reasonable effort to communicate and co-operate with D with a view to resolving the matter without the notice being issued.7Sub-paragraph (6) does not apply where NHS England is satisfied—aits concerns relate to a matter that has already been the subject of dispute resolution between NHS England and D and there are no new issues of substance to delay issuing the notice; orbthat it is appropriate to proceed immediately to issuing a notice—ito protect the safety of any persons to whom D may provide pharmaceutical services, oriito protect NHS England from material financial loss.8After issuing a notice of objection, unless—ait was delayed by virtue of sub-paragraph (6); orbNHS England is satisfied its concerns related to a matter that has already been the subject of dispute resolution between NHS England and D and there are no new issues of substance to be resolved,NHS England must, where requested to do so by D, make every reasonable effort to communicate and co-operate with D with a view to resolving the matter in a manner that may lead to the notice of objection being withdrawn.4ZC1This paragraph applies to “relevant data”, which is data that relates to a patient and which is shared for the purpose of fulfilling an order under hub and spoke arrangements (as defined in paragraph 4ZA(4)) which is a non-regulation-222A order (as defined in paragraph 4ZA(7)(c)).2For the purposes of section 8(c) (lawfulness of processing: public interest etc) of, and paragraph 2(2)(a), (c) and (d) of Schedule 1 (special categories of personal data etc – health or social care purpose) to, the Data Protection Act 2018, sub-paragraph (3) applies to the processing of any relevant data—aby D or P (as defined in paragraph 4ZA(3) and (4)) which relates to a patient; andbwhich is necessary for the purposes of—ifulfilling an order of a type mentioned in paragraph 4ZA(4)(a) under valid hub and spoke arrangements, oriidischarging any related professional obligations to the patient (including obligations relating to the keeping of records).3That processing is—anecessary for the performance of a task carried out in the public interest; andbif the data is personal data concerning health, necessary for the purposes of preventative medicine, medical diagnosis or for the provision of health care or treatment.4Any person (X) who—ais employed or engaged by D or P; andbin the course of being so employed or engaged is required to undertake the processing of data described in sub-paragraph (2),owes a duty of confidentiality in respect of that data (whether or not they would do so but for this sub-paragraph).5The duty under paragraph (4)—ais a duty of confidentiality which, if not owed by a health care professional, is owed under an enactment or rule of law for the purposes of section 11(1)(b) of the Data Protection Act 2018 (special categories of personal data etc: supplementary); andbis such that, if the processing is necessary for the purposes described in sub-paragraph (2)(b), X is able, lawfully, to process that data by virtue of this paragraph.6For the purposes of sub-paragraph (2)(b)(ii), a professional obligation to a patient is to be regarded as such notwithstanding that discharging the obligation may—aalso be an obligation that arises in some other way (for example, arising from a duty of care); orbbe done by a person who is not a health care professional.7Sub-paragraphs (2) and (3) do not apply where, in reliance or purported reliance on valid hub and spoke arrangements, a person processes any data which relates to a patient but, in the course of the doing of anything that relates to the fulfilling of the order to which that data relates, there is a breach of—athe requirements to be fulfilled if what is done is to be treated as part of valid hub and spoke arrangements; orba duty of confidentiality owed in respect of the data by a health care professional or under an enactment or rule of law as mentioned in sub-paragraph (5)(a).8Words and expressions used in both—asub-paragraphs (1) to (7); andbParts 1 and 2 (preliminary and general processing) of, and paragraphs 2(2)(a), (c) and (d) of Schedule 1 to, the Data Protection Act 2018,bear the meanings they bear in those provisions of the Data Protection Act 2018.4A1For the purposes of paragraph 4, satisfactory evidence includes evidence derived from a check, known as a real time exemption check, of electronic records that are managed by the NHS BSA for the purposes (amongst other purposes) of providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under the Charges Regulations.2If D dispenses an electronic prescription, D must send the form duly completed by or on behalf of the patient, if one is required under regulation 4(2)(b) or (3A) of the Charges Regulations in respect of that electronic prescription (which may be the associated EPS token), to the NHS BSA.4BIn a case involving providing drugs or appliances in accordance with paragraph 3A, the references in paragraph 4 to a prescription form or repeatable prescription are to be construed as references to the prescription for product reimbursement purposes, as mentioned in paragraph 3A(2)(b).51A dispensing doctor (D) must only provide for a patient any Scheduled drug if—ait is ordered as specified in sub-paragraph (2) or (4); orbin the case of a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances), it is ordered in the circumstances prescribed in that Schedule.2A Scheduled drug that is a drug with an appropriate non-proprietary name may be provided in response to an order on a prescription form or repeatable prescription for a drug (“the prescribed drug”) that is not a Scheduled drug but which has the same non-proprietary name as the Scheduled drug if—athe prescribed drug is ordered by that non-proprietary name or by its formula; andbthe prescribed drug has the same specification as the Scheduled drug (so the Scheduled drug may be dispensed generically).3If a Scheduled drug is a combination of more than one drug, it can only be ordered as specified in sub-paragraph (2) if the combination has an appropriate non-proprietary name, whether or not the drugs in the combination each have such names.4Nothing in this Schedule prevents D providing, otherwise than under pharmaceutical services, a Scheduled drug or a restricted availability appliance for a patient.61A dispensing doctor (D) may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—aD reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example because D reasonably believes it has been stolen or forged);bit appears to D that there is an error on the prescription form or on the repeatable prescription or, in the case of a non-electronic repeatable prescription, its associated batch issue (including a clinical error made by the prescriber) or that, in the circumstances, providing the drugs or appliances would be contrary to D's clinical judgement; orcwhere the prescription form or repeatable prescription is incomplete because it does not include the information relating to the identification of the prescriber that NHS England (or a person exercising its functions) requires in order to perform its functions relating to—ithe remuneration of persons providing pharmaceutical services, andiiany apportionment of, or any arrangements for recharging in respect of, that remuneration,unless D (or the person who employs or engages D) is to receive no pharmaceutical remuneration of any kind in respect of the drug or appliance.1AD may refuse to provide a drug or appliance ordered on an electronic prescription if the access that D has to the Electronic Prescription Service is not such as to enable D to dispense that prescription promptly (or at all).2D must refuse to provide drugs or appliances ordered on a repeatable prescription where—aD has no record of that prescription;bD does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to D;cit is not signed by a prescriber;dto do so would not be in accordance with any intervals specified in the prescription;eit would be the first time a drug or appliance had been provided pursuant to the prescription and the prescription was signed (whether electronically or otherwise) more than 6 months previously;fif the repeatable prescription was signed (whether electronically or otherwise) more than one year previously;gthe expiry date on the repeatable prescription has passed; orhD has been informed by the prescriber that the prescription is no longer required.3Where a patient requests the supply of drugs or appliances ordered on a repeatable prescription (other than on the first occasion that the patient makes such a request), D must only provide the drugs or appliances ordered if D is satisfied—athat the patient to whom the prescription relates—iis taking or using, and is likely to continue to take or use, the drug or appliance appropriately, andiiis not suffering from any side effects of the treatment which indicates the need or desirability of reviewing the patient's treatment;bthat the medication regimen of the patient to whom the prescription relates has not altered in a way which indicates the need or desirability of reviewing the patient's treatment; andcthere have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient's treatment.4D must refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—aa SSP has effect in respect of—ithe requested drug or appliance; oriidrugs or appliances of a specified description, and the requested drug or appliance is of that description; andbalternative provision has already taken place in accordance with the SSP.5D may refuse to fulfil an order or a request for a drug that is or is purportedly in accordance with a LPIV, a PTP or a PTPGD where—aD reasonably believes it is not a genuine order or valid request for the person who requests, or on whose behalf is requested, the provision of the drug;bproviding it would be contrary to D’s clinical judgement;cD or other persons are subjected to or threatened with violence by the person who requests the provision of the drug, or by any person accompanying that person; ordthe person who requests the provision of the drug, or any person accompanying that person, commits or threatens to commit a criminal offence.6D must refuse to provide, pursuant to a LPIV, a PTP or a PTPGD, an order or a request for a drug that is or is purportedly in accordance with the LPIV, the PTP or PTPGD where D is not satisfied that it is in accordance with the LPIV, the PTP or PTPGD.7D may refuse to provide a prescription item ordered on a prescription form or repeatable prescription where—amore than one prescription item has been ordered on the prescription form or repeatable prescription;bat least one of those prescription items is a listed HRT prescription item and at least one of those prescription items is not; andcthe person named on the prescription form or repeatable prescription is claiming entitlement to exemption under regulation 10(1)(j) of the Charges Regulations (exemptions) in respect of any of those prescription items which is a listed HRT prescription item.7Notwithstanding the existence of arrangements under which a dispensing doctor (D) is to provide pharmaceutical services to a patient (P), if D determines that P requires a drug or appliance that is available on prescription at or from an NHS chemist—aD may with the agreement of P issue; orbif P so requests, D must not unreasonably refrain from issuing,a prescription form that P may present to any NHS chemist instead of D supplying that drug or appliance to P.7A1Before dispensing any item on a prescription form or supplying it in accordance with a serious shortage protocol, a dispensing doctor (D) must provide a home delivery option to eligible patients in respect of the item where, as a consequence of a disease being or in anticipation of a disease being imminently—apandemic; andba serious risk or potentially a serious risk to human health,NHS England with the agreement of the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are advised to stay away from listed dispensing premises in the area specified, in the circumstances specified and for the duration of the period specified in the announcement.2If D’s listed dispensing premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from D’s premises, D must ascertain from—aan eligible patient—iwho has contacted D about the home delivery of prescription items, oriiwho is a person whom D considered, on the basis of the nature of an item on a prescription form, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; orba person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted D about the home delivery of prescription items,whether or not the item could be supplied by a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which D must provide.3Where paragraph (2) does not apply, if D’s listed dispensing premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from D’s premises, the home delivery option that P must provide must comprise—aD delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);bD arranging for an item dispensed by D to be delivered by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; orcif D is unable to deliver the item or arrange for its delivery by another dispensing doctor, or by an NHS pharmacist or by an LPS contractor, D arranging for the dispensing or supply of the item by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, who would be able to deliver the dispensed item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.4Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at D’s listed dispensing premises for the purposes of receiving dispensing services.5Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, D may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.7AA1Before dispensing a notified item on a prescription form or supplying it in accordance with a serious shortage protocol, a PTP or a PTPGD, a dispensing doctor (D) must provide a home delivery option to eligible patients in respect of that item.2For the purposes of this paragraph, a “notified item” is an item that, as a consequence of a disease being or in anticipation of a disease being imminently—apandemic; andba serious risk or potentially a serious risk to human health,is the subject of an announcement made by NHS England, with the agreement of the Secretary of State, to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are entitled to be provided with a home delivery option in respect of that item, if it is supplied to them as part of pharmaceutical services.3Where D is to, or may be required to, dispense a notified item on a prescription form or supply it in accordance with a serious shortage protocol, a PTP or a PTPGD, D must ascertain from—aan eligible patient—iwho has contacted D about the home delivery of a notified item, oriiwho is a person whom D considered, on the basis of an order or request for a notifiable item, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; orba person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted D about the home delivery of a notified item,whether or not the item could be supplied via a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which D must provide.4Where paragraph (3) does not apply, the home delivery option that D must provide must comprise—aD delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);bD arranging for an item dispensed by D to be delivered by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; orcif D is unable to deliver the item or arrange for its delivery by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, D arranging for the dispensing or supply of the item by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, who would be able to deliver the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.5Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at D’s listed dispensing premises for the purposes of being supplied with the notifiable item.6Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, D may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.8Where a dispensing doctor is a provider of primary medical services, or is employed or engaged by such a provider, the complaints procedure established by—athe provider or practice; orbthe provider or practice that employs or engages the dispensing doctor,to deal with complaints in relation to the provision of primary medical services is also to apply in relation to a complaint about any matter reasonably connected with the provision of pharmaceutical services by that provider, practice or individual.91A dispensing doctor (D) must allow persons authorised in writing by NHS England to enter and inspect any premises D uses for the provision of pharmaceutical services at any reasonable time, for the purposes of—aascertaining whether or not D is complying with the requirements of this Schedule;bauditing, monitoring and analysing—ithe provision made by D, in the course of providing pharmaceutical services, for patient care and treatment, andiithe management by D of the pharmaceutical services D provides,where the conditions in sub-paragraph (2) are satisfied.2The conditions are that—areasonable notice of the intended entry has been given;bthe Local Medical Committee for the area where the premises are situated have been invited to be present at the inspection, where this is requested by D;cthe person authorised in writing (X) carries written evidence of X's authorisation, which X produces on request; anddX does not enter any part of the premises used solely as residential accommodation without the consent of the resident.3D must, at the request of NHS England or of X, allow it or X access to any information which it or X reasonably requires—afor the purposes mentioned in sub-paragraph (1); orbin the case of NHS England, in connection with its functions that relate to pharmaceutical services.101Where a dispensing doctor (D) wishes—ato withdraw from a dispensing doctor list, orbexcept in the circumstances described in paragraph (2), for particular listed dispensing premises no longer to be listed in relation to D,D must notify NHS England of D's wish at least 3 months in advance of the date on which pharmaceutical services are no longer to be provided, unless it is impracticable for D to do so, in which case D must notify NHS England as soon as it is practicable for D to do so.2If particular listed dispensing premises no longer need to be listed in relation to D as a consequence of a relocation application under regulation 55, before the date on which D commences the provision of pharmaceutical services at or from the new premises, D must give notice to NHS England of when, before that date, D is to cease to provide pharmaceutical services at or from the existing premises.SCHEDULE 7 Regulation 102(3)11The LPS contractor must comply with all relevant legislation, including—athe relevant provisions of Part 13 of these Regulations; andbrelevant provisions that are—iincluded in regulations under section 225 of the 2007 Act (duties of services-providers to allow entry by Local Healthwatch organisations or contractors), andiimade 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.2The LPS contractor must comply with the relevant provisions of the Drug Tariff.3The LPS contractor must have regard to all relevant guidance issued by—aNHS England; orbthe Secretary of State.4To the extent that the provisions of the terms required by this Schedule impose a requirement on the LPS contractor (C) in respect of an activity which could only, or would normally, be undertaken by a natural person—aif C is a registered pharmacist—iC must comply with the requirement, oriiif C employs or engages a registered pharmacist in connection with the provision of local pharmaceutical services under C's LPS scheme, C must either comply with that requirement or secure compliance with that requirement by the registered pharmacist C employs or engages; orbif C is not a natural person, C must secure compliance with that requirement by the registered pharmacists C employs or engages, and references in this Schedule to an LPS contractor are to be construed accordingly.21Where an LPS scheme is limited to the provision of specified drugs or appliances, the LPS contractor must not provide other drugs or appliances at or from the scheme premises.2An LPS scheme must contain the following terms, where applicable—awhere the local pharmaceutical services to be provided include the supply of appliances—ithe only appliances which may be supplied are appliances listed in Parts IXA, IXB, IXC or X of the Drug Tariff, andiithose appliances must be supplied in accordance with the provisions of the Notes, and the List of Technical Specifications, which appear at the beginning of Part IX of the Drug Tariff, which apply at the time of supply; andbwhere the local pharmaceutical services to be provided include the supply of chemical reagents, the only chemical reagents which may be supplied are those listed from time to time in Part IXR of the Drug Tariff.3Where an LPS scheme is limited to the provision of services—ato a specified class of persons (for example persons who require the provision of local pharmaceutical services for the treatment of a specified disease or condition); orbto persons residing in a particular place (for example persons in a specified residential home),the LPS contractor must not provide local pharmaceutical services to persons other than those so specified.31Subject to any provisions of an LPS scheme included pursuant to paragraph 2 and the following provisions of this Schedule, where—aany person presents to the LPS contractor (C) a non-electronic prescription form which contains—ian order for a drug, not being a Scheduled drug, or for an appliance, not being a restricted availability appliance, signed by a prescriber,iian order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances), signed by a prescriber and including the reference “SLS”, oriiian order for a restricted availability appliance, signed by a prescriber and including the reference “SLS”; ...bC receives as a nominated dispensing contractor from the Electronic Prescription Service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) to (iii), and—iany person requests the provision of a drug or appliance in accordance with that prescription, oriiC has previously arranged with the patient that it will dispense that prescription on receipt; or cany person—ipresents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iii), andiirequests the provision of a drug or appliance in accordance with the related electronic prescription form,C must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as C supplies in the normal course of business.2Where an LPS scheme includes the provision of repeat dispensing services, subject to any provisions of the LPS scheme included pursuant to paragraph 2 and the following provisions of this Schedule, where—aany person presents to C a non-electronic repeatable prescription which contains—ian order for a drug, not being a Scheduled drug or a controlled drug within the meaning of the Misuse of Drugs Act 1971 , other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a prescriber,iian order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, not being a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001, signed by a prescriber and including the reference “SLS”,iiian order for an appliance, not being a restricted availability appliance, signed by a prescriber, orivan order for a restricted availability appliance, signed by a prescriber, and including the reference “SLS”,and also presents an associated batch issue; ...bC receives as a nominated dispensing contractor from the Electronic Prescription Service an electronic repeatable prescription which contains an order of a kind specified in sub-paragraph (a)(i) to (iv) and—iany person requests the provision of a drug or an appliance in accordance with that repeatable prescription, oriiC has previously arranged with the patient that it will dispense that repeatable prescription on receipt; or cany person—ipresents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iv), andiirequests the provision of a drug or appliance in accordance with the related electronic repeatable prescription,C must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as C supplies in the normal course of business.3C must not provide under an electronic prescription form a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedules 2 to 5 to the Misuse of Drugs Regulations 2001.4For the purposes of this paragraph, a non-electronic repeatable prescription for drugs or appliances must be taken to be presented even if the person who wishes to obtain the drug or appliance does not present that prescription, where—aC has that prescription in C's possession; andbthat person presents, or C has in C's possession, an associated batch issue.3A1This sub-paragraph applies where—aany person requests a drug or appliance from an LPS contractor (C) in accordance with a prescription form or repeatable prescription; andba SSP has effect in respect of—ithe requested drug or appliance, oriidrugs or appliances of a specified description, and the requested drug or appliance is of that description.2Where sub-paragraph (1) applies, C must consider whether it is reasonable and appropriate to supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.3Where sub-paragraph (1) applies, C may provide a different product or quantity of product to the product or quantity of product ordered on the prescription form or repeatable prescription, where—aC is able to do so with reasonable promptness;bto do so is in accordance with the SSP; andcthe supply of a different product or quantity of product to that ordered by the prescriber is by or under the direct supervision of a registered pharmacist who is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is reasonable and appropriate.4Where C, in accordance with sub-paragraph (3), provides a different product or quantity of product to that ordered by the prescriber—athe registered pharmacist mentioned in sub-paragraph (3)(c) must endorse the prescription or the associated batch issue accordingly (if the manner for making the endorsement is provided for in the Drug Tariff, in the manner provided for in the Drug Tariff), and the prescription or associated batch issue as thus endorsed is treated as being the prescription for product reimbursement purposes (even though the supply is not in pursuance of that prescription); andbif the patient to or for whom the product is provided is on a patient list, and the supply—iby virtue of regulation 226A(5)(c)(iii) of the Human Medicines Regulations 2012 (sale etc. by a pharmacist in accordance with a serious shortage protocol), is of a prescription only medicine that is different to but has a similar therapeutic effect to the product ordered by the prescriber, oriiis of any other type, and the Secretary of State and the person who is, for the time being, the person consulted under section 165(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of LPS chemists, acting jointly, have issued and publicised in such manner as they see fit a recommendation to the effect that, for clinical reasons, in the case of supplies of that type, providers of primary medical services should be notified of a supply to a patient on its patient list that is in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription,C must notify the provider of primary medical services on whose patient list the patient is of the supply in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription.5Where—asub-paragraph (1) applies;ba registered pharmacist is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; andcC is able to supply the product or quantity of product ordered by the prescriber within a reasonable timescale but not with reasonable promptness,the requirements to act with reasonable promptness in paragraph 3(1) and (2) are to be read as requirements to act within a reasonable timescale.3B1Subject to the following provisions of this Schedule, where—aa LPS Contractor (C) receives a LPIV; andba person who is entitled to be supplied by C with a prescription item ordered on the LPIV requests the provision of the item in accordance with that LPIV,C must, with reasonable promptness, provide the prescription item so ordered.2If a person who is entitled as mentioned in sub-paragraph (1)(b) asks C to do so—aC must give an estimate of the time when the prescription item will be ready; andbif they are not ready by then, C must give a revised estimate of the time when the item will be ready (until it is ready).3Sub-paragraph (1) does not apply where arrangements are in place for the provision of the item ordered on the LPIV as part of a directed service which includes arrangements for the provision of such an item ordered on such a LPIV.4Where, in case of urgency, a prescriber personally known to the LPS contractor (C) requests C to provide a drug, C may provide that drug (where it would otherwise be able to provide that drug in accordance with the LPS scheme) before receiving a prescription form or repeatable prescription, provided that—athe drug is not a Scheduled drug;bthe drug is not a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under the Regulations); andcthe prescriber undertakes to—igive C a non-electronic prescription form or non-electronic repeatable prescription in respect of the drug within 72 hours of the request being made, oriitransmit to the Electronic Prescription Service within 72 hours of the request being made an electronic prescription.51If a person specified in paragraph (2) asks the LPS contractor (C) to do so—aC must give an estimate of the time when the drugs or appliances will be ready; andbif they are not ready by then, C must give a revised estimate of the time when they will be ready (until they are ready).2A person specified in paragraph (1) is a person—apresenting a non-electronic prescription form or non-electronic repeatable prescription; orbrequesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription.3Before providing any drugs or appliances in accordance with a prescription form or a repeatable prescription, C must ask any person who makes or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription that the person named on the prescription form or the repeatable prescription does not have to pay the charges specified in regulation 3(1) or (2) of the Charges Regulations (supply of drugs and appliances by chemists) by virtue of either—aentitlement to exemption under regulation 10(1) of the Charges Regulations (exemptions); orbentitlement to remission of charges under regulation 5 of the Remission of Charges Regulations (entitlement to full remission and payment),to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of sub-paragraph (a), (c), (d), (e), (f) or (g) of regulation 10(1) of the Charges Regulations or in respect of entitlement to remission by virtue of regulation (5)(1)(e) or (2) of the Remission of Charges Regulations, and at the time of the declaration C already has such evidence available to C.3ZAFor the purposes of sub-paragraph (3), satisfactory evidence includes evidence derived from a check, known as a real time exemption check, of electronic records that are managed by the NHS BSA for the purposes (amongst other purposes) of providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under the Charges Regulations.3AIn any case where no satisfactory evidence, as required by sub-paragraph (3), is produced to C, C must ensure before the drugs or appliances are provided that the person who was asked to produce that evidence is advised, in appropriate terms, that checks are routinely undertaken to ascertain entitlement to—aexemption under the Charges Regulations; orbremission of charges under the Remission of Charges Regulations,where such entitlement has been claimed, as part of the arrangements for preventing or detecting fraud or error in relation to such claims.4If, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by sub-paragraph (3), is produced, C must endorse the form on which the declaration is made to that effect.5In the case of an electronic prescription, C must ensure that the following information is duly entered into the records managed by NHS England that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as a real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (3))—ain a case where exemption from or remission of charges is claimed for all or some of the items included in the prescription, a record of—ithe exemption category specified in regulation 10(1) of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which is claimed applies to the case, andiiwhether or not satisfactory evidence was produced to C as required by sub-paragraph (3);bin any case where a charge is due, confirmation that the relevant charge was paid; andcin a case of a prescription for or including contraceptive substances, confirmation that no charge was payable in respect of those substances.6Sub-paragraphs (3) to (5) apply to the provision of a drug or appliance in accordance with a SSP as they apply to the provision of a drug or appliance in accordance with a prescription form or a repeatable prescription (or an associated batch issue), and for these purposes the prescription for product reimbursement purposes, as mentioned in paragraph 3A(4)(a), is treated as being the prescription in accordance with which the drug or appliance is provided (even though the supply is not in pursuance of that prescription).5A1Subject to sub-paragraph (3), an LPS contractor (C) must not sub-contract the performance of any of its core dispensing functions.2For the purposes of this paragraph and paragraph 5B, “core dispensing functions” means the assembly or part-assembly of any prescription item (including bagging and the application of dispensing labels) with a view to the supply of that prescription item in accordance with a prescription, a SSP, a LPIV, a PTP or a PTPGD.3Sub-paragraph (1) does not apply to—aa contract for services between C and—ia health care professional (for example, a locum) or a provider of locums, oriia corporate body that is—aaa subsidiary undertaking of C, orbba subsidiary undertaking of a parent undertaking of which C is also a subsidiary undertaking,for the performance by that health care professional, a locum provided by that provider of locums or the corporate body of core dispensing functions at C’s pharmacy premises;barrangements whereby a retail pharmacy business that is not C is nevertheless carrying on a retail pharmacy business at C’s premises as a temporary arrangement related to the purchase of those premises; orcthe performance of any of C’s core dispensing functions under valid hub and spoke arrangements.4For the purposes of this paragraph and paragraphs 5B and 5C, “hub and spoke arrangements” are arrangements between C and a retail pharmacy business (P) which—aare for the purpose of P supporting C with regard to the fulfilment of orders—isubmitted to C on prescription forms or LPIVs, oriifor the provision of prescription items by C in accordance with PTPs or PTPGDs;bprovide for the assembly or part-assembly of those orders (including in accordance with an SSP) at premises of P with a view to the supply of the prescription items at or from the scheme premises of C to or for the use of the patients for whom they were ordered.5For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 5B and 5C, C must—ahave given notice in writing to NHS England of C’s intention to sub-contract core dispensing functions—inot less than 28 days before the date on which the proposed arrangements are intended to commence, oriiby a date agreed with NHS England on which the proposed arrangements are to commence; andbhave taken reasonable steps, before entering into the arrangements, to satisfy itself of P’s fitness to carry out core dispensing functions on behalf of C.6A notice under sub-paragraph (5)(a) must include the particulars which have been approved by NHS England for the purposes of making such notifications.7For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 5B and 5C, they must have the following features—athey must provide, and ensure, that any prescription item that is assembled or part-assembled under the arrangements is supplied to or for the use of the patient for whom it is dispensed at or from the scheme premises of C (and so the arrangements must not allow P to fulfil the order directly);bin the case of an order for a medicine on a prescription form or LPIV, they must ensure that what is done, in the course of fulfilling the order, is done in a manner that ensures compliance with the requirements that are to be complied with for the supply from P to C of the medicine to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012 (assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses);cin the case of orders for prescription items that are not orders for medicines on a prescription form or a LPIV (“non-regulation-222A orders”)—ithey must relate to fulfilling both orders for medicines on prescription forms and non-regulation-222A orders, and accordingly C cannot only sub-contract to P core dispensing functions in respect of non-regulation-222A orders, andiithey must ensure that what is done, in the course of fulfilling the non-regulation-222A order, is done in a manner that would ensure compliance with the requirements that would need to be complied with for the supply from P to C of the prescription item, if it were instead of a medicine ordered on a prescription form or a LPIV, to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012;dthey must provide, and ensure, that P does not sub-contract any of the core dispensing functions that P performs on behalf of C;ethey must provide for the discontinuation of the arrangements, as set out in paragraph 5B (in addition to any patient safety or commercial grounds C or P may have for discontinuing the arrangements); andfthey must not be or have become invalid by virtue of paragraph 5B.8If C has hub and spoke arrangements in place, C must also have business continuity arrangements in place which ensure that C is able to meet all C’s obligations to provide dispensing services in the event of any temporary or permanent discontinuation or disruption of the hub and spoke arrangements.9C must give notice in writing to NHS England of any—atemporary discontinuation of hub and spoke arrangements that amounts to a suspension of those arrangements; orbpermanent discontinuation of hub and spoke arrangements,either before that discontinuation occurs or as soon as is reasonably practicable after it occurs, unless it is in response to a notice of objection from NHS England.5B1At any stage after receipt of a notice under paragraph 5A(5)(a), NHS England may request from C (as defined in paragraph 5A(1)) further information relating to the proposed or commenced hub and spoke arrangements that is relevant to one or more of the objection criteria, and if NHS England makes such a request, C must supply the requested information to NHS England promptly.2For the purposes of this paragraph, the objection criteria are—athe proposed or commenced hub and spoke arrangements do not have the features required by paragraph 5A(7), including where they have had them but they have lapsed;bin the case of commenced hub and spoke arrangements, they have the features required by paragraph 5A(7) but there has been a breach of those requirements;cthe proposed hub and spoke arrangements would put, or the commenced hub and spoke arrangements put, the safety of any persons to whom C provides pharmaceutical services at serious risk;dthe proposed hub and spoke arrangements would put, or the commenced hub and spoke arrangements put, NHS England at risk of material financial loss;ein the case of commenced hub and spoke arrangements, those arrangements have led to C repeatedly breaching C’s terms of service, or to C breaching its terms of service in circumstances where C is likely to continue to do so repeatedly;fP’s (as defined in paragraph 5A(4)) fitness to carry out core dispensing functions is impaired; orgin the opinion of NHS England, there are reasonable grounds for believing one or more of the objection criteria in paragraphs (a) to (f) are established.3NHS England may, before the commencement of proposed hub and spoke arrangements, issue a notice of objection to the proposed arrangements, based on one or more of the objection criteria and if it does so—aC must not commence the arrangements unless or until the notice of objection is withdrawn by NHS England; andbany arrangements that are commenced, in breach of this sub-paragraph, are invalid.4NHS England may, after the commencement of hub and spoke arrangements, issue a notice of objection to the arrangements, based on one or more of the objection criteria, and if it does so—athose arrangements become invalid; andbC must discontinue the arrangements promptly.5NHS England may withdraw a notice of objection issued under sub-paragraph (4), which has the effect of the arrangements to which the notice related no longer being invalid.6NHS England must, in a notice of objection, give its reasons for issuing the notice.7Subject to sub-paragraph (9), before issuing a notice under sub-paragraph (4), NHS England must make every reasonable effort to communicate and co-operate with C with a view to resolving the matter without the notice being issued.8Where C invites a Local Pharmaceutical Committee to participate in the attempts to resolve the matter referred to in sub-paragraph (7), NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the matter.9Sub-paragraphs (7) and (8) do not apply where NHS England is satisfied—aits concerns relate to a matter that has already been the subject of dispute resolution between NHS England and C and there are no new issues of substance to delay issuing the notice; orbthat it is appropriate to proceed immediately to issuing a notice—ito protect the safety of any persons to whom C may provide pharmaceutical services, oriito protect NHS England from material financial loss.10After issuing a notice of objection under sub-paragraph (3), or issuing a notice of objection under sub-paragraph (4) which was not delayed by virtue of sub-paragraph (7) or (8), NHS England must, where requested to do so by C, make every reasonable effort to communicate and co-operate with C with a view to resolving the matter in a manner that may lead to the notice of objection being withdrawn.11Where C invites a Local Pharmaceutical Committee to participate in the attempts to resolve the matter referred to in sub-paragraph (10), NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the matter.12Sub-paragraphs (10) and (11) do not apply where NHS England is satisfied its concerns that led to the notice of objection being issued relate to a matter that has already been the subject of dispute resolution between NHS England and there are no new issues of substance to be resolved.5C1This paragraph applies to “relevant data”, which is data that relates to a patient and which is shared for the purpose of fulfilling an order under hub and spoke arrangements (as defined in paragraph 5A(4)) which is a non-regulation-222A order (as defined in paragraph 5A(7)(c)).2For the purposes of section 8(c) (lawfulness of processing: public interest etc) of, and paragraph 2(2)(a), (c) and (d) of Schedule 1 (special categories of personal data etc – health or social care purpose) to, the Data Protection Act 2018, sub-paragraph (3) applies to the processing of any relevant data—aby C or P (as defined in paragraph 5A(1) and (4)) which relates to a patient; andbwhich is necessary for the purposes of—ifulfilling an order of a type mentioned in paragraph 5A(4)(a) under valid hub and spoke arrangements, oriidischarging any related professional obligations to the patient (including obligations relating to the keeping of records).3That processing is—anecessary for the performance of a task carried out in the public interest; andbif the data is personal data concerning health, necessary for the purposes of preventative medicine, medical diagnosis or for the provision of health care or treatment.4Any person (X) who—ais employed or engaged by C or P; andbin the course of being so employed or engaged is required to undertake the processing of data described in sub-paragraph (2),owes a duty of confidentiality in respect of that data (whether or not they would do so but for this sub-paragraph).5The duty under paragraph (4)—ais a duty of confidentiality which, if not owed by a health care professional, is owed under an enactment or rule of law for the purposes of section 11(1)(b) of the Data Protection Act 2018 (special categories of personal data etc: supplementary); andbis such that, if the processing is necessary for the purposes described in sub-paragraph (2)(b), X is able, lawfully, to process that data by virtue of this paragraph.6For the purposes of sub-paragraph (2)(b)(ii), a professional obligation to a patient is to be regarded as such notwithstanding that discharging the obligation may—aalso be an obligation that arises in some other way (for example, arising from a duty of care); orbbe done by a person who is not a health care professional.7Sub-paragraphs (2) and (3) do not apply where, in reliance or purported reliance on valid hub and spoke arrangements, a person processes any data which relates to a patient but, in the course of the doing of anything that relates to the fulfilling of the order to which that data relates, there is a breach of—athe requirements to be fulfilled if what is done is to be treated as part of valid hub and spoke arrangements; orba duty of confidentiality owed in respect of the data by a health care professional or under an enactment or rule of law as mentioned in sub-paragraph (5)(a).8Words and expressions used in both—asub-paragraphs (1) to (7); andbParts 1 and 2 (preliminary and general processing) of, and paragraphs 2(2)(a), (c) and (d) of Schedule 1 to, the Data Protection Act 2018,bear the meanings they bear in those provisions of the Data Protection Act 2018.61Where the LPS contractor (C) is presented with, or receives from the Electronic Prescription Service, a prescription form or a repeatable prescription, C must only provide the drugs or appliances so ordered—aif the prescription form or repeatable prescription is duly signed and completed as described in paragraph 3(1) or (2); andbin accordance with the order on the prescription form or repeatable prescription,subject to any regulations in force under the Weights and Measures Act 1985 and the following provisions of this Schedule.1ASubject to sub-paragraphs (1B) to (1E) and without prejudice to sub-paragraphs (8) and (9), for the purposes of sub-paragraph (1)(b), a drug is provided in accordance with the order on a prescription form or repeatable prescription if (in addition to where the provision is exactly in accordance with the order)—aa different quantity is provided to that ordered on the prescription form or repeatable prescription in order to allow for the provision of the drug in its manufacturer’s original outer packaging; andbthe provision is otherwise in accordance with the order.1BIn the case of an order for a prescription only medicine, sub-paragraph (1A) only applies if sub-paragraph (6) applies or one of the following applies—athe provision is in accordance with regulation 217B(1) to (3) of the Human Medicines Regulations 2012 (original pack dispensing), and accordingly, regulation 217B(1) to (3) of those Regulations is expressly applied to such supplies; orbthe medicine must be provided in the manufacturer’s original outer packaging in order to comply with regulation 217C of the Human Medicines Regulations 2012 (original pack dispensing: medicinal products containing a relevant substance).1CIn the case of an order for a drug that is not a prescription only medicine, sub-paragraph (1A) only applies if sub-paragraph (6) applies or the provision of a different quantity to that ordered on the prescription is in circumstances where—athe different quantity is no more than 10% greater or no more than 10% less than the quantity ordered; andbthe registered pharmacist carrying out or directly supervising the provision does not consider, in the exercise of their professional skill and judgement, that the provision of a different quantity to that ordered may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber.1DWhere C may, pursuant to sub-paragraph (1A) and sub-paragraph (1B)(a) or (1C)(a) and (b), provide a different quantity of a drug to that ordered on a prescription form or a repeatable prescription, C must consider, in the exercise of their professional skill and judgement, whether it is reasonable and appropriate to do so, having regard to the benefits to patients where they are provided with drugs in their manufacturer’s original outer packaging.1ESub-paragraphs (1B)(a) and (1C)(a) and (b) do not apply to the provision of any drug which is—afor the time being specified in Schedules 2 to 4 of the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain provisions under the Regulations); orba special medicinal product for the purposes of regulation 167 of the Human Medicines Regulations 2012 (supply to fulfil special patient needs).2If the order is for , or a product to be provided in accordance with a SSP is, an appliance of a type requiring measuring and fitting by C (for example a truss), C shall make all necessary arrangements for—ameasuring the person named on the prescription form or repeatable prescription for the appliance; andbfitting the appliance.3If the order is for , or a product to be provided in accordance with a SSP is, a drug or appliance included in the Drug Tariff, the British National Formulary (including any Appendix published as part of that Formulary), the Dental Practitioner's Formulary, the European Pharmacopoeia or the British Pharmaceutical Codex, the drug or appliance provided must comply with the relevant standard or formula specified therein.4If the order—ais an order for a drug; butbis not an order for a controlled drug within the meaning of the Misuse of Drugs Act 1971 , other than a drug which is for the time being specified in Schedule 4 or 5 of the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under the Regulations),and does not prescribe its quality, strength or dosage, C (in practice, a registered pharmacist) may provide the drug in such strength and dosage as in the exercise of C's professional skill, knowledge and care C considers to be appropriate and, subject to sub-paragraph (5), in such quantity as C considers to be appropriate for a course of treatment for a period not exceeding 5 days.5Where an order to which sub-paragraph (4) applies is for—aan oral contraceptive substance;ba drug, which is available for supply as part of local pharmaceutical services only together with one or more other drugs; orcan antibiotic in a liquid form for oral administration in respect of which pharmaceutical considerations require its provision in an unopened package,which is not available for provision as part of local pharmaceutical services except in such packages that the minimum size available contains a quantity appropriate to a course of treatment for a period of more than 5 days, C may provide the minimum size available package.6Where any drug to which this sub-paragraph applies (that is, a drug that is not one to which the Misuse of Drugs Act 1971 applies, unless it is a drug for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001), ordered by a prescriber on a prescription form or repeatable prescription, is available for provision by C in a pack in a quantity which is different to the quantity which has been so ordered, and that drug is—asterile;beffervescent or hygroscopic;ca liquid preparation for addition to bath water;da coal tar preparation;ea viscous preparation; orfpacked at the time of its manufacture in a special container,C must provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.7In this paragraph, “special container” means any container with an integral means of application or from which it is not practicable to dispense an exact quantity.8Subject to sub-paragraph (9), where a drug is ordered by a prescriber on a prescription form or repeatable prescription , or is to be provided in accordance with a SSP, in a quantity that is, or is a multiple of a quantity that is, readily available in a pack size manufactured for a holder of a UK marketing authorisation for the drug, C must provide the drug in an original pack (or in original packs) of that size which has been assembled by a manufacturer of the drug for such a holder of a UK marketing authorisation, unless—ait is not possible for C to obtain such a pack (or packs) with reasonable promptness in the normal course of business; orbit is not practicable for C to provide such a pack (or packs) in response to the order (for example, because of patient needs or the method of administration of the drug).9In the case of oral liquid methadone, C (in practice, a registered pharmacist) must decide whether it would be most appropriate to provide—aeach dose in a separate container;ban original pack (or original packs); orcthe oral liquid methadone in some other way,and C must then provide it in packaging that accords with that decision.10C must only provide a Scheduled drug in response to an order by name, formula or other description on a prescription form or repeatable prescription if—ait is ordered as specified in sub-paragraph (11); orbin the case of a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances), it is ordered in the circumstances prescribed in that Schedule.11A Scheduled drug that is a drug with an appropriate non-proprietary name may be provided in response to an order on a prescription form or repeatable prescription for a drug (“the prescribed drug”) that is not a Scheduled drug but which has the same non-proprietary name as the Scheduled drug if—athe prescribed drug is ordered by that non-proprietary name or by its formula;bthe prescribed drug has the same specification as the Scheduled drug (so the Scheduled drug may be dispensed generically); andcthe Scheduled drug is not in a pack which consists of a drug in more than one strength, and providing it would involve the supply of part only of the pack.12If a Scheduled drug is a combination of more than one drug, it can only be ordered as specified in sub-paragraph (11) if the combination has an appropriate non-proprietary name, whether or not the drugs in the combination each have such names.13C must provide any drug which it is required to provide under paragraph 3 or 3B , or provides under paragraph 3A, in a suitable container.14Where C provides a drug or appliance under paragraph 3A, C must include in the dispensing label on the packaging of the product, for the patient’s benefit, information to the effect that the product is being supplied in accordance with a SSP, identifying the particular SSP.15Sub-paragraphs (3) to (8) apply to the provision of a drug in accordance with a LPIV as they apply to the provision of a drug in accordance with a prescription form or a repeatable prescription (or an associated batch issue).71The LPS contractor (C) may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—aC reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example because C reasonably believes it has been stolen or forged);bit appears to C that—ithere is an error on the prescription form or on the repeatable prescription, or in the case of a non-electronic repeatable prescription, its associated batch issue (including a clinical error made by the prescriber), oriiin the circumstances, providing the drugs or appliances would be contrary to the C's (in practice, a registered pharmacist's) clinical judgement;cC or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or by any person accompanying that person;dthe person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or any person accompanying that person, commits or threatens to commit a criminal offence; orethe prescription form or repeatable prescription is incomplete because it does not include the information relating to the identification of the prescriber that NHS England (or a person exercising its functions) requires in order to perform its functions relating to—ithe remuneration of persons providing local pharmaceutical services, andiiany apportionment of, or any arrangements for recharging in respect of, that remuneration,unless C is to receive no pharmaceutical remuneration of any kind in respect of the drug or appliance.2C must refuse to provide a drug ordered on a prescription form or repeatable prescription where the order is for a prescription only medicine which the prescriber was not entitled to prescribe.2AC may refuse to provide a drug or appliance ordered on an electronic prescription if the access that C has to the Electronic Prescription Service is not such as to enable C to dispense that prescription promptly (or at all) , but where C does so, C must take all reasonable steps to ensure that the product ordered by the prescriber is supplied within a reasonable timescale, which may include (depending on what steps or combination of steps the circumstances require)—aproviding details of other LPS chemists or NHS pharmacists whose premises are situated in the same area and who may be able to provide the product ordered by the prescriber;burgent supply without a prescription in accordance with paragraph 4;carranging for the urgent provision of a non-electronic prescription form by the prescriber.2BC must refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—aa SSP has effect in respect of—ithe requested drug or appliance, oriidrugs or appliances of a specified description, and the requested drug or appliance is of that description; andbalternative provision has already taken place in accordance with the SSP.2CC may refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—aa SSP has effect in respect of—ithe requested drug or appliance, oriidrugs or appliances of a specified description, and the requested drug or appliance is of that description;ba registered pharmacist is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; andcC is unable to provide the drug or appliance within a reasonable timescale,but if C does refuse to do so, C must provide the patient or the person requesting the drug or appliance on behalf of a patient with appropriate advice, as necessary, about reverting to the prescriber for the prescriber to review the patient’s treatment.3C must refuse to provide drugs or appliances ordered on a repeatable prescription where—aC has no record of that prescription;bC does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to C;cit is not signed by a prescriber;dto do so would not be in accordance with any intervals specified in the prescription;eit would be the first time a drug or appliance had been provided pursuant to the prescription and the prescription was signed (whether electronically or otherwise) more than 6 months previously;fthe repeatable prescription was signed (whether electronically or otherwise) more than one year previously;gthe expiry date on the repeatable prescription has passed; orhC has been informed by the prescriber that the prescription is no longer required.4Where a patient requests the supply of drugs or appliances ordered on a repeatable prescription (other than on the first occasion that he makes such a request), C must only provide the drugs or appliances ordered if C is satisfied—athat the patient to whom the prescription relates—iis taking or using, and is likely to continue to take or use, the drug or appliance appropriately, andiiis not suffering from any side effects of the treatment which indicates the need or desirability of reviewing the patient's treatment;bthat the medication regimen of the patient to whom the prescription relates has not altered in a way which indicates the need or desirability of reviewing the patient's treatment; andcthat there have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient's treatment.5C may refuse to provide a prescription item that is or is purportedly ordered on a LPIV where—aC reasonably believes it is not a genuine order for the person who requests, or on whose behalf is requested, the provision of the prescription item;bproviding it would be contrary to C’s clinical judgement;cC or other persons are subjected to or threatened with violence by the person who requests the provision of the prescription item, or by any person accompanying that person; ordthe person who requests the provision of the prescription item, or any person accompanying that person, commits or threatens to commit a criminal offence.6C must refuse to provide a prescription item that is or is purportedly ordered on a LPIV where C is satisfied that C is not entitled to provide it or the prescriber was not entitled to prescribe it.7C may refuse to provide a prescription item ordered on a prescription form or repeatable prescription where—amore than one prescription item has been ordered on the prescription form or repeatable prescription;bat least one of those prescription items is a listed HRT prescription item and at least one of those prescription items is not; andcthe person named on the prescription form or repeatable prescription is claiming entitlement to exemption under regulation 10(1)(j) of the Charges Regulations (exemptions) in respect of any of those prescription items which is a listed HRT prescription item.8In connection with the services provided under paragraphs 3 to 7, the LPS contractor (C) must—aensure that appropriate advice is given to patients about any drugs or appliances provided to them—ito enable them to utilise the drugs or appliances appropriately, andiito meet the patient's reasonable needs for general information about the drugs or appliances;bprovide appropriate advice to patients to whom they provide drugs or appliances on—ithe safe keeping of the drugs or appliances, andiireturning unwanted drugs or appliances to the scheme premises for safe destruction;cprovide a patient with a written note (which may be in an electronic form) of any drug or appliance which is owed, and inform the patient when it is expected that the drug or appliance will become available;dkeep and maintain records—iof drugs and appliances provided, in order to facilitate the continued care of the patient,iiin appropriate cases, of advice given and any interventions or referrals made (including clinically significant interventions in cases involving repeatable prescriptions), andiiiof notes provided under sub-paragraph (c);eif C provides a drug or appliance under an electronic prescription, provide the patient, if the patient so requests, with a written record of the drugs or appliances ordered on that prescription and, in the case of an electronic repeatable prescription, of the number of occasions on which it can be dispensed; andfensure that where a person is refused drugs or appliances pursuant to paragraph 7(1)(b), (2), (3) or (4), the patient is referred back to the prescriber for further advice.91The LPS contractor (C) must, if requested to do so by any person—a. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .bwhere the Electronic Prescription Service is temporarily unavailable through C's scheme premises, provide that person with contact details of at least two pharmacies in the area through which the service is available, if these details are known to C.2... C must, if requested to do so by any person, enter in that person's PDS patient details—awhere the person does not have a nominated dispensing contractor, a nominated dispensing contractor; orbwhere the person does have a nominated dispensing contractor—ia replacement dispensing contractor, oriia further dispensing contractor,chosen by that person.3Sub-paragraph (2)(b)(ii) does not apply if the number of nominated dispensing contractors for that person would thereby exceed the maximum number permitted by the Electronic Prescription Service.4If C is a nominated dispensing contractor for a person (X) but the nomination was made before C became the person specified in an LPS scheme in relation to the scheme premises nominated in X's PDS patient details, C must within 6 months of C becoming the person so specified—aexplain to X that the ownership of the scheme premises has changed; andbask X whether X wishes to maintain the nomination in respect of those scheme premises.5If C dispenses an electronic prescription or makes an urgent supply without a prescription, C must send the form duly completed by or on behalf of the patient, if one is required under regulation 3(3)(b) or (c), (5C) or (5E) of the Charges Regulations in respect of that prescription (which may be the associated EPS token), to the NHS BSA.10In connection with the services provided under paragraphs 3 to 7, the LPS contractor (C) must—aprovide appropriate advice to patients to whom C provides drugs or appliances in accordance with a repeatable prescription, in particular on the importance of only requesting those items which they actually need;bundertake appropriate training in respect of repeat dispensing, having regard to any recommendations in respect of such training set out in the Drug Tariff;cif C takes possession of a non-electronic repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue;dmaintain records of repeatable prescriptions in such a form as to provide a clear audit trail of supplies under the repeatable prescription (including dates and quantities supplied);edestroy any surplus batch issues relating to drugs or appliances—iwhich are not required, oriiwhere a patient is refused the drugs or appliances pursuant to paragraph 7;fwhere a patient is provided with drugs or appliances under a repeatable prescription, notify the prescriber of any clinically significant issues arising in connection with the prescription and keep a record of that notification; andgnotify the prescriber of any refusal to provide drugs or appliances pursuant to paragraph 7(4).10A1Before dispensing any item on a prescription form or supplying it in accordance with a serious shortage protocol, an LPS contractor (C) must provide a home delivery option to eligible patients in respect of the item where, as a consequence of a disease being or in anticipation of a disease being imminently—apandemic; andba serious risk or potentially a serious risk to human health,NHS England with the agreement of the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are advised to stay away from listed chemist premises in the area specified, in the circumstances specified and for the duration of the period specified in the announcement.2If C’s listed chemist premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from C’s premises, C must ascertain from—aan eligible patient—iwho has contacted C about the home delivery of prescription items, oriiwho is a person whom C considered, on the basis of the nature of an item on a prescription form, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; orba person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted C about the home delivery of prescription items,whether or not the item could be supplied by a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which C must provide.3Where paragraph (2) does not apply, if C’s listed chemist premises are in the area specified in the announcement, during the period when, in the circumstances specified in the announcement, eligible patients need to stay away from C’s premises, the home delivery option that C must provide must comprise—aC delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);bC arranging for an item dispensed by C to be delivered by another LPS contractor or by an NHS pharmacist to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; orcif C is unable to deliver the item or arrange for its delivery by another LPS contractor or by an NHS pharmacist, C arranging for the dispensing or supply of the item by another LPS contractor or by an NHS pharmacist who would be able to deliver the dispensed item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.4Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at C’s chemist premises for the purposes of receiving dispensing services.5Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, C may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.10AA1Before dispensing a notified item on a prescription form or supplying it in accordance with a serious shortage protocol, an LPS contractor (C) must provide a home delivery option to eligible patients in respect of that item.2For the purposes of this paragraph, a “notified item” is an item that, as a consequence of a disease being or in anticipation of a disease being imminently—apandemic; andba serious risk or potentially a serious risk to human health,is the subject of an announcement made by NHS England, with the agreement of the Secretary of State, to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are entitled to be provided with a home delivery option in respect of that item, if it is supplied to them as part of local pharmaceutical services.3Where C is to, or may be required to, dispense a notified item on a prescription form or supply it in accordance with a serious shortage protocol, C must ascertain from—aan eligible patient—iwho has contacted C about the home delivery of a notified item, oriiwho is a person whom C considered, on the basis of an order or request for a notifiable item, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; orba person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted C about the home delivery of a notified item,whether or not the item could be supplied via a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which C must provide.4Where paragraph (3) does not apply, the home delivery option that C must provide must comprise—aC delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);bC arranging for an item dispensed by C to be delivered by another LPS contractor or by an NHS pharmacist to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; orcif C is unable to deliver the item or arrange for its delivery by another LPS contractor or by an NHS pharmacist, C arranging for the dispensing or supply of the item by another LPS contractor or by an NHS pharmacist who would be able to deliver the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.5Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at C’s chemist premises for the purposes of being supplied with the notifiable item.6Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, C may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.111The LPS contractor (C) must ensure that C provides to NHS England, on request, an up to date record of—athe services that C provides; andbthe days on which and times at which those services are provided.2Sub-paragraph (1) is without prejudice to the need for a variation of the LPS scheme if C wishes to change—athe services that C provides; andbthe days on which and times at which those services are provided.121The LPS contractor must participate, in the manner reasonably required by NHS England in an acceptable system of clinical governance.2In this paragraph, “system of clinical governance” means a framework through which an LPS contractor endeavours to improve continuously the quality of the LPS contractor's services and safeguards high standards of care by creating an environment in which clinical excellence can flourish.13The LPS contractor must provide local pharmaceutical services and exercise any professional judgement in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession.13A1An LPS chemist (C) must have access to summary care records at C’s scheme premises, and must ensure that the access that C has to summary care records at those premises is constant and reliable during the hours when the scheme premises are open to the public, in so far as that is within the control of C.2C must access the summary information in a patient’s summary care record whenever C is providing local pharmaceutical services to the patient, to the extent that C, in the exercise of C’s clinical judgement, considers it appropriate to do so.3In this paragraph, a “summary care record” and “summary information” mean a summary care record and summary information within the meanings given in—aregulation 68 of the GMS Regulations (summary care records); andbregulation 61 of the PMS Regulations (summary care records).13BAn LPS chemist (C) must have access to the EPS at C’s scheme premises, and must ensure that the access that C has to the EPS at those premises is constant and reliable during the hours when the scheme premises are open to the public, in so far as that is within the control of C.13C1An LPS chemist (C) must ensure that pharmacy staff at listed premises (including locums) have access to, and are able to send and receive messages via NHS.net Connect from, a premises specific NHS.net Connect account.2C must ensure that at least two members of the pharmacy staff have live, linked NHS.net Connect accounts to the premises specific NHS.net Connect account (unless fewer than two members of the pharmacy staff are engaged in the provision of NHS services).3As regards the Central Alerting System (CAS) operated by the Medicines and Healthcare products Regulatory Agency (MHRA)—aC must register C’s premises specific NHS.net Connect address with MHRA as an address at which C is content to accept notifications as part of the CAS (unless they are content with the address already in the system);bif C changes C’s premises specific NHS.net Connect address, P must immediately notify MHRA of C’s new premises specific NHS.net Connect address, in accordance with paragraph (a); andcC must monitor C’s premises specific NHS.net Connect account with sufficient frequency to ensure the safe and effective supply of medicinal products at or from C’s pharmacy premises, and must act on the alerts C receives as part of the CAS, as appropriate.141The LPS contractor (C) (including C's staff) must not give, promise or offer to any person any gift or reward (whether by way of a share of or dividend on the profits of C's business or by way of discount or rebate or otherwise) as an inducement to or in consideration of a person (X)—apresenting an order for drugs or appliances on a non-electronic prescription form or non-electronic repeatable prescription;bnominating C as X's dispensing contractor (or one of them) in X's PDS patient details; orcbeing provided with any LP service by C.2Promising, offering or providing an auxiliary aid in relation to the supply of drugs or a home delivery service is not a gift or reward for the purposes of sub-paragraph (1).3C (including C's staff) must not give, promise or offer to any relevant person any gift or reward (including by way of a share of, or dividend on, the profits of C's business, or by way of a discount or rebate) as an inducement to or in consideration of the relevant person recommending to any person that they—apresent to C an order for drugs or appliances on a prescription form or repeatable prescription;bnominate C as their dispensing contractor (or one of them) on their PDS patient details; orcare provided with any LP service by C.4For the purpose of sub-paragraph (3), “relevant person” means any person who performs or provides NHS services, whether on their own behalf or on behalf of another, and includes—aany NHS body or provider of primary medical services; andbany person employed or engaged by any of the persons mentioned in paragraph (a).151The LPS contractor (C) must within 7 days of its occurrence supply in writing information to NHS England as to whether a person (P) who is a relevant person in relation to C—ahas been convicted of any criminal offence in the United Kingdom;bhas been convicted elsewhere of an offence which would constitute a criminal offence if committed in England and Wales;chas been charged with an offence and is currently the subject of any proceedings which might lead to a conviction, which have not yet been notified to NHS England;dhas accepted a police caution in the United Kingdom;ehas become subject to an order under section 246(2) or (3) of the Criminal Procedure (Scotland) Act 1995 (admonition and absolute discharge) discharging R absolutely;fhas accepted a conditional offer under section 302 of the Criminal Procedure (Scotland) Act 1995 (fixed penalty: conditional offer by procurator fiscal);ghas agreed to pay a penalty under section 115A of the Social Security Administration Act 1992 (penalty as alternative to prosecution);hhas, to P's knowledge, become subject to any investigation into P's professional conduct by any licensing body or is notified of the outcome of such an investigation where it is adverse;ihas, to P's knowledge, become subject to an investigation into P's professional conduct in respect of any current or previous employment or is notified of the outcome of such an investigation where it is adverse;jhas, to P's knowledge, become subject to any investigation by the NHS CFA in relation to fraud or is notified of the outcome of such an investigation where it is adverse;khas, to P's knowledge, become the subject of any investigation by another primary care organisation, which might lead to P's removal from any relevant list; orleither—ihas been removed or contingently removed from, refused admission to, or conditionally included in, any relevant list of another primary care organisation,iihas been suspended from such a list, on fitness to practise grounds, and if so, why and the name of that other primary care organisation, oriiihas become the subject of a national disqualification,and if so, C must give details of any investigation or proceedings which are being or were undertaken or brought, including the nature of that investigation or proceedings, where and approximately when that investigation or those proceedings commenced, and any outcome.2P is a “relevant person” in relation to C for these purposes, in the case of a contractor that is—aan individual, if P is C;ba partnership, if P is a partner in C;ca body corporate, if P is a director, the chief executive, the company secretary or the superintendent pharmacist of C.3C or any relevant person must consent to a request being made by NHS England to any employer or former employer or licensing body in the United Kingdom or elsewhere, for information relating to a current investigation, or an investigation where the outcome was adverse.16The LPS contractor must co-operate with NHS England in the discharge by NHS England of the duty under section 1F(1) of the 2006 Act (duty as to education and training).171Subject to regulations made under Part 9 of the 2006 Act (charging), all drugs, containers and appliances provided under these terms of service must be provided free of charge.2Where the LPS contractor supplies a container in response to an order for drugs signed by a prescriber, other than equipment specified in the Drug Tariff as not returnable to the contractor, the container and equipment must remain the property of the LPS contractor.181Where any person who is entitled to a repayment of any charge paid under the Charges Regulations presents the LPS contractor with a valid claim for the repayment within three months of the date on which the charge was paid, the LPS contractor must make the repayment.2For the purposes of sub-paragraph (1), a claim for repayment is only valid if duly made—ain such form and manner as the Secretary of State has determined for an application for such a repayment under regulation 18(2)(b) of the Charges Regulations (repayment of charges); orbon the equivalent form issued in Scotland, Wales or Northern Ireland.191NHS England must ensure that the LPS scheme requires it to remunerate the LPS contractor (C) promptly, in accordance with the remuneration arrangements provided for in the scheme, but subject to the arrangements for reductions of and deductions from payments provided for in the scheme.2NHS England must ensure that the LPS scheme requires that payment of any item of remuneration which would, if it were payable to an NHS pharmacist in connection with providing pharmaceutical services, be pharmaceutical reimbursement, is to be paid in accordance with the Drug Tariff.3For these purposes, “pharmaceutical reimbursement” means pharmaceutical remuneration of the type which may be payable to NHS chemists in accordance with determinations by (only) the Secretary of State under section 164 of the 2006 Act (remuneration for persons providing pharmaceutical services).4Where an LPS scheme requires a fee, allowance or other item of remuneration to be made in accordance with the Drug Tariff and the Drug Tariff provides that the fee, allowance or other item of remuneration is to be determined by NHS England, that fee, allowance or other item of remuneration must be determined by NHS England.5NHS England must ensure that the LPS scheme—aallows it to recover any payment made to C which should not have been made;bprovides that any such recovery of an overpayment is without prejudice to any investigation of any alleged breach of the scheme; andcprovides that the remuneration arrangements under the scheme, referred to in sub-paragraphs (1) to (4), are subject to any right NHS England may have to set off against any amount payable to C, any amount—iowed by C to it, oriiwhich it is entitled to withhold under the terms of the scheme (including terms of the Drug Tariff applied by the scheme).20In the case of any dispute arising out of, or in connection with, the LPS scheme, the LPS contractor and NHS England must made every reasonable effort to communicate and co-operate with each other with a view to resolving the dispute, before referring the dispute for determination in accordance with the NHS dispute resolution procedure (or, where applicable, before commencing court proceedings).211In the case of an LPS scheme that is not an NHS contract, any dispute arising out of or in connection with the scheme, except matters dealt with under the complaints procedure pursuant to paragraph 25, may be referred for consideration and determination to the Secretary of State—aif it relates to a period when the contractor was treated as a health service body, by the contractor or by NHS England; orbin any other case, by the contractor or, if the contractor agrees in writing, by NHS England.2In the case of a dispute referred to the Secretary of State under sub-paragraph (1)—athe procedure to be followed is the NHS dispute resolution procedure; andbthe parties must agree to be bound by any determination made by the adjudicator.221The procedure specified in this paragraph and paragraph 23 applies in the case of any dispute arising out of or in connection with an LPS scheme which is referred to the Secretary of State—ain accordance with section 9(6) of the 2006 Act (NHS contracts), where the scheme is an NHS contract; orbin accordance with paragraph 21(1), where the scheme is not an NHS contract.2Any party wishing to refer a dispute as mentioned in sub-paragraph (1) must send to the Secretary of State a written request for dispute resolution which must include or be accompanied by—athe names and addresses of the parties to the dispute;ba copy of the LPS scheme; andca brief statement describing the nature and circumstances of the dispute.3Any party wishing to refer a dispute as mentioned in sub-paragraph (1) must send the request under sub-paragraph (2) within a period of 3 years beginning with the date on which the matter giving rise to the dispute happened or should reasonably have come to the attention of the party wishing to refer the dispute.4Where the dispute relates to an LPS scheme which is not an NHS contract, the Secretary of State may determine the matter himself or, if the Secretary of State considers it appropriate, appoint a person or persons to consider and determine it.5Before reaching a decision as to who should determine the dispute, either under sub-paragraph (4) or under section 9(8) of the 2006 Act, the Secretary of State must, within the period of 7 days beginning with the date on which a matter was referred to the Secretary of State, send a written request to the parties to make in writing, within a specified period, any representations which they may wish to make about the matter.6The Secretary of State must give, with the notice given under sub-paragraph (5) to the party other than the one which referred the matter to dispute resolution a copy of any document by which the matter was referred to dispute resolution.7The Secretary of State must give a copy of any representations received from a party to the other party and must in each case request (in writing) a party to whom a copy of the representations is given to make within a specified period any written observations which it wishes to make on those representations.8Following receipt of any representations from the parties or, if earlier, at the end of the period for making such representations specified in the request sent under sub-paragraph (5) or (7), the Secretary of State must, if the Secretary of State decides to appoint a person or persons to hear the dispute—ainform the parties in writing of the name of the person or persons whom the Secretary of State has appointed; andbpass to the person or persons so appointed any documents received from the parties pursuant to sub-paragraph (2), (5) or (7).9For the purpose of assisting them in their consideration of the matter, the adjudicator may—ainvite representatives of the parties to appear before the adjudicator to make oral representations either together or, with the agreement of the parties, separately, and may in advance provide the parties with a list of matters or questions to which the adjudicator wishes them to give special consideration; orbconsult other persons whose expertise the adjudicator considers will assist the adjudicator's consideration of the matter.10Where the adjudicator consults another person under sub-paragraph (9)(b), the adjudicator must notify the parties accordingly and, where the adjudicator considers that the interests of any party might be substantially affected by the result of the consultation, the adjudicator must give to the parties such opportunity as the adjudicator considers reasonable in the circumstances to make observations on those results.11In considering the matter, the adjudicator must consider—aany written representations made in response to a request under sub-paragraph (5), but only if they are made within the specified period;bany written observations made in response to a request under sub-paragraph (7), but only if they are made within a specified period;cany oral representations made in response to an invitation under sub-paragraph (9)(a);dthe results of any consultation under sub-paragraph (9)(b); andeany observations made in accordance with an opportunity given under sub-paragraph (10).12In this paragraph, “specified period” means such period as the Secretary of State must specify in the request, being not less than 2, nor more than 4 weeks beginning with the date on which the notice referred to is given, but the Secretary of State may, if the Secretary of State considers that there is good reason for doing so, extend any such period (even after it has expired) and, where the Secretary of State does so, a reference in this paragraph to the specified period is to the period as so extended.13Subject to the other provisions of this paragraph and paragraph 23, the adjudicator is to have wide discretion in determining the procedure of the dispute resolution to ensure the just, expeditious, economical and final determination of the dispute.231The adjudicator must record the adjudicator's determination, and the reasons for it, in writing and must give notice of the determination (including a record of the reasons) to the parties.2In the case of a scheme referred for determination in accordance with paragraph 21(1), section 9(11) of the 2006 Act must apply as that subsection applies in the case of an LPS scheme referred for determination in accordance with section 9(6) of that Act.241In this Schedule, where reference is made to any dispute arising out of, or in connection with, an LPS scheme, that includes any dispute arising out of, or in connection with, the termination of the scheme.2Any term of the LPS scheme that makes provision in respect of the requirements in paragraphs 20 to 23 must survive even where the scheme has terminated.251The LPS contractor must have in place arrangements which comply with the requirements of the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 , for the handling and consideration of any complaints.2In this paragraph, “complaint” means a complaint about a matter connected with the provision of local pharmaceutical services by the LPS contractor.261Subject to sub-paragraphs (2) to (4), no amendment or variation to the LPS scheme is to have effect unless it is in writing and signed by or on behalf of NHS England and the (relevant) LPS contractor (C).2NHS England may vary an LPS scheme without C's consent where it—ais reasonably satisfied that it is necessary to vary the scheme so as to comply with the 2006 Act, any regulations made under that Act, or any direction given by the Secretary of State under that Act; andbnotifies C in writing of the wording of the proposed variation and the date upon which that variation is to take effect,and, where it is reasonably practicable to do so, the date that the proposed variation is to take effect must be not less than 14 days after the date on which the notice under paragraph (b) is served on C.3During an emergency requiring the flexible provision of pharmaceutical services, NHS England may, on application from C—apermit C a temporary change to the days on which or times at which C is obliged to provide local pharmaceutical services at or from the scheme premises, or permit temporary closure of those premises, if—iC gives at least 24 hours notice of the change or closure, andiithe reasons given by C for the request are, in the opinion of NHS England adequate reasons; orbpermit C any other temporary variation to C's LPS scheme that, in the opinion of NHS England, will facilitate continuity of the provision of services of a kind that may be provided under section 126, or by virtue of section 127, of the 2006 Act (arrangements for pharmaceutical services and additional pharmaceutical services) during the emergency.4NHS England need not approve the request referred to in sub-paragraph (3)(a)(ii) in advance of the change or closure, but if it does not do so and decides subsequently that C's reasons are not, in its opinion, adequate reasons, then the days on which or times at which C is obliged to provide local pharmaceutical services at or from the scheme premises are to revert to the overridden days and times, from the day after the date on which that decision is given to C.27NHS England and the LPS contractor may agree in writing to terminate the LPS scheme (or end the LPS contractor's participation in it, in the case of more than one LPS contractor being party to the scheme), and if the parties so agree, they must agree the date upon which that termination should take effect and any further terms upon which the scheme should be terminated.281Either the LPS contractor or NHS England may terminate the LPS scheme (or end the LPS contractor's participation in it, in the case of more than one LPS contractor being party to the scheme), at any time by serving notice of not less than 6 months in writing to the other party.2Where a notice is served pursuant to sub-paragraph (1), the LPS scheme must terminate on the expiry of the notice period.3This paragraph is without prejudice to any other rights to terminate the agreement which the LPS contractor and NHS England may have.291NHS England may serve notice in writing on the LPS contractor terminating the LPS scheme (or ending the LPS contractor's participation in it, in the case of more than one LPS contractor being party to the scheme) with immediate effect, or from such date as may be specified in the notice, if, in the case of an LPS scheme (or an agreement that is part of an LPS scheme) entered into—awith an individual as a party, that individual;bwith more than one individual (whether or not practising in partnership), any of those individuals; orcwith a body corporate—ithe body corporate, oriiany director, chief executive, superintendent or company secretary of the body corporate,falls within sub-paragraph (2) during the existence of the scheme (or the agreement).2A person (X) falls within this sub-paragraph if—aX is the subject of a national disqualification;bsubject to sub-paragraph (3), X is disqualified or suspended (other than by an interim suspension order or direction pending an investigation) from practising by any licensing body anywhere in the world;cX is removed from, or refused admission to, a relevant list by reason that amounts to inefficiency, fraud or unsuitability (as understood by reference to the conditions in section 151(2) to (4) of the 2006 Act (disqualification of practitioners)), unless X has subsequently been included in such a list;dX has been convicted in the United Kingdom of murder or a criminal offence other than murder—iwhich was committed on or after 1st April 2006, andiifor which X has been sentenced to a term of imprisonment of over six months;esubject to sub-paragraph (4), X has been convicted outside the United Kingdom of an offence which, if committed in England and Wales—iwould constitute murder, oriiwould constitute an offence, and—aawhich was committed on or after 1st April 2006, andbbfor which X has been sentenced to a term of imprisonment of over six months;fX has been convicted of an offence referred to in—iSchedule 1 to the Children and Young Persons Act 1933 (offences against children and young persons with respect to which special provisions of this Act apply), oriiSchedule 1 to the Criminal Procedure (Scotland) Act 1995 (offences against children under the age of 17 years to which special provisions apply),which was committed on or after 1st April 2006;gX—ihas been made bankrupt, or sequestration of X's estate has been ordered, unless X has been discharged from the bankruptcy or the order has been annulled,iihas become a person in relation to whom a moratorium period under a debt relief order (under Part 7A of the Insolvency Act 1986 (debt relief orders)) applies,iiihas been made the subject of a bankruptcy restrictions order, an interim bankruptcy restrictions order, a debt relief restrictions order or an interim debt relief restrictions order under Schedule 4A or 4ZB to the Insolvency Act 1986 or Schedule 2A of the Insolvency (Northern Ireland) Order 1989 (which relate to bankruptcy and debt relief restrictions orders and undertakings), which has not been annulled,ivif X is a body corporate, has been wound up under Part 4 of the Insolvency Act 1986;vhas made a composition or arrangement with, or granted a trust deed for, X's creditors and X has not been discharged in respect of it;hin respect of X there is—ian administrator, administrative receiver or receiver appointed, oriian administration order made under Schedule B1 to the Insolvency Act 1986 (administration);iX has been removed—ifrom the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners, the Charity Commission, the Charity Commission for Northern Ireland or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity—aafor which the person was responsible or to which the person was privy, orbbwhich the person by their conduct contributed to or facilitated, oriiunder—aasection 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990 (powers of Court of Session to deal with management of charities), orbbsection 34(5)(e) or (ea) of the Charities and Trustee Investment (Scotland) Act 2005 (powers of the Court of Session),from being concerned with the management or control of any body;jX has been subject to—ia disqualification order or disqualification undertaking under the Company Directors Disqualification Act 1986 or the Company Directors Disqualification (Northern Ireland) Order 2002 , oriian order made under section 429(2) of the Insolvency Act 1986 (disabilities on revocation of a county court administration order);kX (in the case of an individual) has refused to comply with a request by NHS England for X to be medically examined on the grounds that it is concerned that X is incapable of adequately providing services under the scheme; orlit comes to the attention of NHS England that information provided to it pursuant to—iregulation 12 or 17 of the 2006 Regulations,iia term of the scheme required by paragraph 16 of Schedule 2 to the 2006 Regulations,iiiregulation 106, orivparagraph 15,was, when given, untrue or inaccurate in a material respect.3NHS England is not to terminate the LPS scheme (or end an LPS contractor's participation in it) pursuant to sub-paragraph (2)(b) where it is satisfied that the disqualification or suspension imposed by a licensing body outside the United Kingdom does not make X unsuitable to be—aan LPS contractor; orbin the case of an LPS scheme (or agreement) with a body corporate, a director, chief executive, superintendent or company secretary of a contractor.4NHS England is not to terminate the scheme pursuant to sub-paragraph (2)(e) where it is satisfied that the conviction does not make X unsuitable to be—aan LPS contractor; orbin the case of an LPS scheme (or agreement) with a body corporate, a director, chief executive, superintendent or company secretary of an LPS contractor.30NHS England may serve notice in writing on the LPS contractor (C) terminating the LPS scheme (or ending the LPS contractor's participation in it, in the case of more than one LPS contractor being party to the scheme) with immediate effect or with effect from such date as may be specified in the notice if—aC has breached the scheme and as a result of that breach, the safety of C's patients is at serious risk if the scheme is not terminated (or C's participation in it is not ended, in the case of more than one LPS contractor being party to the scheme); orbC's financial situation is such that NHS England considers that NHS England is at risk of material financial loss.311Where NHS England is entitled to serve written notice on the LPS contractor (C) terminating the LPS scheme (or ending C's participation in it) pursuant to paragraph 29 or 30, it must, in the notice served on C pursuant to those provisions, specify a date on which the scheme terminates (or C's participation in it is to end) that is not less than 28 days after the date on which NHS England has served that notice on C, unless sub-paragraph (2) applies.2This sub-paragraph applies if NHS England is satisfied that a period less than 28 days, or termination with immediate effect, is necessary in order to—aprotect the safety of the C's patients; orbprotect itself from material financial loss.3In a case falling within sub-paragraph (1), where—athe exceptions in sub-paragraph (2) do not apply;bC invokes the NHS dispute resolution procedure before the end of the period of notice referred to in sub-paragraph (1); andcC notifies NHS England in writing that it has done so,subject to paragraph (5), the LPS scheme (or C's participation in it) is not to terminate at the end of the notice period but instead is only to terminate in the circumstances specified in sub-paragraph (4).4Subject to paragraph (5), the LPS scheme (or C's participation in it) is only to terminate if and when—athere has been a determination of the dispute pursuant to paragraph 23 and that determination permits NHS England to terminate the scheme; orbC ceases to pursue the NHS dispute resolution procedure,whichever is the sooner.5If NHS England is satisfied that it is necessary to terminate the scheme before the NHS dispute resolution procedure is concluded in order to—aprotect the safety of the C's patients; orbprotect itself from material financial loss,sub-paragraphs (3) and (4) shall not apply and NHS England is entitled to confirm, by written notice to be served on C, that the LPS scheme (or C's participation in it) will nevertheless terminate at the end of the period of the notice it served pursuant to paragraph 29(1) or 30.32The LPS scheme shall not create any right enforceable by any person not a party to it.SCHEDULE 8 Regulation 91(1)(a)11Any fees and allowances payable to NHS pharmacists for professional services provided as part of the provision of pharmaceutical services.2Without prejudice to the generality of sub-paragraph (1), those fees and allowances may include—afees in connection with the dispensing of drugs and appliances, including any additional fees relating to the dispensing of particular types of drug or appliance;bpayments made to NHS pharmacists in respect of their providing particular types of advice or assistance to patients or in respect of their participation in particular activities or schemes; andcpayments made to NHS pharmacists that are a contribution to the overall cost of professional services provision (which may be calculated by reference to particular levels of activity).3For the purposes of sub-paragraph (1), “professional services” does not include providing pre-registration training experience for pharmacy graduates or undergraduates.21Any fees and allowances payable to NHS appliance contractors for professional services provided as part of the provision of pharmaceutical services.2Without prejudice to the generality of sub-paragraph (1), those fees and allowances may include—afees in connection with the dispensing of appliances, including any additional fees relating to the dispensing of particular types of appliance;bpayments made to NHS appliance contractors in respect of their providing particular types of advice or assistance to patients or in respect of their participation in particular activities or schemes; andcpayments made to NHS appliance contractors that are a contribution to the overall cost of professional services provision (which may be calculated by reference to particular levels of activity).SCHEDULE 9 Regulation 11911Where by virtue of this Schedule—aa matter is to be dealt with in accordance with the 2006 Regulations or the 2012 Regulations; orba matter (by virtue of having been dealt with in accordance with Schedule 7 to the 2012 Regulations (transitional provisions)), is to be dealt with in accordance with the 2005 Regulations or the SCAT Regulations,if that matter under those Regulations would fall to be dealt with by a Primary Care Trust, unless the context requires otherwise, that matter is to be dealt with instead by NHS England.2Any matter that is ongoing under the 2006 Regulations or the 2012 Regulations (including, by virtue of Schedule 7 of those Regulations, under the 2005 Regulations or the SCAT Regulations) immediately before the appointed day, unless the context requires otherwise—ais to be treated as ongoing under these Regulations on the appointed day (and where appropriate after that); andbwhere that matter becomes the responsibility of NHS England on the appointed day, anything done in relation to that matter by or with regard to a Primary Care Trust before the appointed day is to be treated as having been done (for the purposes of the ongoing treatment of the matter) by or with regard to NHS England.3Where a period of time specified in a provision of the 2006 Regulations or the 2012 Regulations is current on the appointed day, and a period of time is also specified in a corresponding provision of these Regulations, unless the context requires otherwise, these Regulations have effect as if the corresponding provision of these Regulations had been in force when that period began to run.4Where—aconsideration of a matter under a provision of these Regulations in respect of a specified period of time requires consideration of a period of time before the appointed day; andba corresponding provision of the 2006 Regulations or the 2012 Regulations also required consideration of that matter in respect of a specified period of time,unless the context requires otherwise, the provision of these Regulations has effect as if it had been in force when the period of time specified in it began to run.5Subject to sub-paragraphs (6) and (7), where on or after the appointed day—aa matter is to be dealt with in accordance with the SCAT Regulations, the 2005 Regulations, the 2006 Regulations or the 2012 Regulations; orba matter that relates to circumstances that arose, or first arose, before the appointed day is to be dealt with in accordance with these Regulations or the Drug Tariff,in dealing with that matter NHS England (or where appropriate, on appeal, the Secretary of State or the First-tier Tribunal) is to apply those Regulations, the Drug Tariff and related provisions of the 2006 Act subject to such modifications as it (or where appropriate, on appeal, the Secretary of State or the First-tier Tribunal) considers necessary or expedient.6Modifications pursuant to paragraph (5) must—abe for a purpose related to—idealing with the matter justly, oriieffecting an orderly transition from the scheme established by the Regulations mentioned in sub-paragraph (5)(a), read with the 2006 Act as in force before the appointed day, to the scheme established by these Regulations, read with the 2006 Act,or for purposes related to both; andbtake account, as appropriate, of the manner in which—iprovisions in the 2005 Regulations were carried forward into the 2012 Regulations,iiprovisions in the 2006 Regulations and the 2012 Regulations were carried forward into these Regulations, andiiithe 2006 Act was amended by the Health and Social Care Act 2012 .7Modifications pursuant to paragraph (5) may—abe for the purpose of seeking to ensure that a matter is dealt with expeditiously;bbe for the purpose of seeking to ensure that a matter is dealt with proportionately, having regard to (as relevant)—ithe importance of protecting the safety of persons to whom pharmaceutical and local pharmaceutical services are provided,iithe need for fairness,iiithe complexity of the issues,ivthe importance of protecting NHS England from material financial loss, andvthe importance of saving expense; orc(without prejudice to the generality of the power to make modifications) have the effect of—iadding to, modifying or removing functions that would have been performed by a Primary Care Trust under the SCAT Regulations, the 2005 Regulations, the 2006 Regulations, the 2012 Regulations or the 2006 Act as in force before the appointed day, oriiadding to, modifying or removing functions that are to be performed by NHS England or a HWB under these Regulations or the 2006 Act.8In this Schedule, “the continuity principles” means the provisions of sub-paragraphs (1) to (7).21An application made to a Primary Care Trust under regulation 5(1), 40(1) or 54(2) of the 2005 Regulations (which relate to applications for inclusion in a pharmaceutical list, preliminary consent applications and temporary provision during a period of suspension) which—ahas not been determined before the appointed day; andbby virtue of Schedule 7 to the 2012 Regulations (transitional provisions), was to be determined in accordance with the 2005 Regulations and if relevant the 2006 Regulations,is to be dealt with by NHS England in accordance with the 2005 Regulations.2Where an application made under the 2005 Regulations for preliminary consent has been finally granted under those Regulations—aan application under regulation 5(1) of the 2005 Regulations that is in accordance with regulation 41(1) of those Regulations (effect of preliminary consent) may be made in relation to that consent (within the 6 months period referred to in regulation 40(4) of the 2005 Regulations); andbany such application is to be dealt with by NHS England in accordance with the 2005 Regulations.3Where on or after the appointed day, by virtue of this paragraph, an application is to be determined by NHS England having regard to regulation 13(1)(a) of the 2005 Regulations (exemptions from the necessary or expedient test), for the purposes of that application an area is an approved retail area if on 31st August 2012 it was a retail area that was for the time being approved by the Secretary of State under regulation 15 of those Regulations (approved retail areas).4Where an application under regulation 5(1), 40(1) or 54(2) of the 2005 Regulations has been determined in accordance with the 2005 Regulations, whether before the appointed day or by virtue of this paragraph—athe arrangements for bringing an appeal in relation to that application; andbthe determination of any appeal validly brought,are to be in accordance with the 2005 Regulations.31Where a routine application has been made to a Primary Care Trust before the appointed day under the 2012 Regulations, subject to paragraph (2)—aif that application has not been notified under Part 3 of Schedule 2 to the 2012 Regulations (applications in respect of pharmaceutical lists and the procedures to be followed – notification of certain applications) before the appointed day, it is to be dealt with by NHS England in accordance with these Regulations; andbif that application has been notified under Part 3 of Schedule 2 to the 2012 Regulations before the appointed day, it is to be dealt by NHS England in accordance with the 2012 Regulations and the 2006 Act as in force immediately before the appointed day.2Where—aa routine application has been made to a Primary Care Trust before the appointed day under the 2012 Regulations; andbdetermination of that application requires determination of whether granting it, or granting it in respect of some only of the services specified in it, would meet a current or future need for pharmaceutical services, or pharmaceutical services of a specified type, which have been included in a pharmaceutical needs assessment,it is to be dealt with by NHS England in accordance with the 2012 Regulations and the 2006 Act as in force immediately before the appointed day, whether or not it has been notified under Part 3 of Schedule 2 to the 2012 Regulations before the appointed day.3Where an excepted application has been made to a Primary Care Trust before the appointed day under the 2012 Regulations—aif that application—iis not a notifiable application, andiihas not been determined by the Primary Care Trust before the appointed day,it is to be dealt with by NHS England in accordance with these Regulations;bif that application—iis a notifiable application, andiihas not been notified under Part 3 of Schedule 2 to the 2012 Regulations before the appointed day,it is to be dealt with in accordance with these Regulations; andcif that application—iis a notifiable application, andiihas been notified under Part 3 of Schedule 2 to the 2012 Regulations before the appointed day,it is to be dealt with in accordance with the 2012 Regulations and the 2006 Act as in force immediately before the appointed day.4Where an application under the 2012 Regulations is determined in accordance with the 2012 Regulations, whether before the appointed day or by virtue of this paragraph—athe arrangements for bringing an appeal in relation to that application; andbthe determination of any appeal validly brought,are to be in accordance with the 2012 Regulations.5In applying the continuity principles in relation to decisions which are to be made under the 2012 Regulations by virtue of this paragraph, NHS England must ensure that LPS chemists that would, by virtue of paragraph 32(5)(b)(ii) of Schedule 2 to these Regulations, have rights of appeal against particular types of decision under these Regulations, have the same rights of appeal against equivalent decisions under the 2012 Regulations, notwithstanding that those rights of appeal were not provided for in the 2012 Regulations.41An application made to a Primary Care Trust under Part 5 of the 2005 Regulations (provision of pharmaceutical services by doctors) for outline consent or premises approval (including temporary premises approval) which—ahas not been determined before the appointed day; andbby virtue of Schedule 7 to the 2012 Regulations (transitional provisions) was to be determined in accordance with the 2005 Regulations,is to be dealt with by NHS England in accordance with the 2005 Regulations.2Where an application under Part 5 of the 2005 Regulations has been determined in accordance with those Regulations, whether before the appointed day or by virtue of sub-paragraph (1)—athe arrangements for bringing an appeal in relation to that application; andbthe determination of any appeal validly brought,are to be in accordance with the 2005 Regulations.3If, before the appointed day—aa Primary Care Trust has required a doctor to provide pharmaceutical services under regulation 60(4)(a) of the 2005 Regulations (arrangements for provision of pharmaceutical services by doctors); andbthe doctor has appealed against that decision,the arrangements for bringing that appeal, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations.51Where an application has been made to a Primary Care Trust before the appointed day under Part 8 of the 2012 Regulations (dispensing doctors) for outline consent or premises approval, other than an application for temporary premises approval to which regulation 58 or 61 of those Regulations (which relate to temporary provision in cases where premises approval has not taken effect or during an emergency requiring the flexible provision of pharmaceutical services) applies—aif that application has not been notified under regulation 52 of the 2012 Regulations (notification of applications for outline consent and premises approval), it is to be dealt with by NHS England in accordance with these Regulations; andbif that application has been notified under regulation 52 of the 2012 Regulations, it is to be dealt with by NHS England in accordance with the 2012 Regulations.2Where—aan application has been made to a Primary Care Trust before the appointed day under regulation 58 or 61 of the 2012 Regulations for temporary premises approval; andbthat application has not been determined before the appointed day,it is to be dealt with by NHS England in accordance with these Regulations.3Where an application under that Part 8 of the 2012 Regulations has been determined in accordance with the 2012 Regulations, whether before the appointed day or by virtue of this paragraph—athe arrangements for bringing an appeal in relation to that application; andbthe determination of any appeal validly brought,are to be in accordance with the 2012 Regulations.4If, before the appointed day, a Primary Care Trust has required a doctor to provide pharmaceutical services under regulation 48(5)(b) of the 2012 Regulations (arrangements for provision of pharmaceutical services by doctors: applications by patients), and—athe doctor has appealed against that decision before the appointed day; orbthe time limit for bringing an appeal against the decision in regulation 63(1) of the 2012 Regulations (appeals against decisions under Part 8) has not elapsed before the appointed day,the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations.61If, before the appointed day the Primary Care Trust was engaged in a process which could have led to the inclusion or removal of a contractor or premises from a dispensing contractor list, that process and the action to be taken following its outcome (including relating to any appeal) are to be dealt with by NHS England in accordance with paragraph 10 of Schedule 7 to the 2012 Regulations (transitional provisions – dispensing contractor lists).2Where—aNHS England grants an application for premises approval by virtue of this paragraph; andbNHS England is as a consequence required to consider any postponement of the making of arrangements to provide dispensing services, arising out of that grant,that consideration, NHS England’s decision on any postponement, the arrangements for bringing an appeal against its decision, and the determination of any appeal validly brought, are to be in accordance with paragraph 10 of Schedule 7 to the 2012 Regulations.3Conditions relating to postponement of the making of arrangements to provide dispensing services which are imposed by virtue of this paragraph, or which continued to have effect by virtue of paragraph 10 of Schedule 7 to the 2012 Regulations, continue to have effect as if imposed under these Regulations in relation to the provision of pharmaceutical services.71NHS England must—ain respect of an area which on the appointed day continues to be, or to be part of, a controlled locality by virtue of regulation 36(1), delineate precisely the boundary of the controlled locality on a map (which may be part of a series of maps which relate to HWB areas);bpublish that map; andcmake that map available as soon as is practicable to any HWB that has all or part of that controlled locality in its area.2Where—abefore the appointed day, a Primary Care Trust was considering whether or not an area is either a controlled locality or part of a controlled locality; orbNHS England is required, by virtue of paragraphs 2 to 5, to determine an application and in connection with determining that application, it also needs to determine whether or not an area is or is not a controlled locality, or part of a controlled locality,paragraph (3) applies.3Where—aconsideration by a Primary Care Trust mentioned in sub-paragraph (2)(a) was, or (by virtue of paragraph 2 or 4) an application referred to in sub-paragraph (2)(b) is, to be dealt with under the 2005 Regulations—ithe consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by NHS England in accordance with the 2005 Regulations, andiithe arrangements for bringing an appeal in relation to the decision of NHS England, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations;bconsideration by a Primary Care Trust mentioned in sub-paragraph (2)(a) was under the 2012 Regulations (unless it was in connection with an application which by virtue of paragraph 3 or 5 is to be determined in accordance with these Regulations)—ithe consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by NHS England in accordance with the 2012 Regulations, andiithe arrangements for bringing an appeal in relation to the decision of NHS England, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations,but if that consideration was in connection with an application which by virtue of paragraph 3 or 5 is to be determined in accordance with these Regulations, the consideration of whether or not a locality is either a controlled locality or part of a controlled locality is also to be dealt with by NHS England in accordance with these Regulations;can application referred to in sub-paragraph (2)(b) is to be dealt with under the 2012 Regulations (by virtue of paragraphs 3 or 5)—ithe related consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by NHS England in accordance with the 2012 Regulations, andiithe arrangements for bringing an appeal in relation to the decision of NHS England, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations;dan application referred to in sub-paragraph (2)(b) is to be dealt with under these Regulations, the related consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by NHS England in accordance with these Regulations.4Where, by virtue of sub-paragraph (3), it is determined (whether by NHS England or on appeal by the Secretary of State) that an area is or is not, or is or is not part of, a controlled locality, NHS England must—adelineate precisely the boundary of any resulting controlled locality on a map;bpublish that map; andcmake that map available as soon as is practicable to any HWB that has all or part of any resulting controlled locality in its area,and any area that becomes, or becomes part of, a controlled locality as a consequence of that determination is then a controlled locality, or part of a controlled locality, for the purposes of these Regulations (unless or until it is determined under these Regulations that it is no longer, or no longer part of, a controlled locality).81Where—aan application has been received which is to be determined under the 2005 Regulations—iin accordance with paragraph 2, andiihaving regard to regulation 12 or 13 of the 2005 Regulations (which relate to the necessary or expedient test and exemptions from it); andbthe premises or relevant location at or from which the applicant wishes to provide pharmaceutical services is or may be a reserved location,pending the final determination of that application, the classification of any area in relation to those premises or that relevant location as, or as not, a reserved location is to be determined in accordance with the 2005 Regulations (if a further reserved location determination is required after the application is finally determined, it is to be in accordance with these Regulations).2Where a determination of whether or not an area is a reserved location is made under the 2005 Regulations by virtue of—asub-paragraph (1); orbbefore the appointed day, paragraph 6 of Schedule 7 to the 2012 Regulations (transitional provisions – reserved locations),the arrangements for bringing an appeal against the decision, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations.3Where—aa routine application was received by a Primary Care Trust which NHS England is required to determine under the 2012 Regulations in accordance with paragraph 3; andbthe premises or relevant location at or from which the applicant wishes to provide pharmaceutical services is or may be a reserved location,pending the final determination of that application, the classification of any area in relation to those premises or that relevant location as, or as not, a reserved location is to be determined in accordance with the 2012 Regulations (if a further reserved location determination is required after the application is finally determined, it is to be in accordance with these Regulations).4Where before the appointed day—aa Primary Care Trust received a request for a determination under regulation 42 of the 2012 Regulations (second and subsequent determinations of reserved location status), but there is no related routine application which is (still) to be finally determined under the 2012 Regulations in accordance with paragraph 2; andbthe request was notified under regulation 42(2)(a) of the 2012 Regulations,the classification of any area as, or as not, a reserved location pursuant to that request is to be determined in accordance with the 2012 Regulations (if a further reserved location determination is required after that determination, it is to be in accordance with these Regulations).5Where a determination of whether or not an area is a reserved location is made under the 2012 Regulations by virtue of sub-paragraph (3) or (4), the arrangements for bringing an appeal against the decision, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations.6Where before the appointed day, a request is made to a Primary Care Trust for a reserved location determination, but the determination is not to be made under the 2005 Regulations or the 2012 Regulations by virtue of sub-paragraphs (1) to (5), it is to be made by NHS England (or on appeal the Secretary of State) under these Regulations.7Where, by virtue of sub-paragraphs (1) to (5), it is determined (whether by NHS England or on appeal by the Secretary of State) that an area is a reserved location, if following the determination a reserved location thereafter takes effect (because the pharmacy premises to which it relates are included in a pharmaceutical list), NHS England must—adelineate precisely the boundary of the reserved location on a map;bpublish that map; andcmake that map available as soon as is practicable to any HWB that has all or part of that reserved location in its area.91Where, when granting an application which by virtue of paragraph 2 is finally determined in accordance with the 2005 Regulations, NHS England is required to consider under regulation 20(2) of the 2005 Regulations (imposition of conditions)—aany termination of arrangements with any person on its dispensing doctor list; andbany postponement of any such termination,arising out of that grant (but not for a reason set out in regulation 50(1)(a) to (c), (e) or (f) of these Regulations), that consideration and its decision are to be in accordance with the 2005 Regulations.2Where before the appointed day a Primary Care Trust was considering under the 2005 Regulations, in any case in which it could postpone the termination of arrangements with a dispensing doctor—athe termination of arrangements with a dispensing doctor; orbthe postponement of the termination of arrangements with a dispensing doctor,that matter is to be dealt with by NHS England, in accordance with the 2005 Regulations.3Where, under the 2005 Regulations—aa decision relating to termination of arrangements, or the postponement of the termination of arrangements, with a dispensing doctor is made by virtue of sub-paragraph (1) or (2); orbbefore the appointed day, a decision relating to termination of arrangements, or the postponement of the termination of arrangements, with a dispensing doctor was made by a Primary Care Trust under the 2005 Regulations, and—ithat decision has been appealed before the appointed day, oriithe time limit for bringing an appeal against that decision has not elapsed before the appointed day,the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations.4Where, when granting an application which by virtue of paragraph 3 is finally determined in accordance with the 2012 Regulations, NHS England is required to consider under regulation 50(1) or (3) of the 2012 Regulations (discontinuation of arrangements for the provision of pharmaceutical services by doctors)—aany termination of arrangements with any person on its dispensing doctor list; andbany postponement of any such termination,arising out of that grant, that consideration and its decision are to be in accordance with the 2012 Regulations.5Where before the appointed day a Primary Care Trust was considering under regulation 50(1) to (6) of the 2012 Regulations, in any case in which it could postpone the termination of arrangements with a dispensing doctor—athe termination of arrangements with a dispensing doctor; orbthe postponement of the termination of arrangements with a dispensing doctor,that matter is to be dealt with by NHS England, in accordance with the 2012 Regulations.6Where, under the 2012 Regulations—aa decision relating to termination of arrangements, or the postponement of the termination of arrangements, with a dispensing doctor is made by virtue of sub-paragraph (4) or (5); orbbefore the appointed day, a decision relating to termination of arrangements, or the postponement of the termination of arrangements, with a dispensing doctor was made by a Primary Care Trust pursuant to the 2012 Regulations, and—ithat decision has been appealed before the appointed day, oriithe time limit for bringing an appeal against that decision has not elapsed before the appointed day,the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations.7Regulation 50(1)(f) applies to a determination under the 2005 Regulations or the 2012 Regulations (either before the appointed day or by virtue of paragraph 8) that a location ceases to be or be part of a reserved location as it does to a determination referred to in regulation 42 as D2.8Conditions imposed by virtue of—aregulation 20(2) or 35(6)(b) (pharmaceutical services in reserved locations) of the 2005 Regulations; orbregulation 50(2), (5) or (6) of the 2012 Regulations,relating to the postponement of termination of arrangements with a dispensing doctor, whether or not imposed by virtue of this paragraph, continue to have effect as if imposed under these Regulations.101Where, when granting an application which by virtue of paragraph 4 is finally determined in accordance with the 2005 Regulations, NHS England is required to consider under regulation 20(2) of the 2005 Regulations (imposition of conditions) any postponement of the making of arrangements with a dispensing doctor arising out of that grant, that consideration and its decision are to be in accordance with the 2005 Regulations.2Where before the appointed day a Primary Care Trust is considering under regulation 20(2) of the 2005 Regulations the postponement of the making of arrangements with a dispensing doctor, that matter is to be dealt with by NHS England, in accordance with the 2005 Regulations.3Where, under the 2005 Regulations—aa decision relating to postponement of the making of arrangements with a dispensing doctor is made by virtue of sub-paragraph (1) or (2); orbbefore the appointed day, a decision relating to postponement of the making of arrangements with a dispensing doctor was made by a Primary Care Trust under the 2005 Regulations, and—ithat decision has been appealed before the appointed day, oriithe time limit for bringing an appeal against that decision has not elapsed before the appointed day,the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations.4Where, when granting an application which by virtue of paragraph 5 is finally determined in accordance with the 2012 Regulations, NHS England is required to consider under regulation 57(1) of the 2012 Regulations (gradual introduction of premises approval)—aany postponement of the making of arrangements with a dispensing doctor arising out of that grant; orbany limitation on the patients to whom a dispensing doctor is able to provide pharmaceutical services,that consideration and its decision are to be in accordance with the 2012 Regulations.5Where before the appointed day a Primary Care Trust is considering under regulation 57(1) of the 2012 Regulations—athe postponement of the making of arrangements with a dispensing doctor; orbany limitation on the patients to whom a dispensing doctor is able to provide pharmaceutical services,that matter is to be dealt with by NHS England, in accordance with the 2012 Regulations.6Where, under the 2012 Regulations—aa decision relating to—ipostponement of the making of arrangements with a dispensing doctor, oriilimiting the patients to whom a dispensing doctor is able to provide pharmaceutical services,is made by virtue of sub-paragraph (1) or (2); orbbefore the appointed day, a decision relating to postponement of the making of arrangements with a dispensing doctor, or to limiting the patients the patients to whom a dispensing doctor is able to provide pharmaceutical services, was made by a Primary Care Trust pursuant to the 2012 Regulations, and—ithat decision has been appealed before the appointed day, oriithe time limit for bringing an appeal against that decision has not elapsed before the appointed day,the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations.7Conditions imposed by virtue of—aregulation 20(2) of the 2005 Regulations relating to postponement of the making of arrangements with a dispensing doctor; orbregulation 57(1) of the 2012 Regulations relating to—ithe postponement of the making of arrangements with a dispensing doctor, oriilimiting the patients to whom a dispensing doctor is able to provide pharmaceutical services,whether or not imposed by virtue of this paragraph, continue to have effect as if imposed under these Regulations.111Where, before the appointed day or as a consequence of paragraphs 2 or 4, a person is entitled on the basis of a decision (whether by a Primary Care Trust or NHS England, or on appeal)—ato be included in a pharmaceutical list but has not been included in that list;bto have listed in relation to their entry in a pharmaceutical list premises that have not been listed in relation to them;cto be included in a dispensing doctor list but has not been included in that list;dto have listed in relation to their entry in a dispensing doctor list premises that have not been listed in relation to them; oreto have listed in relation to their entry in a dispensing doctor list an area that has not been listed in relation to them,the arrangements for the listing of that person, those premises or that area, and the circumstances in which that decision lapses, are as set out in the 2005 Regulations.2Where, before the appointed day or as a consequence of paragraphs 3 or 5, a person is entitled on the basis of a decision (whether by a Primary Care Trust or NHS England, or on appeal)—ato be included in a pharmaceutical list but has not been included in that list;bto have listed in relation to their entry in a pharmaceutical list premises that have not been listed in relation to them;cto be included in a dispensing doctor list but has not been included in that list;dto have listed in relation to their entry in a dispensing doctor list premises that have not been listed in relation to them; oreto have listed in relation to their entry in a dispensing doctor list an area that has not been listed in relation to them,the arrangements for the listing of that person, those premises or that area, and the circumstances in which that decision lapses, are as set out in the 2012 Regulations.121Subject to sub-paragraph (2), the entries in pharmaceutical lists, EPS lists or dispensing doctor lists of Primary Care Trusts that are current immediately before the appointed day are to be current entries in the pharmaceutical lists, EPS lists and dispensing doctor lists maintained by NHS England on the appointed day under regulations 10 and 46 (albeit that the lists may be maintained by reference to different geographical areas).2Where immediately before the appointed day a Primary Care Trust was required or entitled to give effect to a decision reached before the appointed day to change, remove or include an entry in a pharmaceutical list, EPS list or dispensing doctor list but had not done so, NHS England is required or entitled (unless the context requires otherwise) to give effect to that decision on or after the appointed day.3If, as regards a decision to which paragraph (2) applies, before the appointed day—aremoval of an entry in a pharmaceutical list, EPS list or dispensing doctor list—iwould have resulted in removal of a person from a pharmaceutical list, EPS list or dispensing doctor list but no longer does so, oriiwould not have resulted in removal of a person from a pharmaceutical list, EPS list or dispensing doctor list but on or after the appointed day does so; orbinclusion of an entry in a pharmaceutical list, EPS list or dispensing doctor list—iwould have required the new inclusion of a person in a pharmaceutical list, EPS list or dispensing doctor list but no longer does so, oriiwould not have required the new inclusion of a person in a pharmaceutical list, EPS list or dispensing doctor list but on or after the appointed day does so,NHS England is nevertheless required or entitled (unless the context requires otherwise) to give effect to that decision, and in a manner that reflects the new arrangements for maintaining pharmaceutical lists, EPS lists and dispensing doctor lists, regardless of whether or not a different procedure would have been followed before the appointed day, had the nature of the listing change been as it is on or after the appointed day.131Subject to sub-paragraph (3), where by virtue of a transfer scheme or paragraph 12, NHS England becomes engaged in any matter—aarising under the 2005 Regulations before the appointed day; andbrelating to compliance with the terms of service of a chemist (whether compliance by the chemist or a Primary Care Trust),that matter is to be resolved in accordance with the 2005 Regulations, and where applicable the SCAT Regulations and the Drug Tariff, and the continuity principles are to be applied accordingly.2Subject to sub-paragraph (3), as regards the resolution of any matter—aarising under the 2005 Regulations before the appointed day; andbrelating to changing or removing any entry in a pharmaceutical list by virtue the 2005 Regulations other than pursuant to an application under regulation 5(1), 40(1) or 54(2) of those Regulations (which relate to applications for inclusion in a pharmaceutical list, preliminary consent applications and temporary provision during a period of suspension) (paragraph 2 applies in those cases),that matter is to be resolved in accordance with the 2005 Regulations, and where applicable the SCAT Regulations and the Drug Tariff, and the continuity principles are to be applied accordingly.3Sub-paragraphs (1) and (2) are without prejudice to the ability of NHS England to commence proceedings under Chapter 6 of Part 7 of the 2006 Act (pharmaceutical services and local pharmaceutical services – disqualification) on or after the appointed day that relate to matters arising before 1st September 2012 (potentially together with matters arising between 1st September 2012 and the appointed day, or on or after the appointed day), but any decisions in such proceedings are be reached in accordance with the relevant provisions of these Regulations (and that Chapter 6).4Subject to sub-paragraph (6), where by virtue of a transfer scheme or paragraph 12, NHS England becomes engaged in any matter—aarising under the 2012 Regulations before the appointed day; andbrelating to compliance with the terms of service of an NHS chemist (whether compliance by the NHS chemist or a Primary Care Trust),that matter is to be resolved in accordance with the 2012 Regulations and where applicable the Drug Tariff, and the continuity principles are to be applied accordingly.5Subject to sub-paragraph (6), as regards the resolution of any matter—aarising under the 2012 Regulations before the appointed day; andbrelating to changing or removing any entry in a pharmaceutical list by virtue the 2012 Regulations other than pursuant to a routine or excepted application (paragraph 3 applies in those cases),that matter is to be resolved in accordance with the 2012 Regulations and where applicable the Drug Tariff, and the continuity principles are to be applied accordingly.6Sub-paragraphs (4) and (5) are without prejudice to the ability of NHS England—ato commence proceedings under Chapter 6 of Part 7 of the 2006 Act on or after the appointed day that relate to matters arising before the appointed day (potentially together with matters arising on or after the appointed day), but any decisions in such proceedings are be reached in accordance with the relevant provisions of these Regulations (and that Chapter 6);bto issue breach or remedial notices under Part 10 on or after the appointed day that relate to matters arising before the appointed day (potentially together with matters arising on or after the appointed day); orcto take action under regulation 73 based on breach or remedial notices issued by a Primary Care Trust under Part 10 of the 2012 Regulations (performance related sanctions and market exit).7Decisions and reviews of decisions in any proceedings commenced under Chapter 6 of Part 7 of the 2006 Act before the appointed day—awhich by virtue of paragraph 10 of Schedule 7 to the 2012 Regulations (transitional provisions – other continuing matters: NHS chemists) were being determined in accordance with the 2005 Regulations and that Chapter 6 are to continue to be so determined; orbwere being determined in accordance with Part 11 of the 2012 Regulations (enforcement, reviews and appeals relating to fitness matters) and that Chapter 6 are to continue to be so determined,except in the case of a review of a decision where the request by the practitioner for a review is made on or after the appointed day (such a review is to be in accordance with the relevant provisions of these Regulations and that Chapter 6).8Where a person was suspended from a pharmaceutical list by virtue of Chapter 6 of Part 7 of the 2006 Act before the appointed day—adecisions on payments in respect of any part of the period of suspension that preceded 1st September 2012, and any appeals relating to those decisions, are to be in accordance with the 2005 Regulations and with the determinations under regulation 58 of the 2005 Regulations (payments to suspended chemists) that were in force immediately before 1st September 2012; andbdecisions on payments in respect of any part of the period of suspension between 1st September 2012 and 31st March 2013 inclusive, and any appeals relating to those decisions, are to be in accordance with the 2012 Regulations and with the determinations under regulation 98 of the 2012 Regulations (payments to suspended chemists) that were in force immediately before the appointed day.9Any direction or approval under, or that continues in effect under, a provision of Schedule 4 or 5 of the 2012 Regulations (terms of service of NHS pharmacists and terms of service of NHS appliance contractors) is to continue in effect as a direction or approval under the corresponding provision of Schedule 4 or 5 to these Regulations, unless or until it is amended or revoked by virtue of that corresponding provision or as a consequence of a decision under this paragraph.141Where, by virtue of a transfer scheme or paragraph 12, NHS England becomes engaged in any matter—aarising under the 2005 Regulations before the appointed day; andbrelating to compliance with the terms of service of a dispensing doctor (whether compliance by the dispensing doctor or a Primary Care Trust),that matter is to be resolved in accordance with the 2005 Regulations, and where applicable the SCAT Regulations and directions under section 87 of the 2006 Act (GMS contracts: payments), and the continuity principles are to be applied accordingly.2Where, by virtue of a transfer scheme or paragraph 12, NHS England becomes engaged in any matter arising under the 2012 Regulations before the appointed day and relating to compliance with the terms of service mentioned in regulation 47(2) of the 2012 Regulations (terms of service of dispensing doctors: general), the arrangements mentioned in regulation 47(2)(a) of those Regulations must provide for the matter to be resolved—ajustly;bin a manner that effects an orderly transition from the scheme established by the 2012 Regulations to the scheme established by these Regulations; andcif necessary or expedient in a manner that is inconsistent with these Regulations, or with regulations or directions under the 2006 Act that were in force immediately before the appointed day,and the continuity principles are to be applied, and that matter is to be acted upon, accordingly.3As regards the resolution of any matter—aarising under the 2012 Regulations before the appointed day; andbrelating to changing or removing any entry in a dispensing doctor list by virtue the 2012 Regulations other than pursuant to an application under Part 8 of those Regulations (dispensing doctors) for premises approval or outline consent (paragraph 5 applies in those cases),the matter is to be resolved in accordance with the 2012 Regulations, and the continuity principles are to be applied accordingly.151For the purposes of this paragraph, “the relevant transitional provisions” means—ain the case of an LPS pilot scheme, paragraph 92(8) of Schedule 4 to the Health and Social Care Act 2012 (amendments of the National Health Service Act 2006); orbin the case of LPS schemes that are not LPS pilot schemes, paragraph 93(6) of Schedule 4 to the Health and Social Care Act 2012.2The changes to LPS schemes by virtue of the relevant transitional provisions take effect on the appointed day without the need for notices—ain the case of LPS pilot schemes, under any terms of those schemes; orbin the case of LPS schemes that are not LPS pilot schemes, under the terms of the schemes that give effect to paragraph 26 of Schedule 7.3Where, by virtue of a transfer scheme or the relevant transitional provisions, NHS England becomes engaged in any matter arising under an LPS scheme before the appointed day and relating to compliance with the terms of the LPS scheme (whether compliance by the LPS chemist or a Primary Care Trust)—athat matter is to be resolved in accordance with the relevant provisions of the LPS scheme, and any applicable provisions of 2006 Regulations and the Drug Tariff; andbNHS England may vary those terms, if necessary or expedient in a manner that is inconsistent with—ithe 2006 Regulations,iithese Regulations, oriiiany directions under Chapter 2 of Part 7 of, and Schedule 11 to, the 2006 Act (which relate to local pharmaceutical services pilot schemes) that were in force immediately before the appointed day,in order to provide for the matter to be resolved justly and in a manner that effects an orderly transition from the regulatory schemes for local pharmaceutical services established by the 2006 Regulations and directions under the 2006 Act to the regulatory schemes for local pharmaceutical services established by these Regulations and directions under the 2006 Act,and the continuity principles are to be applied, and the matter is to be acted upon, accordingly.161The making, varying or cancellation of a designation by a Primary Care Trust under Part 2 of the 2006 Regulations (designation) before the appointed day that was not, before the appointed day, notified in accordance with that Part is to be notified by NHS England as if it were made, varied or notified under Part 13 of these Regulations.2Any review of a designation which was being undertaken by a Primary Care Trust before the appointed day but which was not completed before the appointed day is to be completed by NHS England.17Pending amendment of Group 12 of Schedule 8 to the Value Added Tax Act 1994 (zero rating: drugs, medicines, aids for the handicapped, etc.) to take account of the coming into force of these Regulations, the definition of “relevant provision” in Note (2D) shall apply in relation to supplies on or after the appointed day as if for paragraph (j) there were substituted—jPart 8 of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013..SCHEDULE 10 Regulation 1201. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2The National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002 are revoked.3The National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002 are revoked.4The National Health Service (Pharmaceutical Services) Amendment Regulations 2005 are revoked.51The National Health Service (Local Pharmaceutical Services etc.) Regulations are revoked.2The following provisions are revoked—aregulation 4 of the National Health Service (Miscellaneous Amendments Relating to Independent Prescribing) Regulations 2006 ;bregulation 8 of the National Health Service (Pharmaceutical Services) (Remuneration for Persons Providing Pharmaceutical Services) (Amendment) Regulations 2007 ;cPart 2 of the National Health Service (Miscellaneous Amendments Relating to Community Pharmaceutical Services and Optometrist Prescribing) Regulations 2009 ;dparagraphs 134 to 136 of Schedule 3 to the Transfer of Tribunal Functions Order 2010 ; andeparagraph 53 of Schedule 4 to the Pharmacy Order 2010 .6The National Health Service (Pharmaceutical Services) (Amendment) Regulations 2006 are revoked.7In the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 —ain the definition of “relevant complaints procedure” in regulation 2 (interpretation), for paragraphs (i) to (iii) of sub-paragraph (a) substitute the following paragraphs—iparagraph 34 of Schedule 4 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013;iaparagraph 24 of Schedule 5 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013;iiparagraph 8 of Schedule 6 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013; oriiiparagraph 25 of Schedule 7 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013; or; andbparagraph 2 of the Schedule is revoked.8The National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) Amendment Regulations 2009 are revoked.9The National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) (Amendment) Regulations 2010 are revoked.10The National Health Service (Local Pharmaceutical Services) Amendment Regulations 2012 are revoked.111The following Regulations are revoked—athe National Health Service (Pharmaceutical Services) Regulations 2012 ; andbNational Health Service (Pharmaceutical Services) Regulations 2012 (Amendment) Regulations 2012 .12In regulation 12(3)(d) of the Local Authorities (Partnership Arrangements, Care Trusts, Public Health and Local Healthwatch Arrangements etc.) Regulations 2012 (National Health Service payments by local authorities to specified NHS bodies in respect of prescribed functions) for “National Health Service (Pharmaceutical Services) Regulations 2012” substitute “ National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 ”.

(This note is not part of the Regulations)

These Regulations replace the National Health Service (Pharmaceutical Services) Regulations 2012 (“the 2012 Regulations”) and the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 (“the 2006” Regulations”) as the Regulations which govern the arrangements, in England, for the provision of pharmaceutical and local pharmaceutical services under Part 7 of the National Health Service Act 2006 (“the 2006 Act”).

Part 1 contains introductory provisions. Part 2 sets out the requirements relating to the production of pharmaceutical needs assessments (“PNAs”) A PNA is a statement of the assessment that each Health and Wellbeing Board (“HWB”) must make, at least every 3 years, of the needs in its area for pharmaceutical services provided as part of the National Health Service. This Part includes the consultation requirements that have to be fulfilled before a PNA is completed and published (regulation 8) and the matters to which a HWB must have regard when producing a PNA (regulation 9) – and Schedule 1 thereafter sets out the information that must be included in PNAs. Pending full revision of a PNA, a HWB may address in a supplementary statement changes to the availability of pharmaceutical services since the PNA was published (regulation 6). Provision is also made for the temporary extension of PNAs of Primary Care Trusts, who were responsible for PNAs prior to their abolition (regulation 7).

Pharmaceutical services provision by virtue of these Regulations is essentially of three types: service provision by virtue of being included in pharmaceutical lists maintained by the National Health Service Commissioning Board (“the NHSCB”); service provision by virtue of being included in a dispensing doctor list maintained by the NHSCB; and service provision by virtue of an agreement to provide local pharmaceutical services with the NHSCB.

The pharmaceutical list system is a system under which retail pharmacy businesses and appliance contractors (together referred to as “chemists”) are given permission to provide NHS pharmaceutical services from particular premises, provided both they and the relevant premises are included in a pharmaceutical list maintained by the NHSCB. These lists are kept by reference to the areas of HWBs (regulation 10).

Part 3 includes general matters relating to pharmaceutical lists and applications from chemists join them – and also relating to applications from chemists on the lists to relocate to different premises or open new premises. The presumption is that “routine” applications (defined in regulation 12) will be assessed against the relevant PNA. The detail of the new arrangements, including the matters to which, in addition to the relevant PNA, the NHSCB must have regard when determining applications, is set out in this Part. There is also provision (regulation 18) for granting routine applications that offer improvements or better access to pharmaceutical services that were not foreseen when the relevant PNA was published, in certain circumstances. Subject to this exception, routine applications must be refused unless they offer to meet needs, or secure improvements or better access, that are mentioned in the relevant PNA (regulation 22).

Part 4 sets out a number of types of applications in respect of pharmaceutical lists, known as “excepted” applications, that do not have to be assessed as provided for in Part 3. These include, for example, relocation applications that do not result in significant change to pharmaceutical services provision (regulation 24) and change of ownership applications (regulation 26). Under Chapter 6 of Part 7 of the 2006 Act, there are powers to suspend chemists on pharmaceutical lists during fitness investigations or pending fitness appeals – and an exception is also made in respect of a temporary chemist joining a pharmaceutical list to provide services in place of a suspended chemist (regulation 27). A further exception is made (in regulation 28) to allow chemists who provide local pharmaceutical services a right of return to a pharmaceutical list in appropriate circumstances. A new exception (with effect from 1st April 2013) has been created to allow for the temporary relocation of chemists to nearby premises where there is a temporary suspension in the provision of pharmaceutical services for a reason beyond the control of the chemist (regulation 29).

Part 5 contains some grounds for refusing different types of applications in respect of pharmaceutical lists, for example because the premises to which the application relates are in an area that has been set aside for tendering arrangements for a contract to provide local pharmaceutical services (regulation 32).

Part 6 provides for refusal and deferral of applications, and for conditional inclusion in pharmaceutical lists, for fitness reasons. There are some mandatory grounds (for example, murder convictions) as a consequence of which a person, partnership or body corporate must be refused entry onto a pharmaceutical list, and some discretionary grounds (regulation 33). If, instead of refusing an application, the NHSCB decides to grant it subject to permissible fitness conditions, and these conditions are not appealed or are upheld on appeal, the applicant has to decide within a set timetable whether or not they wish to withdraw the granted application (regulation 35).

Part 7 covers determinations as to whether or not an area is a controlled locality or a reserved location. Controlled locations are areas that are rural in character where doctors may apply to provide dispensing services (a restricted range of pharmaceutical services), if certain conditions are met. Determinations that an area is a controlled locality may only take place once every 5 years unless there is a substantial change of circumstances in the intervening period (regulation 36). Routine applications from retail pharmacy businesses to locate pharmacy premises in a controlled locality face two additional hurdles to those already set out in Part 3: firstly, applications in defined parts of a controlled locality cannot be made within 5 years of either the refusal of a similar pharmacy application or the grant of a relevant permission to doctors to dispense, unless there is a substantial change of circumstances affecting the locality (regulation 40); and secondly, the applications are subject to the “prejudice test” (regulation 44), under which the NHSCB is required to refuse the application if it would prejudice the proper provision of relevant NHS services. Where an application for a new pharmacy in a controlled locality is granted, the NHSCB may determine that the pharmacy is at the centre of a reserved location – that is, essentially, an area of below a specified population threshold in which patients are to have the option of receiving dispensing services from either a dispensing doctor or a retail pharmacy business.

The procedures, generally, for dealing with pharmaceutical list applications and related appeals are dealt with in Schedules 2 and 3. These procedures provide for the content of applications (Part 1 of Schedule 2), the process for notifying most types of applications to interested parties that might want to make representations in relation to them (Part 3 of Schedule 2), and the decision making processes – including provision for oral hearings (Part 4 of Schedule 2). There are is also provision for the notification of decisions – and arrangements for when, and subject to what notification requirements, chemists may open new premises that are the subject of successful applications (Part 5 of Schedule 2). The procedures with regard to appeals, either by applicants against refusals or by third parties with appeal rights, are for the most part covered in Schedule 3 – and again there is provision for notification of interested parties both of appeals (to allow for third party representations in most cases) and of decisions on appeals.

Part 8 sets out the arrangements under which an NHS general practitioner who has, or whose practice has, a registered patient list may provide dispensing services. Generally to do so, individual general practitioners or their medical practice face three hurdles: firstly, the patients to whom they could provide dispensing services must have applied to them for such services (regulation 48); secondly, they must have been granted premises approval for the medical practice premises from which they wish to dispense; and thirdly, they must have been granted outline consent in relation to the area to whose residents they wish to dispense (or have relevant historic rights to dispense). The taking effect of decisions to grant outline consent and premises approval may be delayed to allow for the processing of outstanding pharmacy applications (regulations 52 and 56) and to mitigate the effects on other providers of pharmaceutical services locally (regulation 57).

Once included on a dispensing doctor list maintained by the NHSCB (under regulation 46) and so permitted to provide dispensing services, dispensing doctors have to comply with the terms of service for dispensing doctors set out in Schedule 6 and which for the most part deal with specific issues relating to dispensing. Dispensing doctors may however be required to discontinue that provision if the conditions that led to the grant of their entitlement to dispense no longer apply (generally, unless the practice premises are in a reserved location, discontinuation will result from the opening of a pharmacy nearby) – subject to arrangements for possible postponement of the discontinuation (regulation 50). There are also circumstances in which outline consent and premises approval may lapse, for example where it has been more than 6 months since any drug or appliance was dispensed under the arrangements with the dispensing doctor (regulation 60) – and there are also procedures for dealing with medical practices either relocating or amalgamating (regulations 54, 55 and 59).

Part 9 sets out some conditions that are to be imposed on chemists as part of their terms of service with the NHSCB, which include requirements relating to co-operation with the NHSCB over local resolution of disputes (regulation 68). These Part 9 conditions are in addition to the principal terms of service for chemists, which are in Schedule 4 for retail pharmacy businesses and Schedule 5 for appliance contractors.

The terms of service in Schedule 4 include obligations to provide what are described as the essential services that must be provided at each pharmacy. These essential services include not only dispensing services but other services, for example disposal services in respect of unwanted drugs and promotion of healthy lifestyles. As well as providing essential services, retail pharmacy businesses are subject to other compulsory requirements by virtue of Schedule 4, for example with regard to having acceptable systems of clinical governance and providing information about fitness matters. The range of necessary services required of appliance contractors in Schedule 5 is more limited, but also includes requirements with regard to dispensing and additional compulsory requirements with regard to clinical governance and providing information about fitness matters. Both of these types of provider of pharmaceutical services are also subject to detailed requirements with regard to their opening hours and changes to them.

Part 10 sets out the arrangements for dealing with breaches of terms of service by chemists (breaches by dispensing doctors are dealt with under their parallel arrangements for providing primary medical services to registered patients, which they must have in order to be providers of pharmaceutical services). Where a dispute between a chemist and the NHSCB cannot be resolved under the local dispute resolution procedures (or where that procedure may be by-passed), the chemist faces the possibility of a breach or remedial notice, as a part of which there may be a payment withholding (regulations 70 to 72). In some cases, repeated failures to comply with terms of service, or failures with particularly serious consequences, may thereafter lead to the removal of a chemist's business premises from the relevant pharmaceutical list. Removal of such premises is also a possibility in other cases, for example (subject to exceptions) where a chemist has not provided NHS pharmaceutical services for more than 6 months, and there are also arrangements for voluntary removal, which may be prevented if the contractor is subject to ongoing fitness proceedings (regulations 73 to 76).

Part 11 contains procedures for dealing with fitness issues with regard to chemists on pharmaceutical lists. These include procedures for reviewing fitness conditions imposed under regulation 35 on chemists as a condition of their inclusion in a pharmaceutical list – but for the most part, the procedures complement the arrangements for imposing fitness sanctions that are set out in Chapter 6 of Part 7 to the 2006 Act. There are also substantive requirements that complement those Chapter 6 arrangements, for example a prescribed list of grounds for which the NHSCB must remove a chemist from a pharmaceutical list in an unsuitability case under section 151(4) of the 2006 Act, a list which includes murder convictions (regulation 81). Where fitness sanctions are imposed, there are notification requirements that provide for dissemination of relevant information to other bodies that may need to consider taking action, for example the devolved administrations and the General Pharmaceutical Council, and to other persons who are entitled to request the information (regulation 88).

Part 12 contains provisions relating to financial matters. Regulation 89 provides for the publication of the Drug Tariff, the main statement of the financial entitlements of chemists that provide pharmaceutical services. The Secretary of State is the determining authority for reimbursement referable to the cost of drugs and appliances, but the NHSCB acts as the determining authority for other remuneration, in particular for some additional services and for the items listed in Schedule 8 (regulation 91). Dispensing doctor remuneration is linked to what their entitlement is or would be under a general medical services contract (regulation 92). There are also provisions for dealing with supplemental matters, for example overpayments and refunds of prescription charges. The Secretary of State is also given powers to make a separate determination of remuneration which will apply to chemists who are suspended from a pharmaceutical list, either during an investigation or pending an appeal, for fitness reasons (regulation 98).

Part 13 and Schedule 7 deal with local pharmaceutical services, which are a set of contractual arrangements, known as LPS schemes, with the NHSCB under which chemists provide pharmaceutical services whilst not on a pharmaceutical list. LPS schemes come in two types: LPS pilot schemes, a set of schemes whose main terms, and any arrangements for entering into them, are set out in a separate set of directions, and the standard form of LPS schemes, the mandatory terms for which are set out in Schedule 7 and cover matters such as dispensing arrangements (all LPS schemes must include provision for the dispensing of drugs – regulation 102), clinical governance, professional standards, inducements, remuneration and charges, complaints, dispute resolution and termination.

Before commissioning services under the standard form of LPS scheme, the NHSCB may decide to designate an area of a HWB, premises or descriptions of premises (regulation 99), the effect of which will be to allow for the deferral of routine applications (regulation 32) for the duration of the designation, facilitating the commissioning of local pharmaceutical services at the location in question. There are also arrangements for the review and cancellation of designations (regulations 100 and 101). Where the NHSCB does enter into the standard form of LPS scheme, there are arrangements for that scheme being (unless the contractor objects) an NHS contract, which affects the arrangements for dispute resolution (regulation 103). Only contractors demonstrating certain fitness requirements may become parties to such schemes (regulation 105), and persons proposing to enter into such schemes must first send the NHSCB information about their fitness to be parties to them (regulation 106). Proposals for the standard form of LPS scheme that may proceed for development also have to be notified to interested parties by the NHSCB (regulation 107). If a contractor, on entering into the standard form of LPS scheme, gives up a right to be on a pharmaceutical list, they may be given a right of return (regulation 108). There are also provisions about whether or not LPS pilot schemes are to be NHS contracts (regulation 109), and about what happens on termination of pilot schemes. In effect, unless the pilot scheme terminates for a reason relating to the fitness of the provider to be a provider of pharmaceutical services, the scheme premises and the contractor are included in a pharmaceutical list (regulation 110). There are also other administrative provisions relating to LPS schemes, including arrangements for dealing with emergencies requiring the flexible provision of pharmaceutical services (regulation 111).

Part 14 deals with some miscellaneous matters, for example a provision that allows for applications for services to be made on behalf of some patients by duly authorised persons (regulation 116) and the delegation of certain functions of the Secretary of State to the National Health Service Litigation Authority (regulation 117).

Regulation 119 introduces Schedule 9, which sets out a number of transitional provisions. These include arrangements to deal with the abolition of Primary Care Trusts. Outstanding listing applications under the 2012 Regulations, and the LPS schemes and listing entries that are already in existence, are preserved. Ongoing matters essentially carry on.

Regulation 120 introduces Schedule 10, which contains a number of consequential amendments and revocations.

These Regulations will be the subject of a published review by 31st August 2017 (regulation 121).

2006 c.41. Section 7 has been amended by the Health and Social Care Act 2012 (c. 7) (“the 2012 Act”), section 21(1) to (4); section 8 has been amended by the 2012 Act, Schedule 4, paragraph 5; section 126 has been amended by the 2012 Act, sections 213(7)(k) and 220(7), and Schedule 4, paragraph 63; section 128A was inserted by the Health Act 2009 (c.21), section 25, and amended by the 2012 Act, section 206(1); section 129 has been amended by the Health Act 2009, sections 26 and 27 and Schedule 6, by the 2012 Act, section 207(1) to (9), and Schedule 4, paragraph 66, by the Protection of Freedoms Act 2012 (c. 9), Schedule 9, paragraph 121, and by S.I. 2010/231; section 130 has been amended by the 2012 Act, section 207(10), and by S.I. 2010/22; section 132 has been amended by the 2012 Act, Schedule 4, paragraph 69, by the Protection of Freedoms Act 2012, Schedule 9, paragraph 122, and by S.I. 2007/289 and 2010/22 and 231; section 136 has been amended by the 2012 Act, section 207(11), and Schedule 4, paragraph 72; section 140 has been amended by the 2012 Act, Schedule 4, paragraph 75; section 148 has been amended by the 2012 Act, Schedule 4, paragraph 77, and by S.I. 2010/22; section 150A was inserted by the Health Act 2009, section 28, and amended by the 2012 Act, Schedule 4, paragraph 78; section 151 has been amended by the 2012 Act, Schedule 4, paragraph 80; section 154 has been amended by the 2012 Act, Schedule 4, paragraph 81, and by S.I. 2010/22; section 160 has been amended by the 2012 Act, Schedule 4, paragraph 86; section 161 has been amended by the 2012 Act, Schedule 4, paragraph 87; section 162 has been amended by the 2012 Act, Schedule 4, paragraph 88; section 164 has been amended by the Health and Social Care Act 2008 (c. 14), section 141(1), and Schedule 15, Part 4, and by the 2012 Act, Schedule 4, paragraph 89; section 169 has been amended by S.I. 2010/22; paragraph 2 of Schedule 12 has been amended by the Health Act 2009, section 29(12), and by the 2012 Act, section 207(12), and Schedule 4, paragraph 93(3); paragraph 3 of Schedule 12 has been amended by the Health Act 2009, section 29(13) to (15), and by the 2012 Act, Schedule 4, paragraph 93(4). By virtue of section 271(1) of the 2006 Act, the functions of the Secretary of State being exercised in the making of these Regulations are exercisable only in relation to England. See also section 275(1) of the 2006 Act, which contains definitions of “prescribed” and “regulations” that are relevant to the powers being exercised.1968 c. 67.1992/662; these Regulations were revoked by S.I. 2005/641.2005/641; these Regulations were revoked by S.I. 2012/1909.S.I. 2006/552; these Regulations are revoked by Schedule 10.2007 c. 28.S.I. 2012/1909; these Regulations are revoked by Schedule 10.Section 127 has been amended by the Health and Social Care Act 2012 (c. 7), Schedule 4, paragraph 64.See section 126(9) of that Act, which provides a definition of “listed” that includes the power for the Secretary of State to approve lists for the purposes of section 126.2006 c. 52.Schedule 12A was inserted by the Health and Social Care Act 2012, Schedule 3.1971 c.80.2000 c.7. The definition of “electronic communication” has been amended by the Communications Act 2003 (c. 21), Schedule 17, paragraph 158.Section 129(2A) was inserted by the Health Act 2009 (c. 21), section 26(3), and has been amended by the Health and Social Care Act 2012 (c. 7), section 207(4), and Schedule 4, paragraph 66(5).S.I. 2010/231.1978 c. 29. Section 2 has been amended by: the Health and Social Services and Social Security Adjudications Act 1983 (c.41), Schedule 7, paragraph 1; the National Health Service and Community Care Act 1990 (c.19), section 28, Schedule 9, paragraph 19(1), and Schedule 10; the National Health Service Reform (Scotland) Act 2004 (asp 7), Schedule 1, paragraph 1(2); the Smoking, Health and Social Care (Scotland) Act 2005 (asp 13), Schedule 2, paragraph 2(2); and the Health Boards (Membership and Elections) (Scotland) Act 2009 (asp 5), section 2(1).Section 25 has been amended by: the Health and Social Care Act 2008 (c. 14), section 113, Schedule 10, paragraph 17, and Schedule 15, Part 2; and by S.I. 2010/231.See section 194 of the Health and Social Care Act 2012 (c. 7).Section 222(2A) was inserted by the Health and Social Care Act 2012, section 183(2).Section 134(2) has been amended by the Health Act 2009 (c. 21), Schedule 1, paragraph 8, and by the Health and Social Care Act 2012, Schedule 4, paragraph 71(3).Section 91 has been amended by the Health and Social Care Act 2012, Schedule 4, paragraph 35.Section 159 has been amended by S.I. 2010/22.S.I. 2005/2414.S.I. 1995/2800; amended by S.I. 2002/2621, 2005/503 and 1445, 2012/1641 and 2013/235.S.I. 2012/1916.S.I. 2002/253; amended by S.I. 2009/1182.1989 c.44; amended by S.I. 2005/848.S.I. 2004/906. See regulation 2(2) of those Regulations.S.I. 1976/1213 (N.I. 22).Section 72A was inserted by the Health Act 2006 (c. 28), section 30, and has been amended by S.I. 2006/2407.S.I. 2004/629.See regulation 5(3) of those Regulations.Paragraph 42 has been amended by S.I. 2005/893 and 2009/2230.Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680.2010 c. 15.2009 c. 1 (N.I.).S.I. 2003/2382.Prior to its revocation, regulation 35 was amended by S.I. 2005/1501.S.I. 1992/664; these Regulations were revoked by S.I. 2012/1909.Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680.Section 71 was substituted by the Health Act 2006 (c. 28), section 28, and has been subsequently amended by S.I. 2007/3101 and 2010/231.Section 168A was inserted by the Health and Social Care Act 2012 (c. 7), section 49(4).Inserted by the Health Act 2009 (c. 21), section 25.Section 225 has been amended by the Health and Social Care Act 2012 (c. 7), section 186(6) to (10), Schedule 14, paragraphs 103 and 106, and Schedule 5, paragraphs 148 and 151.Section 225 has been amended by the Health and Social Care Act 2012 (c. 7), section 186(6) to (10), Schedule 14, paragraphs 103 and 106, and Schedule 5, paragraphs 148 and 151.Section 129(2A) was inserted by the Health Act 2009 (c. 21), section 26(3), and has been amended by the Health and Social Care Act 2012 (c. 7), section 207(4), and Schedule 4, paragraph 66(5).Sections 13I and 13P were inserted by the Health and Social Care Act 2012, section 23(1).Sections 13G was inserted by the Health and Social Care Act 2012, section 23(1).Sections 13K was inserted by the Health and Social Care Act 2012 (c. 7), section 23(1).Section 129(2A) was inserted by the Health Act 2009 (c. 21), section 26(3), and has been amended by the Health and Social Care Act 2012 (c. 7), section 207(4), and Schedule 4, paragraph 66(5).Prior to its revocation, the heading of regulation 13 was amended by S.I. 2009/2205.Prior to its revocation, regulation 16 was amended by S.I. 2005/1501.Prior to their revocation, regulations 6 and 7 were both amended by S.I. 2005/1501 and 2006/3373.Section 129(2A) was inserted by the Health Act 2009 (c. 21), section 26(3), and has been amended by the Health and Social Care Act 2012 (c. 7), section 207(4), and Schedule 4, paragraph 66(5).Section 129(2A) was inserted by the Health Act 2009 (c. 21), section 26(3), and has been amended by the Health and Social Care Act 2012 (c. 7), section 207(4), and Schedule 4, paragraph 66(5).Section 129(2A) was inserted by the Health Act 2009 (c. 21), section 26(3), and has been amended by the Health and Social Care Act 2012 (c. 7), section 207(4), and Schedule 4, paragraph 66(5).S.I. 2002/2016. These Regulations are revoked by Schedule 10.S.I. 2006/552. These Regulations are revoked by Schedule 10.Prior to its revocation, regulation 4 was amended by S.I. 2009/599 and 2010/914.2003 c. 42.S.I. 2008/2699 (L 16); see rule 19 of those Rules.Prior to its revocation, regulation 18ZA was inserted by S.I. 2005/1501.Prior to its revocation, regulation 20 was amended by S.I. 2006/552.Section 225 has been amended by the Health and Social Care Act 2012 (c. 7), section 186(6) to (10), Schedule 14, paragraphs 103 and 106, and Schedule 5, paragraphs 148 and 151.Prior to its revocation, regulation 18(2) was amended by S.I. 2005/1501 and 2010/914.Prior to its revocation, regulation 65 was amended by S.I. 2006/3373.Prior to its revocation, regulation 20 was amended by S.I. 2006/552.Prior to its revocation, regulation 14 was amended by S.I. 2006/3373.Section 72 has been amended by: the Insolvency Act 1985 (c. 65), Schedule 8, paragraph 15; the Insolvency Act 1986 (c. 45), Schedule 14; the Adults with Incapacity (Scotland) Act 2000 (asp 4), Schedule 5, paragraph 12, and Schedule 6; the Mental Incapacity Act 2005 (c. 9), Schedule 6, paragraph 14; the Health Act 2006 (c. 28), section 29; and S.I. 1989/ 2405, 2007/289 and 2010/231.Section 154 has been amended by S.I. 2010/22.S.I. 2008/2699 (L 16); see rule 19 of those Rules.Section 151 has been amended by the Health and Social Care Act 2012 (c. 7) (“the 2012 Act”), Schedule 4, paragraph 79. Section 152(3) has been amended by the 2012 Act, Schedule 4, paragraph 80.Section 152(1) has been amended by the Health and Social Care Act 2012 (c. 7), Schedule 4, paragraph 80.Section 158 has been amended by the Health and Social Care Act 2012, Schedule 4, paragraph 84, and by S.I. 2010/22.S.I. 2008/2699 (L 16); see rule 19 of those Rules.Section 157 has been amended by the Health and Social Care Act 2012, Schedule 4, paragraph 83, and by S.I. 2010/22.Section 154 has been amended by the Health and Social Care Act 2012 (c. 7) (“the 2012 Act”), Schedule 4, paragraph 81, and by S.I. 2010/22. Section 155 has been amended by the 2012 Act, Schedule 4, paragraph 82, and by S.I. 2010/22.Section 157 has been amended by the Health and Social Care Act 2012, Schedule 4, paragraph 83, and by S.I. 2010/22.Section 158 has been amended by the Health and Social Care Act 2012 (c. 7), Schedule 4, paragraph 84, and by S.I. 2010/22.See rule 19 of those Rules.Section 157 has been amended by the Health and Social Care Act 2012, Schedule 4, paragraph 83, and by S.I. 2010/22.Section 159 has been amended by the Health and Social Care Act 2012, Schedule 4, paragraph 85, and by S.I. 2010/22.Section 151 has been amended by the Health and Social Care Act 2012 (c. 7) (“the 2012 Act”), Schedule 4, paragraph 79. Section 152 has been amended by the 2012 Act, Schedule 4, paragraph 80.Section 154 has been amended by the Health and Social Care Act 2012 (c. 7) (“the 2012 Act”), Schedule 4, paragraph 81, and by S.I. 2010/22. Section 155 has been amended by the 2012 Act, Schedule 4, paragraph 82, and by S.I. 2010/22.Section 164 has been amended by the Health and Social Care Act 2008 (c. 14), section 141(1), and Schedule 15, Part 4, and by the Health and Social Care Act 2012 (c. 7), Schedule 4, paragraph 89.Section 164 has been amended by the Health and Social Care Act 2008 (c. 14), section 141(1), and Schedule 15, Part 4, and by the Health and Social Care Act 2012 (c. 7), Schedule 4, paragraph 89..Section 87 has been amended by the Health and Social Care Act 2012 (c. 7), Schedule 4, paragraph 33.Section 164 has been amended by the Health and Social Care Act 2008 (c. 14), section 141(1), and Schedule 15, Part 4, and by the Health and Social Care Act 2012, Schedule 4, paragraph 89.Regulation 10 has been amended by S.I. 2000/3189, 2002/2352 and 2004/696.Paragraph 2 has been amended by: the Health Act 2009 (c. 21), section 29(12); and the Health and Social Care Act 2012 (c. 7), section 207(12), and Schedule 4, paragraph 93(3).Prior to its revocation, regulation 4 was amended by S.I. 2009/599 and 2010/914.Section 168A was inserted by the Health and Social Care Act 2012 (c. 7), section 49(4).Section 9 has been amended by the Health and Social Care Act 2008 (c. 14), Schedule 5, paragraph 82, and by the Health and Social Care Act 2012, Schedule 4, paragraph 6, Schedule 7, paragraph 18, Schedule 14, paragraph 4, Schedule 17, paragraph 10, Schedule 19, paragraph 9, and Schedule 21, paragraph 6.1933 c. 12. Schedule 1 has been amended by: the Sexual Offences Act 1956 (c. 69), Schedule 4; the Criminal Justice Act 1988 (c. 33), Schedule 15, paragraph 8, and Schedule 16; the Sexual Offences Act 2003 (c. 42), Schedule 6, paragraph 7; the Domestic Violence, Crime and Victims Act 2004 (c. 28), Schedule 10, paragraph 2; the Coroners and Justice Act 2009 (c. 25), Schedule 21, paragraph 53; and the Protection of Freedoms Act 2012 (c. 9), Schedule 9, paragraph 136.1995 c. 46.1986 c. 45; Part 7A was inserted by the Tribunals, Courts and Enforcement Act 2007 (c. 15), Schedule 17.Schedule 4A was inserted by Schedule 20 to the Enterprise Act 2002 (c.40). Schedule 4ZB was inserted by the Tribunals, Courts and Enforcement Act 2007 (c. 15), Schedule 19.S.I. 1989/2405 (N.I. 19); Schedule 2A was inserted by S.I. 2005/1455 (N.I. 10).Schedule B1 was inserted by the Enterprise Act 2002 (c. 40), Schedule 16.1990 c.40; section 7 was repealed by the Charities and Trustee Investment (Scotland) Act 2005 (asp 10), Schedule 4, paragraph 7(b).2005 asp 10; section 34(5) has been amended by the section the Public Services Reform (Scotland) Act 2010 (asp 8), section 122.1986 c.46.S.I. 2002/3150 (N.I. 4); relevant amendments were made by S.I. 2005/1454 (N.I. 9).Section 429(2) was amended by the Enterprise Act 2002 (c.40), Schedule 23, paragraph 15.1995 c. 46; section 246(2) and (3) have been amended by the Criminal Justice and Licensing (Scotland) Act 2010 (asp 13), Schedule 2, paragraph 26.1995 c. 46. Section 302 has been amended by: the Communications Act 2003 (c. 21), Schedule 17, paragraph 133; the Wireless Telegraphy Act 2006 (c. 36), Schedule 7, paragraph 16; the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6), section 50(1); and the Criminal Justice and Licensing (Scotland) Act 2010 (asp 13), section 70(3).1992 c. 5. Section 115A was inserted by the Social Security Administration (Fraud) Act 1997 (c. 47), section 15, and amended by the Social Security Fraud Act 2001 (c. 11) (“the 2001 Act”), section 14. The amendments made by the 2001 Act are to be repealed by, and other amendments to section 115A are to be made by, the Welfare Reform Act 2012 (c. 5), sections 113 to 115, and Schedule 14, Part 1.1989 c. 41.Section 69 has been amended by the Statute Law (Repeals) Act 1993 (c. 50), Schedule 1, Part 12, and by S.I. 1976/1213, 2007/289 and 3101 and 2010/231.1995 c. 46. Section 302 has been amended by: the Communications Act 2003 (c. 21), Schedule 17, paragraph 133; the Wireless Telegraphy Act 2006 (c. 36), Schedule 7, paragraph 16; the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6), section 50(1); and the Criminal Justice and Licensing (Scotland) Act 2010 (asp 13), section 70(3).1992 c. 5. Section 115A was inserted by the Social Security Administration (Fraud) Act 1997 (c. 47), section 15, and amended by the Social Security Fraud Act 2001 (c. 11) (“the 2001 Act”), section 14. The amendments made by the 2001 Act are to be repealed by, and other amendments to section 115A are to be made by, the Welfare Reform Act 2012 (c. 5), sections 113 to 115, and Schedule 14, Part 1.Amended by S.I. 1968/1699 and 2010/231.Section 129(2A) was inserted by the Health Act 2009 (c. 21), section 26(3), and has been amended by the Health and Social Care Act 2012 (c. 7), section 207(4), and Schedule 4, paragraph 66(5).Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.1971 c.38; see section 2(1)(a) of that Act, which defines “controlled drug” for the purposes of that Act.S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432, 2005/3372, 2007/2154, 2009/3136 and 2012/973, and Schedule 5 has been amended by S.I. 2005/2864.Regulation 3 has been amended by S.I. 2002/2352, 2003/1084, 2004/865, 2005/578, 2008/571, 2009/411, 2010/1727, 2011/518 and 2012/470.Regulation 7 has been amended by S.I. 2000/3189, 2002/2352, 2004/696, 2005/578 and 2009/29.Regulation 5 has been amended by S.I. 2004/663 and 936, 2006/562, 2008/1697 and 2009/411.1985 c.72.S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432, 2005/3372, 2007/2154, 2009/3136 and 2012/973, and Schedule 5 has been amended by S.I. 2005/2864.Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.The Medicines and Healthcare Products Regulatory Agency, which is an executive agency of the Department of Health, issues safety advice, warnings, alerts and recalls in respect of medical devices on behalf of the Secretary of State, and also safety advice, warnings, alerts and recalls in respect of medicines on behalf of the Secretary of State and the Minister for Health, Social Services and Public Safety, acting jointly. The Department of Health also, separately, issues other communications concerning patient safety, on behalf of the Secretary of State.1974 c. 37.1996 c. 18; section 43A was inserted by the Public Interest Disclosure Act 1998 (c. 23), section 1. See also section 43K(1)(c) (i) of the Employment Rights Act 1996 (inserted by the Public Interest Disclosure Act 1998, section 1, and amended by: the National Health Service Reform and Health Care Professions Act 2002 (c. 17), Schedule 2, paragraph 63; the National Health Service (Consequential Provisions) Act 2006 (c. 43), Schedule 1, paragraphs 177 and 178(b); and S.I. 2007/961).1995 c. 46. Section 302 has been amended by: the Communications Act 2003 (c. 21), Schedule 17, paragraph 133; the Wireless Telegraphy Act 2006 (c. 36), Schedule 7, paragraph 16; the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6), section 50(1); and the Criminal Justice and Licensing (Scotland) Act 2010 (asp 13), section 70(3).1992 c. 5. Section 115A was inserted by the Social Security Administration (Fraud) Act 1997 (c. 47), section 15, and amended by the Social Security Fraud Act 2001 (c. 11) (“the 2001 Act”), section 14. The amendments made by the 2001 Act are to be repealed by, and other amendments to section 115A are to be made by, the Welfare Reform Act 2012 (c. 5), sections 113 to 115, and Schedule 14, Part 1.Section 1F was inserted by the Health and Social Care Act 2012 (c. 7), section 7.S.I. 2009/309; amended by S.I. 2009/1768.Regulation 3 has been amended by S.I. 2002/2352, 2003/1084, 2004/865, 2005/578, 2008/571, 2009/411, 2010/1727, 2011/518 and 2012/470.Regulation 7 has been amended by S.I. 2000/3189, 2002/2352, 2004/696, 2005/578 and 2009/29.Regulation 5 has been amended by S.I. 2004/663 and 936, 2006/562, 2008/1697 and 2009/411.1985 c. 72.2010 c. 15.1974 c. 37.1995 c. 46. Section 302 has been amended by: the Communications Act 2003 (c. 21), Schedule 17, paragraph 133; the Wireless Telegraphy Act 2006 (c. 36), Schedule 7, paragraph 16; the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6), section 50(1); and the Criminal Justice and Licensing (Scotland) Act 2010 (asp 13), section 70(3).1992 c. 5. Section 115A was inserted by the Social Security Administration (Fraud) Act 1997 (c. 47), section 15, and amended by the Social Security Fraud Act 2001 (c. 11) (“the 2001 Act”), section 14. The amendments made by the 2001 Act are to be repealed by, and other amendments to section 115A are to be made by, the Welfare Reform Act 2012 (c. 5), sections 113 to 115, and Schedule 14, Part 1.Section 1F was inserted by the Health and Social Care Act 2012 (c. 7), section 7.S.I. 2009/309; amended by S.I. 2009/1768.Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.1971 c.38; see section 2(1)(a) of that Act, which defines “controlled drug” for the purposes of that Act.S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432, 2005/3372, 2007/2154, 2009/3136 and 2012/973, and Schedule 5 has been amended by S.I. 2005/2864.Paragraph 39 has been amended by S.I. 2005/893, 2007/3491 and 2009/2230.Paragraph 39A was inserted by S.I. 2005/893 and has been amended by S.I. 2007/3491.Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.Paragraph 42 has been amended by S.I. 2005/893 and 2009/2230.Regulation 4 has been amended by S.I. 2000/2393, 2001/2887, 2002/548 and 2352, 2005/578, 2008/571, 2009/411, 2010/1727 and 2011/518.Regulation 7 has been amended by S.I. 2000/3189, 2002/2352, 2004/696, 2005/578 and 2009/29.Regulation 5 has been amended by S.I. 2004/663 and 936, 2006/562, 2008/1697 and 2009/411.Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.Section 225 has been amended by the Health and Social Care Act 2012 (c. 7), section 186(6) to (10), Schedule 14, paragraphs 103 and 106, and Schedule 5, paragraphs 148 and 151.Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.1971 c.38; see section 2(1)(a) of that Act, which defines “controlled drug” for the purposes of that Act.S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432, 2005/3372, 2007/2154, 2009/3136 and 2012/973, and Schedule 5 has been amended by S.I. 2005/2864.Regulation 3 has been amended by S.I. 2002/2352, 2003/1084, 2004/865, 2005/578, 2008/571, 2009/411, 2010/1727, 2011/518 and 2012/470.Regulation 7 has been amended by S.I. 2000/3189, 2002/2352, 2004/696, 2005/578 and 2009/29.Regulation 5 has been amended by S.I. 2004/663 and 936, 2006/562, 2008/1697 and 2009/411.1985 c. 72.1971 c.38; see section 2(1)(a) of that Act, which defines “controlled drug” for the purposes of that Act.S.I. 2001/3998. Schedule 4 has been amended by S.I. 2003/1432, 2005/3372, 2007/2154 and 2009/3136, and Schedule 5 has been amended by S.I. 2005/2864.Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.1995 c. 46; section 246(2) and (3) have been amended by the Criminal Justice and Licensing (Scotland) Act 2010 (asp 13), Schedule 2, paragraph 26.1995 c. 46. Section 302 has been amended by: the Communications Act 2003 (c. 21), Schedule 17, paragraph 133; the Wireless Telegraphy Act 2006 (c. 36), Schedule 7, paragraph 16; the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6), section 50(1); and the Criminal Justice and Licensing (Scotland) Act 2010 (asp 13), section 70(3).1992 c. 5. Section 115A was inserted by the Social Security Administration (Fraud) Act 1997 (c. 47), section 15, and amended by the Social Security Fraud Act 2001 (c. 11) (“the 2001 Act”), section 14. The amendments made by the 2001 Act are to be repealed by, and other amendments to section 115A are to be made by, the Welfare Reform Act 2012 (c. 5), sections 113 to 115, and Schedule 14, Part 1.Section 1F was inserted by the Health and Social Care Act 2012 (c. 7), section 7.Regulation 10 has been amended by S.I. 2000/3189, 2002/2352 and 2004/696.Section 164 has been amended by: the Health and Social Care Act 2008 (c. 14), section 141, and Schedule 15, Part 4; and by the Health and Social Care Act 2012 (c. 7), Schedule 4, paragraph 89.S.I. 2009/309; amended by S.I. 2009/1768.Section 126 has been amended by the Health and Social Care Act 2012 (c. 7) (“the 2012 Act”), sections 220(7) and 213(7)(k), and Schedule 4, paragraph 63. Section 127 has been amended by the 2012 Act, Schedule 4, paragraph 64.1933 c. 12. Schedule 1 has been amended by: the Sexual Offences Act 1956 (c. 69), Schedule 4; the Criminal Justice Act 1988 (c. 33), Schedule 15, paragraph 8, and Schedule 16; the Sexual Offences Act 2003 (c. 42), Schedule 6, paragraph 7; the Domestic Violence, Crime and Victims Act 2004 (c. 28), Schedule 10, paragraph 2; the Coroners and Justice Act 2009 (c. 25), Schedule 21, paragraph 53; and the Protection of Freedoms Act 2012 (c. 9), Schedule 9, paragraph 136.1995 c. 46.1986 c. 45. Part 7A was inserted by the Tribunals, Courts and Enforcement Act 2007 (c. 15), Schedule 17.Schedule 4A was inserted by Schedule 20 to the Enterprise Act 2002 (c.40). Schedule 4ZB was inserted by the Tribunals, Courts and Enforcement Act 2007 (c. 15), Schedule 19.S.I. 1989/2405 (N.I. 19); Schedule 2A was inserted by S.I. 2005/1455 (N.I. 10).Schedule B1 was inserted by the Enterprise Act 2002 (c. 40), Schedule 16.1990 c.40; section 7 was repealed by the Charities and Trustee Investment (Scotland) Act 2005 (asp 10), Schedule 4, paragraph 7(b).2005 asp 10; section 34(5) has been amended by the section the Public Services Reform (Scotland) Act 2010 (asp 8), section 122.1986 c.46.S.I. 2002/3150 (N.I. 4); relevant amendments were made by S.I. 2005/1454 (N.I. 9).Section 429(2) was amended by the Enterprise Act 2002 (c.40), Schedule 23, paragraph 15.2012 c. 7.Prior to its revocation, regulation 60(4) was amended by S.I. 2005/1015 and 2006/3373.Prior to its revocation, regulation 58 was amended by S.I. 2006/3373.2012 c. 7.1994 c.23; relevant amendments have been made to Group 12 by S.I. 2009/2972.S.I. 2002/888.S.I. 2002/2016.S.I. 2005/1015.S.I. 2006/552.S.I. 2006/913.S.I. 2007/674.S.I. 2009/2205.S.I. 2010/22.S.I. 2010/231.S.I. 2006/3373.S.I. 2009/309.S.I. 2009/599.S.I. 2010/914.S.I. 2012/1467.S.I. 2012/1909.S.I. 2012/2371.S.I. 2012/3094.Reg. 64(3)(c) excluded (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 16Reg. 13(1) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 3Reg. 15(1) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 4Reg. 17(1) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 5Word in reg. 18(2)(b)(ii) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 6Reg. 20(1) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 7Words in reg. 24(1)(c) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 8(a)Words in reg. 24(2)(d) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 8(b)Word in reg. 24(3)(b) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 8(c)(i)Reg. 24(3)(d) inserted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 8(c)(iii)Word in reg. 24(3)(c) inserted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 8(c)(ii)Reg. 26(3)(4) inserted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 9(b)Words in reg. 26(2)(d) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 9(a)(i)Words in reg. 26(2)(e) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 9(a)(ii)Reg. 31(1) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 10Reg. 32(1) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 11Reg. 33(A1) inserted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 12(a)Word in reg. 33(1) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 12(b)(i)Words in reg. 33(1)(a)(b) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 12(b)(ii)Words in reg. 33(2)(c)(i)(ii) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 12(c)Words in reg. 33(2)(d)(i)(ii) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 12(c)Words in reg. 33(3)(g)(h) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 12(c)(d)Reg. 34(A1) inserted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(a)Word in reg. 34(1) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(i)Words in reg. 34(1)(a) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(ii)(aa)Words in reg. 34(1)(a) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(ii)(bb)Words in reg. 34(1)(b) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(iii)Words in reg. 34(1)(c)(i) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(iv)(aa)Words in reg. 34(1)(c)(ii) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(iv)(bb)Words in reg. 34(1)(c) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(iv)(cc)Words in reg. 34(1)(d) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(v)Words in reg. 34(1)(j) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(v)Words in reg. 34(1)(k) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(v)Words in reg. 34(1)(e) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(vi)Words in reg. 34(1)(f) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(vii)(aa)Words in reg. 34(1)(f) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(vii)(bb)Words in reg. 34(1)(g) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(viii)(aa)Words in reg. 34(1)(g) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(viii)(bb)Words in reg. 34(1)(h) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(ix)(aa)Words in reg. 34(1)(h) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(ix)(bb)Words in reg. 34(1)(i) omitted (1.4.2014) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(x)(aa)Words in reg. 34(1)(i) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(x)(bb)Words in reg. 34(1)(l)(ii) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 13(b)(xi)Reg. 40(4)(5) inserted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 14Reg. 64(1) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 15Word in Sch. 2 para. 7(1)(b) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 17(a)Words in Sch. 2 para. 13 heading substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 17(b)Sch. 2 para. 31(3A) inserted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 17(c)Sch. 2 para. 32(3A) inserted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 17(d)Words in Sch. 4 para. 12(5)(b) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 18Words in Sch. 5 para. 11(5)(b) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 19Words in Sch. 9 para. 11(1)(a) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 20(a)Words in Sch. 9 para. 11(2)(a) substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 20(b)Word in reg. 25(1)(b) omitted (1.3.2015) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 2 (with reg. 10)Words in reg. 32(1) substituted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 3 (with reg. 10)Reg. 103(6)(a) substituted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 4 (with reg. 10)Reg. 109(4)(a) substituted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 5(a) (with reg. 10)Words in reg. 109(4)(b) substituted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 5(b) (with reg. 10)Sch. 2 para. 4(10) inserted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 6(a) (with reg. 10)Sch. 2 para. 6(a)(b) omitted (1.3.2015) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 6(b) (with reg. 10)Words in Sch. 3 para. 5(2)(a) substituted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 7 (with reg. 10)Sch. 4 para. 10(1)(da) inserted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 8(2) (with reg. 10)Sch. 4 para. 28(2)(b) substituted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 8(3) (with reg. 10)Sch. 7 para. 21(1) substituted (1.3.2015) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015 (S.I. 2015/58), regs. 1(1), 9 (with reg. 10)Words in reg. 2(1) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(2)Words in reg. 96(2)(a) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(3)Words in Sch. 4 para. 7(3) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(4)(a)Words in Sch. 4 para. 7 substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(4)(b)Words in Sch. 5 para. 6 substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(5)(b)Words in Sch. 5 para. 6(3) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(5)(a)Words in Sch. 6 para. 4(a) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(6)(a)Words in Sch. 6 para. 4(c)(i)(aa) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(6)(b)Words in Sch. 7 para. 5 substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(7)(a)(ii)Words in Sch. 7 para. 5(3) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(7)(a)(i)Words in Sch. 7 para. 18(2)(a) substituted (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 2 para. 5(7)(b)Sch. 10 para. 1 revoked (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 3Words in Sch. 4 para. 5(4) substituted (1.7.2015) by The National Health Service (Amendments to Primary Care Terms of Service relating to the Electronic Prescription Service) Regulations 2015 (S.I. 2015/915), regs. 1, 4(2)Words in Sch. 6 para. 2(4) substituted (1.7.2015) by The National Health Service (Amendments to Primary Care Terms of Service relating to the Electronic Prescription Service) Regulations 2015 (S.I. 2015/915), regs. 1, 4(3)Words in Sch. 7 para. 3(3) substituted (1.7.2015) by The National Health Service (Amendments to Primary Care Terms of Service relating to the Electronic Prescription Service) Regulations 2015 (S.I. 2015/915), regs. 1, 4(4)Words in reg. 33(3)(f) inserted (31.7.2015) by The Modern Slavery Act 2015 (Consequential Amendments) Regulations 2015 (S.I. 2015/1472), regs. 1, 12Words in reg. 2(1) substituted (7.12.2015) by The National Health Service (Personal Medical Services Agreements) Regulations 2015 (S.I. 2015/1879), reg. 1(2), Sch. 3 para. 4 (with regs. 2, 88)Words in reg. 2(1) substituted (7.12.2015) by The National Health Service (General Medical Services Contracts) Regulations 2015 (S.I. 2015/1862), reg. 1(2), Sch. 4 para. 8 (with reg. 2)Reg. 121 substituted (1.4.2016) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016 (S.I. 2016/296), regs. 1(1)(a), 3Sch. 4 para. 29A inserted (1.4.2016) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016 (S.I. 2016/296), regs. 1(1)(a), 4(3)Sch. 7 para. 13A inserted (1.4.2016) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016 (S.I. 2016/296), regs. 1(1)(a), 5(3)Words in reg. 75(2)(a) substituted (1.4.2016) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016 (S.I. 2016/296), regs. 1(1)(a), 2(2)(a)Words in reg. 75(2)(b) substituted (1.4.2016) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016 (S.I. 2016/296), regs. 1(1)(a), 2(2)(b)Word in art. 105(2)(h)(i) substituted (6.4.2016) by The Enterprise and Regulatory Reform Act 2013 (Consequential Amendments) (Bankruptcy) and the Small Business, Enterprise and Employment Act 2015 (Consequential Amendments) Regulations 2016 (S.I. 2016/481), reg. 1, Sch. 2 para. 13Word in Sch. 7 para. 29(2)(g) substituted (6.4.2016) by The Enterprise and Regulatory Reform Act 2013 (Consequential Amendments) (Bankruptcy) and the Small Business, Enterprise and Employment Act 2015 (Consequential Amendments) Regulations 2016 (S.I. 2016/481), reg. 1, Sch. 2 para. 13Sch. 4 para. 7(3A) inserted (E.) (1.7.2016) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016 (S.I. 2016/296), regs. 1(1)(b), 4(2)Sch. 7 para. 5(3A) inserted (E.) (1.7.2016) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2016 (S.I. 2016/296), regs. 1(1)(b), 5(2)Words in reg. 2(1) substituted (22.7.2016) by The Electronic Identification and Trust Services for Electronic Transactions Regulations 2016 (S.I. 2016/696), reg. 1, Sch. 3 para. 9(a)Words in reg. 2(1) inserted (22.7.2016) by The Electronic Identification and Trust Services for Electronic Transactions Regulations 2016 (S.I. 2016/696), reg. 1, Sch. 3 para. 9(b)Words in reg. 2(1) inserted (22.7.2016) by The Electronic Identification and Trust Services for Electronic Transactions Regulations 2016 (S.I. 2016/696), reg. 1, Sch. 3 para. 9(c)Words in reg. 2(1) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 2(a)Words in reg. 2(1) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 2(b)Words in reg. 2(1) substituted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 21(a)Words in reg. 2(1) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 21(c)Word in reg. 2(1) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 21(b)Reg. 6(4) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 3Words in reg. 10(6) added (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 4Reg. 18(2)(g) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 5Words in reg. 19(5) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 6Words in reg. 31(1) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 8Reg. 67(5)(6) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 9(c)Words in reg. 67(1) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 9(a)(i)Words in reg. 67(1) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 9(a)(ii)Words in reg. 67(3) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 9(b)Words in reg. 75(2) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 10(b)Words in reg. 75(1) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 10(a)Sch. 2 para. 9 renumbered as Sch. 2 para. 9(1) (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 11Sch. 2 para. 9(2) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 11Words in Sch. 2 para. 18(b) substituted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 12Sch. 2 para. 19(5) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 13Words in Sch. 2 para. 28(3)(b) substituted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 14Words in Sch. 2 para. 29 inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 15Words in Sch. 2 para. 34(1) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 17Words in Sch. 2 para. 36(1)(e) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 19(a)Words in Sch. 2 para. 36(2) substituted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 19(b)Sch. 3 para. 10(1A) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 20(a)Words in Sch. 3 para. 10(2)(a) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 20(b)(i)Words in Sch. 3 para. 10(2)(b) substituted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 20(b)(ii)Words in Sch. 4 para. 28(2)(a)(ii) inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 25Reg. 26A inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 7Sch. 2 para. 29A inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 16Sch. 2 para. 34A inserted (5.12.2016) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2016 (S.I. 2016/1077), regs. 1(1), 18Words in reg. 121(3) substituted (E.) (30.8.2017) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2017 (S.I. 2017/709), regs. 1, 2Sch. 6 para. 4A inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(4)Words in reg. 2(1) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 2(2)Words in reg. 2(1) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 2(3)Words in reg. 2(1) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 2(4)Words in reg. 2(1) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 2(5)Words in reg. 2(1) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 2(6)Words in reg. 69(3)(b)(i) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 3(2)Reg. 70(8) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 4(2)Reg. 71(5) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 5(2)Words in Sch. 3 para. 8(2)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 6(2)Word in Sch. 4 para. 5(2)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(a)(i)Sch. 4 para. 5(2)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(a)(iv)Words in Sch. 4 para. 5(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(a)(ii)Word in Sch. 4 para. 5(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(a)(iii)Word in Sch. 4 para. 5(3)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(b)(i)Sch. 4 para. 5(3)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(b)(iv)Words in Sch. 4 para. 5(3)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(b)(ii)Word in Sch. 4 para. 5(3)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(2)(b)(iii)Sch. 4 para. 7(3ZA) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(3)(b)Words in Sch. 4 para. 7(3) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(3)(a)Words in Sch. 4 para. 7(5) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(3)(c)Sch. 4 para. 9(2A) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(4)Sch. 4 para. 11(6) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(5)(b)Words in Sch. 4 para. 11(2)(a) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 7(5)(a)Word in Sch. 5 para. 4(2)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(a)(i)Sch. 5 para. 4(2)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(a)(iv)Words in Sch. 5 para. 4(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(a)(ii)Word in Sch. 5 para. 4(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(a)(iii)Word in Sch. 5 para. 4(3)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(b)(i)Sch. 5 para. 4(3)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(b)(iv)Words in Sch. 5 para. 4(3)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(b)(ii)Word in Sch. 5 para. 4(3)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(2)(b)(iii)Sch. 5 para. 6(3A) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(3)(c)Words in Sch. 5 para. 6(3)(a) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(3)(a)Words in Sch. 5 para. 6(3)(c) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(3)(b)Sch. 5 para. 8(1A) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(4)Sch. 5 para. 10(6) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(5)(b)Words in Sch. 5 para. 10(2)(a) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 8(5)(a)Word in Sch. 6 para. 2(2)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(a)(i)Sch. 6 para. 2(2)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(a)(iv)Words in Sch. 6 para. 2(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(a)(ii)Word in Sch. 6 para. 2(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(a)(iii)Word in Sch. 6 para. 2(3)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(b)(i)Sch. 6 para. 2(3)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(b)(iv)Words in Sch. 6 para. 2(3)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(b)(ii)Word in Sch. 6 para. 2(3)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(2)(b)(iii)Words in Sch. 6 para. 4(a) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(3)(a)Words in Sch. 6 para. 4(c) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(3)(b)Sch. 6 para. 6(1A) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 9(5)Word in Sch. 7 para. 3(1)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(a)(i)Sch. 7 para. 3(1)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(a)(v)Words in Sch. 7 para. 3(1)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(a)(ii)Word in Sch. 7 para. 3(1)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(a)(iv)Words in Sch. 7 para. 3(1)(b)(i) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(a)(iii)Word in Sch. 7 para. 3(2)(a) omitted (26.11.2018) by virtue of The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(b)(i)Sch. 7 para. 3(2)(c) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(b)(iv)Words in Sch. 7 para. 3(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(b)(ii)Word in Sch. 7 para. 3(2)(b) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(2)(b)(iii)Sch. 7 para. 5(3ZA) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(3)(b)Words in Sch. 7 para. 5(3) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(3)(a)Words in Sch. 7 para. 5(5) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(3)(c)Sch. 7 para. 7(2A) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(4)Sch. 7 para. 9(5) inserted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(5)(b)Words in Sch. 7 para. 9(2)(a) substituted (26.11.2018) by The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 (S.I. 2018/1114), regs. 1(1), 10(5)(a)Reg. 119A inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 3Sch. 4 para. 5A inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(2)Sch. 6 para. 3A inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 6(2)Sch. 5 para. 4A inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 5(2)Sch. 6 para. 4B inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 6(4)Sch. 7 para. 3A inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(2)Words in reg. 2(1) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 2(2)Sch. 4 para. 7(6) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(3)Sch. 4 para. 8(16) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(4)(e)Words in Sch. 4 para. 8(10) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(4)(c)Words in Sch. 4 para. 8(4) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(4)(a)Words in Sch. 4 para. 8(5) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(4)(b)Words in Sch. 4 para. 8(15) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(4)(d)Sch. 4 para. 9(2B)(2C) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(5)Words in Sch. 4 para. 10(2) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 4(6)Sch. 5 para. 6(3B) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 5(3)Sch. 5 para. 7(4) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 5(4)(c)Words in Sch. 5 para. 7(2) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 5(4)(a)Words in Sch. 5 para. 7(3) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 5(4)(b)Sch. 5 para. 8(1B)(1C) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 5(5)Words in Sch. 6 para. 4 inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 6(3)Sch. 6 para. 6(4) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 6(5)Sch. 7 para. 5(6) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(3)Sch. 7 para. 6(14) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(4)(e)Words in Sch. 7 para. 6(8) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(4)(c)Words in Sch. 7 para. 6(2) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(4)(a)Words in Sch. 7 para. 6(3) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(4)(b)Words in Sch. 7 para. 6(13) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(4)(d)Sch. 7 para. 7(2B)(2C) inserted (1.7.2019) by The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019 (S.I. 2019/990), regs. 1, 7(5)Words in reg. 2(1) substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 31(a); S.I. 2019/1436, reg. 2(b)Words in reg. 2(1) substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 31(b); S.I. 2019/1436, reg. 2(b)Words in reg. 2(1) substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 31(c); S.I. 2019/1436, reg. 2(b)Words in reg. 2(1) substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 31(d); S.I. 2019/1436, reg. 2(b)Words in reg. 2(1) substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 31(e); S.I. 2019/1436, reg. 2(b)Reg. 71A inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 7Reg. 102A inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 8Sch. 4 para. 22A inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 9(2)Sch. 4 para. 27A inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 9(3)Sch. 6 para. 7A inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 10Sch. 7 para. 10A inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 11Reg. 2(8) inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 5Reg. 11(3) inserted (27.3.2020) by The National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/351), regs. 1(2), 6Reg. 6(A1)(A2) inserted (14.9.2020) by The National Health Service (Coronavirus) (Charges and Further Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/885), regs. 1(2), 4(2)(a)Words in reg. 6 heading inserted (14.9.2020) by The National Health Service (Coronavirus) (Charges and Further Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/885), regs. 1(2), 4(2)Words in Sch. 2 para. 34(4)(b) substituted (14.9.2020) by The National Health Service (Coronavirus) (Charges and Further Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/885), regs. 1(2), 4(3)(a)Sch. 2 para. 34(6)(7) inserted (14.9.2020) by The National Health Service (Coronavirus) (Charges and Further Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 (S.I. 2020/885), regs. 1(2), 4(3)(b)Reg. 67A inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 3Sch. 4 para. 5B inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 6Sch. 4 para. 27B inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 13Sch. 4 paras. 29B, 29C inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 17Sch. 4 para. 32A inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 18Sch. 6 para. 3B inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 21Sch. 7 paras. 13B, 13C inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 28Words in reg. 2(1) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 2(a)Words in reg. 2(1) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 2(b)Words in Sch. 2 para. 34(2) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 4(a)Sch. 2 para. 34(3A)(3B) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 4(b)Words in Sch. 4 para. 8(15) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 7(a)Sch. 4 para. 8(17)(18) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 7(b)Words in Sch. 4 para. 9(2A) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 8(a)Sch. 4 para. 9(5)(6) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 8(b)Words in Sch. 4 para. 10(1)(e) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 9(a)Sch. 4 para. 10(1)(g) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 9(b)Sch. 4 para. 11(1)(a) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 10(a)(i)Words in Sch. 4 para. 11(1)(b) substituted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 10(a)(ii)Words in Sch. 4 para. 11(2) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 10(b)Word in Sch. 4 para. 18 heading omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 11(2)Word in Sch. 4 para. 18(a) substituted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 11(3)(a)Word in Sch. 4 para. 18(a) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 11(3)(b)Word in Sch. 4 para. 18(b) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 11(4)Sch. 4 para. 18(c) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 11(5)Sch. 4 para. 29A(1)(2) substituted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 16Sch. 4 para. 35(4)-(6) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 19Sch. 6 para. 6(5)(6) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 22Words in Sch. 7 para. 7(2A) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 24Words in Sch. 7 para. 8(c) inserted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 25Sch. 7 para. 9(1)(a) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 26(a)(i)Words in Sch. 7 para. 9(1)(b) substituted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 26(a)(ii)Words in Sch. 7 para. 9(2) omitted (9.11.2020) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 26(b)Sch. 7 para. 13A(1)(2) substituted (9.11.2020) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(2), 27Words in reg. 2(1) omitted (31.12.2020) by virtue of The European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/593), reg. 1(2), Sch. 2 para. 43(a) (with reg. 12A, Sch. 2 Pt. 2) (as amended by S.I. 2020/1394, regs. 4, 10(3)-(7)); 2020 c. 1, Sch. 5 para. 1(1)Words in reg. 2(1) omitted (31.12.2020) by virtue of The European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/593), reg. 1(2), Sch. 2 para. 43(b) (with reg. 12A, Sch. 2 Pt. 2) (as amended by S.I. 2020/1394, regs. 4, 10(3)-(7)); 2020 c. 1, Sch. 5 para. 1(1)Word in Sch. 4 para. 8(10) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 11(2); 2020 c. 1, Sch. 5 para. 1(1)Word in Sch. 7 para. 6(8) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 11(3); 2020 c. 1, Sch. 5 para. 1(1)Words in Sch. 4 para. 28 heading inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(2)Words in Sch. 4 para. 28(1) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(3)Words in Sch. 4 para. 28(2) inserted (1.1.2021) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(a)Sch. 4 para. 28(2)(a)(viii) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(b)(iii)Word in Sch. 4 para. 28(2)(a)(vi) omitted (1.1.2021) by virtue of The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(b)(i)Word in Sch. 4 para. 28(2)(a)(vii) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(b)(ii)Words in Sch. 4 para. 28(2)(c)(v) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(c)Words in Sch. 4 para. 28(2)(e)(iv) substituted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(d)Words in Sch. 4 para. 28(2)(g)(ii) inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 14(4)(e)Sch. 4 paras. 22B, 22C inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 12Sch. 4 paras. 28A, 28B inserted (1.1.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(3), 15(1)Words in reg. 2(1) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 2Word in Sch. 7 para. 10A(4) substituted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 5(2)Words in Sch. 4 para. 9(5) substituted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(4)(a)(i)Words in Sch. 4 para. 9(5) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(4)(a)(ii)Words in Sch. 4 para. 9(6) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(4)(b)(i)Words in Sch. 4 para. 9(6) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(4)(b)(ii)Words in Sch. 4 para. 9(6) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(4)(b)(iii)Words in Sch. 4 para. 9(5)(a) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(4)(a)(iii)Sch. 6 para. 3B(1A) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(2)(b)Words in Sch. 6 para. 3B(1)(a) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(2)(a)Words in Sch. 6 para. 3B(3) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(2)(c)(i)Words in Sch. 6 para. 3B(3) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(2)(c)(ii)Words in Sch. 6 para. 3B(3) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(2)(c)(iii)Words in Sch. 6 para. 3B heading inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(2)(c)(iii)Words in Sch. 4 para. 8(17) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(3)(a)Words in Sch. 4 para. 8(18) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(3)(b)(i)Words in Sch. 4 para. 8(18) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(3)(b)(ii)Sch. 4 para. 5B(1A) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(2)(b)Words in Sch. 4 para. 5B(1)(a) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(2)(a)Words in Sch. 4 para. 5B(2) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(2)(c)Words in Sch. 4 para. 5B heading inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(2)(c)Sch. 4 para. 22AA inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 3(5)Sch. 6 para. 7AA inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(4)Sch. 7 para. 10AA inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 5(3)Words in Sch. 6 para. 6(5) substituted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(3)(a)(i)Words in Sch. 6 para. 6(5) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(3)(a)(ii)Words in Sch. 6 para. 6(6) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(3)(b)(i)Words in Sch. 6 para. 6(6) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(3)(b)(ii)Words in Sch. 6 para. 6(6) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(3)(b)(iii)Words in Sch. 6 para. 6(5)(a) inserted (1.3.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Amendment) Regulations 2021 (S.I. 2021/169), regs. 1(2), 4(3)(a)(iii)Sch. 4 para. 28C inserted (1.4.2021) by The National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020 (S.I. 2020/1126), regs. 1(4), 15(2)Words in reg. 2 inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 2(2)Sch. 4 para. 5C inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(3)Sch. 6 para. 3C inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(3)Sch. 7 para. 3B inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 10(2)Sch. 6 para. 3B(4)(5) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(2)(d)Words in Sch. 6 para. 3B(1) substituted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(2)(a)Words in Sch. 6 para. 3B(1A) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(2)(c)Words in Sch. 6 para. 3B(1)(b) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(2)(b)Words in Sch. 4 para. 9(5) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(5)(a)Words in Sch. 4 para. 9(6) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(5)(b)(i)Words in Sch. 4 para. 9(6) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(5)(b)(ii)Words in Sch. 6 para. 6(5) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(4)(a)Words in Sch. 6 para. 6(6) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(4)(b)(i)Words in Sch. 6 para. 6(6) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 9(4)(b)(ii)Words in Sch. 4 para. 8(15) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(4)(a)Words in Sch. 4 para. 8(17) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(4)(b)Sch. 7 para. 6(15) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 10(3)(b)Words in Sch. 7 para. 6(13) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 10(3)(a)Reg. 91(5) substituted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 6(2)Sch. 4 para. 5B(3)(4) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 7(2)Sch. 7 para. 7(5)(6) inserted (21.12.2021) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(a), 10(4)Reg. 21A inserted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 5Sch. 4 para. 28(2)(ca) inserted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 8(2)Reg. 6(A3) inserted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 3(4)Reg. 6(3A) inserted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 3(7)Words in reg. 6(A1) inserted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 3(2)(a)Words in reg. 6(A1) substituted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 3(2)(b)Words in reg. 6(A2) substituted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 3(3)Words in reg. 6(1) substituted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 3(5)Words in reg. 6(2) substituted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 3(6)Word in reg. 7 heading substituted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 4(2)Reg. 7(1A) inserted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 4(4)Reg. 7(1) omitted (1.1.2022) by virtue of The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 4(3)Words in reg. 7(2)(b) substituted (1.1.2022) by The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021 (S.I. 2021/1346), regs. 1(2)(b), 4(5)Words in Regulations substituted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), reg. 1(2), Sch. para. 1Words in reg. 2(1) omitted (1.7.2022) by virtue of The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), regs. 1(2), 62(2)(a)Words in reg. 2(1) inserted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), regs. 1(2), 62(2)(b)Words in reg. 10 heading omitted (1.10.2022) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 4(2)Words in reg. 10(6) omitted (1.10.2022) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 4(1)(b)Reg. 10(4) omitted (1.10.2022) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 4(1)(a)Reg. 10(5) omitted (1.10.2022) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 4(1)(a)Words in reg. 2(1) inserted (1.10.2022) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 3Sch. 4 para. 28(2)(e)(iiia) inserted (1.10.2022) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 8(3)(b)Sch. 4 para. 28(2)(a)(iv) omitted (1.10.2022) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 8(3)(a)Reg. 91A inserted (1.10.2022) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 5Sch. 2 para. 5A inserted (1.10.2022) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 6(2)Words in Sch. 2 para. 19(4) inserted (1.10.2022) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 6(3)Sch. 3 para. 7(4)(5) inserted (1.10.2022) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2022 (S.I. 2022/930), regs. 1(2), 7Words in reg. 2(1) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(2)(a) (with reg. 3)Words in reg. 2(1) omitted (1.2.2023) by virtue of The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(2)(b) (with reg. 3)Words in reg. 2(1) inserted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(2)(c) (with reg. 3)Words in reg. 2(1) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(2)(d) (with reg. 3)Words in Sch. 4 para. 7(5) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(3)(a) (with reg. 3)Words in Sch. 4 para. 29C(3) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(3)(b) (with reg. 3)Words in Sch. 5 para. 6(3)(c) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(4) (with reg. 3)Words in Sch. 6 para. 4(c) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(5) (with reg. 3)Words in reg. 2(1) inserted (1.4.2023) by The National Health Service (Amendments Relating to Pre-Payment Certificates, Hormone Replacement Therapy Treatments and Medicines Shortages) Regulations 2023 (S.I. 2023/171), regs. 1(1), 2Words in reg. 2(1) omitted (1.4.2023) by virtue of The Health Education England (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/368), reg. 1(2), Sch. 2 para. 14(2) (with reg. 7)Sch. 4 para. 9(7) inserted (1.4.2023) by The National Health Service (Amendments Relating to Pre-Payment Certificates, Hormone Replacement Therapy Treatments and Medicines Shortages) Regulations 2023 (S.I. 2023/171), regs. 1(1), 3Words in Sch. 4 para. 33 substituted (1.4.2023) by The Health Education England (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/368), reg. 1(2), Sch. 2 para. 14(3) (with reg. 7)Words in Sch. 5 para. 23 substituted (1.4.2023) by The Health Education England (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/368), reg. 1(2), Sch. 2 para. 14(4) (with reg. 7)Sch. 7 para. 7(7) inserted (1.4.2023) by The National Health Service (Amendments Relating to Pre-Payment Certificates, Hormone Replacement Therapy Treatments and Medicines Shortages) Regulations 2023 (S.I. 2023/171), regs. 1(1), 5Words in Sch. 7 para. 16 substituted (1.4.2023) by The Health Education England (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/368), reg. 1(2), Sch. 2 para. 14(5) (with reg. 7)Sch. 6 para. 6(7) inserted (1.4.2023) by The National Health Service (Amendments Relating to Pre-Payment Certificates, Hormone Replacement Therapy Treatments and Medicines Shortages) Regulations 2023 (S.I. 2023/171), regs. 1(1), 4Reg. 65A inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 4Sch. 4 para. 23A inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 10Reg. 65(3) omitted (25.5.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 3(2)Reg. 65(3A) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 3(3)Words in reg. 65(4)(a)(i) omitted (25.5.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 3(4)(a)Words in reg. 65(4)(a)(ii) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 3(4)(b)(i)Words in reg. 65(4)(a)(ii) substituted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 3(4)(b)(ii)Words in reg. 65(4)(a)(ii) substituted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 3(4)(b)(iii)Words in reg. 65(4)(a)(iii) substituted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 3(4)(c)Words in reg. 65(4)(a)(iii) omitted (25.5.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 3(4)(d)Words in reg. 65(4)(a)(iii) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 3(4)(e)Words in reg. 65(5)(b)(ii)(aa) substituted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 3(5)(a)Words in reg. 65(5) omitted (25.5.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 3(5)(b)Words in reg. 65(5) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 3(5)(c)Reg. 67(2)(b)(i) substituted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 5Sch. 2 para. 3(7)(b) substituted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 6Sch. 2 para. 5(3)-(5) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 7Words in Sch. 2 para. 34(3B) substituted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 8(2)Sch. 2 para. 34(3C) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 8(3)Words in Sch. 4 para. 23(1) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(2)(a)Words in Sch. 4 para. 23(1)(d) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(2)(b)Words in Sch. 4 para. 23(1)(e) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(2)(c)(i)Words in Sch. 4 para. 23(1)(e)(ii) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(2)(c)(ii)Words in Sch. 4 para. 23(6) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(3)Word in Sch. 4 para. 23(7)(a) omitted (25.5.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(4)Sch. 4 para. 23(7)(ba)-(bd) substituted for Sch. 4 para. 23(7)(b) (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(4)Sch. 4 para. 23(7A) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 9(5)Sch. 4 para. 24(1) substituted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 11(2)Sch. 4 para. 24(5) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 11(3)Words in Sch. 4 para. 26(1) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(2)(a)Words in Sch. 4 para. 26(1)(a) omitted (25.5.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(2)(b)Words in Sch. 4 para. 26(2) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(3)(a)Words in Sch. 4 para. 26(2) substituted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(3)(b)Sch. 4 para. 26(2A)(2B) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(4)Word in Sch. 4 para. 26(4)(a) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(5)(a)Words in Sch. 4 para. 26(4)(c) omitted (25.5.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(5)(b)Sch. 4 para. 26(4A)(4B) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(6)Words in Sch. 4 para. 26(5)(a) inserted (25.5.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(2), 12(7)Sch. 4 para. 29D inserted (31.7.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 13Sch. 4 para. 23(8) omitted (31.7.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(6)Sch. 4 para. 23(9) omitted (31.7.2023) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(6)Words in Sch. 4 para. 23(10) substituted (31.7.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(7)(a)Words in Sch. 4 para. 23(10) inserted (31.7.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(7)(b)Sch. 4 para. 23(10)(aa) inserted (31.7.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(7)(d)Words in Sch. 4 para. 23(10)(a) substituted (31.7.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(7)(c)Word in Sch. 4 para. 23(11) substituted (31.7.2023) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (S.I. 2023/479), regs. 1(3), 9(8)Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1Word in reg. 2(1) omitted (6.11.2023) by virtue of The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), regs. 1(1), 62(2)(a)Words in reg. 2(1) inserted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), regs. 1(1), 62(2)(b)Words in Sch. 7 para. 5(5) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 47(6) (with reg. 3)Word in reg. 91A heading omitted (1.9.2024) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2024 (S.I. 2024/838), regs. 1(2), 2(2)Reg. 91A(3A) inserted (1.9.2024) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2024 (S.I. 2024/838), regs. 1(2), 2(5)Words in reg. 91A(2)(a) omitted (1.9.2024) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2024 (S.I. 2024/838), regs. 1(2), 2(3)(a)Word in reg. 91A(2)(a) omitted (1.9.2024) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2024 (S.I. 2024/838), regs. 1(2), 2(3)(b)Reg. 91A(2)(aa)(ab) inserted (1.9.2024) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2024 (S.I. 2024/838), regs. 1(2), 2(3)(c)Word in reg. 91A(3)(d) omitted (1.9.2024) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2024 (S.I. 2024/838), regs. 1(2), 2(4)(b)Word in reg. 91A(3)(a)-(c) substituted (1.9.2024) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2024 (S.I. 2024/838), regs. 1(2), 2(4)(a)Reg. 91A(2)(ac) inserted (1.10.2024) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No. 2) Regulations 2024 (S.I. 2024/894), regs. 1(3), 2(2)(b)Word in reg. 91A(2)(ab) omitted (1.10.2024) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No. 2) Regulations 2024 (S.I. 2024/894), regs. 1(3), 2(2)(a)Sch. 2 para. 3(8) omitted (1.10.2024) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No. 2) Regulations 2024 (S.I. 2024/894), regs. 1(3), 3(2) (with reg. 3(4))Sch. 2 para. 23(1)(c) omitted (1.10.2024) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No. 2) Regulations 2024 (S.I. 2024/894), regs. 1(3), 3(3)Sch. 4 para. 8(2A)-(2E) inserted (1.1.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No. 2) Regulations 2024 (S.I. 2024/894), regs. 1(2), 4Sch. 7 para. 6(1A)-(1E) inserted (1.1.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No. 2) Regulations 2024 (S.I. 2024/894), regs. 1(2), 5Reg. 25A inserted (E.) (23.6.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 8Words in reg. 25(1) inserted (23.6.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 7(2)(a)Reg. 25(1)(a) omitted (23.6.2025) by virtue of The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 7(2)(b)Words in reg. 25(2)(b)(ii) substituted (23.6.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 7(3)(a)Words in reg. 25(2)(b)(ii) inserted (23.6.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 7(3)(b)Reg. 91A(8) inserted (23.6.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 10(5)Reg. 91A(2)(ad) inserted (23.6.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 10(2)(b)Words in reg. 91A(3)(c) substituted (23.6.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 10(3)Word in reg. 91A(2)(ac) omitted (23.6.2025) by virtue of The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 10(2)(a)Words in Sch. 4 para. 24(1) inserted (23.6.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 11(2)Sch. 4 para. 26(1A) inserted (23.6.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 11(3)(a)Words in Sch. 4 para. 26(2) substituted (23.6.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 11(3)(b)Sch. 4 para. 26(2ZA)(2ZB) inserted (23.6.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 11(3)(c)Words in Sch. 4 para. 26(3) inserted (23.6.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(2), 11(3)(d)Words in reg. 2(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 3Words in reg. 2(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 15(2)Words in reg. 2(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 15(3)(a)Words in reg. 2(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 15(3)(b)Words in reg. 2(1) omitted (1.10.2025) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 60(a)Words in reg. 2(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 60(b)Reg. 6(3ZA)(3ZB) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 61Words in reg. 10(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 16(2)Words in reg. 10(3)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 16(3)(a)Words in reg. 10(3)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 16(3)(b)Words in reg. 10(7)(a)(ii)(aa) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 16(4)(a)Words in reg. 10(7)(a)(ii)(bb) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 16(4)(b)Words in reg. 10(7)(a)(ii)(cc) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 16(4)(c)Words in reg. 11(1)(d)(ii) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 17(2)Words in reg. 11(2)(d)(ii) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 17(3)Words in reg. 12(b)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 18(a)Words in reg. 12(b)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 18(b)Words in reg. 12(b)(iii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 18(c)Words in reg. 24(1)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 19(2)(a)Words in reg. 24(1)(d) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 19(2)(b)(i)Words in reg. 24(1)(d) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 19(2)(b)(ii)Words in reg. 24(2)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 19(3)(a)Words in reg. 24(2)(e) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 19(3)(b)(i)Words in reg. 24(2)(e) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 19(3)(b)(ii)Words in reg. 24(3)(b)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 19(4)(a)Words in reg. 24(3)(b)(iii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 19(4)(b)Words in reg. 26(1)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(2)(a)(i)Words in reg. 26(1)(a)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(2)(a)(ii)Words in reg. 26(1)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(2)(b)(i)Words in reg. 26(1)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(2)(b)(ii)Words in reg. 26(1)(d) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(2)(c)Words in reg. 26(2)(a)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(3)(a)(i)Words in reg. 26(2)(a)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(3)(a)(ii)(aa)Words in reg. 26(2)(a)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(3)(a)(ii)(bb)Words in reg. 26(2)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(3)(b)Words in reg. 26(2)(c) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(3)(c)(i)Words in reg. 26(2)(c) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(3)(c)(ii)Words in reg. 26(2)(e)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(3)(d)(i)Words in reg. 26(2)(e)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(3)(d)(ii)(aa)Words in reg. 26(2)(e)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 20(3)(d)(ii)(bb)Words in reg. 26A(7)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 21(a)(i)Words in reg. 26A(7)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 21(a)(ii)Words in reg. 26A(7)(c) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 21(b)Words in reg. 29(1)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 22(a)Words in reg. 29(3) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 22(b)(i)Words in reg. 29(3) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 22(b)(ii)Words in reg. 31(2)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 23Words in reg. 33(2)(c)(i) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 4Words in reg. 34(1)(h) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 5(a)Words in reg. 34(1)(i) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 5(b)Words in reg. 40(1)(b)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 24Words in reg. 41(1)(b)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 25(a)Words in reg. 41(3)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 25(b)Words in reg. 42(5)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 26Words in reg. 44(1)(b)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 27Words in reg. 46(1)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 28(a)Words in reg. 46(1)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 28(b)Words in reg. 47(1)(d)(ii) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 29Words in reg. 48(3)(a)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 30(2)(a)Words in reg. 48(3)(b)(iii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 30(2)(b)Words in reg. 48(5)(a)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 30(3)(a)(i)Words in reg. 48(5)(a)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 30(3)(a)(ii)Words in reg. 48(5)(b)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 30(3)(b)(i)Words in reg. 48(5)(b)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 30(3)(b)(ii)Words in reg. 50(7)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 31Words in reg. 51(1)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 32(2)Words in reg. 51(2)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 32(3)(a)Words in reg. 51(2)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 32(3)(b)Words in reg. 53(7)(a)(ii)(bb) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 33(2)(a)Words in reg. 53(7)(b)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 33(2)(b)Words in reg. 53(11) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 33(3)Words in reg. 53(13)(b)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 33(4)Words in reg. 54(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 34Words in reg. 55(1)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 35(2)(a)Words in reg. 55(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 35(2)(b)Words in reg. 55(2)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 35(3)Words in reg. 56(3) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 36Words in reg. 57(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 37(a)Words in reg. 57(1)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 37(b)Words in reg. 60(3)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 38(a)Words in reg. 60(3)(c) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 38(b)Words in reg. 61(5) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 39(a)Words in reg. 61(6) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 39(b)(i)Words in reg. 61(6) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 39(b)(ii)Words in reg. 63(1)(b)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 40Reg. 64(3A)(3B) inserted (1.10.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(3), 9(4)Words in reg. 64(3)(a) omitted (1.10.2025) by virtue of The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(3), 9(2)Words in reg. 64(3)(b) omitted (1.10.2025) by virtue of The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(3), 9(2)Words in reg. 64(3)(d)(ii) substituted (1.10.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(3), 9(3)(a)Words in reg. 64(3)(d)(ii) inserted (1.10.2025) by The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025 (S.I. 2025/636), regs. 1(3), 9(3)(b)Words in reg. 64(3)(e) omitted (1.10.2025) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 62Words in reg. 65(4)(a)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 41(2)(a)(i)Words in reg. 65(4)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 41(2)(a)(iii)Words in reg. 65(4)(a)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 41(2)(a)(ii)Words in reg. 65(4)(b)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 41(2)(b)(i)Words in reg. 65(4)(b)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 41(2)(b)(ii)Words in reg. 65(4)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 41(2)(b)(iii)Words in reg. 65(5)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 41(3)(a)Words in reg. 65(5)(b)(ii)(aa) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 41(3)(b)(i)Words in reg. 65(5)(b)(ii)(bb) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 41(3)(b)(ii)Words in reg. 65(5)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 41(3)(b)(iii)Words in reg. 65A(3) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 42(2)Words in reg. 65A(4)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 42(3)Words in reg. 66(1)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 43(2)(a)Words in reg. 66(1)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 43(2)(b)Words in reg. 66(2)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 43(3)Words in reg. 66(5) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 43(4)Words in reg. 67(4) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 44Words in reg. 73(5)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 45Words in reg. 74(3) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 46Words in reg. 75(3) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 47Words in reg. 88(2)(h) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 6Reg. 91A(2)(ae) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 63(2)(b)Words in reg. 91A(3A) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 63(3)Word in reg. 91A(2)(ad) omitted (1.10.2025) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 63(2)(a)Words in reg. 99(2) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 48Words in reg. 101(2)(d) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 49(a)Words in reg. 101(2)(e) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 49(b)Words in reg. 106(2)(l) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 7Words in reg. 109(5) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 50Words in reg. 114(2)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 51Words in Sch. 1 para. 7 inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 52Words in Sch. 2 para. 3(10) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 8(2)(a)Words in Sch. 2 para. 4(7) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 8(2)(b)Words in Sch. 2 para. 9(1)(c)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 53(2)(a)Words in Sch. 2 para. 9(1)(d)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 53(2)(b)Words in Sch. 2 para. 23(1)(a) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 8(3)Words in Sch. 2 para. 29(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 53(3)(a)(i)Words in Sch. 2 para. 29(d) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 53(3)(a)(ii)Words in Sch. 2 para. 29A(2)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 53(3)(b)(i)Words in Sch. 2 para. 29A(2)(c) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 53(3)(b)(ii)Words in Sch. 2 para. 29A(2)(d) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 53(3)(b)(iii)Words in Sch. 2 para. 33(2) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 53(3)(c)(i)Words in Sch. 2 para. 33(2) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 53(3)(c)(ii)Words in Sch. 2 para. 34(2) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 53(3)(d)(ii)Words in Sch. 2 para. 34(1)(b)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 53(3)(d)(i)(aa)Words in Sch. 2 para. 34(1)(b)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 53(3)(d)(i)(bb)Words in Sch. 2 para. 34(1)(b)(iii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 53(3)(d)(i)(cc)Sch. 4 paras. 7A-7C inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 12Words in Sch. 4 para. 11(1)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 54Words in Sch. 4 para. 23(7) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(2)(d)(i)Words in Sch. 4 para. 23(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(2)(a)(i)Words in Sch. 4 para. 23(1)(c) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(2)(a)(ii)Words in Sch. 4 para. 23(1)(d) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(2)(a)(iii)Words in Sch. 4 para. 23(1)(e) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(2)(a)(iv)Words in Sch. 4 para. 23(5)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(2)(b)(i)Words in Sch. 4 para. 23(5)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(2)(b)(ii)Words in Sch. 4 para. 23(6)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(2)(c)Words in Sch. 4 para. 23(7)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(2)(d)(ii)Words in Sch. 4 para. 23(7)(ba) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(2)(d)(iii)Words in Sch. 4 para. 23(7)(bc)(ii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(2)(d)(iv)Words in Sch. 4 para. 23(7)(bd) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(2)(d)(v)Words in Sch. 4 para. 23A(5)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(3)Words in Sch. 4 para. 24(3) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(4)(a)Words in Sch. 4 para. 24(4) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(4)(b)Words in Sch. 4 para. 25(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(5)(a)Words in Sch. 4 para. 25(3)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(5)(b)(i)Words in Sch. 4 para. 25(3)(c)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(5)(b)(ii)Words in Sch. 4 para. 25(4)(a)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(5)(c)(i)Words in Sch. 4 para. 25(4)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(5)(c)(ii)Words in Sch. 4 para. 25(6) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(5)(d)Words in Sch. 4 para. 25(10) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(5)(e)Words in Sch. 4 para. 26(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(6)(a)(i)Words in Sch. 4 para. 26(1)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(6)(a)(ii)Words in Sch. 4 para. 26(4)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(6)(b)(i)Words in Sch. 4 para. 26(4)(c)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(6)(b)(ii)Words in Sch. 4 para. 26(5)(a)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(6)(c)(i)Words in Sch. 4 para. 26(5)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(6)(c)(ii)Words in Sch. 4 para. 26(12) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(6)(d)Words in Sch. 4 para. 27(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(6)(e)(i)Words in Sch. 4 para. 27(2) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 55(6)(e)(ii)Sch. 4 para. 28(2)(a)(i) omitted (1.10.2025) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 64(2)(a)Words in Sch. 4 para. 28(2)(e)(iii) omitted (1.10.2025) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 64(2)(b)Words in Sch. 4 para. 29C heading substituted (1.10.2025) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 64(3)(a)Words in Sch. 4 para. 29C(1) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 64(3)(b)(i)Words in Sch. 4 para. 29C(1) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 64(3)(b)(ii)Words in Sch. 4 para. 29C(2) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 64(3)(c)Words in Sch. 4 para. 29C(5)(a) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 64(3)(d)(i)Words in Sch. 4 para. 29C(5)(b) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 64(3)(d)(ii)Words in Sch. 4 para. 29C(5)(c) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 64(3)(d)(iii)Words in Sch. 4 para. 29D(2)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 56Words in Sch. 4 para. 31(1)(k) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 9(a)Words in Sch. 4 para. 31(2)(f) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 9(b)Words in Sch. 5 para. 13(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(2)(a)(i)Words in Sch. 5 para. 13(1)(c) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(2)(a)(ii)Words in Sch. 5 para. 13(1)(d) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(2)(a)(iii)Words in Sch. 5 para. 13(1)(e) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(2)(a)(iv)Words in Sch. 5 para. 13(4)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(2)(b)(i)Words in Sch. 5 para. 13(4)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(2)(b)(ii)Words in Sch. 5 para. 13(5)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(2)(c)Words in Sch. 5 para. 13(6) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(2)(d)(i)Words in Sch. 5 para. 13(6)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(2)(d)(ii)Words in Sch. 5 para. 13(6)(b)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(2)(d)(iii)(aa)Words in Sch. 5 para. 13(6)(b)(iii) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(2)(d)(iii)(bb)Words in Sch. 5 para. 13(6)(b)(iv) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(2)(d)(iii)(cc)Words in Sch. 5 para. 14(3) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(3)(a)Words in Sch. 5 para. 14(4) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(3)(b)Words in Sch. 5 para. 15(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(4)(a)Words in Sch. 5 para. 15(3)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(4)(b)(i)Words in Sch. 5 para. 15(3)(c)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(4)(b)(ii)Words in Sch. 5 para. 15(4)(a)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(4)(c)(i)Words in Sch. 5 para. 15(4)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(4)(c)(ii)Words in Sch. 5 para. 15(6) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(4)(d)Words in Sch. 5 para. 15(10) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(4)(e)Words in Sch. 5 para. 16(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(5)(a)Words in Sch. 5 para. 16(4)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(5)(b)(i)Words in Sch. 5 para. 16(4)(c)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(5)(b)(ii)Words in Sch. 5 para. 16(5)(a)(i) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(5)(c)(i)Words in Sch. 5 para. 16(5)(b) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(5)(c)(ii)Words in Sch. 5 para. 16(12) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(5)(d)Words in Sch. 5 para. 17(1) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(6)(a)Words in Sch. 5 para. 17(2) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 57(6)(b)Sch. 5 para. 18(2)(a)(i) omitted (1.10.2025) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 65(a)Words in Sch. 5 para. 18(2)(e)(iii) omitted (1.10.2025) by virtue of The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 65(b)Words in Sch. 5 para. 21(1)(k) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 10(a)Words in Sch. 5 para. 21(2)(f) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 10(b)Sch. 6 paras. 4ZA-4ZC inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 13Words in Sch. 6 para. 7 inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 58(2)Words in Sch. 6 para. 10(2) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 58(3)(a)Words in Sch. 6 para. 10(2) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 58(3)(b)Words in Sch. 7 para. 1(1)(b)(ii) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 59(2)Sch. 7 paras. 5A-5C inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 14Words in Sch. 7 para. 13C heading substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 66(2)(a)Words in Sch. 7 para. 13C(1) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 66(2)(b)(i)Words in Sch. 7 para. 13C(1) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 66(2)(b)(ii)Words in Sch. 7 para. 13C(2) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 66(2)(c)Words in Sch. 7 para. 13C(3)(a) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 66(2)(d)(i)Words in Sch. 7 para. 13C(3)(b) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 66(2)(d)(ii)Words in Sch. 7 para. 13C(3)(c) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 66(2)(d)(iii)Words in Sch. 7 para. 15(1)(j) substituted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 11Words in Sch. 7 para. 26(3)(a) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 59(3)(a)Words in Sch. 7 para. 26(4) inserted (1.10.2025) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (S.I. 2025/989), regs. 1(2), 59(3)(b)