2013 No. 349

National Health Service, England

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

Made14th February 2013

Laid before Parliament22nd February 2013

Coming into force1st April 2013

The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 7, 8, 126, 128A, 129, 130, 132, 136, 139, 140, 142(b), 143, 145, 148, 150A, 151(5) and (7), 154, 159(9), 160, 161, 162, 163(3), 164, 169(3) and 272(7) and (8) of, and paragraph 1(2)(b) of Schedule 11 and paragraphs 2 and 3 of Schedule 12 to, the National Health Service Act 2006 M1.

Annotations:

Marginal Citations

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.

PART 1Introductory

Citation and commencement1

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

Interpretation2

1

Subject to paragraph (7), in these Regulations—

“100 hours condition” is to be construed in accordance with regulation 65(1);
“the 1968 Act” means the Medicines Act 1968 M2;
“the 1992 Regulations” means the National Health Service (Pharmaceutical Services) Regulations 1992 M3, as in force on 31st March 2005;
“the 2005 Regulations” means the National Health Service (Pharmaceutical Services) Regulations 2005 M4, 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 M5, as in force immediately before the appointed day;
“the 2007 Act” means the Local Government and Public Involvement in Health Act 2007 M6;
“the 2012 Regulations” means the National Health Service (Pharmaceutical Services) Regulations 2012 M7, 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;
F91“advanced electronic signature” means an electronic signature which meets the following requirements—
1. a
  it is uniquely linked to the signatory;
2. b
  it is capable of identifying the signatory;
3. c
  it is created using electronic signature creation data that the signatory can, with a high level of confidence, use under the signatory's sole control; and
4. d
  it is linked to the data signed in such a way that any subsequent change in the data is detectable;
“advanced services” means the directed services which F427NHS England is required (as opposed to authorised) to arrange by virtue of directions under section 127 of the 2006 Act M8 (arrangements for additional pharmaceutical services);
“APMS contractor” means a person or partnership that provides primary medical services under contractual arrangements with F427NHS 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 M9 (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 M10 (definitions applying for the purposes of whole Act).
“arrangements for recharging” means arrangements under paragraph 3 of Schedule 12A to the 2006 Act M11 (pharmaceutical remuneration – other pharmaceutical remuneration) under which F427NHS 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 M12 (which relate to bank holidays) a bank holiday in England;
“batch issue” means a form, in the format required by F427NHS England (or a person exercising its functions) and approved by the Secretary of State, which—
1. a
  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;
2. b
  relates to a particular non-electronic repeatable prescription and contains the same date as that prescription;
3. c
  is generated by a computer and not signed by a prescriber;
4. d
  is issued as one of a sequence of forms, the number of which is equal to the number of occasions on which the drugs or appliances ordered on the non-electronic repeatable prescription may be provided; and
5. e
  has included on it a number denoting its place in the sequence referred to in sub-paragraph (d);
“best estimate”, in the context of the location of proposed appliance contractor premises or pharmacy premises mentioned in a routine application, is to be construed in accordance with paragraph 1(10) of Schedule 2;
“breach notice” is to be construed in accordance with regulation 71(1);
F352...
“change of ownership application” means an application pursuant to regulation 26;
F64“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 F220Health 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;
F94“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;
F358“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 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 M13 (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—
1. a
  is compatible with the systems used by F427NHS England (or a person exercising its functions) for—
  1. i
    the remuneration of persons providing pharmaceutical services, and
  2. ii
    any apportionment of, or any arrangements for recharging in respect of, that remuneration,
  unless the NHS chemist, dispensing doctor or LPS chemist dispensing the prescription is to receive no pharmaceutical remuneration of any kind in respect of any drug or appliance ordered on the form;
2. b
  is signed with a prescriber's advanced electronic signature;
3. c
  is transmitted as an electronic communication to a nominated dispensing contractor F130or via an information hub by the Electronic Prescription Service; and
4. d
  does not indicate that the drug or appliance ordered may be provided more than once;
“electronic repeatable prescription” means data created in an electronic form, which—
1. a
  is signed with a prescriber's advanced electronic signature;
2. b
  is transmitted as an electronic communication to a nominated dispensing contractor F131or via an information hub by the Electronic Prescription Service;
3. c
  indicates that the drugs or appliances ordered may be provided more than once; and
4. d
  specifies the number of occasions on which they may be provided;
F92“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 F427NHS England is authorised (as opposed to required) to arrange by virtue of directions under section 127 of the 2006 Act;
F128“EPS token” means a form (which may be an electronic form), approved by the Secretary of State, which—
1. a
  is issued by a prescriber at the same time as an electronic prescription is created; and
2. b
  has a barcode that enables the prescription to be dispensed by a provider of pharmaceutical services that is able to use the Electronic Prescription Service for the purposes of dispensing prescriptions, in circumstances where the provider is not dispensing the prescription as a nominated dispensing contractor;
“essential services”, except in the context of the definition of “distance selling premises”, is to be construed in accordance with paragraph 3 of Schedule 4;
“EPS list” is to be construed in accordance with regulation 10(4)(a);
“Electronic Prescription Service” means the service of that name which is managed by F365NHS England;
“excepted application” means an application to which section 129(2A) of the 2006 Act M14 (regulations as to pharmaceutical services) does not apply by virtue of any provision of Part 4 F95or a consolidation application to which regulation 26A(2) does not apply;
F244“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 F427NHS England;
F81“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 M15 (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 M16 (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 M17 (the Professional Standards Authority for Health and Social Care);
F374...
“home Primary Care Trust” has the same meaning as in the 2012 Regulations;
“HWB” means a Health and Wellbeing Board M18;
“independent nurse prescriber” means a person—
1. a
  who is registered in the Nursing and Midwifery Register; and
2. b
  against whose name in that register is recorded an annotation signifying that they are qualified to order drugs and appliances as a community practitioner nurse prescriber, a nurse independent prescriber or a nurse independent/supplementary prescriber;
F366...
F353“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);
F373“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;
F317“listed prescription items voucher” means a form which—
1. a
  is provided or approved by F427NHS England for the purposes of ordering a prescription item mentioned in regulation 13(1) of the Charges Regulations (exemption from charges: risks to public health); and
2. b
  may be an electronic form sent or to be sent via a secure service approved for this purpose by F427NHS England;
F317“LPIV” means a listed prescription items voucher;
“Local Healthwatch organisation” is to be construed in accordance with section 222(2A) of the 2007 Act M19 (arrangements under section 221(1));
“LPS chemist” means a party, other than the commissioning body, to—
1. a
  an LPS pilot scheme; or
2. b
  an LPS scheme for the provision of LP services;
“LPS contractor” means a person who is an LPS chemist by virtue of being a party to an LPS scheme which is not an LPS pilot scheme;
“LPS pilot scheme” means a pilot scheme within the meaning given in section 134(2) of the 2006 Act M20 (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 M21 (persons performing primary medical services);
“medical practice premises” means—
1. a
  in relation to a provider of primary medical services, premises which are identified in the provider's arrangements with F427NHS England as the practice premises from which primary medical services are to be provided during core hours to patients on the provider's patient list; or
2. b
  in relation to a general practitioner on a dispensing doctor list who is not a provider of primary medical services but who performs services on behalf of a provider of primary medical services, the practice premises 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—
1. a
  a member of or partner in the partnership that is the provider; or
2. b
  a shareholder in the company limited by shares that is the provider,
but no other providers of primary medical services are to be treated as having members;
“national disqualification” includes, in addition to a national disqualification as mentioned in section 159 of the 2006 Act M22 (national disqualification)—
1. a
  a national disqualification as mentioned in section 115 of the National Health Service (Wales) Act 2006 (national disqualification);
2. b
  any decision in Scotland or Northern Ireland corresponding to a national disqualification as mentioned in section 159 to the 2006 Act; and
3. c
  any other decision that was a national disqualification for the purposes of the 2012 Regulations;
“neighbouring HWB”, in relation to a HWB (HWB1), means the HWB of an area that borders any part of the area of HWB1;
F428...
“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 M23;
“NHS chemist” means an NHS appliance contractor or an NHS pharmacist;
F366...
F429“NHS England” means the body corporate established under section 1H of the 2006 Act;
F367“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 M24;
F244“NHSmail” means the secure e-mail service of that name for the sharing of patient identifiable and patient sensitive information, for which F368NHS 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—
1. a
  is compatible with the systems used by F427NHS England (or a person exercising its functions) for—
  1. i
    the remuneration of persons providing pharmaceutical services, and
  2. ii
    any apportionment of, or any arrangements for recharging in respect of, that remuneration,
  unless the NHS chemist, dispensing doctor or LPS chemist dispensing the prescription is to receive no pharmaceutical remuneration of any kind in respect of any drug or appliance ordered on the form;
2. b
  has been provided for use by a prescriber by—
  1. i
    F427NHS England,
  2. ii
    another primary care organisation,
  3. iii
    a local authority, under arrangements for providing NHS services which include, with the consent of F427NHS England, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,
  4. iv
    the Secretary of State,
  5. v
    F351an integrated care board, under arrangements for providing NHS services which include, with the consent of F427NHS England, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,
  6. vi
    an NHS Trust, or
  7. vii
    an NHS Foundation Trust;
3. c
  if—
  1. i
    it has been so provided for use by a prescriber in England, and
  2. ii
    a prescription charge may be payable in relation to the prescription or a prescription charge exemption in the Charges Regulations may apply to it,
  is in a format that has been approved by the Secretary of State;
4. d
  has been issued by a prescriber; and
5. e
  does not indicate that the drug or appliance ordered may be provided more than once;
“non-electronic repeatable prescription” means a repeatable prescription which is not an electronic repeatable prescription;
“non-proprietary name” means a name which is, or which is a permitted variation of—
1. a
  an International Nonproprietary Name (INN);
2. b
  an International Nonproprietary Name Modified (INNM);
3. c
  a British Approved Name (BAN);
4. d
  a British Approved Name Modified (BANM); or
5. e
  an approved name,
and for this purpose these names (and their permitted variations) have the same meanings as in a list of names which has been prepared and caused to be published in accordance with regulation 318 of the Human Medicines Regulations 2012 M25 (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 M26 (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 M27 (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—
1. a
  as regards Wales—
  1. i
    a Local Health Board, or
  2. ii
    in relation to any time prior to 1st April 2003 a Health Authority;
2. b
  as regards Scotland, a Health Board;
3. c
  as regards Northern Ireland—
  1. i
    the Regional Health and Social Care Board, or
  2. ii
    in relation to any time prior to 1st April 2010, a Health and Social Services Board; and
4. d
  as regards England in relation to any time prior to 1st April 2013, a Primary Care Trust;
“outline consent”, in the context of—
1. a
  an application for outline consent, is to be construed in accordance with regulation 51(1)(a); or
2. b
  a subsisting outline consent, means outline consent—
  1. i
    granted under these Regulations, or
  2. ii
    which was outline consent for the purposes of the 2012 Regulations;
“outstanding pharmacy application” has the meaning given in regulation 53(7);
F129“paramedic independent prescriber” means a person—
1. a
  who is registered in Part 8 of the register maintained under article 5 of the F221Health Professions Order 2001; and
2. b
  against whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines or appliances as a paramedic independent prescriber;
“patient list” means a list of patients that is a registered patient list for the purposes of the Primary Medical Services (Sale of Goodwill and Restrictions on Sub-contracting) Regulations 2004 M28;
“PDS patient details” means the information held about a patient in the Patient Demographics Service managed by F368NHS 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)—
1. a
  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 M29 (which relate to the registers and the registrar) is recorded an annotation signifying that P is qualified to order drugs and appliances as a pharmacist independent prescriber; and
2. b
  who is prescribing under arrangements for the provision of NHS services which are neither—
  1. i
    pharmaceutical services, unless they are arrangements for the provision of enhanced services, nor
  2. ii
    local pharmaceutical services, unless they are arrangements for the provision of services that are of the same type as enhanced services;
“pharmacy premises” means listed chemist premises (or in the context of an applicant seeking the listing of premises, proposed listed chemist premises) of an NHS pharmacist;
“pharmacy procedures” are the procedures required by section 72A(3) of the 1968 Act M30 (the responsible pharmacist);
“physiotherapist independent prescriber” means a physiotherapist who is registered in Part 9 of the register maintained under article 5 of the F222Health 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—
1. a
  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;
2. b
  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;
F80“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—
1. a
  an application for premises approval, is to be construed in accordance with regulation 51(1)(b); or
2. b
  a subsisting premises approval, means premises approval—
  1. i
    granted under these Regulations, or
  2. ii
    which was a premises approval for the purposes of the 2012 Regulations;
“prescriber”, unless the context otherwise requires, means a medical practitioner, a dental practitioner, a pharmacist independent prescriber, a supplementary prescriber, a chiropodist or podiatrist independent prescriber, a physiotherapist independent prescriber, an independent nurse prescriber F96, an optometrist independent prescriberF132, 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;
F286“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 M31;
“prescription only medicine” has the same meaning as in the Human Medicines Regulations 2012 M32;
“product with an appropriate non-proprietary name” means a product with a non-proprietary name which is not mentioned in—
1. a
  Schedule 1 to the Prescription of Drugs Regulations (drugs and other substances not to be ordered under a general medical services contract); or
2. b
  except where the conditions set out in paragraph 42(2)(a) and (b) of Schedule 6 to the GMS Regulations M33 (other contractual terms – restrictions on prescribing by medical practitioners) are satisfied, in Schedule 2 of the Prescription of Drugs Regulations M34 (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 M35 (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);
F245“PTP” means a pandemic treatment protocol, which is a protocol—
1. a
  relating to the supply of a prescription only medicine to be used for the prevention of or as a treatment for a disease that is, or in anticipation of it being imminently, pandemic; and
2. b
  approved in accordance with regulation 247 of the Human Medicines Regulations 2012 (exemption for supply in the event or anticipation of pandemic disease);
F286“PTPGD” means a pandemic treatment patient group direction, which is a patient group direction—
1. a
  relating to the supply of a prescription only medicine to be used for the prevention of or as a treatment for a disease that is, or in anticipation of it being imminently, pandemic; and
2. b
  which is in accordance with regulation 233 of the Human Medicines Regulations 2012 (exemption for supply etc under a PGD by a person conducting a retail pharmacy business);
“Regional Health and Social Care Board” means the Regional Health and Social Care Board established under section 7 of the Health and Social Care (Reform) Act (Northern Ireland) 2009 M36 (Regional Health and Social Care Board);
“registered pharmacist” means a person who is registered in Part 1 F271... 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 F272... of the GPhC register;
“relevant HWB” means—
1. a
  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;
2. b
  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;
3. c
  in the context of an application by a person for dispensing services, the HWB which is, as regards the dispensing doctor from whom the applicant is seeking dispensing services, the relevant HWB (by virtue of sub-paragraph (b)); and
4. d
  in the context of a decision to suspend or remove any type of entry of a person in a pharmaceutical list or dispensing doctor list, the HWB for the area to which the list relates;
“relevant list” means—
1. a
  a pharmaceutical list or an equivalent list maintained by another primary care organisation; or
2. b
  a list maintained by F427NHS 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 M37;
“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—
1. a
  is compatible with the systems used by F427NHS England (or a person exercising its functions) for—
  1. i
    the remuneration of persons providing pharmaceutical services, and
  2. ii
    any apportionment of, or any arrangements for recharging in respect of, that remuneration,
  unless the NHS chemist, dispensing doctor or LPS chemist dispensing the prescription is to receive no pharmaceutical remuneration of any kind in respect of any drug or appliance ordered on the form;
2. b
  has been provided for use by a prescriber by—
  1. i
    F427NHS England,
  2. ii
    another primary care organisation,
  3. iii
    a local authority, under arrangements for providing NHS services which include, with the consent of F427NHS England, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,
  4. iv
    the Secretary of State,
  5. v
    F351an integrated care board, under arrangements for providing NHS services which include, with the consent of F427NHS England, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,
  6. vi
    an NHS Trust, or
  7. vii
    an NHS Foundation Trust;
3. c
  if—
  1. i
    it has been so provided for use by a prescriber in England, and
  2. ii
    a prescription charge may be payable in relation to the prescription or a prescription charge exemption in the Charges Regulations may apply to it,
  is in a format that has been approved by the Secretary of State;
4. d
  has been issued by a prescriber,
5. e
  indicates that the drugs or appliances ordered may be provided more than once; and
6. f
  specifies the number of occasions on which they may be provided;
“reserved location” means, unless the context otherwise requires, an area classified as such following a determination (that has not lapsed) under—
1. a
  regulation 41(2) or 42(1);
2. b
  regulation 41(2) or 42(1) of the 2012 Regulations (which related to initial, second and subsequent determinations of reserved location status), whether or not by virtue of paragraph 8 of Schedule 9; or
3. c
  regulation 35 of the 2005 Regulations M38 (pharmaceutical services in reserved locations), whether or not by virtue of—
  1. i
    paragraph 8 of Schedule 9, or
  2. ii
    paragraph 6 of Schedule 7 to the 2012 Regulations (transitional provisions – reserved locations);
“restricted availability appliance” means an appliance which is approved for particular categories of person or particular purposes only;
“routine application” is to be construed in accordance with regulation 12;
“the SCAT Regulations” means the National Health Service (Service Committees and Tribunal) Regulations 1992 M39, as in force on 31st August 2012;
“Scheduled drug” means a drug specified in Schedule 1 or 2 to the Prescription of Drugs Regulations M40 (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);
F197“serious shortage protocol” means—
1. a
  in the case of a prescription only medicine, a serious shortage protocol for the purposes of regulation 226A of the Human Medicines Regulations 2012 (sale etc. by a pharmacist in accordance with a serious shortage protocol); or
2. b
  in the case of any other drug or appliance, a written protocol that—
  1. i
    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—
    1. aa
      a specified drug or appliance, or
    2. bb
      drugs or appliances of a specified description,
  2. ii
    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—
    1. aa
      the specified drug or appliance, or
    2. bb
      a drug or appliance of the specified description,
    of a different product or quantity of product to the product or quantity of product ordered, subject to such conditions as may be specified in the protocol, and
  3. iii
    specifies the period for which, and the parts of England (which may be all of England) in which, the protocol is to have effect;
F93“signatory” means a natural person who creates an electronic signature;
“specified appliance” means—
1. a
  any of the following appliances listed in Part IXA of the Drug Tariff—
  1. i
    a catheter appliance (including a catheter accessory and maintenance solution),
  2. ii
    a laryngectomy or tracheostomy appliance,
  3. iii
    an anal irrigation system,
  4. iv
    a vacuum pump or constrictor ring for erectile dysfunction, or
  5. v
    a drainage wound pouch;
2. b
  an incontinence appliance listed in Part IXB of the Drug Tariff; or
3. c
  a stoma appliance listed in Part IXC of the Drug Tariff;
F197“SSP” means a serious shortage protocol;
“stoma appliance customisation” means the customisation of a quantity of more than one stoma appliance, where—
1. a
  the stoma appliances to be customised are listed in Part IXC of the Drug Tariff;
2. b
  the customisation involves modification to the same specification of multiple identical parts for use with each appliance; and
3. c
  that modification is based on the patient's measurements or a record of those measurements and, if applicable, a template;
“superintendent” has the same meaning as in section 71 of the 1968 Act M41 (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—
1. a
  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;
2. b
  a person—
  1. i
    who is registered in a part of the register maintained under article 5 of the F223Health Professions Order 2001 (establishment and maintenance of register) which relates to chiropodists and podiatrists, F98dietitians, physiotherapists or radiographers, and
  2. ii
    against whose name in that register is recorded an annotation signifying that they are qualified to order drugs and appliances as a supplementary prescriber; or
3. c
  an optometrist against whose name in the register of optometrists maintained under section 7 of the Opticians Act 1989 is recorded an annotation signifying that the optometrist is qualified to order drugs and appliances as a supplementary prescriber;
F97“therapeutic radiographer independent prescriber” means a radiographer—
1. a
  who is registered in Part 11 of the register maintained under article 5 of the F224Health Professions Order 2001; and
2. b
  against whose name in that register is recorded—
  1. i
    an entitlement to use the title “therapeutic radiographer”, and
  2. ii
    an annotation signifying that the radiographer is qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;
“transfer scheme” means a property transfer scheme under section 300 of the Health and Social Care Act 2012 (transfer schemes) that transfers the rights and liabilities of a Primary Care Trust under arrangements for the provision of pharmaceutical or local pharmaceutical services to other persons.

2

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

a

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

b

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

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

3

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

a

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

i

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

ii

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

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

b

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

i

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

ii

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

pandemic; and

b

a serious risk or potentially serious risk to human health,

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

PART 2Pharmaceutical needs assessments

Pharmaceutical needs assessments3

1

The statement of the needs for pharmaceutical services which each HWB is required to publish by virtue of section 128A of the 2006 Act M43 (pharmaceutical needs assessments), whether it is the statement of its first assessment or of any revised assessment, is referred to in these Regulations as a “pharmaceutical needs assessment”.

2

The pharmaceutical services to which each pharmaceutical needs assessment must relate are all the pharmaceutical services that may be provided under arrangements made by F427NHS England for—

a

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

b

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

c

the dispensing of drugs and appliances by a person on a dispensing doctors list (but not other NHS services that may be provided under arrangements made by F427NHS England with a dispensing doctor).

Information to be contained in pharmaceutical needs assessments4

1

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

2

Each HWB must, in so far as is practicable, keep up to date the map which it includes in its pharmaceutical needs assessment pursuant to paragraph 7 of Schedule 1 (without needing to republish the whole of the assessment or publish a supplementary statement).

Date by which the first HWB pharmaceutical needs assessments are to be published5

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

Subsequent assessments F234and later first assessments6

F233A1

F342Subject 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 F3431st October 2022.

A2

Any HWB that has published a pharmaceutical needs assessment before 1st July 2020 must publish a revised assessment by F3441st October 2022 (but it is not required to publish a revised assessment before that date).

F340A3

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

1

F345Subject 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

F346Each HWB that has published a pharmaceutical needs assessment must make a revised assessment as soon as is reasonably practicable after identifying changes since the previous assessment, which are of a significant extent, to the need for pharmaceutical services in its area, having regard in particular to changes to—

a

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

b

the demography of its area; and

c

c

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

which is sufficient to enable F427NHS England to carry out its functions under these Regulations.

3

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

Consultation on pharmaceutical needs assessments8

1

other related matters.

8

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

Terms of service of NHS chemists: general11

1

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

a

that are included in these Regulations, including—

i

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

ii

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

b

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

c

where F427NHS England makes an arrangement with the NHS pharmacist for the provision of any directed services, that are included in that arrangement; and

d

that are—

i

included in regulations under section 225 of the 2007 Act M44 (duties of services-providers to allow entry by Local Healthwatch organisations or contractors), and

ii

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

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

2

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

a

that are included in these Regulations, including—

i

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

ii

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

b

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

c

where F427NHS England makes an arrangement with the NHS appliance contractor for the provision of any directed services, that are included in that arrangement; and

d

that are—

i

included in regulations under section 225 of the 2007 Act M45 (duties of services-providers to allow entry by Local Healthwatch organisations or contractors), and

ii

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

F2323

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

a

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

i

pandemic, and

ii

a serious risk or potentially a serious risk to human health,

F427NHS England with the agreement of the Secretary of State has made an announcement in respect of the prioritisation of services to be provided in, or in any part of, England as part of the health service;

b

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

c

as part of the announcement, F427NHS England with the agreement of the Secretary of State has issued advice to the effect that NHS chemists are not to comply with a specified term of service—

i

in the area to which the announcement relates,

ii

in the circumstances specified in the announcement, and

iii

during the period specified in the announcement; and

d

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

Routine applications for inclusion in or amendments to a pharmaceutical list12

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

a

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

b

who is included in a pharmaceutical list and who is seeking—

i

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

ii

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

iii

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

Current needs: additional matters to which F427NHS England must have regard13

F11

If—

a

F427NHS England receives a routine application and is required to determine whether granting it, or granting it in respect of some only of the services specified in it, would meet a current need for pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB; and

b

b

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

c

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

d

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

e

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

b

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

c

Future needs: consequences of additional matters16

1

b

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

c

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

d

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

e

whether it is satisfied that—

i

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

ii

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

f

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

g

whether it is satisfied that—

i

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

ii

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

h

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

3

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

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

i

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

ii

the arrangements F427NHS England has in place for the provision of pharmaceutical services in that area;

b

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

i

there being a reasonable choice with regard to obtaining pharmaceutical services in the area of the relevant HWB (taking into account also F427NHS England’s duties under sections 13I and 13P of the 2006 Act M47 (duty as to patient choice and duty as respects variation in provision of health services)),

ii

people who share a protected characteristic having access to services that meet specific needs for pharmaceutical services that, in the area of the relevant HWB, are difficult for them to access (taking into account also F427NHS England’s duties under section 13G of the 2006 Act M48 (duty as to reducing inequalities)), F4or

iii

there being innovative approaches taken with regard to the delivery of pharmaceutical services (taking into account also F427NHS England’s duties under section 13K of the 2006 Act M49 (duty to promote innovation)),

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

c

d

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

e

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

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

ii

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

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

3

If F427NHS England is satisfied as mentioned in regulation 17(2)(b) or 18(2)(d), it may defer consideration of the application until it can be considered at the same time as the other application.

4

If F427NHS England is satisfied as mentioned in regulation 17(2)(c) or 18(2)(e), it may defer consideration of the application until after the appeal has reached its final outcome.

5

If F427NHS England is satisfied as mentioned in regulation 17(2)(d) to (g) or 18(2)(a) F102or (g), it must refuse the application.

6

If F427NHS England is satisfied as mentioned in regulation 18(2)(b), it may grant the application notwithstanding that the improvements or better access were or was not included in the relevant pharmaceutical needs assessment.

Future improvements or better access: additional matters to which F427NHS England must have regard20

F51

If—

a

F427NHS England receives a routine application and is required to determine whether granting it, or granting it in respect of some only of the services specified in it, would secure improvements, or better access, in the future to pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB; and

b

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

2

Those matters are—

a

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

b

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

c

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

d

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

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

c

b

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

PART 4Excepted applications

Applications from NHS chemists in respect of providing directed services23

Section 129(2A) of the 2006 Act M50 (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.

Relocations that do not result in significant change to pharmaceutical services provision24

1

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

a

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

b

in the opinion of F427NHS England, granting the application would not result in a significant change to the arrangements that are in place for the provision of local pharmaceutical services or of pharmaceutical services other than those provided by a person on a dispensing doctor list—

i

in any part of the area of HWB1, or

ii

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

c

F427NHS EnglandF6is not of the opinion that granting the application would cause significant detriment to proper planning in respect of the provision of pharmaceutical services in the area of HWB1;

d

the services the applicant undertakes to provide at the new premises are the same as the services the applicant has been providing at the existing premises (whether or not, in the case of enhanced services, F427NHS England chooses to commission them); and

e

the provision of pharmaceutical services will not be interrupted (except for such period as F427NHS England may for good cause allow).

2

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

a

the purpose of the application is to relocate to different premises;

b

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

c

i

in any part of HWB3's area; or

ii

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

d

F427NHS EnglandF7is not of the opinion that granting the application would cause significant detriment to proper planning in respect of the provision of pharmaceutical services in the area of HWB3;

e

the services the applicant undertakes to provide at P2 are the same as the services the applicant has been providing at P1 (whether or not, in the case of enhanced services, F427NHS England chooses to commission them);

f

the provision of pharmaceutical services will not be interrupted (except for such period as F427NHS England may for good cause allow); and

g

the applicant consents to—

i

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

ii

F9d

are distance selling premises, unless—

i

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

ii

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

Distance selling premises applications25

1

Section 129(2A) of the 2006 Act M54 (regulations as to pharmaceutical services) does not apply to an application—

a

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

b

by a person already included in a pharmaceutical list for inclusion in that list F53...in respect of premises other than those already listed in relation to that person,

in respect of pharmacy premises that are distance selling premises.

2

F427NHS England must refuse an application to which paragraph (1) applies—

a

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

b

unless F427NHS England is satisfied that the pharmacy procedures for the pharmacy premises are likely to secure—

i

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

ii

the safe and effective provision of essential services without face to face contact between any person receiving the services, whether on their own or on someone else's behalf, and the applicant or the applicant's staff.

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

4

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

that—

i

P1 consents to the change of ownership of S1, and

ii

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

8

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

Applications for temporary listings arising out of suspensions27

1

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

a

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

b

4

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

it has been determined in accordance with—

i

regulation 4 of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002 M57 (right of return to pharmaceutical lists),

ii

regulation 15 of the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 M58 (right of return to pharmaceutical lists), or

iii

regulation 108,

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

b

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

c

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

3

F427NHS England must refuse an application to which paragraph (1) applies, unless—

a

the change from providing local pharmaceutical services to providing pharmaceutical services will not give rise to any interruption in the receipt and dispensing of prescriptions by the applicant (except for such period as F427NHS England may for good cause allow); and

b

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

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

b

curtail the period specified,

in appropriate circumstances.

5

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

6

The applicant may revert to the applicant's overridden entry in the pharmaceutical list before the end of the period specified by under paragraph (3), on giving F427NHS England at least 24 hours notice.

7

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

8

There is no right of appeal under these Regulations in respect of a decision of F427NHS England under this regulation.

PART 5Specific grounds for refusal or deferral of applications under Parts 3 and 4 which are not linked to fitness grounds

Refusal: language requirement for some NHS pharmacists30

An application for inclusion in a pharmaceutical list by a person not already included must be refused if the applicant is an individual (X) who qualified as a pharmacist in Switzerland or an EEA state other than the United Kingdom, unless X satisfies F427NHS 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.

Refusal: same or adjacent premises31

F141

A routine or excepted applicationF103, other than a consolidation application, must be refused where paragraph (2) applies.

2

This paragraph applies where—

a

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

having—

i

checked with the NHS BSA for any facts that it considers relevant relating to past or current fraud investigations involving or related to A F19..., and

ii

considered these and any other facts in its possession relating to fraud involving or relating to A F19...,

considers the outcome of these enquiries justify such refusal;

d

having—

i

checked with the Secretary of State for any facts considered by the Secretary of State to be relevant relating to past or current investigations or proceedings involving or relating to A F20..., and

ii

considered these and any other facts in its possession involving or relating to A F20...,

considers the outcome of these enquiries justify such refusal; or

e

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

3

Where F427NHS England is considering refusal of an application under paragraph (2), it must consider all facts which appear to it to be relevant and must in particular take into consideration in relation to paragraph (2)(b) to (e)—

a

the nature of any offence, investigation or incident;

b

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

c

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

d

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

e

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

f

whether any offence was a sexual offence to which Part 1 of the Sexual Offences Act 2003 M60 (sexual offences) F79or section 2 of the Modern Slavery Act 2015 in respect of sexual exploitation (human trafficking) applies, or if it had been committed in England and Wales, would have applied;

g

whether A F21... 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 F427NHS England or another primary care organisation for such action; or

h

whether A F21...was, at the time of the originating events, or has in the preceding 6 months been—

i

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

ii

is currently suspended from a relevant list,

for a reason relating to unsuitability, fraud or efficiency of service provision, and if so, what the facts were in each such case and the reasons given by F427NHS England or another primary care organisation in each case.

4

When F427NHS England takes into consideration the matters set out in paragraph (3), it must consider the overall effect of all the matters being considered.

5

If an application for inclusion in a pharmaceutical list by a person who is not already included in it is refused under paragraph (1) or (2), F427NHS England must notify the applicant of that decision and it must include with the notification an explanation of—

a

the reasons for the decision;

b

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

Deferral of consideration of applications for inclusion in a pharmaceutical list on fitness grounds34

F22A1

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

a

an individual, the individual making the application;

b

a partnership, any partner in the partnership making the application; or

c

a body corporate—

i

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

ii

any director or superintendent of the body corporate making the application.

1

An application for inclusion in a pharmaceutical list by a person F23...who is not already included in it may be deferred if F427NHS England is satisfied that—

a

there are, in respect of A F24...—

i

criminal proceedings in the United Kingdom, or

ii

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

which, if they result in a conviction, or the equivalent of a conviction, would be likely to lead to F25the person’s removal from the pharmaceutical list, if the person were to be included in it;

b

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

i

criminal proceedings in the United Kingdom, or

ii

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

which, if they resulted in a conviction, or the equivalent of a conviction, would be likely to lead to F26the person’s removal from the pharmaceutical list, if the person were to be included in it;

c

there is an investigation anywhere in the world—

i

by A's F27... licensing or regulatory body, or

ii

relating to A F28... in A's professional capacity (including one by F427NHS England or another primary care organisation),

which, if the outcome were adverse, would be likely to lead to the removal of F29the person from the pharmaceutical list if the person were to be included in it;

d

A F30...is suspended from a relevant list;

e

a body corporate of which A F33... was, at the time of the originating events, a director or superintendent, is suspended from a relevant list;

f

the First-tier Tribunal is considering an appeal by A F34... against a decision of F427NHS England or another primary care organisation—

i

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

ii

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

and if that appeal were to be unsuccessful, F427NHS England would be likely to remove F35the person from the pharmaceutical list if the person were to be included in it;

g

the First-tier Tribunal is considering an appeal by a body corporate of which A F36... was, at the time of the originating events, or has in the preceding 6 months been, a director or superintendent, against a decision of F427NHS England or another primary care organisation—

i

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

ii

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

and if that appeal were to be unsuccessful F427NHS England would be likely to remove F37the person from the pharmaceutical list if the person were to be included in it;

h

A F38... is being investigated by the NHS BSA in relation to any fraud, where the result, if adverse, would be likely to lead to the removal of F39the person from the pharmaceutical list if the person were to be included in it;

i

a body corporate, of which A F40...was, at the time of the originating events, a director or superintendent, is being investigated by the NHS BSA in relation to any fraud, where the result if adverse would be likely to lead to the removal of F41the person from the pharmaceutical list if the person were to be included in it;

j

the First-tier Tribunal is considering an application from F427NHS England or a Local Health Board for a national disqualification of A F31...;

k

the First-tier Tribunal is considering an application from F427NHS England or a Local Health Board for a national disqualification of a body corporate of which A F32... was, at the time of the originating events, a director or superintendent; or

l

F427NHS England or another primary care organisation, for a reason relating to unsuitability, fraud or efficiency of service provision—

i

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

ii

has taken a decision to remove (other than voluntary removal) or contingently remove F42the applicant from a relevant list but that decision has yet to take effect.

2

F427NHS England may only defer a decision under paragraph (1) until—

a

the outcome of the cause for the deferral is known; or

b

the reason for the deferral no longer exists.

the First-tier Tribunal confirms the decision of F427NHS England; or

b

imposes a different condition,

P must, within 30 days of P being notified of the First-tier Tribunal's decision, notify F427NHS England as to whether or not P wishes to withdraw P's application

8

If P fails, in the circumstances described in paragraph (7), to notify F427NHS England within that 30 days that P does not wish to withdraw P's application, the grant of P's application lapses.

PART 7Areas that are controlled localities or reserved locations, and new pharmacies within them

Determination that an area is a controlled locality36

1

Any area that was, or was part of, a controlled locality for the purposes of the 2012 Regulations immediately before these Regulations come into force continues to be, or to be part of, a controlled locality for the purposes of these Regulations (unless or until it is determined that the area is no longer, or no longer part of, a controlled locality).

2

Subject to paragraph (3), F427NHS England may at any time consider and determine whether or not any locality, because it is rural in character, is to be, or to be part of, a controlled locality.

3

Where the question of whether or not an area is to be, or to be part of, a controlled locality has been determined by F427NHS England, a Primary Care Trust or on appeal (whether under these Regulations, the 2012 Regulations or the 2005 Regulations), that question must not be considered again in relation to that area—

a

for 5 years, beginning with the date of the determination of F427NHS England or the Primary Care Trust, or if that determination was appealed, the date of the decision on appeal;

b

unless F427NHS 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.

Process for determining controlled localities: preliminary matters37

1

A Local Medical Committee or Local Pharmaceutical Committee may apply in writing to F427NHS England for it to determine whether or not an area specified in the application (which must be all or part of the Committee's area) is to be, or is to be part of, a controlled locality.

2

Before considering the application, F427NHS England must consider whether or not the application raises a question that it cannot consider by virtue of regulation 36(3).

3

If F427NHS 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).

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

ii

publish that map, and

iii

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

b

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

i

its determination and the reasons for it,

ii

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

iii

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

3

The persons mentioned in this paragraph are—

a

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

b

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

ending on the date on which A1 is made; or

b

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

i

a routine application under these Regulations or the 2012 Regulations, or

ii

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

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

unless F427NHS England is satisfied that since the date on which the 5 year period started, there has been a substantial and relevant change of circumstances affecting the controlled locality.

3

For the purposes of paragraphs (1) and (2), if no particular premises are proposed for listing in A1, the applicant is to be treated as seeking the listing of pharmacy premises at the location which is the best estimate that F427NHS 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.

F434

Paragraph (2)(b) does not apply where F427NHS England is satisfied that there are reasonable grounds for believing the person making the refused application was motivated (wholly or partly) by a desire for that application to be refused.

5

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

Applications for new pharmacy premises in controlled localities: reserved locations41

1

This paragraph applies to any routine application—

F427NHS England is not satisfied that if pharmaceutical services were provided at the relevant location, the use of those services would be similar to, or greater than, the use that might be expected if the number of individuals residing in that area who are on a patient list were 2,750 or more.

4

Before making a determination under paragraph (2) (referred to in this regulation and regulation 42 as “D1”), F427NHS England must—

a

notify the persons notified under Part 3 of Schedule 2 about A1 that F427NHS England is required to make D1 (and it may make this notification at the same time as it notifies those persons about A1); and

b

invite them, within a specified period of not less than 30 days, to make representations to F427NHS England with regard to D1 (and the period specified must end no earlier than the date by which the person notified needs to make any representations that they have with regard to A1).

5

F427NHS 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 M62 (refusal: premises which are in a controlled locality but not a reserved location) applied was refused—

that, on the basis of the circumstances that pertained on the day on which the request for D2 was received by F427NHS England, there is no longer—

i

a reserved location, or

ii

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

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

2

3

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

4

Once a reserved location takes effect, F427NHS England must—

a

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

b

publish that map; and

c

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

Prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved location44

1

This paragraph applies to all routine applications—

a

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

b

from an NHS pharmacist included in such a list—

i

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

ii

to open, within the area of the relevant HWB, additional pharmacy premises from which to provide pharmaceutical services.

2

As regards any application to which paragraph (1) applies, F427NHS England must have regard to whether or not the applicant is seeking the listing of pharmacy premises which are in a part of a controlled locality that is not a reserved location.

3

If the applicant is seeking the listing of pharmacy premises which are in a part of a controlled locality that is not in a reserved location, F427NHS England must refuse the application if granting it would, in the opinion of F427NHS England, prejudice the proper provision of relevant NHS services in the area of—

a

the relevant HWB; or

b

a neighbouring HWB of the relevant HWB.

4

For the purposes of paragraphs (2) and (3), if no particular premises are proposed for listing in the application, the applicant is to be treated as seeking the listing of pharmacy premises which are in a controlled locality if the best estimate that F427NHS 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.

Appeals against decisions under Part 745

1

A person with appeal rights (as provided for in this regulation) may appeal to the Secretary of State against the following decisions by F427NHS England—

a

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

i

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

ii

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

b

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

c

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

i

the person making the application to which the determination relates, and

ii

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

d

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

i

the person making the application to which the determination relates, and

ii

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

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

they may request that F427NHS England lists that provider instead of them as the dispensing doctor (or doctors) on a dispensing doctors list.

5

In the circumstances described in paragraph (4)—

a

F427NHS England must agree to that request;

b

the arrangements that F427NHS England had with the individual dispensing doctor or doctors become arrangements with the provider of primary medical services; and

c

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

6

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

a

the provider must notify F427NHS England—

i

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

ii

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

b

as part of the listing of the provider in its dispensing doctors list, F427NHS England must include the names of any general practitioner notified under sub-paragraph (a)(i), unless F427NHS England has received a further notification in respect of that general practitioner under sub-paragraph (a)(ii).

Terms of service of dispensing doctors: general47

1

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

a

are included in these Regulations, including—

i

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

ii

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

b

were imposed, in relation to the dispensing doctor's ability to provide pharmaceutical services, by virtue of regulation 20(2) of the 2005 Regulations M63 (imposition of conditions);

c

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

d

are—

i

included in regulations under section 225 of the 2007 Act M64 (duties of services-providers to allow entry by Local Healthwatch organisations or contractors), and

ii

2

F427NHS England must ensure that those terms of service—

a

if the dispensing doctor has arrangements with F427NHS England for the provision of primary medical services to the patients to whom the dispensing doctor provides pharmaceutical services, are conditions of and so are enforceable under those arrangements; or

b

if the dispensing doctor has no such arrangements, are terms of service of, and so are enforceable under, the arrangements that F427NHS 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.

b

D's right of appeal under regulation 63(1)(a).

Necessary services for temporary patients49

A 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.

Discontinuation of arrangements for the provision of pharmaceutical services by doctors50

1

In circumstances where F427NHS 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—

a

pharmaceutical services have been provided to P because of the circumstances described in Condition 1 in regulation 48(2), but F427NHS England determines that Condition 1 no longer applies in relation to P;

b

the 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;

c

P 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;

d

P 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—

i

F427NHS England determines that Condition 3 in regulation 48(4) does not apply in respect of P, or

ii

F427NHS England determines that Condition 3 in regulation 48(4) does apply in respect of P, but P informs F427NHS 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);

e

P is resident in a reserved location, and—

i

had previously informed F427NHS England (or a Primary Care Trust) that P wished to be provided with pharmaceutical services by D, but

ii

P has since informed F427NHS 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); or

f

7

F427NHS England must notify any decision under this regulation to terminate arrangements to provide pharmaceutical services, subject to any postponement of the discontinuation, to—

a

b

if 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 from which, led to the determination of F427NHS England;

is not, or is not part of, a controlled locality; or

b

is within 1.6 kilometres of pharmacy premises that are not distance selling premises.

7

Where F427NHS 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).

8

Subject to paragraph (9), F427NHS 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—

a

the relevant HWB; or

b

a neighbouring HWB of the relevant HWB.

9

If F427NHS 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—

a

the relevant HWB; or

b

a neighbouring HWB of the relevant HWB,

it may grant the application in respect of that smaller area.

10

F427NHS England must refuse an application (A1) under paragraph (1)—

a

for 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; or

b

for 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—

i

under this regulation,

ii

under regulation 51 of the 2012 Regulations (outline consent and premises approval: applications by doctors), or

iii

by virtue of regulation 18(2) of the 2005 Regulations M65 (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 F427NHS 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.

included in a pharmaceutical list for the area of the relevant HWB, or

ii

A does not consent to the information being disclosed as part of the notification,

F427NHS 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.

10

The “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.

11

If 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.

to relocate to different premises in the area of the relevant HWB, or

bb

i

where 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 the relevant practice premises, or

ii

by virtue of paragraph (11),

and it must inform D accordingly.

14

F427NHS 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—

a

the reasons for the determination; and

b

the applicant's rights of appeal in relation to it under regulation 63(1)(e).

Premises approval: relocations of practice premises which are not significant before outline consent takes effect54

1

If 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 F427NHS England to change the premises from which D wishes to dispense to other premises in the area of the relevant HWB.

2

F427NHS 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).

3

Where F427NHS 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 F427NHS England.

4

F427NHS 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—

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

b

granting 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—

i

in any part of the area of the relevant HWB, or

ii

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

c

F427NHS 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.

3

F427NHS England must, unless it has good cause not to do so, refuse an application under paragraph (1) if an application under—

a

that paragraph;

b

regulation 55(1) of the 2012 Regulations (premises approval: relocations of practice premises which are not significant after outline consent has taken effect); or

c

regulation 65(4)(a) of the 2005 Regulations M66 (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).

4

a

the reasons for the decision; and

b

if 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.

Taking effect of premises approval where there is no related application for outline consent56

1

Where—

a

premises 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; and

b

the application for premises approval had no related application for outline consent,

paragraph (2) applies.

2

In the circumstances described in paragraph (1), the approval takes effect—

a

on the date the determination of the application takes effect, and that date is—

i

if no appeal is made against the decision within the period for bringing an appeal, the date on which that period expires, or

ii

if the decision is appealed within that period, the date on which the appeal reaches its final outcome; or

b

if 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—

i

the day after the end of a period of one year from the date on which that outstanding pharmacy application reaches its final outcome, or

ii

such longer period (not exceeding 3 months) as F427NHS England may for good cause allow before the expiry of that year.

3

Premises 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 the pharmacy premises to which the outstanding pharmacy application relates.

Gradual introduction of premises approval57

1

Where a dispensing doctor (D) has outline consent but F427NHS 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 from medical practice premises which have been subject to a related application for premises approval (whether under regulation 51, 54 or 55), F427NHS England may by conditions—

a

postpone the taking effect of the related premises approval for such period as it thinks fit; or

b

an explanation of how D's rights of appeal under regulation 63(1)(c)(iii) may be exercised.

Practice amalgamations59

1

A “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.

2

If, 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.

3

If, 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—

a

if any listed dispensing premises become medical practice premises of SP—

i

the premises approvals for those premises, and the related outline consents, become approvals and consents of SP, and

ii

any 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;

b

if none of the listed dispensing premises become medical practice premises of SP—

i

SP 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, and

ii

any 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.

4

Where 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—

a

any premises approval granted as a consequence becomes, when the practice amalgamates, a premises approval granted to SP; or

b

if 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.

5

If 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.

3

F427NHS England may grant temporary premises approval—

a

in relation to additional premises that are not listed dispensing premises; or

b

to 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.

4

In the circumstances described in paragraph (3)—

is employed or engaged by a primary medical services provider; or

g

is 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.

2

No 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.

Appeals against decisions under Part 863

1

A person with appeal rights (as provided for in this regulation) may appeal to the Secretary of State against the following decisions by F427NHS England—

P1 was a person whom F427NHS England was required to notify about the relevant application for outline consent or premises approval by virtue of P1 being—

i

included in a pharmaceutical list,

ii

entitled to be included in a pharmaceutical list because of the grant of a routine or excepted application but not (yet) included,

iii

an LPS chemist with whom F427NHS England has made arrangements for the provision of any local pharmaceutical services, or

iv

(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 F427NHS England, be significantly affected by the decision;

b

P1 made representations in writing about the application under regulation 52(4); and

c

subject to sub-paragraph (5), F427NHS England is satisfied, having regard to those representations in writing and any oral representations made at any oral hearing, that P1—

i

made a reasonable attempt to express P1's grounds for opposing the application adequately in P1's representations, and

ii

has grounds for opposing the application, which—

aa

do 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, and

bb

are not vexatious or frivolous.

4

If F427NHS 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.

5

A person to whom paragraph (3)(a) and (b) applies (P2) who is not notified by F427NHS England that they are person with third party appeal rights may appeal to the Secretary of State against the determination (D2) by F427NHS England that it is not satisfied as mentioned in sub-paragraph (3)(c), provided that P2—

a

notifies the Secretary of State within 30 days of the date on which that person was notified of F427NHS England’s decision that P2 wishes to appeal against both D1 and D2; and

b

includes 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.

6

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

PART 9Conditional inclusion in pharmaceutical lists: certain specific conditions that do not relate to fitness or performance

Distance selling premises: specific conditions64

F441

Paragraph (2) applies where—

a

an application in respect of distance selling premises is granted under these Regulations; or

b

an 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.

2

The inclusion in the pharmaceutical list of the person (X) listed in relation to—

a

those distance selling premises; or

b

if 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).

3

Those conditions are—

a

X must not offer to provide pharmaceutical services, other than directed services, to persons who are present at (which includes in the vicinity of) the listed chemist premises;

b

the means by which X provides pharmaceutical services, other than directed services, must be such that any person receiving those services does so otherwise than at the listed chemist premises;

C1c

the 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;

d

in the case of pharmacy premises, the pharmacy procedures for the premises must be such as to secure—

i

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

ii

e

nothing in X's practice leaflet, 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—

i

the essential services provided at or from the premises are only available to persons in particular areas of England, or

ii

X 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).

4

F427NHS England may not vary or remove the conditions set out in paragraph (3).

Core opening hours conditions65

1

If 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—

a

the premises that were listed as a consequence of that application; or

b

if 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”).

2

The condition is that the premises must be kept open for at least 100 hours per week for the provision of pharmaceutical services.

F3833

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3843A

NHS 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.

an increased number of core opening hours, and

ii

if the NHS chemist—

aa

is an NHS pharmacist, that pharmaceutical services are to be provided at the pharmacy premises during any additional opening hours F392, or any core hours specified that replace (at any distance in succession) a 100 hours condition, at set times and on set days, and

bb

is an NHS appliance contractor, that pharmaceutical services are to be provided at 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,

F427NHS England must direct that the person listed in relation to the premises is to provide pharmaceutical services at those premises for the specified number of core opening hours so undertaken, and F393... at the set times and on the set days so agreed F394or undertaken.

6

Except as provided for under paragraph (5) and subject to paragraph (7), F427NHS 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.

7

A 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.

F381Continuity in respect of opening hours directions65A

1

In 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.

2

Opening 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.

3

Where, 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 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—

not withhold agreement to a service specification for those services unreasonably.

on the date on which provision of the directed service is commenced,

whichever is the sooner.

7

F427NHS England may not vary or remove the condition imposed by virtue of paragraphs (3) to (5).

Conditions relating to voluntary closure of premises67

1

Except in the circumstances described in paragraph (3) F105or (5), where an NHS chemist (C) wishes, other than as a consequence of a change of ownership application F106or a consolidation application—

a

to withdraw from a pharmaceutical list, or

b

for particular listed chemist premises no longer to be listed in relation to C,

C must comply with paragraph (2).

2

C must notify F427NHS England of C's wish—

a

unless sub-paragraph (b) applies, at least 3 months in advance of the date on which pharmaceutical services are no longer to be provided;

b

at least—

F395i

6 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, or

ii

30 days in advance of that date, if—

aa

a condition is imposed under regulation 35,

bb

C appeals that condition to the First-tier Tribunal,

cc

on appeal, the First-tier Tribunal confirms the imposition of that condition or imposes another condition, and

dd

within 30 days of being informed of the decision of the First-tier Tribunal, C notifies F427NHS 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 F427NHS England as soon as it is practicable for C to do so, or F427NHS England agrees to a shorter notification period.

3

If C has consented to—

a

particular listed chemist premises no longer being listed in relation to C by F427NHS England; or

b

being removed from the pharmaceutical list for the area of a HWB,

in the context of a relocation application, F107which is not part of a consolidation application, paragraph (4) applies.

4

In the circumstances described in paragraph (3), C must, where the relocation application is granted, when C gives notice to F427NHS England of C's intention to commence the provision of pharmaceutical services at the new premises (in accordance with paragraph 34 of Schedule 2), give notice to F427NHS England of when, before C commences the provision of pharmaceutical services at the new premises, C is to cease to provide pharmaceutical services at the existing premises.

F1045

If C has consented to—

a

particular listed chemist premises no longer being listed by F427NHS England; or

b

being removed from a pharmaceutical list for the area of a HWB,

in the context of a consolidation application, paragraph (6) applies.

6

In the circumstances described in paragraph (5), in the context of an application—

a

to which regulation 26A(3) applies, if it is granted—

i

C 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; but

ii

C who is P1 for the purposes of regulation 26A(3) need not issue a notice under this regulation;

b

to which regulation 26A(4) applies, if it is granted—

i

C 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; but

ii

C who is P2 for the purposes of regulation 26A(4) need not issue a notice under this regulation.

F237Condition relating to entering administration67A

1

An NHS chemist must, if the NHS chemist enters administration, notify F427NHS England of that fact.

2

For these purposes, “enters administration” has the meaning given in paragraph 1(2)(b) of Schedule B1 to the Insolvency Act 1986 (administration).

Conditions relating to local resolution of disputes over terms of service68

1

It is a condition of the inclusion of each NHS chemist (C) in a pharmaceutical list by F427NHS England that C makes every reasonable effort to communicate and co-operate with F427NHS England with a view to resolving any dispute between C and F427NHS England relating to C's compliance with the terms of service under which C provides pharmaceutical services for F427NHS England.

2

F427NHS England may not vary or remove the condition imposed by virtue of paragraph (1).

PART 10Performance related sanctions and market exit

Local dispute resolution before serving remedial notices or breach notices69

1

Subject to paragraph (3), before issuing a notice under regulation 70 or 71, F427NHS 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 F427NHS England relating to C's compliance with C's terms of service.

2

Where an NHS pharmacist invites a Local Pharmaceutical Committee to participate in the attempts to resolve the dispute, F427NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the dispute.

3

Paragraphs (1) and (2) do not apply where F427NHS England is satisfied—

a

the dispute relates to a matter that has already been the subject of dispute resolution between F427NHS 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; or

b

that it is appropriate to proceed immediately to issuing a notice under regulation 70 or 71—

i

because listed chemist premises are not, or have not been, open during core opening hours or supplementary opening hours without good causeF133, F427NHS England having made reasonable efforts to communicate with C with a view to establishing what the cause was,

ii

to protect the safety of any persons to whom C may provide pharmaceutical services, or

iii

to protect F427NHS England from material financial loss.

F427NHS England may rescind a remedial notice at any time.

is situated in the area to which the announcement relates, and

ii

has 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).

Payment withholdings: supplementary matters72

1

A 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—

a

F427NHS England is satisfied that the breach to which the withholding relates is, or was, without good cause;

b

the amount withheld is justifiable and proportionate, having regard to the nature and seriousness of the breach and the reasons for it;

c

F427NHS 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.

2

F427NHS 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.

3

Withholdings 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.

4

For the purposes of regulations 70(4) and 71(3), remuneration determined by the Secretary of State, or by F427NHS England acting as determining authority pursuant to regulation 91(1), is remuneration due to C under the Drug Tariff.

1

Subject to paragraphs (2) and (4), if an NHS chemist (C)—

a

dies;

b

in the case of an NHS pharmacist, ceases to carry on a retail pharmacy business; or

c

c

in compulsory whole-time service in the armed forces of the Crown (including service resulting from reserve liability); or

d

where 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.

5

Before taking a decision to remove C, or chemist premises listed in relation to C, from a pharmaceutical list under paragraph (1) or (3), F427NHS England must—

a

give notice to C (or, in appropriate circumstances, a person whom F427NHS England reasonably believes is representing C or is an executor of C) of the decision that F427NHS England is minded to take;

b

as part of that notification, advise C (or the representative or executor) that they may make—

i

written representations to F427NHS England with regard to that action, provided they notify F427NHS England with those representations within 30 days beginning with the date of the notification by F427NHS England, and

ii

oral representations to F427NHS England with regard to that action, provided—

aa

they notify F427NHS England of their wish to do so within 30 days beginning with the date of the notification by F427NHS England, and

bb

C (or the representative or executor, or someone representing the representative or executor) attends the hearing that F427NHS England arranges for the purpose of hearing those representations, which F427NHS England must give C reasonable notice of; and

c

consult any Local Pharmaceutical Committee whose area includes the chemist premises that F427NHS England is minded to remove from the pharmaceutical list.

6

If F427NHS 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—

a

a statement of the reasons for the decision; and

b

an explanation of how C's rights of appeal under regulation 77(1)(d) may be exercised.

Voluntary and automatic removal of listings: change of ownership, relocation, temporary provision and voluntary closure75

1

If, as a consequence of a change of ownership application F109or 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—

a

if there are other chemist premises listed in that pharmaceutical list in relation to C, F427NHS England must remove the listing of the particular premises in relation to C from that list; or

b

if there are no other chemist premises listed in that pharmaceutical list in relation to C, subject to regulation 76, F427NHS England must remove C from that pharmaceutical list.

2

If C is relocating from existing chemist premises listed in a particular pharmaceutical list to new chemist premises F108other than as a consequence of a consolidation application—

a

if—

i

there are other chemist premises listed in that pharmaceutical list in relation to C, or

ii

there 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,

F427NHS 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 F427NHS England under F85regulation 67(4); or

b

if—

i

there are no other premises listed in that pharmaceutical list in relation to C, and

ii

Limitation on withdrawal from pharmaceutical lists while fitness investigations or proceedings are ongoing76

1

If F427NHS England would otherwise remove an NHS chemist (C) from a pharmaceutical list under regulation 75, but—

a

is 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 M70(which relate to disqualification of practitioners, contingent removal and suspension), or regulation 80;

b

has decided to—

i

remove C from a pharmaceutical list under section 151 or 152 of the 2006 Act or regulation 80, or

ii

contingently remove C under section 152 of the 2006 Act,

but C has not yet been removed or contingently removed; or

c

has 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.

2

If C's name is kept on a pharmaceutical list pursuant to paragraph (1)—

a

as regards C, F427NHS England may exercise its functions under—

i

Part 11 of these Regulations, and

ii

Chapter 6 of Part 7 of the 2006 Act (pharmaceutical services and local pharmaceutical services – disqualification); but

b

for all other purposes, C is to be treated as having been removed from that pharmaceutical list under regulation 75.

Appeals against decisions under Part 1077

1

An NHS chemist (C) may appeal against the following decisions by F427NHS England—

a

the issuing of a remedial notice under regulation 70, including—

i

the specified steps that C must take that are in the notice,

ii

the duration of the notice period in the notice,

iii

any decision to provide for a withholding of remuneration that is included in the notice, and

regulation 35 or 79, or as varied under regulation 79; or

b

regulation 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.

Mandatory removal in suitability cases81

In unsuitability cases, F427NHS England must remove an NHS chemist (C) from a pharmaceutical list if—

a

C (or where C is a body corporate, any director or superintendent of C) has been convicted in the United Kingdom of murder;

b

C (or where C is a body corporate, any director or superintendent of C)—

i

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

ii

has been sentenced to a term of imprisonment of over 6 months; or

c

C is the subject of a national disqualification.

Fitness cases: procedures for removal or contingent removal from pharmaceutical lists82

1

This paragraph applies where F427NHS England is considering—

a

removing an NHS chemist (C) from a pharmaceutical list under section 151 or 152(3)(b) of the 2006 Act M72 (which relate to disqualification of practitioners and contingent removal);

b

removing C from a pharmaceutical list under regulation 80; or

c

contingently removing C from a pharmaceutical list under section 152(1) of the 2006 Act M73.

2

Where paragraph (1) applies, before reaching its decision, F427NHS England must—

a

notify C of the action F427NHS England is considering taking and its grounds for considering taking that action; and

b

as part of that notification—

i

inform C of any allegation against C, and

ii

advise C that C may make—

aa

bb

oral representations to F427NHS England with regard to that action, provided C notifies F427NHS England of C's wish to do so within 30 days beginning with the date of the notification by F427NHS England and C (or a representative of C) attends the hearing that F427NHS England arranges for the purpose of hearing those representations, which F427NHS England must give C reasonable notice of; and

c

in an unsuitability case to which regulation 81(a) or (b) applies, if C is a body corporate, advise C that F427NHS 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—

i

the 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 F427NHS England, and

ii

within that period, C notifies F427NHS England of the date on which the director or superintendent has ceased or is to cease to be a director or superintendent of C.

3

Once F427NHS 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—

a

the reasons for the decision;

b

if F427NHS England has decided to remove or contingently remove C from a pharmaceutical list—

i

C's rights of appeal in relation to that decision under section 158 of the 2006 Act M74 (appeals), and

ii

the time limit within which, in accordance with the Tribunal Procedure (First-tier Tribunal) (Health, Education and Social Care Chamber) Rules 2008 M75, the application notice must be sent to the Tribunal if an appeal is to be brought; and

c

if F427NHS England has decided to contingently remove C, the arrangements for review of the conditions under section 157(1) of the 2006 Act M76 (review of decisions).

4

If F427NHS 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—

a

if C does not appeal against the decision, until the period for bringing an appeal against the decision has elapsed; or

b

if C does appeal against the decision, unless the First-tier Tribunal has determined the appeal and confirmed the decision of F427NHS England (if the First-tier Tribunal takes a different decision to the decision taken by F427NHS England, that decision takes effect upon the taking of that decision, unless the First-tier Tribunal directs otherwise).

ii

the time limit within which, in accordance with the Tribunal Procedure (First-tier Tribunal) (Health, Education and Social Care Chamber) Rules 2008 M80, the application notice must be sent to the Tribunal if an appeal is to be brought; and

c

if 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.

General power to revoke suspensions in appropriate circumstances85

1

If an NHS chemist is suspended from a pharmaceutical list, in addition to F427NHS England’s powers to terminate suspensions under section 157(3)(b) of the 2006 Act M81 (review of decisions) on a review, F427NHS England may terminate the suspension at any time, in appropriate circumstances.

2

If F427NHS England terminates a suspension under paragraph (1), it must notify the NHS chemist that it has done so.

Internal handling of fitness information by F427NHS England or an agent of F427NHS England86

1

F427NHS 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 F427NHS England employs in circumstances where F427NHS England is satisfied that they—

a

should have access to the information on a need-to-know basis; and

b

fully understand the confidential nature of the information and the purposes for which they are being permitted access to it.

2

Where functions of F427NHS England relating to the fitness of NHS chemists or LPS chemists are carried out on behalf of F427NHS England by an agent of F427NHS England—

a

the reference in paragraph (1) to persons whom F427NHS 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 F427NHS England’s behalf as mentioned in sub-paragraphs (a) and (b) of paragraph (1)); and

b

F427NHS 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.

Review periods for national disqualifications87

1

Section 159(8)(a) of the 2006 Act M82 (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.

2

Section 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.

3

Section 159(8) of the 2006 Act is to have effect as if the references to “two years” and “one year”—

a

in a case where—

i

a national disqualification has been imposed as a consequence of a criminal conviction, and

ii

on appeal, the conviction has been quashed or the penalty imposed by the court has been reduced; or

b

in a case where—

i

a national disqualification has been imposed as a consequence of an adverse decision of a licensing body, and

ii

on 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.

Wider notifications of fitness decisions88

1

Where F427NHS England—

a

refuses an application from a person (P) by virtue of regulation 33;

b

grants an application subject to conditions imposed on P by virtue of regulation 35;

c

imposes or varies a condition imposed on P by virtue of regulation 79;

d

removes P from a pharmaceutical list by virtue of section 151 or 152(3)(b) of the 2006 Act M83 (which relate to disqualification of practitioners and contingent removal);

e

contingently 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; or

f

8

If—

a

having notified a person under paragraph (1) of a suspension or a condition (including a condition imposed on contingent removal); or

b

after 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),

F427NHS England terminates the suspension or removes the condition, F427NHS England must notify that person with the notification given to P of the decision to terminate the suspension or remove the condition.

PART 12Remuneration, charges and refunds

The Drug Tariff and section 164: general provisions89

1

The Drug Tariff referred to in section 127(4) of the 2006 Act (arrangements for additional pharmaceutical services) is the aggregate of—

a

the determinations of remuneration made by the Secretary of State, acting as a determining authority, under section 164 of the 2006 Act M85 (remuneration for persons providing pharmaceutical services), but not of the remuneration of dispensing doctors;

b

the determinations of remuneration made by F427NHS England, acting as a determining authority, pursuant to regulation 91(1); and

c

any 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.

2

Determinations under section 164 of the 2006 Act by the Secretary of State or F427NHS England may be made by reference to—

a

the drugs and appliances dispensed or expected to be dispensed in accordance with NHS prescriptions during a reference period determined by the Secretary of State;

b

lists of published prices produced by suppliers of the drugs or appliances that are available from them on NHS prescription;

c

scales, 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; and

d

any 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—

i

in the form current at the time of the determination; and

ii

in any subsequent form taking effect after that time.

3

Amendments 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.

4

The 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).

5

The 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 F427NHS England), and—

a

claims by NHS chemists for payments under the Drug Tariff must be made in accordance with those arrangements;

b

payments under the Drug Tariff must be made—

i

by F427NHS England (or a person exercising its functions), and

ii

in 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); and

c

the arrangements may include arrangements for auditing, monitoring or analysing the making of payments.

Data to be provided to assist Drug Tariff determinations90

1

The data which the Secretary of State and F427NHS England may take into account prior to making a determination under section 164 of the 2006 Act M86 (remuneration for persons providing pharmaceutical services) may include information obtained pursuant to paragraph (3) by—

a

the Secretary of State or a person appointed by the Secretary of State under this paragraph; or

b

F427NHS England or a person appointed by F427NHS England under this paragraph,

and a person appointed under this paragraph is referred to in this regulation as “a nominee”.

2

Before appointing a person to be a nominee, the Secretary of State or F427NHS 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.

3

An NHS chemist must, within 30 days of a request to do so, provide—

a

the 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; or

b

F427NHS England or a nominee of F427NHS England with information (for example invoices) which F427NHS England considers to be relevant to the matters F427NHS England may take into account prior to making a determination under section 164 of the 2006 Act.

4

A nominee may handle and process information obtained under paragraph (3).

5

The Secretary of State may require—

a

information obtained by a nominee of the Secretary of State under paragraph (3)(a) to be obtained; and

b

information 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.

6

F427NHS England may require—

a

information obtained by a nominee of F427NHS England under paragraph (3)(b) to be obtained; and

b

information processed or handled by a nominee of F427NHS England under paragraph (4) to be processed or handled,

in such manner as F427NHS England may reasonably specify.

7

The Secretary of State and F427NHS 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).

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.

7

In 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—

a

the amount that they paid for the drug or medicine when they purchased it; and

b

the 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.

Dispensing doctor remuneration92

1

As regards the pharmaceutical services provided by dispensing doctors—

a

For the purposes of paragraph (1), a claim for repayment is only valid if duly made—

a

in such form and manner as the Secretary of State has determined for an application for such a repayment under F65regulation 18(2)(b) of the Charges Regulations M89 (repayment of charges); or

b

on an equivalent form issued in Scotland, Wales or Northern Ireland.

Reward scheme97

1

An 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 F427NHS England, in accordance with the Drug Tariff, if—

a

the 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 F427NHS England of this action as soon as practicable; or

b

has 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 F427NHS 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 F427NHS England.

2

Where F427NHS England establishes that an order about which it has been notified in accordance with paragraph (1) was not a genuine order, F427NHS England must make such payment as is due to the NHS chemist under the Drug Tariff.

3

In this regulation, “order” includes a purported order.

Payments to suspended chemists98

1

If an NHS chemist (C) is suspended from a pharmaceutical list, F427NHS 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.

2

A determination under paragraph (1) may be amended from time to time by a further determination under that paragraph.

3

Before 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.

4

A determination under paragraph (1) must be published in the Drug Tariff.

5

A 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.

6

If 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 F427NHS England, directs otherwise) draw the overpayment to the attention of C, and—

a

where C admits the overpayment; or

b

if 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.

7

C may appeal to the Secretary of State against the following decisions by F427NHS England—

a

a refusal to make payments to C under the determination under paragraph (1);

b

the level of any payments made to C under the determination under paragraph (1); or

c

a 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.

8

A notice under paragraph (7) is valid only if it includes a concise and reasoned statement of the grounds of appeal.

9

Schedule 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 13Local Pharmaceutical Services

Designation of areas, premises or descriptions of premises99

1

F427NHS England may designate relevant areas, premises or descriptions of premises for the purposes of paragraph 2 of Schedule 12 to the 2006 Act M90 (LPS schemes – designation of priority neighbourhoods or premises).

2

Any designation made is to be of an area in which, or premises or descriptions of premises at 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.

3

Any designation made must—

a

be made in writing and be dated;

b

include a map showing the location of the area, premises or description of premises designated; and

c

include an outline of the services to be provided under the relevant scheme.

4

F427NHS England must give notice of the designation to—

a

the 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;

b

any Local Pharmaceutical Committee whose area includes the premises, descriptions of premises, or all or part of the area to which the designation relates;

c

any Local Medical Committee whose area includes the premises, descriptions of premises, or all or part of the area to which the designation relates;

d

any NHS chemist whose listed chemist premises—

i

are in the area of HWB1, or

ii

are in the area of a neighbouring HWB and whose interests are likely, in the opinion of F427NHS England, to be affected by the designation;

e

any person who is entitled because of the grant of a routine or excepted application to be included in a pharmaceutical list—

i

for the area of HWB1, or

ii

ii

all the (current) designations of Primary Care Trusts, including their varied designations, under regulation 4 of the 2006 Regulations; and

b

ensure that each HWB has access to those designations which is sufficient to enable the HWB to carry out its functions under these Regulations.

Review of designations100

1

F427NHS England must regularly review—

a

all its designations, including designations it has varied, under regulation 99; and

b

all 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.

2

When conducting a review under paragraph (1), F427NHS England must take into account any responses it or a Primary Care Trust received when the designation was last notified.

3

In a case where a designation is not varied or cancelled as a result of a review, F427NHS 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.

Cancellation of designations101

1

F427NHS England may at any time cancel—

a

any of its designations, including designations it has varied, under regulation 99; and

b

any of the designations of Primary Care Trusts, including their varied designations, under regulation 4 of the 2006 Regulations (designation of priority neighbourhoods or premises).

2

F427NHS England must cancel a designation—

a

if required to do so by a direction given by the Secretary of State under section 168A of the 2006 Act M92 (exercise of functions);

b

within 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 F427NHS England (or before the appointed day by a Primary Care Trust) for approval;

c

if, 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;

d

if there has been a significant change to the area in which, or to the premises from which, LP services are to be provided, other than a change which leads to a variation of the designation under regulation 99(5); or

e

if or when an LPS contractor commences the provision of LP services at the designated location.

3

F427NHS 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.

4

If a designation has been cancelled under this regulation or regulation 6 of the 2006 Regulations (cancellation of designations by a Primary Care Trust), F427NHS 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 F427NHS England or a Primary Care Trust of a proposal to enter into an LPS scheme.

Terms of service for LPS schemes: general102

1

Each LPS scheme must specify—

a

the LP services to be provided under the scheme, which must include the dispensing of drugs; and

b

the address of the premises at or from which those services are to be provided (“the scheme premises”).

2

If the provider of services under an LPS scheme is a health service body, the scheme must state that it is an NHS contract.

3

Each LPS scheme must contain the terms, or terms which make provision that has the same effect as the terms, set out in Schedule 7.

the LPS contractor—

i

is situated in the area to which the announcement relates, and

ii

has 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).

LPS schemes: health service body status103

1

Subject 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 M93 (NHS contracts) unless—

a

as regards an LPS scheme established by a Primary Care Trust before the appointed day, either—

i

before 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, or

ii

before 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; or

b

before the LPS scheme is entered into, the proposed provider (or providers) under the scheme object to that by a notice in writing to F427NHS England.

2

Where 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.

3

C 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—

a

if—

i

C is the only other party to the scheme, F427NHS England must agree to the variation, or

ii

if all the parties to the scheme other than F427NHS England are together making the request, F427NHS England must agree to the variation; and

b

the procedure in paragraph 26 of Schedule 7 is to apply.

4

Where, pursuant to paragraph (3), F427NHS England agrees to a variation of an LPS scheme, C is (as the case may be)—

a

to be treated as a health service body; or

b

subject 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.

5

Subject 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—

a

the scheme is varied so that person is no longer a provider under that scheme; or

b

the scheme, or the agreement that is part of the scheme to which that person is a party, is terminated.

6

Where a person ceases to be treated as a health service body pursuant to—

F55a

paragraph (4)(b), where C or F427NHS England—

i

has referred any matter to the NHS dispute resolution procedure before C ceases to be a health service body, or

ii

refers 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;

b

paragraph (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.

Development of LPS schemes104

1

F427NHS England may make payments of financial assistance in respect of the development of LPS schemes.

2

If a proposal for an LPS scheme is submitted to F427NHS England, it must consider whether or not to select that proposal for development, unless the proposal is vexatious or frivolous.

Persons permitted to be parties to LPS schemes: fitness criteria105

1

F427NHS England may only be a party to an LPS scheme with the following—

a

an individual who does not fall within paragraph (2);

b

a partnership (other than a limited liability partnership) where each partner does not fall within paragraph (2);

c

a body corporate where—

i

the body corporate, and

ii

any director, chief executive, superintendent or company secretary of the body corporate,

do not fall within paragraph (2).

2

A person (P) falls within this paragraph if—

a

P is the subject of a national disqualification;

b

Subject 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;

c

P 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;

d

P has been convicted in the United Kingdom of murder;

e

P has been convicted in the United Kingdom of a criminal offence other than murder—

i

which was committed on or after 1st April 2006, and

ii

for which P has been sentenced to a term of imprisonment of over 6 months;

f

subject to paragraph (4), P has elsewhere than the United Kingdom been convicted of an offence which, if committed in England or Wales—

i

would constitute murder, or

ii

would constitute a criminal offence, and

aa

which was committed on or after 1st April 2006, and

bb

for which P has been sentenced to a term of imprisonment of over 6 months;

g

P has been convicted of an offence referred to in—

i

Schedule 1 to the Children and Young Persons Act 1933 M94 (offences against children and young persons with respect to which special provisions of the Act apply), or

ii

bb

section 34(5)(e) or (ea) of the Charities and Trustee Investment (Scotland) Act 2005 M101 (powers of the Court of Session),

from being concerned with the management or control of any body;

k

P 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—

i

a disqualification order or disqualification undertaking under the Company Directors Disqualification Act 1986 M102 or the Company Directors Disqualification (Northern Ireland) Order 2002 M103, or

ii

an order made under section 429(2) of the Insolvency Act 1986 M104 (disabilities on revocation of a county court administration order); or

l

P has, in the case of an individual, refused to comply with a request from F427NHS England for P to be medically examined on the grounds that F427NHS England is concerned that P is incapable of adequately providing services under the scheme.

3

A person does not fall within paragraph (2)(b) if F427NHS 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—

a

a party to an LPS scheme; or

b

in 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.

4

A person does not fall within paragraph (2)(f) where F427NHS England is satisfied that the conviction does not make P unsuitable to be—

a

a party to an LPS scheme; or

b

in 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.

has had an application for inclusion in a relevant list refused,

ii

has been conditionally included in a relevant list,

iii

has been removed or contingently removed from a relevant list,

iv

is suspended from a relevant list,

and if so, the name of the relevant primary care organisation; or

n

but who is not (yet) included;

f

any LPS chemist whose scheme premises—

i

are in the area of HWB1, or

ii

are in the area of a neighbouring HWB and whose interests are likely, in the opinion of F427NHS England, to be affected by the proposal;

g

any dispensing doctor whose listed dispensing premises—

i

are in the area of HWB1, or

ii

are in the area of a neighbouring HWB and whose interests are likely, in the opinion of F427NHS England, to be affected by the proposal; and

h

any Local Healthwatch organisation for the area of HWB1.

Right of return to pharmaceutical lists: LPS contractors108

1

Before F427NHS 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.

2

If an LPS scheme is varied so as to—

a

relocate the provision of local pharmaceutical services under the scheme to different scheme premises; or

b

change a party (other than F427NHS England) to the scheme,

F427NHS 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.

3

If 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).

4

F427NHS 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—

a

at 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)); or

b

if asked to do so by an LPS contractor.

5

F427NHS England must publish the principles by reference to which it makes determinations under this regulation and may amend those principles from time to time.

6

Where F427NHS England makes, varies or rescinds a determination under this regulation, it must give notice of that decision to—

a

the HWB (HWB1) for the area in which are situated the scheme premises for the relevant LPS scheme;

b

any Local Pharmaceutical Committee for the area in which are situated the scheme premises for the relevant LPS scheme;

c

any Local Medical Committee for the area in which are situated the scheme premises for the relevant LPS scheme;

d

any NHS chemist whose listed chemist premises—

i

are in the area of HWB1, or

ii

are in the area of a neighbouring HWB and whose interests are likely, in the opinion of F427NHS England, to be affected by the decision;

e

any person who is entitled because of the grant of a routine or excepted application to be included in a pharmaceutical list—

i

for the area of HWB1, or

ii

for the area of a neighbouring HWB, if their interests are likely, in the opinion of F427NHS England, to be affected by the decision,

but who is not (yet) included;

f

any LPS chemist whose scheme premises—

i

are in the area of HWB1, or

ii

are in the area of a neighbouring HWB and whose interests are likely, in the opinion of F427NHS England, to be affected by the decision;

g

any dispensing doctor whose listed dispensing premises—

i

are in the area of HWB1, or

ii

are in the area of a neighbouring HWB and whose interests are likely, in the opinion of F427NHS England, to be affected by the decision; and

h

any Local Healthwatch organisation for the area of HWB1.

LPS pilot schemes: health service body status109

1

Where 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.

2

If P is a health service body for the purposes of an LPS pilot scheme, P may at any time request a variation by F427NHS England of the scheme so as to provide that the scheme is to cease to be an NHS contract, and if P does—

a

F427NHS England must agree to the variation; and

b

subject 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.

3

Subject 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—

a

is varied so that person is no longer the provider of piloted services under that scheme; or

b

is terminated.

4

Where a person ceases to be a health service body for the purposes of an LPS pilot scheme agreement pursuant to—

F56a

paragraph (2)(b), where P or F427NHS England—

i

has referred any matter to the NHS dispute resolution procedure before P ceases to be a health service body, or

ii

3

There 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.

Sharing of information about LPS chemists and their employees with the General Pharmaceutical Council112

Where F427NHS 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.

Directions to the First-tier Tribunal relating to local pharmaceutical services113

1

The 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—

a

give effect to paragraphs 21, 22 and 29 of Schedule 7; and

b

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—

i

as to whether a person falls within paragraph 29(2) of Schedule 7 during the existence of the scheme, or

ii

in respect of a decision by F427NHS England under paragraph 29(3) or (4) of Schedule 7.

2

The 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.

Lists of LPS chemists114

1

In respect of the area of each HWB, F427NHS 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.

2

The lists must include—

a

i

in the care of an authority to whose care that person has been committed under the Children Act 1989 M108, by a person duly authorised by that authority, or

ii

in the care of a voluntary organisation, by that organisation or a person duly authorised by them;

c

on 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; or

d

on behalf of any other person by a duly authorised person.

the functions relating to—

i

receiving and determining any appeal which, by virtue of Schedule 9, the Secretary of State is required to determine, and

ii

dispute 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).

2

The 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.

3

The 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.

Proceedings relating to overridden arrangements118

Where, 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—

a

any 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); and

b

if 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.

Transitional provisions119

The transitional provisions set out in Schedule 9 have effect.

paragraph 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).

4

For the purposes of this regulation, “pharmaceutical reimbursement” has the meaning given in paragraph 19(3) of Schedule 7.

Amendments and revocations120

The amendments to and revocations of enactments set out in Schedule 10 have effect.

Review of these RegulationsF82121

Information to be included in all routine and excepted applications for inclusion in a pharmaceutical list2

1

The information mentioned below in this paragraph must be included in all routine and excepted applications for inclusion in a pharmaceutical list.

2

If the applicant (A) is an individual or a partnership—

a

A's or each partner's full name;

b

A's or each partner's sex;

c

A's or each partner's date of birth;

d

A's or each partner's private address and telephone number;

e

a declaration that A or each partner is a registered pharmacist, if A is seeking entry in the list mentioned in regulation 10(2)(a);

f

if 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 M109 (general provisions), if A is seeking entry in the list mentioned in regulation 10(2)(a); and

g

if 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).

3

If A is a body corporate—

a

A's registered name and any other name under which A trades;

b

A's company registration number;

c

A's registered office and any fixed line telephone number relating to that office;

d

the private address and date of birth of A's superintendent (if A is seeking entry in the list mentioned in regulation 10(2)(a));

e

the 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;

f

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, if A is seeking entry in the list mentioned in regulation 10(2)(a); and

g

4

If the services that A undertakes to provide consists of or includes the supply of appliances, the appliances A undertakes to supply.

is the person making the application; and

b

qualified 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.

Details of any case in which an application by C1 or C2 has lapsed by virtue of regulation 35(8).

Fitness information that has already been provided under pharmaceutical or local pharmaceutical services5

1

If information mentioned in paragraph 3 or 4 has already been provided to F427NHS 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 F427NHS England in relation to the current application.

2

An applicant relying on paragraph (1) must, when making its application—

a

confirm to F427NHS England that F427NHS England already has all the information required under paragraphs 3 and 4; or

b

if there is any missing information required under those paragraphs—

i

confirm to F427NHS England what information F427NHS England already has, and

ii

provide the missing information.

F3973

Unless 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.

4

Information 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.

5

If 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—

a

an up to date declaration, together with any information that the applicant needs to provide in support of that declaration; or

b

any 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).

F362Updating of information about or relating to a superintendent5A

1

Where, 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—

a

the details about that superintendent that the applicant would have been required to submit under paragraph 3; and

b

the 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.

2

If—

a

the application has been determined by NHS England but—

i

there are proceedings relating to the application that have not yet reached their final outcome, or

ii

in 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; and

b

NHS 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).

Applications seeking the listing of premises that are already, or are in close proximity to, listed chemist premises6

If, as regards a routine or excepted application—

F59a

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F59b

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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.

Additional information to be included with routine applications7

1

If an applicant (A) is making a routine application and is seeking to satisfy F427NHS 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—

a

that 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); or

b

that 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 F45Trust), A must include in that application, details that explain A's belief that regulation 18(1)(b) is satisfied in relation to that application.

2

Where an applicant includes information in an application pursuant to paragraph (a) but not paragraph (b) of sub-paragraph (1), F427NHS England must not consider whether regulation 18(1)(b) applies in relation to that application when it determines that application.

Additional information to be included with excepted applications8

If the applicant (A) is making an excepted application, A must include in that application details that explain—

a

A'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 M113 (regulations as to pharmaceutical services) are not to apply in relation to that application; and

b

if the regulation includes reasons for which the application must be refused, why the application should not be refused for those reasons.

Undertakings9

F1101

An applicant (A) must provide the following undertakings—

a

an undertaking to notify F427NHS England within 7 days of any material changes to the information provided in the application that occur before—

i

the application is withdrawn,

ii

while 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, or

iii

if 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;

b

an undertaking to notify F427NHS England if A is included, or applies to be included, in any other relevant list of another primary care organisation before—

i

the application is withdrawn,

ii

while 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, or

iii

if the application is granted, A commences the provision of the services to which the application relates,

ending on the date specified by the applicant in accordance with paragraph (1)(b)(ii), if F427NHS 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;

b

in circumstances where the applicant has, in accordance with sub-paragraph (1)(b)(iii), sought a review by F427NHS England of the reasonableness of the request, if the review determines that any or all of the information or documentation requested—

i

must after all, be provided, the application is to be treated as withdrawn unless the information or documentation that must still be provided is provided within a new period reasonably specified by F427NHS England for the provision of that information or documentation,

ii

need not be provided by the applicant, the request of F427NHS England is to be treated as withdrawn to the extent that it relates to information or documentation that need not be provided.

3

F427NHS 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.

Failure to provide undertakings or fees12

1

If, when an applicant (A) submits an application, A fails to provide with the application—

a

the undertakings referred to in paragraph 9 that are relevant to the application, F427NHS 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; or

b

any fee payable in respect of that application by virtue of directions under section 131 of the 2006 Act (power to charge), F427NHS 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.

2

If A fails to comply with a request under sub-paragraph (1) within a period reasonably specified by F427NHS England under that sub-paragraph, the application is to be treated as withdrawn.

Functions of F427NHS England in relation to fitness information relevant to F46applications: aggregation of information13

Where an applicant (A) is relying on paragraph 5(1), F427NHS 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.

Deferral of notifiable applications prior to notification14

1

F427NHS England, having received—

a

a 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); or

b

a 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.

2

If consideration of the application is deferred prior to notification, once F427NHS 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 F427NHS England is required to treat it as withdrawn.

Refusal of notifiable applications prior to notification because of the language requirement for some NHS pharmacists15

F427NHS 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.

Refusal of notifiable applications on fitness grounds prior to notification16

F427NHS 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).

Proposed new pharmacy premises in controlled localities: refusal of routine applications because of preliminary matters prior to notification17

F427NHS 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 3Notification of certain applications

Applications requiring notifications18

An application is a “notifiable application” for the purposes of this Schedule if—

a

it is a routine application; or

b

it is an excepted application pursuant to regulation 24, 25F112, 26(2) or 26A,

and F427NHS England has not decided to dispense with the notification pursuant to paragraphs 15 to 17.

d

any LPS chemist—

i

with whom F427NHS England has made arrangements for the provision of any local pharmaceutical services in the area of HWB2, and

ii

whose interests might, in the opinion of F427NHS England, be significantly affected if the application were granted;

e

f

if the applicant is seeking to locate premises within 1.6 kilometres of a controlled locality in the area of HWB2—

i

any provider of primary medical services, or

ii

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 F427NHS England, has a significant interest in the outcome of the application.

4

Those notified under sub-paragraphs (1) to (3) may make representations in writing about the application that is the subject of the notification to F427NHS England, provided they do so within 45 days of the date on which notice of the application was given to them F363, or within 30 days in the case of applications pursuant to regulation 26A.

F1135

A 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—

a

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

b

to secure improvements, or better access, to pharmaceutical services.

Parallel notifications20

1

If F427NHS 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).

2

If, as a consequence of a notifiable application, F427NHS England is required, by virtue of regulation 41 to determine whether or not an area is a reserved location, F427NHS England must consider giving notice under this Part at the same time that it gives notice under regulation 41(4).

information supplied by A is considered by A to be confidential to A; and

b

A does not consent to the information being disclosed as part of the notification,

F427NHS 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.

5

6

If 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 4Determination and deferral of applications

Flexibility with regard to determining or deferring applications22

1

Except in so far as these Regulations provide to the contrary, F427NHS England is to determine or defer routine and excepted applications in such manner (including with regard to procedures) as it sees fit.

2

F427NHS England may determine a routine or excepted application without hearing any oral representations, if it considers that oral representations are unnecessary.

3

Where appropriate, F427NHS 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).

Additional matters for consideration in relation to applications for inclusion in a pharmaceutical list23

1

In 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, F427NHS England must, prior to determining the application—

a

check with the NHS BSA 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;

b

check 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—

i

the application should be refused or deferred under regulations 33 or 34, or

ii

conditions should be imposed under regulation 35;

c

take up references from, and check the references provided by, the referees whose details A is required to provide pursuant to paragraph 3(8).

2

In such a case, having considered whether—

a

the application should be refused or deferred under regulations 33 or 34; or

b

conditions 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.

a 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.

3

If A informs F427NHS 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.

Oral hearings25

1

If F427NHS England does decide to hear oral representations, it must—

a

give 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; and

b

in 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.

2

For these purposes, a person (P) is an “additional presenter” if—

a

the application to which the oral hearing relates is a notifiable application;

b

P was given notice of the application under Part 3 and made representations about the application in accordance with paragraph 19(4), which—

i

indicated that, if there were to be an oral hearing in relation to the application, P would wish to make oral representations at that hearing, and

ii

identified a matter about which F427NHS England considers it would be desirable to hear further evidence from P at the oral hearing; and

c

F427NHS England is satisfied that P made a reasonable attempt to express P's views on the application adequately in P's written representations.

3

If F427NHS 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.

Persons barred from taking part in decision making on routine and excepted applications26

1

No person is to take part in determining or deferring any routine or excepted application who—

a

is a person who is included in a pharmaceutical list or is an employee of such a person;

b

assists 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);

c

is an LPS chemist, or provides or assists in the provision of local pharmaceutical services;

d

is a provider of primary medical services;

e

is 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;

f

is employed or engaged by a primary medical services provider; or

g

is employed or engaged by an APMS contractor in any capacity relating to the provision of primary medical services,

any part of whose area is within 2 kilometres of the premises or location to which the application relates;

d

any person—

i

included in a pharmaceutical list for the area of the relevant HWB, or

ii

who 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 F427NHS England, be significantly affected by the decision;

e

any LPS chemist—

i

with whom F427NHS England has made arrangements for the provision of any local pharmaceutical services in the area of the relevant HWB, and

ii

whose interests might, in the opinion of F427NHS England, be significantly affected by the decision;

f

any 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 F427NHS England, has a significant interest in the decision;

g

if the applicant is seeking to locate premises in or within 1.6 kilometres of a controlled locality in the area of the relevant HWB—

i

any provider of primary medical services, or

ii

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 F427NHS England, has a significant interest in the decision;

h

any person—

i

whom F427NHS England notified under paragraph 19(2), and

ii

who made representations in writing about the application under paragraph 19(4);

i

any Local Health Board any part of whose area is within 2 kilometres of the premises or location to which the decision relates; and

j

the 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.

who 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 F427NHS England, be significantly affected by the decision;

d

any LPS chemist—

i

with whom F427NHS England has made arrangements for the provision of any local pharmaceutical services in the area of HWB2, and

ii

whose interests might, in the opinion of F427NHS England, be significantly affected by the decision;

e

any Local Healthwatch organisation for the area of HWB2, and any other patient, consumer or community group in its area which, in the opinion of F427NHS England, has a significant interest in the decision; and

f

if the applicant is seeking to locate premises within 1.6 kilometres of a controlled locality in the area of HWB2—

aa

any provider of primary medical services, or

bb

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 F427NHS England, has a significant interest in the decision.

3

As regards any excepted application, once it has determined the application, F427NHS England must, as soon as is practicable, give notice of its decision to—

a

in the case of an application pursuant to regulation 23, the applicant;

b

in the case of an application pursuant to regulation 24, 25F114, 26(2) or 26A—

i

the applicant,

ii

any Local Pharmaceutical Committee whose area includes the premises or location to which the application relates,

iii

any Local Medical Committee whose area includes the premises or location to which the application relates,

iv

the relevant HWB, and if the applicant is relocating to different premises in the area of another HWB, the other HWB, and

v

any (other) person whom F427NHS England notified under paragraph 19 and who made representations in writing about the application under paragraph 19(4);

c

in the case of an application pursuant to regulation 26(1) or 27 to 29—

i

the applicant,

ii

any Local Pharmaceutical Committee whose area includes the premises or location to which the application relates,

iii

any Local Medical Committee whose area includes the premises or location to which the application relates,

iv

any person—

aa

included in a pharmaceutical list for the area of the relevant HWB, or

bb

who 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 F427NHS England, be significantly affected by the decision;

v

any LPS chemist—

aa

with whom F427NHS England has made arrangements for the provision of any local pharmaceutical services in the area of the relevant HWB, and

bb

whose interests might, in the opinion of F427NHS England, be significantly affected by the decision,

who 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 F427NHS England, be significantly affected by the decision;

d

any LPS chemist—

i

with whom F427NHS England has made arrangements for the provision of any local pharmaceutical services in the area of HWB3, and

ii

whose interests might, in the opinion of F427NHS England, be significantly affected by the decision; and

e

any Local Healthwatch organisation for the area of HWB3, and any other patient, consumer or community group in its area which, in the opinion of F427NHS England, has a significant interest in the decision.

5

Where F427NHS 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.

6

Each notification of a decision under this paragraph must include a statement by F427NHS England of the reasons for the decision.

Template notice of commencement to be included with a notice of decision29

F115Subject to paragraph 29A,F427NHS 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 F427NHS England may have included in the template that it sends)—

a

the address of the premises to which the application relates;

b

the services that are to be provided from those premises;

c

the date of the grant of the application;

d

a declaration with regard to when the applicant intends to commence the provision of those services at those premises;

e

in the case of pharmacy premises, the registration number for those premises with the General Pharmaceutical Council; and

f

a signature on behalf of the applicant and the date of the notice.

F124Template notice of consolidation29A

1

This 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—

a

P1 for the purposes of regulation 26A (P1), if regulation 26A(3) applied to that application; or

b

P2 for the purposes of regulation 26A (P2), if regulation 26A(4) applied to that application.

2

F427NHS 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 F427NHS England may have included in the template that it sends)—

a

the date of the grant of the application;

b

the address of the premises at which pharmaceutical services are no longer to be provided (“the closing premises”);

c

the date on which pharmaceutical services are to cease being provided at the closing premises;

d

the address of the premises at which pharmaceutical services are to continue to be provided (“the continuing premises”);

e

the registration number of the continuing premises with the General Pharmaceutical Council;

f

confirmation 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;

g

the date on which the consolidation is to take effect;

h

a signature on behalf of P1 or P2 (whichever has been sent the template) and the date of the notice.

Third party rights of appeal to the Secretary of State where an application is granted30

1

A person with third party rights (as provided for in this paragraph) may appeal to the Secretary of State against a decision of F427NHS 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 F427NHS England’s decision under paragraph 28.

2

For the purposes of this Schedule, a person (P1) is a person with third party rights if—

a

P1 is a person to whom sub-paragraph (3) applies; or

b

P1 was entitled to receive notification of the decision to grant the application by virtue of paragraph 28(5).

3

P1 is a person to whom this sub-paragraph applies if—

a

P1 was a person whom F427NHS 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 F427NHS England, be significantly affected by the decision, and also being—

i

included in a pharmaceutical list,

ii

entitled to be included in a pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,

iii

an LPS chemist, or

iv

either—

aa

a provider of primary medical services, or

bb

another 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 F427NHS 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;

b

in the case of a notifiable application, P1 made representations in writing about the application under paragraph 19(4); and

c

the date on which A was sent the notice of decision under paragraph 28 (having regard also to paragraph 10(2) of Schedule 3);

b

if 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; or

c

in 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.

3

A notification under sub-paragraph (2) is only valid if F427NHS 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).

F473A

For 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.

4

If F427NHS England receives a purported notification under sub-paragraph (2), it must, within 14 days of receiving that purported notification—

a

notify A of whether or not it is satisfied that it is a valid notification;

b

if it is satisfied that it is a valid notification, notify the address to the persons notified of the decision to grant the application; and

c

if F427NHS England is not satisfied that it is a valid notification, it must include with that notification—

i

the reasons for its decision, and

ii

an explanation of how A's rights of appeal under paragraph 36(1)(b) may be exercised.

5

F427NHS England may not vary or remove a condition imposed by virtue of this paragraph.

6

If A breaches a condition imposed by virtue of this paragraph, the grant of the application lapses.

Conditional grant in cases relating to future needs or future improvements or better access33

1

Where F427NHS England grants a routine application because doing so—

a

will meet a future need for pharmaceutical services, or pharmaceutical services of a specified type in its area; or

b

will secure future improvements or better access to pharmaceutical services, or pharmaceutical services of a specified type, in its area,

sub-paragraph (2) applies.

2

Where this sub-paragraph applies, F427NHS England may grant the application subject to a condition that pharmaceutical services are not provided at the listed chemist premises to which the application relates (or at any premises to which the business relocates) until—

a

some or all of the future circumstances, as a consequence of which the application was granted, have arisen; or

b

a 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).

A notice of commencement is invalid unless it is given to F427NHS 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 F427NHS England has agreed with P a shorter period of prior notice.

3B

P must notify F427NHS 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 F398the date on which the provision of services is to commence.

F3993C

A 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).

4

A notice of commencement is invalid unless it is sent to F427NHS England within—

a

if, prior to F427NHS England determining the application—

i

P undertook to commence the provision of the services in respect of which the application was made within a period of less than 6 months, and

ii

that undertaking was not withdrawn,

that period;

b

F23512 months of—

i

unless paragraph (a) applies, the date on which P was sent the notice of F427NHS England’s decision under paragraph 28 granting the application,

ii

if 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,

iii

if, 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),

iv

if the grant of the application was subject to a condition imposed by virtue of paragraph 31, the date on which—

aa

P validly notifies to F427NHS England under a condition imposed by virtue of paragraph 31 of the address of the premises, or

bb

if P appeals successfully against a decision of F427NHS England that a notification under a condition imposed by virtue of paragraph 31 is invalid, that appeal is determined by the Secretary of State,

v

if P, pursuant to paragraph 32—

aa

notifies F427NHS England of a new address,

bb

F427NHS England does not accept the validity of the notification, and

cc

P appeals successfully against that decision,

the date on which that appeal is determined by the Secretary of State, or

vi

if 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, or

whichever is the latest; or

c

such longer period—

i

not exceeding a further 3 months as F427NHS England may allow, or

ii

if—

aa

the grant is appealed by a person with third party appeal rights,

bb

a decision to accept a notification pursuant to paragraph 32 is appealed by a third party,

cc

P appeals successfully against a notice under paragraph 35, or

dd

if 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.

5

A notice of commencement ceases to have effect if the Secretary of State receives a valid notice of appeal—

a

from a person with third party appeal rights relating to the grant to which the notice of commencement relates; or

b

from a third party, in a case to which sub-paragraph (4)(c)(ii)(bb) applies.

F2366

In any case where a longer period allowed by virtue of sub-paragraph (4)(c)—

a

began 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; and

b

ended 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.

7

In 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.

if—

aa

the grant is appealed by a person with third party appeal rights, or

bb

P1 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,

5

A 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.

6

Once, 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.

Notice requiring the commencement of pharmaceutical services35

1

F427NHS England, having granted a routine application—

a

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

b

if 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.

2

to impose or vary a condition imposed pursuant to paragraph 33;

e

to refuse to allow A an extension period under paragraph 34(4)(c)(i) F117or 34A(4)(b)(i); or

f

to 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.

b

contains 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 2Notification of appeals

Notification of appeals notices under paragraph 30, 32(5) or 36 of Schedule 23

1

Unless 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—

a

F427NHS England;

b

in 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;

c

in 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—

i

the applicant (unless they are the person bringing the appeal),

ii

any 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), and

d

in 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).

2

Any 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.

Notification of appeals relating to notices under regulation 454

1

A valid notice of appeal under regulation 45(1)(b) does not need to be notified to others.

2

The Secretary of State must send a valid notice of appeal—

a

against a determination under regulation 36(2) to the persons given notice of the proposed determination under regulation 38(1) or (2); or

b

against a determination under regulation 41(2) or 42(1) to—

i

the person making the routine application to which the determination relates, and

ii

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

unless they are the person bringing the appeal.

3

Any 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.

Notification of appeals relating to decisions under Part 8 of these Regulations5

1

A valid notice of appeal under regulation 63(1)(a) does not need to be notified to others.

2

The Secretary of State must send a valid notice of appeal against—

a

a decision mentioned in regulation 63(1)(b) to the persons, other than the appellant, given notice of the decision under F60regulation 50(7); or

b

a decision or determination mentioned in regulation 63(1)(c) to (f) to—

i

the person who made the original application for outline consent or premises approval,

ii

any 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), and

iii

if 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.

3 Non notification of appeals relating to notices under regulation 77 or 986

A valid notice of appeal under regulation 77 or 98 does not need to be notified to others.

PART 3Determination of appeals

Flexibility with regard to the manner of determining appeals7

1

Except 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.

2

The Secretary of State may determine the appeal without hearing any oral representations, if the Secretary of State considers that oral representations are unnecessary.

3

Where 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—

a

F427NHS England;

b

the appellants; and

c

any other person notified in relation to the appeals under Part 2.

F3644

Where 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—

a

the reason for the deferral no longer exists; or

b

the outcome of the cause of the deferral is known and NHS England has—

i

decided, in the light of that outcome, whether or not to redetermine the application, and

ii

redetermined the application, if it is to be redetermined.

5

Where 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.

Oral hearings8

1

If 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—

a

F427NHS England;

b

the person who made the original application to which the appeal relates;

c

if a person other than that applicant is bringing the appeal, the person bringing the appeal;

d

any 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;

e

any 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; and

f

any additional presenters,

and they (or their duly authorised representatives) are to be the only persons entitled to make oral representations at the hearing.

2

For these purposes, a person (P) is an “additional presenter” if—

a

P was notified of the appeal under Part 2 and has made written representations in accordance with paragraph 3(2), 4(3) or 5(3) F136...; and

b

the 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.

b

if the appeal is against a decision to grant or refuse an application for outline consent or premises approval—

i

confirm the decision of F427NHS England,

ii

quash the decision of F427NHS England and redetermine the application, or

iii

quash the decision of F427NHS England and remit the matter to it for it to redetermine the application, subject to such directions as the Secretary of State considers appropriate.

5

On determining an appeal relating to a valid notice under regulation 77, the Secretary of State may—

a

confirm the decision of F427NHS England; or

b

substitute for that decision any decision that F427NHS England could have taken when it took that decision.

6

If the Secretary of State grants or confirms the grant of an application for—

a

outline consent, the Secretary of State may direct F427NHS England to take such action under regulation 53(3) as the Secretary of State thinks fit; or

b

premises approval, the Secretary of State may direct F427NHS England to take such action under regulation 57 as the Secretary of State thinks fit.

Notification of decisions and subsequent action by F427NHS England10

1

Once the Secretary of State has determined the appeal, the Secretary of State must notify the following—

being the subject of any activity, and it is an activity to which a natural person could only, or would normally, be subject; or

b

forming 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.

3

References in this Schedule to an NHS pharmacist are to be construed in accordance with sub-paragraphs (1) and (2).

Breaches by directors and superintendents2

Where 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 2Essential services

Essential services3

For the purposes of these Regulations, “essential services” means—

a

the services described in this Part; and

b

the activities described in this Part to be carried out in connection with those services.

Dispensing services4

An 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.

requests 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.

3

Subject to the following provisions of this Part, where—

a

any person presents to P a non-electronic repeatable prescription which contains—

i

an order for drugs, not being Scheduled drugs or controlled drugs within the meaning of the Misuse of Drugs Act 1971 M115, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 M116 (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a prescriber,

ii

an 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”,

iii

an order for appliances, not being restricted availability appliances, signed by a prescriber, or

iv

an order for a restricted availability appliance, signed by a prescriber, and including the reference “SLS”,

and also presents an associated batch issue; F141...

b

P receives F143as 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—

i

any person requests the provision of drugs or appliances in accordance with that repeatable prescription, or

ii

P has previously arranged with the patient that P will dispense that repeatable prescription on receiptF144; or

F142c

any person—

i

presents P with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iv), and

ii

requests 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.

4

P 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 F76Schedules 2 to 5 to the Misuse of Drugs Regulations 2001.

5

For 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—

a

P has that prescription in P's possession; and

b

that person presents, or P has in P's possession, an associated batch issue.

the 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); and

b

if the patient to or for whom the product is provided is on a patient list, and the supply—

i

by 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, or

ii

is 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.

5

Where—

a

sub-paragraph (1) applies;

b

a 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; and

c

P is able to supply the product or quantity of product ordered by the prescriber within a reasonable timescale but not with reasonable promptness,

3

Sub-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.

Urgent supply without a prescription6

1

This paragraph applies where, in a case of urgency, a prescriber requests an NHS pharmacist (P) to provide a drug or appliance.

2

P may provide the drug or appliance requested before receiving a prescription form or repeatable prescription in respect of that drug or appliance, provided that—

a

in the case of a request for a drug, the drug is neither—

i

a Scheduled drug, nor

ii

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

b

in the case of a request for a drug or an appliance, the prescriber undertakes to—

i

give 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, or

ii

transmit an electronic prescription to the Electronic Prescription Service within 72 hours of the request being made.

Preliminary matters before providing ordered drugs or appliances7

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 F67regulation 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.

F1453ZA

For 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.

F893A

In 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—

a

exemption under the Charges Regulations; or

b

remission 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.

4

If, 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.

5

In the case of an electronic prescription, P must F147ensure that the following information is duly entered into the records managed by F369NHS 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))—

a

in 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—

i

the exemption category specified in F67regulation 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, and

ii

whether or not satisfactory evidence was produced to P as required by sub-paragraph (3);

b

in any case where a charge is due, confirmation that the relevant charge was paid; and

c

in a case of a prescription for or including contraceptive substances, confirmation that no charge was payable in respect of those substances.

F1986

Sub-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).

Providing ordered drugs or appliances8

1

Where 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—

a

if the prescription form or repeatable prescription is duly signed and completed as described in paragraph 5(2) or (3); and

b

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.

7

Where an order to which sub-paragraph (6) applies is for—

a

an oral contraceptive substance;

b

a drug, which is available for supply as part of pharmaceutical services only together with one or more other drugs; or

c

an 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.

8

Where 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—

a

sterile;

b

effervescent or hygroscopic;

c

a liquid preparation for addition to bath water;

d

a coal tar preparation;

e

a viscous preparation; or

f

packed 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.

9

In 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.

10

Subject to sub-paragraph (11), where a drug is ordered by a prescriber on a prescription form or a repeatable prescriptionF200, 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 F273UK 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 F273UK marketing authorisation holder, unless—

a

it is not possible for P to obtain such a pack (or packs) with reasonable promptness in the normal course of business; or

b

it 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).

11

In the case of oral liquid methadone, P (in practice, a registered pharmacist) must decide whether it would be most appropriate to provide—

a

each dose in a separate container;

b

an original pack (or original packs); or

c

the oral liquid methadone in some other way,

and P must then provide it in packaging that accords with that decision.

12

P 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—

a

it is ordered as specified in sub-paragraph (13); or

b

in the case of a drug specified in Schedule 2 to the Prescription of Drugs Regulations M122 (drugs, medicines and other substances that may be ordered only in certain circumstances), it is ordered in the circumstances prescribed in that Schedule.

13

A 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—

a

the prescribed drug is ordered by that non-proprietary name or by its formula;

b

the prescribed drug has the same specification as the Scheduled drug (so the Scheduled drug may be dispensed generically); and

c

the 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.

14

If 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.

15

P must provide any drug which P is required to provide under paragraph 5 F331or 5CF203, or provides under paragraph 5A F248or 5B, in a suitable container.

F19916

Where 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.

F24917

Sub-paragraphs (5) to (10) apply to the provision of a drug in accordance with F332a LPIV, a PTP F300or 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).

18

Where 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 F301or a PTPGD, identifying the particular PTP F302or PTPGD.

Refusal to provide drugs or appliances ordered9

1

An NHS pharmacist (P) may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

a

P 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);

b

it 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;

c

P 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;

d

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 any other person accompanying that person, commits or threatens to commit a criminal offence; or

e

the prescription form or repeatable prescription is incomplete because it does not include the information relating to the identification of the prescriber that F427NHS England (or a person exercising its functions) requires in order to perform its functions relating to—

i

the remuneration of persons providing pharmaceutical services, and

ii

any 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.

c

the 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.

ensure that appropriate advice about the benefits of repeat dispensing is given to any patient who—

i

has a long term, stable medical condition (that is, a medical condition that is unlikely to change in the short to medium term), and

ii

2

Where, on presentation of a prescription form or repeatable prescription in connection with the dispensing services under paragraph 4, P is unable F205(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—

a

if the patient consents, refer the prescription form or repeatable prescription to another NHS pharmacist or to an NHS appliance contractor; and

b

if 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.

Additional requirements in relation to electronic prescribing11

1

An NHS pharmacist (P) must, if requested to do so by any person—

F254a

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

b

where the Electronic Prescription Service is F255temporarily unavailable through P's pharmacy premises, provide that person with contact details of at least 2 NHS pharmacists in the area at whose premises the service is available, if these details are known to P.

2

F256... P must, if requested to do so by any person, enter in that person's PDS patient details—

a

where the person does not have a nominated dispensing contractor, F150a nominated dispensing contractor; or

b

where the person does have a nominated dispensing contractor—

i

a replacement dispensing contractor, or

ii

a further dispensing contractor,

chosen by that person.

3

Sub-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.

4

Regulation 116(a) to (c) applies to a request under this paragraph as it applies to an application to an NHS chemist for pharmaceutical services.

5

If 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—

a

explain to X that the ownership of the pharmacy premises has changed; and

b

ask X whether X wishes to maintain the nomination in respect of those pharmacy premises.

F1496

If 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.

F49telephone 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.

6

For 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.

Disposal service in respect of unwanted drugs13

An 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.

Basic procedure in respect of unwanted drugs14

1

Subject 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—

a

a private household; or

b

a children's home; or

auditing of the provision of pharmaceutical services by P; and

b

follow-up care for the person who has been given the advice.

F257... Health campaigns18

An NHS pharmacist (P) must, at the request of F427NHS England, ensure that—

a

P (including P's staff) participates, in the manner reasonably requested by F427NHS England, in up to 6 campaigns in each F258financial year to promote F259... health messages to users of P's pharmacy;

b

where requested to do so by F427NHS England, P records the number of people to whom P (including P's staff) has provided information as part of one of those campaigns F260; and

F261c

where requested to do so by F427NHS England, P sends to F427NHS England by means of an electronic communication of the type specified in the request—

i

the number recorded pursuant to sub-paragraph (b), and

ii

information which is reasonably requested by F427NHS 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.

Signposting19

An 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.

Service outline in respect of signposting20

1

Where 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—

a

requires advice, treatment or support that P cannot provide; but

b

another 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.

2

Where, 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—

a

if the patient consents, refer the prescription form or repeatable prescription to another NHS pharmacist or to an NHS appliance contractor; and

b

3

Where appropriate, a referral under this paragraph may be made by means of a written referral note.

4

P 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—

a

auditing of the provision of pharmaceutical services by P; and

b

follow-up care for the person who has been given the information or in respect of whom the referral has been made.

Support for self-care21

An 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.

Service outline in respect of support for self-care22

1

Where 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—

a

on treatment options, including advice on the selection and use of appropriate drugs which are not prescription only medicines; and

b

on changes to the patient's lifestyle.

2

P 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—

an eligible patient—

i

who has contacted P about the home delivery of prescription items, or

ii

who 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; or

b

a 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.

3

Where 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—

a

P 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);

b

P 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; or

c

if 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.

4

Paragraph (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.

5

Notwithstanding 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.

6

Where 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.

7

This paragraph does not apply to an NHS pharmacist in respect of distance selling premises.

F307Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.22AA

1

Before 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.

to 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;

b

draw to X’s or Y’s attention (where appropriate via a carer of X or Y)—

i

P’s disposal service in respect of unwanted drugs, and

ii

any 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;

c

d

keep and maintain records, as appropriate—

i

of the discussion pursuant to paragraphs (a) and (b), and of any raising of concerns and any actions taken, and

ii

for service evaluation purposes.

6

If 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 3Hours of opening

Pharmacy opening hours: general23

1

F400Subject to paragraph 23A, an NHS pharmacist (P) must ensure that pharmaceutical services are provided at P's pharmacy premises—

a

for 40 hours each week;

b

for not less than 100 hours each week, in the case of premises in respect of which a 100 hours condition applies;

c

if F427NHS England or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at 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;

d

if a Primary Care Trust, or on appeal the Secretary of State, has (under previous Regulations) directed that pharmaceutical services are to be provided at 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 F401, subject to any variation in respect of a rest break in accordance with sub-paragraph (7)(bd); or

e

if F427NHS England or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at the premises for more than 40 hours each week, but only on set times and on set days as regards the additional opening hours F402, or the core opening hours where paragraph 26(4A) applied to the issuing of the direction—

i

for the total number of hours each week required by virtue of that direction, and

ii

as 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 F403, subject to any variation in respect of a rest break in accordance with sub-paragraph (7)(bd),

but F427NHS 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.

2

The hours during which pharmacy premises must be open by virtue of sub-paragraph (1) are referred to in these Regulations as “core opening hours”.

3

P must notify F427NHS 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”).

4

Unless P is a distance selling chemist, at P's pharmacy premises P must exhibit—

a

a 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); and

b

at times when the premises are not open, a notice based on information provided by F427NHS England, where practicable legible from outside the premises, specifying—

i

the addresses of other NHS pharmacists and the days on which and times at which drugs and appliances may be obtained from those addresses, and

ii

the 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.

5

P must, on request, submit a return to F427NHS England setting out—

a

the days on which and times at which pharmaceutical services are provided at P's pharmacy premises (including times at which P is providing pharmaceutical services during supplementary opening hours); and

b

the pharmaceutical services which P ordinarily provides at those premises.

6

Where P changes—

a

the supplementary opening hours of P's pharmacy premises; or

b

the pharmaceutical services which P ordinarily provides at those premises,

P must supply F427NHS England with a return informing it of the change F404before the change takes place.

7

Where P has notified to F427NHS 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 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)—

a

P must ensure that pharmaceutical services are provided at 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)); F405...

on a Sunday, and

ii

does 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.

F4077A

Paragraphs (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.

F4208

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F4219

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10

Where there is a temporary suspension in the provision of pharmaceutical services by P F422because of illness or another reason beyond the control of P, P is not in breach of sub-paragraphs (1) and (7), F423or of paragraph 23A(5)(a), provided that—

a

P notifies F427NHS England of that suspension as soon F425as practicable, in the manner required by paragraph 29D(2)(a) and wherever possible before the start of the suspension;

F424aa

P uses all reasonable endeavours to implement the business continuity plan that P is required to have by virtue of paragraph 29D; and

b

P uses all reasonable endeavours to resume provision of pharmaceutical services as soon as is practicable.

11

Planned refurbishment of pharmacy premises is F426not a “reason beyond the control of P” for the purposes of sub-paragraph (10).

12

For 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.

13

For 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).

F382Local hours plans23A

1

Where 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.

2

NHS 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.

3

NHS 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.

4

The 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).

5

NHS pharmacists that have agreed to participate in a local hours plan—

a

must ensure that pharmaceutical services are provided at their pharmacy premises during the agreed temporary opening hours; and

b

may 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.

6

NHS 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.

7

A 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.

8

If 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—

a

the NHS pharmacist does not wish to participate in the plan beyond the expiry date that has been extended;

b

the timing of the revision means it is not possible, or not reasonably practicable, for prior notice to be given for the agreed notice period; and

c

the 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.

9

While 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.

Matters to be considered when issuing directions in respect of pharmacy premises core opening hours24

F4081

Subject to paragraph 26(2A), 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—

a

to maintain as necessary the existing level of service provision for the people in that area or other likely users of the pharmacy premises; or

b

to 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.

2

In considering the matters mentioned in sub-paragraph (1), F427NHS England—

a

must treat any local pharmaceutical services being provided in its area as if they were pharmaceutical services being so provided; and

b

may have regard to any pharmaceutical services that are being provided in its area during supplementary opening hours.

3

F427NHS England may only direct that an NHS pharmacist (P) may provide pharmaceutical services at 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.

4

Except 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), F427NHS England may only direct that P must provide pharmaceutical services at 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).

F4095

Sub-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.

Determination of pharmacy premises core opening hours instigated by F427NHS England25

1

Where it appears to F427NHS 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—

a

people in its area; or

b

other 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 the pharmacy premises at set times and on set days (which may include Christmas Day, Good Friday and bank holidays).

2

Before concluding the assessment under sub-paragraph (1) F427NHS England must—

a

give notice to P of any proposed changes to the days on which or times at which the pharmacy premises are to be open; and

b

allow P 30 days within which to make written representations to F427NHS England about the proposed changes.

3

When it determines the outcome of its assessment, F427NHS England must—

a

issue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs (4) and (5);

b

confirm any existing direction in respect of the times at which P must provide pharmaceutical services at 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); or

c

either—

i

revoke, without replacing it, any existing direction in respect of the times at which P must provide pharmaceutical services at the pharmacy premises (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), or

ii

in 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.

4

Where F427NHS England issues a direction under sub-paragraph (3) in respect of pharmacy premises that are to be required to be open—

a

for more than 40 hours each week, it must set out in that direction—

i

the total number of hours each week for which P must provide pharmaceutical services at the pharmacy, and

ii

11

This paragraph does not apply where regulation 65(5) to (7) applies.

Determination of pharmacy premises core opening hours instigated by the NHS pharmacist26

1

An NHS pharmacist (P) may apply to F427NHS England for it to change the days on which or times at which P is obliged to provide pharmaceutical services F410during core opening hours at P's pharmacy premises in a way that—

a

reduces the total number of hours for which P is obliged to provide pharmaceutical services at those premises each week F411...; or

b

keeps that total number of hours the same.

2

F412Except where sub-paragraph (2A) applies, where P makes an application under sub-paragraph (1), as part of that application P must provide F427NHS England with such information as F427NHS England may reasonably request in respect of F413the matters that NHS England must seek to ensure pursuant to paragraph 24(1).

F4142A

In 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—

a

the core opening hours on a Monday to Saturday at times between 5pm and 9pm;

b

the 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—

i

is no longer than one hour, and

ii

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; and

c

the 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.

2B

In the case of a valid application for a direction under sub-paragraph (4) to which sub-paragraph (2A) applies, if—

a

the 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; and

b

NHS 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.

3

F427NHS England must determine the application within 60 days of receiving it (including any information required of P in accordance with sub-paragraph (2)).

4

When it determines the application, F427NHS England must—

a

issue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs F415(4A), (5) and (6) and which has the effect of either granting the application under this paragraph or granting it only in part;

b

c

either—

i

ii

in a case where there is no existing direction, issue no direction.

F416...

F4174A

NHS 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—

a

the total number of core opening hours to below 72;

b

the core opening hours on a Monday to Saturday at times between 5pm and 9pm;

c

the 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—

i

is no longer than one hour, and

ii

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; and

d

the 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).

4B

On 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—

a

the core opening hours on a Monday to Saturday at times between 5pm and 9pm;

b

the 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—

i

is no longer than one hour, and

ii

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; and

c

the total number of core opening hours on a Sunday.

5

Where F427NHS England issues a direction under sub-paragraph (4) in respect of pharmacy premises that are to be required to be open—

a

for more than 40 hours each week, it must set out in that direction—

i

the total number of hours each week for which P must provide pharmaceutical services at the pharmacy premises, and

ii

as 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 F418except 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; or

b

for 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 the pharmacy premises.

6

F427NHS 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).

7

Where F427NHS 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.

8

F427NHS 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—

a

the reasons for the refusal or, as the case may be, for granting the application only in part; and

b

P's right of appeal under sub-paragraph (9).

9

P 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.

10

The Secretary of State may, when determining an appeal, either confirm the action taken by F427NHS England or take any action that F427NHS England could have taken under sub-paragraph (4).

11

The Secretary of State must notify the pharmacist of the determination and must include with the notification a statement of the reasons for the determination.

12

If the days on which or times at which P is to provide pharmaceutical services at pharmacy premises have been changed in accordance with this paragraph, P must introduce the changes—

a

if 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); or

b

if P has appealed under sub-paragraph (9), not earlier than 30 days after the date on which P receives notification under sub-paragraph (11).

13

This paragraph does not apply where regulation 65(5) to (7) applies.

Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical services27

1

Notwithstanding the provisions of this Part, during an emergency requiring the flexible provision of pharmaceutical services, F427NHS 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 pharmacy premises, or permit temporary closure of those premises, if—

a

P gives at least 24 hours notice of the change or closure; and

b

the reasons given by P for the request are, in the opinion of F427NHS England, adequate reasons.

2

F427NHS 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 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.

F228Pharmacy opening hours: arrangements while a disease is or in anticipation of a disease being imminently pandemic etc.27A

1

Notwithstanding the foregoing provisions of this Part, the core or supplementary opening hours of an NHS pharmacist (P) may be changed by F427NHS England where, as a consequence of a disease being, or in anticipation of a disease being imminently—

a

pandemic; and

b

a serious risk or potentially a serious risk to human health,

F427NHS 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, F427NHS 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.

2

Where paragraph (1) applies, where F427NHS 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 F427NHS England specifies in the notification (unless F427NHS England notifies P of further changes to P’s opening hours).

F239Flexible provision of relevant immunisation services during a pandemic etc.27B

1

Notwithstanding 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 F427NHS 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.

2

If F427NHS 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 F427NHS England to P) that P has the agreement of F427NHS England to those arrangements.

3

In 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—

a

a 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); or

b

a protocol that meets the conditions of regulation 247A of the Human Medicines Regulations 2012 (protocols relating to coronavirus and influenza vaccinations and immunisations),

arrangements for appropriate updating of the standard operating procedures mentioned in sub-paragraph (c)(v) and any business continuity plan of P, and

v

arrangements 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), F427NHS 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;

d

a clinical effectiveness programme, which includes arrangements for ensuring that appropriate advice is given by P—

i

in respect of the provision of drugs in accordance with a repeatable prescription,

ii

in respect of the provision of appliances in accordance with a prescription form or repeatable prescription, or

iii

to 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;

e

a staffing and staff management programme, which includes—

i

arrangements for appropriate induction for staff (including locums),

ii

appropriate training for all staff in respect of any role they are asked to perform,

iii

arrangements for the checking of qualifications and references of all staff engaged in the provision of NHS services,

F359iiia

a requirement that P undertakes an approved workforce survey annually, in an approved manner,

iv

arrangements 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 F282, certification or declarations of competence in respect of any role they are asked to perform,

v

arrangements for addressing poor performance (in conjunction with F427NHS England as appropriate), and

vi

arrangements (which must include a written policy) for ensuring that all staff and locums who, arising out of their employment with the pharmacist—

aa

make what is a protected disclosure within the meaning given in section 43A of the Employment Rights Act 1996 M125 (meaning of protected disclosure) have the rights afforded in respect of such disclosures by that Act, and

bb

provide information in good faith and not for purposes of personal gain to the General Pharmaceutical Council or to F427NHS 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;

f

an information governance programme, which provides for—

i

compliance with approved procedures for information management and security, and

ii

submission of an annual self assessment of compliance (to an approved level) with those procedures via approved data submission arrangements which allow F427NHS England to access that assessment; and

g

a premises standards programme, which includes—

i

a 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, and

ii

arrangements 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 F283and for the promotion of healthy living,

and for the purposes of this sub-paragraph, “approved” means approved by F427NHS England.

via a live video link.

F316Distance selling premises requirements in respect of websites and health promotion zones28C

An 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.

Professional Standards29

An 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.

F83Accessing summary care records29A

F2621

An 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.

2

P 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.

3

In this paragraph, a “summary care record” and “summary information” mean a summary care record and summary information within the meanings given in—

a

regulation 68 of the GMS Regulations (summary care records); and

b

regulation 61 of the PMS Regulations (summary care records).

F240Electronic Prescription Service access29B

An 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.

F240Contact via NHSmail, pharmacy profiles and the Central Alerting System29C

1

An NHS pharmacist (P) must ensure that pharmacy staff at pharmacy premises (including locums) have access to, and are able to send and receive NHSmail from, a premises specific NHSmail account.

2

P must ensure that at least two members of the pharmacy staff have live, linked NHSmail accounts to the premises specific NHSmail account (unless fewer than two members of the pharmacy staff are engaged in the provision of NHS services).

3

P must ensure that there is a comprehensive and accurate pharmacy profile in respect of P’s pharmacy premises in the F370NHS 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.

4

P 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.

5

As regards the Central Alerting System (CAS) operated by the Medicines and Healthcare products Regulatory Agency (MHRA)—

a

P must register P’s premises specific NHSmail 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);

b

if P changes P’s premises specific NHSmail address, P must immediately notify MHRA of P’s new premises specific NHSmail address, in accordance with paragraph (a); and

c

P must monitor P’s premises specific NHSmail 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.

have booked appointments, or

ii

attend the pharmacy premises regularly for the supervised administration of medicines.

3

For the purposes of sub-paragraph (2), “approved” means approved by NHS England.

4

In 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.

In 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—

a

providing contact details of alternative NHS pharmacists or NHS appliance contractors pursuant to paragraph 10(2)(b), 12(4) or 20(2)(b); or

b

referring 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.

Duty to provide information about fitness matters as they arise31

1

An NHS pharmacist (P) and, where P is a body corporate, every director and superintendent of P must, within 7 days of its occurrence, inform F427NHS England in writing if they—

a

are convicted of any criminal offence in the United Kingdom;

b

are bound over following a criminal conviction in the United Kingdom;

c

accept a police caution in the United Kingdom;

d

have, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging them absolutely (without proceeding to conviction);

e

have accepted and agreed to pay either a procurator fiscal fine under section 302 of the Criminal Procedure (Scotland) Act 1995 M126 (fixed penalty: conditional offer by procurator fiscal) or a penalty under section 115A of the Social Security Administration Act 1992 M127 (penalty as alternative to prosecution);

f

have 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;

g

are 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;

h

are 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;

i

become the subject of any investigation into their professional conduct by any licensing, regulatory or other body;

j

become 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;

k

become the subject of any investigation by the NHS BSA in relation to fraud;

l

become the subject of any investigation by another primary care organisation which might lead to their removal from a relevant list; or

m

are 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.

2

If 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 F427NHS England within 7 days if any such body corporate—

a

is convicted of any criminal offence in the United Kingdom;

b

is 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;

c

is 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;

d

is 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;

e

becomes the subject of any investigation into its provision of professional services by any licensing, regulatory or other body;

f

becomes the subject of any investigation by the NHS BSA in relation to any fraud or is notified of the outcome of such an investigation where it is adverse;

g

becomes the subject of any investigation by another primary care organisation which might lead to its removal from any relevant list; or

h

is 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.

3

P or X must consent to a request being made by F427NHS 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.

in 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; and

b

particulars of the other relevant list.

6

P or the director or superintendent of P (if P is a body corporate) must inform F427NHS 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.

F241Facilitating remote access to pharmaceutical services32A

1

An NHS pharmacist (P) must, to the extent reasonable—

a

facilitate 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; and

b

establish, maintain and keep under review procedures to facilitate remote access to those services under arrangements that make those services available using remote access.

Co-operation with F376NHS England33

An NHS pharmacist must co-operate with F376NHS England in the discharge by F376NHS England of the duty under section 1F(1) of the 2006 Act M128 (duty as to education and training).

Complaints34

1

An 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 M129, for the handling and consideration of any complaints.

2

In this paragraph, “complaint” means a complaint about a matter connected with the provision of pharmaceutical services by the NHS pharmacist.

Inspections and access to information35

1

An NHS pharmacist (P) must allow persons authorised in writing by F427NHS England to enter and inspect P's pharmacy premises at any reasonable time, for the purposes of—

a

ascertaining whether or not P is complying with the requirements of this Schedule;

b

auditing, monitoring and analysing—

i

the 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, and

ii

6

Before information is requested pursuant to sub-paragraph (5), F427NHS 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 5Terms of service of NHS appliance contractors

Regulation 11(2)(a)(i)

Division of responsibilities between individuals and corporate bodies1

1

To 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—

a

if the NHS appliance contractor is a natural person—

i

that person must comply with that requirement, or

ii

if 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; or

b

if 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.

2

Where in this Schedule reference is made to an NHS appliance contractor—

a

being the subject of any activity, and it is an activity to which a natural person could only, or would normally, be subject; or

b

forming 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.

3

References in this Schedule to an NHS appliance contractor are to be construed in accordance with sub-paragraphs (1) and (2).

Breaches by directors2

Where 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.

Dispensing services3

An 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.

Dispensing of appliances4

1

In this Part, “signed” includes signature with a prescriber's advanced electronic signature.

2

Subject to the following provisions of this Schedule, where—

a

any person presents to an NHS appliance contractor (C) a non-electronic prescription form which contains—

i

an order for an appliance, not being a restricted availability appliance, signed by a prescriber, or

ii

an order for a restricted availability appliance, signed by a prescriber and including the reference “SLS”; F151...

b

C receives F153as 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—

any person—

i

presents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) or (ii), and

ii

requests 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.

4

For 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—

a

C has that prescription in the supplier's possession; and

b

that person presents, or C has in C's possession, an associated batch issue.

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); and

b

if—

i

the patient to or for whom the product is provided is on a patient list, and

ii

the 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.

5

Where—

a

sub-paragraph (1) applies;

b

C is of the opinion that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; and

c

C 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.

Urgent supply without a prescription5

1

This paragraph applies where, in a case of urgency, a prescriber requests an NHS appliance contractor (C) to provide an appliance.

2

C may provide the appliance requested before receiving a prescription form or repeatable prescription in respect of that appliance, provided that the prescriber undertakes to—

a

give C a non-electronic prescription form or non-electronic repeatable prescription in respect of the appliance within 72 hours of the request being made; or

b

transmit an electronic prescription to the Electronic Prescription Service within 72 hours of the request being made.

entitlement to exemption under F68regulation 10(1) of the Charges Regulations M131 (exemptions), or

ii

entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations M132 (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 F68regulation 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;

b

if, 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; and

c

in the case of an electronic prescription form or an electronic repeatable prescription, C must F161ensure that the following information is duly entered into the records managed by F371NHS 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))—

i

in a case where exemption from or remission of charges is claimed, a record of—

aa

the exemption category specified in F68regulation 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; and

bb

whether or not satisfactory evidence was produced to C as required by sub-paragraph (a), and

ii

in any case where a charge is due, confirmation that the relevant charge was paid.

F1593A

F2063B

Sub-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).

Providing appliances7

1

Where 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—

a

if the prescription form or repeatable prescription is duly signed and completed as described in paragraph 4; and

b

in accordance with the order on the prescription form or repeatable prescription,

subject to any regulations in force under the Weights and Measures Act 1985 M133 and the following provisions of this Schedule.

2

If the order is forF208, 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—

a

measuring the person named on the prescription form for the appliance; and

b

fitting the appliance.

3

If the order is forF209, 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.

F2074

Where 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.

Refusal to provide appliances ordered8

1

An NHS appliance contractor (C) may refuse to provide an appliance ordered on a prescription form or repeatable prescription where—

a

C 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);

b

it 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;

c

C 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 person

d

the 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; or

e

the prescription form or repeatable prescription is incomplete because it does not include information relating to the identification of the prescriber that F427NHS England (or a person exercising its functions) requires in order to perform its functions relating to—

i

the remuneration of persons providing pharmaceutical services, and

ii

any 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.

F1621A

C 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).

F2101B

C must refuse to provide an appliance ordered on a prescription form or a repeatable prescription where—

a

a SSP has effect in respect of—

i

the requested appliance; or

ii

appliances of a specified description, and the requested appliance is of that description; and

b

alternative provision has already taken place in accordance with the SSP.

1C

C may refuse to provide an appliance ordered on a prescription form or a repeatable prescription where—

a

a SSP has effect in respect of—

i

the requested appliance, or

ii

appliances of a specified description, and the requested appliance is of that description;

b

C is of the opinion that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; and

c

C 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.

2

C must refuse to provide appliances ordered on a repeatable prescription where—

a

C has no record of that prescription (other than on the first occasion on which the prescription is presented);

b

C does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to the supplier;

c

it is not signed by a prescriber;

d

to do so would not be in accordance with any intervals specified in the prescription;

e

it 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;

f

the repeatable prescription was signed (whether electronically or otherwise) more than one year previously;

g

the expiry date on the repeatable prescription has passed; or

h

C has been informed by the prescriber that the prescription is no longer required.

3

Where 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—

a

the patient to whom the prescription relates—

i

is using and is likely to continue to use the appliance appropriately, and

ii

is not suffering from any side effects of the treatment which indicate the need or desirability of reviewing the patient's treatment;

b

the 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; and

c

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.

Further activities to be carried out in connection with the provision of dispensing services9

1

In connection with the services provided under paragraph 3, an NHS appliance contractor (C) must—

a

ensure that appropriate advice is given to patients about any appliances provided to them—

i

to enable them to utilise the appliances appropriately, and

ii

to meet the patient's reasonable needs for general information about the appliances;

b

provide appropriate advice to patients to whom they provide appliances on the safe keeping of the appliances;

c

when providing appliances to patients in accordance with a prescription form or repeatable prescription—

i

provide appropriate advice in particular on the importance of only requesting those items which they actually need, and

a replacement dispensing contractor, or

ii

a further dispensing contractor,

chosen by that person.

3

Sub-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.

4

Regulation 116(a) to (c) applies to a request under this paragraph as it applies to an application to an NHS chemist for pharmaceutical services.

5

If 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—

a

explain to X that the ownership of the appliance contractor premises has changed; and

b

ask X whether X wishes to maintain the nomination in respect of those appliance contractor premises.

F1636

If 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.

F50telephone 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.

6

For 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.

Signposting12

1

Where, 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—

a

if the patient consents, refer the prescription form or repeatable prescription to another NHS appliance contractor or to an NHS pharmacist; and

b

2

C 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—

a

auditing of the provision of pharmaceutical services by C; and

b

follow-up care for the person who has been given the information or in respect of whom the referral has been made.

the supplementary opening hours of C's appliance contractor premises; or

b

the pharmaceutical services which C is ordinarily to provide at those premises,

C must supply F427NHS England with a return informing it of the change.

6

Where C has notified to F427NHS 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 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)—

a

C must ensure that pharmaceutical services are provided at 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)); and

b

C must not change—

i

the days on which or the times at which pharmaceutical services are to be provided at 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,

ii

the 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),

iii

the days on which or the times at which pharmaceutical services are to be provided at those premises during supplementary opening hours, or

iv

the pharmaceutical services which P is ordinarily to provide at those premises,

for a period of at least 3 months after that notification was received by F427NHS England (or, before the appointed day, a Primary Care Trust), unless F427NHS England agrees otherwise.

7

Subject 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.

8

C 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.

9

Where 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—

a

C notifies F427NHS England of that suspension as soon as practical; and

b

C uses all reasonable endeavours to resume provision of pharmaceutical services as soon as is practicable.

10

Planned 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).

11

For 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.

12

In 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).

Matters to be considered when issuing directions in respect of core opening hours14

1

Where F427NHS 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.

2

In considering the matters mentioned in sub-paragraph (1), F427NHS England—

a

3

After considering any representations made in accordance with sub-paragraph (2)(b), F427NHS England must—

a

issue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs (4) and (5);

b

confirm any existing direction in respect of the times at which C must provide pharmaceutical services at 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);

c

either—

i

revoke (without replacing it) any existing direction in respect of the times at which C must provide pharmaceutical services at the premises (whether issued under regulation 65, this Schedule, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), or

ii

in 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.

4

Where F427NHS England issues a direction under sub-paragraph (3) in respect of appliance contractor premises that are to be required to be open—

a

for more than 30 hours each week, it must set out in that direction—

i

the total number of hours each week for which C must provide pharmaceutical services at the premises, and

ii

11

This paragraph does not apply where regulation 65(5) to (7) applies.

Determination of core opening hours instigated by the NHS appliance contractor16

1

An NHS appliance contractor (C) may apply to F427NHS England for it to change the days on which or times at which C is obliged to provide pharmaceutical services at C's premises, in a way that—

a

reduces 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); or

b

keeps that total number of hours the same.

2

Where C makes an application under sub-paragraph (1), as part of that application C must provide F427NHS England with such information as F427NHS 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.

3

F427NHS 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)).

4

In determining the application, F427NHS England must—

a

issue 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;

b

confirm any existing direction in respect of the times at which C must provide pharmaceutical services at 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); or

c

either—

ii

a requirement that C publicises the NHS services that are available at or from C's appliance contractor premises,

iii

a requirement that C undertakes an approved patient satisfaction survey annually, in an approved manner,

iv

C's monitoring arrangements in respect of appliances owed to patients but which are out of stock,

v

an approved complaints system (which meets the requirements of paragraph 24),

vi

a 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,

vii

a requirement that C co-operates appropriately with any reasonable inspection or review that F427NHS England or any relevant statutory authority wishes to undertake, and

viii

C's monitoring arrangements in respect of C's compliance with the Equality Act 2010 M134;

b

a clinical audit programme (normally of 5 days) twice in each financial year;

c

a risk management programme, which includes—

i

arrangements for ensuring that all stock is procured and handled in an appropriate way,

ii

arrangements for ensuring that all equipment used in the provision of pharmaceutical services is maintained appropriately,

iii

an approved incident reporting system, together with arrangements for analysing and responding to critical incidents,

iv

appropriate 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,

v

appropriate waste disposal arrangements for clinical and confidential waste,

vi

identifying a clinical governance lead person in respect of each of C's appliance contractor premises,

vii

C's monitoring arrangements of C's compliance with the Health and Safety at Work etc. Act 1974 M135;

d

a clinical effectiveness programme, which includes arrangements for ensuring that appropriate advice is given by C—

i

in respect of the provision of appliances in accordance with a prescription form or repeatable prescription, or

ii

to 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;

e

a staffing and staff management programme, which includes—

i

arrangements for appropriate induction for staff (including locums),

ii

appropriate training for all staff in respect of any role they are asked to perform,

iii

arrangements for the checking of qualifications and references of all staff engaged in the provision of NHS services,

iv

arrangements 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, and

v

arrangements for addressing poor performance (in conjunction with F427NHS England as appropriate); and

f

an information governance programme, which provides for—

i

compliance with approved procedures for information management and security, and

ii

submission of an annual self assessment of compliance (to an approved level) with those procedures via approved data submission arrangements which allow F427NHS England to access that assessment.

3

For the purposes of sub-paragraph (2), “approved” means approved by F427NHS England.

Professional Standards19

An 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.

Inducements etc.20

1

An 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)—

a

If 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 F427NHS England within 7 days if any such body corporate—

a

is convicted of any criminal offence in the United Kingdom;

b

is 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;

c

d

is 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;

e

becomes the subject of any investigation into its provision of professional services by any licensing, regulatory or other body;

f

becomes the subject of any investigation by the NHS BSA in relation to any fraud or is notified of the outcome of such an investigation where it is adverse;

g

becomes the subject of any investigation by another primary care organisation which might lead to its removal from any relevant list; or

h

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.

3

C or X must consent to a request being made by F427NHS 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.

Other information to be supplied22

1

An NHS appliance contractor (C) must give notice to F427NHS England within 30 days (or if this is impracticable, as soon as practicable thereafter) of—

a

any occurrence requiring a change in the information recorded about C in the pharmaceutical list which C has not otherwise notified to F427NHS England in accordance with these Regulations;

b

if C is an individual, any change of C's private address;

c

if C is a body corporate, any change to the name, registered number, registered office, telephone number relating to that office of the body corporate; and

d

any occurrence requiring C's addition to or removal from the EPS list or a change in the information recorded about C in that list.

2

C must give F427NHS England, if it so requests, the name of any pharmacist employed or engaged by C who is responsible for dispensing a particular prescription.

3

If C is a body corporate, it must give notice to F427NHS 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.

4

If 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 F427NHS England the information mentioned in paragraphs 3 and 4 of Schedule 2 about that person.

5

If 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 F427NHS England, they must supply in writing to F427NHS England—

a

in the case of a director of a body corporate, the name and registered office of the body corporate on the other relevant list; and

b

particulars of the other relevant list.

6

C or a director C (if C is a body corporate) must inform F427NHS 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 F427NHS England, and of the outcome of any such application.

Co-operation with F377NHS England23

An NHS appliance contractor must co-operate with F377NHS England in the discharge by F377NHS England of the duty under section 1F(1) of the 2006 Act M138 (duty as to education and training).

Complaints24

1

An 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 M139, for the handling and consideration of any complaints.

2

In this paragraph, “complaint” means a complaint about a matter connected with the provision of pharmaceutical services by the NHS appliance contractor.

Inspections and access to information25

1

An NHS appliance contractor (C) must allow persons authorised in writing by F427NHS England to enter and inspect any premises C uses for the provision of pharmaceutical services at any reasonable time, for the purposes of—

a

ascertaining whether or not C is complying with the requirements of this Schedule;

b

auditing, monitoring and analysing—

i

the 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, and

ii

the management by C of the pharmaceutical services C provides,

where the conditions in sub-paragraph (2) are satisfied.

2

The conditions are that—

a

reasonable notice of the intended entry has been given;

b

the 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;

c

the person authorised in writing (X) carries written evidence of X's authorisation, which X produces on request; and

d

X does not enter any part of the premises used solely as residential accommodation without the consent of the resident.

3

C must, at the request of F427NHS England or of X, allow it or X access to any information which it or X reasonably requires—

a

for the purposes mentioned in sub-paragraph (1); or

b

in the case of F427NHS England, in connection with its functions that relate to pharmaceutical services.

SCHEDULE 6Terms of service of dispensing doctors

Regulation 47(1)(a)(i)

Persons duly authorised to dispense on behalf of dispensing doctors1

1

Where 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—

a

that other person must comply with that requirement; and

b

the dispensing doctor must secure compliance with that requirement by that other person.

2

Where reference is made in this Schedule to a dispensing doctor—

a

being the subject of an activity, and in fact a person duly authorised by the dispensing doctor is the subject of that activity; or

b

forming 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.

3

References in this Schedule to a dispensing doctor are to be construed in accordance with sub-paragraphs (1) and (2).

requests 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.

3

Subject to the following provisions of this Schedule, where—

a

any person presents to D a non-electronic repeatable prescription which contains—

i

an order for drugs, not being Scheduled drugs or controlled drugs within the meaning of the Misuse of Drugs Act 1971 M141, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 M142 (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a prescriber other than D,

ii

iii

an order for appliances, not being restricted availability appliances, signed by a prescriber other than D, or

iv

an 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; F169...

b

D receives F171as 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—

i

any person requests the provision of drugs or appliances in accordance with that repeatable prescription, or

ii

D has previously arranged with the patient that D will dispense that repeatable prescription on receiptF172; or

F170c

any person—

i

presents D with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iv), and

ii

requests the provision of drugs or appliances in accordance with the related electronic repeatable prescription,

4

D 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 F77Schedules 2 to 5 to the Misuse of Drugs Regulations 2001.

5

a

D has that prescription in D's possession; and

b

that person presents, or D has in D's possession, an associated batch issue.

6

Drugs and appliances provided under this paragraph must be provided in a suitable container.

Dispensing of drugs and appliances ordered by the dispensing doctor3

In 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—

a

D 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)—

i

on 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 M143 (other contractual terms – prescribing) or an equivalent provision applying in relation to that contract,

ii

if paragraph 39A of Schedule 6 to the GMS Regulations M144 (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, or

iii

in 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);

b

D must provide those drugs or appliances in a suitable container (unless it is personally administered);

c

D must provide for the patient a drug specified in Schedule 2 to the Prescription of Drugs Regulations M145 (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 M146 (other contractual terms – a restrictions on prescribing by medical practitioners) are satisfied; and

d

D 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.

F193Supply in accordance with a SSP3A

1

This sub-paragraph applies where, in relation to an order for a drug or an appliance on a prescription form or a repeatable prescription—

a

a SSP has effect in respect of—

i

the requested drug or appliance, or

ii

drugs or appliances of a specified description, and the requested drug appliance is of that description.

2

c

having regard to what is reasonable and appropriate,

that a person is entitled to be supplied with the drug F323by 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.

2

If a person requesting the provision of the drug asks D to do so—

a

D must give an estimate of the time when the drug will be ready; and

b

if they are not ready by then, D must give a revised estimate of the time when they will be ready (until they are ready).

3

Where D provides a drug under sub-paragraph (1) F296or (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 F297or a PTPGD, identifying the particular PTP F298or PTPGD.

F3214

Sub-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.

5

Sub-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.

F319Supply in accordance with a LPIV3C

1

Subject to the following provisions of this Schedule, where—

a

a dispensing doctor (D) receives a LPIV; and

b

a 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.

2

If a person who is entitled as mentioned in sub-paragraph (1)(b) asks D to do so—

a

D must give an estimate of the time when the prescription item will be ready; and

b

if 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).

3

Sub-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.

Preliminary matters before providing ordered drugs or appliances4

Before providing any drugs or appliances in accordance with paragraph 3 F211or 3A, or in the circumstances set out in paragraph 5—

a

a dispensing doctor (D) must ask any person who makes F173or 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 M147 (supply of drugs and appliances by doctors) by virtue of either—

i

entitlement to exemption under F70regulation 10(1) of the Charges Regulations M148 (exemptions), or

ii

entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations M149 (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 F70regulation 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;

b

if, 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; and

c

in the case of an electronic prescription, D must F174ensure that the following information is duly entered into the records managed by F372NHS 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))—

i

in 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—

aa

the exemption category specified in F71regulation 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, and

bb

whether or not satisfactory evidence was produced to D as required by sub-paragraph (a),

ii

in any case where a charge is due, confirmation that the relevant charge was paid, and

iii

in a case of a prescription for or including contraceptive substances, confirmation that no charge was payable in respect of those substances.

F127Charge exemption and remission of charges: declarations and checks4A

1

For 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.

2

If 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.

F195Checks and records in the case of supply in accordance with a SSP4B

In 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).

Provision of Scheduled drugs5

1

A dispensing doctor (D) must only provide for a patient any Scheduled drug if—

a

it is ordered as specified in sub-paragraph (2) or (4); or

b

in the case of a drug specified in Schedule 2 to the Prescription of Drugs Regulations M150 (drugs, medicines and other substances that may be ordered only in certain circumstances), it is ordered in the circumstances prescribed in that Schedule.

2

a

the prescribed drug is ordered by that non-proprietary name or by its formula; and

b

the prescribed drug has the same specification as the Scheduled drug (so the Scheduled drug may be dispensed generically).

3

If 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.

4

Nothing in this Schedule prevents D providing, otherwise than under pharmaceutical services, a Scheduled drug or a restricted availability appliance for a patient.

Refusal to provide drugs or appliances ordered6

1

A dispensing doctor (D) may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

a

D 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);

b

it 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; or

c

where the prescription form or repeatable prescription is incomplete because it does not include the information relating to the identification of the prescriber that F427NHS England (or a person exercising its functions) requires in order to perform its functions relating to—

i

the remuneration of persons providing pharmaceutical services, and

ii

b

at least one of those prescription items is a listed HRT prescription item and at least one of those prescription items is not; and

c

Dispensing doctors issuing prescription forms which may be presented to an NHS chemist7

Notwithstanding 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 from an NHS chemist—

a

D may with the agreement of P issue; or

b

if 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.

F229Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.7A

1

Before 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—

a

pandemic; and

b

a serious risk or potentially a serious risk to human health,

F427NHS 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.

2

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, D must ascertain from—

a

an eligible patient—

i

who has contacted D about the home delivery of prescription items, or

ii

who 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; or

b

a 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.

3

Where 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—

a

D 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);

b

D 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; or

c

if 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.

4

Paragraph (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.

5

Notwithstanding 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.

F308Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.7AA

1

Before 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.

2

For 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—

a

pandemic; and

b

a serious risk or potentially a serious risk to human health,

3

Where 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—

a

an eligible patient—

i

who has contacted D about the home delivery of a notified item, or

ii

who 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; or

b

a 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.

4

Where paragraph (3) does not apply, the home delivery option that D must provide must comprise—

a

b

c

if 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.

5

Paragraph (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.

6 Complaints procedures8

Where a dispensing doctor is a provider of primary medical services, or is employed or engaged by such a provider, the complaints procedure established by—

a

the provider or practice; or

b

the 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.

Inspections and access to information9

1

A dispensing doctor (D) must allow persons authorised in writing by F427NHS England to enter and inspect any premises D uses for the provision of pharmaceutical services at any reasonable time, for the purposes of—

a

ascertaining whether or not D is complying with the requirements of this Schedule;

b

auditing, monitoring and analysing—

i

the provision made by D, in the course of providing pharmaceutical services, for patient care and treatment, and

ii

the management by D of the pharmaceutical services D provides,

where the conditions in sub-paragraph (2) are satisfied.

2

The conditions are that—

a

reasonable notice of the intended entry has been given;

b

the 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;

c

the person authorised in writing (X) carries written evidence of X's authorisation, which X produces on request; and

d

X does not enter any part of the premises used solely as residential accommodation without the consent of the resident.

3

D must, at the request of F427NHS England or of X, allow it or X access to any information which it or X reasonably requires—

a

for the purposes mentioned in sub-paragraph (1); or

b

in the case of F427NHS England, in connection with its functions that relate to pharmaceutical services.

Voluntary closure of premises10

1

Where a dispensing doctor (D) wishes—

a

to withdraw from a dispensing doctor list, or

b

except in the circumstances described in paragraph (2), for particular listed dispensing premises no longer to be listed in relation to D,

D must notify F427NHS 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 F427NHS England as soon as it is practicable for D to do so.

2

If 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 the new premises, D must give notice to F427NHS England of when, before that date, D is to cease to provide pharmaceutical services at the existing premises.

SCHEDULE 7Mandatory terms for LPS schemes

Regulation 102(3)

General provisions1

1

The LPS contractor must comply with all relevant legislation, including—

a

the relevant provisions of Part 13 of these Regulations; and

b

relevant provisions that are—

i

included in regulations under section 225 of the 2007 Act M151 (duties of services-providers to allow entry by Local Healthwatch organisations or contractors), and

ii

2

The LPS contractor must comply with the relevant provisions of the Drug Tariff.

3

The LPS contractor must have regard to all relevant guidance issued by—

a

F427NHS England; or

b

the Secretary of State.

4

To 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—

a

if C is a registered pharmacist—

i

C must comply with the requirement, or

ii

if 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; or

b

if 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.

Restrictions in an LPS scheme on supply2

1

Where 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.

2

2

Where 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—

a

any person presents to C a non-electronic repeatable prescription which contains—

i

an order for a drug, not being a Scheduled drug or a controlled drug within the meaning of the Misuse of Drugs Act 1971 M153, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 M154 (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a prescriber,

ii

iii

an order for an appliance, not being a restricted availability appliance, signed by a prescriber, or

iv

an order for a restricted availability appliance, signed by a prescriber, and including the reference “SLS”,

and also presents an associated batch issue; F181...

3

Where 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—

a

C is able to do so with reasonable promptness;

b

to do so is in accordance with the SSP; and

c

4

Where C, in accordance with sub-paragraph (3), provides a different product or quantity of product to that ordered by the prescriber—

a

b

if the patient to or for whom the product is provided is on a patient list, and the supply—

i

ii

is 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,

5

Where—

a

sub-paragraph (1) applies;

b

c

C 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.

F320Supply in accordance with a LPIV3B

1

Subject to the following provisions of this Schedule, where—

a

a LPS Contractor (C) receives a LPIV; and

b

a 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.

2

If a person who is entitled as mentioned in sub-paragraph (1)(b) asks C to do so—

a

C must give an estimate of the time when the prescription item will be ready; and

b

if 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).

3 Urgent supply without a prescription4

Where, 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—

a

the drug is not a Scheduled drug;

b

the 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); and

c

the prescriber undertakes to—

i

give C a non-electronic prescription form or non-electronic repeatable prescription in respect of the drug within 72 hours of the request being made, or

ii

transmit to the Electronic Prescription Service within 72 hours of the request being made an electronic prescription.

entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations M157 (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 F72regulation 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.

F1853ZA

F903A

In 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—

a

exemption under the Charges Regulations; or

b

remission 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.

4

If, 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.

5

In the case of an electronic prescription, C must F187ensure that the following information is duly entered into the records managed by F430NHS 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))—

a

in 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—

i

the exemption category specified in F72regulation 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, and

ii

a coal tar preparation;

e

a viscous preparation; or

f

packed 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.

7

In 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.

8

Subject to sub-paragraph (9), where a drug is ordered by a prescriber on a prescription form or repeatable prescriptionF215, 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 F274UK 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 F274UK marketing authorisation, unless—

a

it is not possible for C to obtain such a pack (or packs) with reasonable promptness in the normal course of business; or

b

it 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).

9

12

If 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.

13

C must provide any drug which it is required to provide under paragraph 3 F334or 3BF218, or provides under paragraph 3A, in a suitable container.

F21414

Where 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.

F33315

Sub-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).

Refusal to provide drugs or appliances ordered7

1

The LPS contractor (C) may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

a

C 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);

b

it appears to C that—

i

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

ii

in the circumstances, providing the drugs or appliances would be contrary to the C's (in practice, a registered pharmacist's) clinical judgement;

c

C 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;

d

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 any person accompanying that person, commits or threatens to commit a criminal offence; or

e

i

the remuneration of persons providing local pharmaceutical services, and

ii

any 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.

of notes provided under sub-paragraph (c);

e

if 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; and

f

ensure 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.

Additional requirements in relation to electronic prescribing9

1

The LPS contractor (C) must, if requested to do so by any person—

F267a

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

b

where the Electronic Prescription Service is F268temporarily 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

F269... C must, if requested to do so by any person, enter in that person's PDS patient details—

a

where the person does not have a nominated dispensing contractor, F190a nominated dispensing contractor; or

b

where the person does have a nominated dispensing contractor—

i

a replacement dispensing contractor, or

ii

a further dispensing contractor,

chosen by that person.

3

Sub-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.

4

If 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—

a

explain to X that the ownership of the scheme premises has changed; and

b

ask X whether X wishes to maintain the nomination in respect of those scheme premises.

F1895

If 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.

Further activities in connection with repeat dispensing10

In connection with the services provided under paragraphs 3 to 7, the LPS contractor (C) must—

a

provide 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;

b

undertake appropriate training in respect of repeat dispensing, having regard to any recommendations in respect of such training set out in the Drug Tariff;

c

if C takes possession of a non-electronic repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue;

d

maintain 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);

e

destroy any surplus batch issues relating to drugs or appliances—

i

which are not required, or

ii

where a patient is refused the drugs or appliances pursuant to paragraph 7;

f

g

notify the prescriber of any refusal to provide drugs or appliances pursuant to paragraph 7(4).

F230Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.10A

1

Before 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—

a

pandemic; and

b

a serious risk or potentially a serious risk to human health,

F427NHS 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.

2

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, C must ascertain from—

a

an eligible patient—

i

who has contacted C about the home delivery of prescription items, or

ii

who 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; or

b

a 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.

3

Where 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—

a

C 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);

b

C 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; or

c

if 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.

4

Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at C’s F287chemist premises for the purposes of receiving dispensing services.

5

Notwithstanding 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.

F309Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.10AA

1

Before 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.

2

For 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—

a

pandemic; and

b

a

regulation 68 of the GMS Regulations (summary care records); and

b

regulation 61 of the PMS Regulations (summary care records).

F243Electronic Prescription Service access13B

An 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.

F243Contact via NHSmail and the Central Alerting System13C

1

An LPS chemist (C) must ensure that pharmacy staff at listed premises (including locums) have access to, and are able to send and receive NHSmail from, a premises specific NHSmail account.

2

C must ensure that at least two members of the pharmacy staff have live, linked NHSmail accounts to the premises specific NHSmail account (unless fewer than two members of the pharmacy staff are engaged in the provision of NHS services).

3

As regards the Central Alerting System (CAS) operated by the Medicines and Healthcare products Regulatory Agency (MHRA)—

a

C must register C’s premises specific NHSmail 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);

b

if C changes C’s premises specific NHSmail address, P must immediately notify MHRA of C’s new premises specific NHSmail address, in accordance with paragraph (a); and

c

C must monitor C’s premises specific NHSmail 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.

any person employed or engaged by any of the persons mentioned in paragraph (a).

Duty to provide information about fitness to practise matters as they arise15

1

The LPS contractor (C) must within 7 days of its occurrence supply in writing information to F427NHS England as to whether a person (P) who is a relevant person in relation to C—

a

has been convicted of any criminal offence in the United Kingdom;

b

has been convicted elsewhere of an offence which would constitute a criminal offence if committed in England and Wales;

c

has 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 F427NHS England;

d

has accepted a police caution in the United Kingdom;

e

has become subject to an order under section 246(2) or (3) of the Criminal Procedure (Scotland) Act 1995 M162 (admonition and absolute discharge) discharging R absolutely;

f

has accepted a conditional offer under section 302 of the Criminal Procedure (Scotland) Act 1995 M163 (fixed penalty: conditional offer by procurator fiscal);

g

has agreed to pay a penalty under section 115A of the Social Security Administration Act 1992 M164 (penalty as alternative to prosecution);

h

has, 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;

i

has, 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;

j

has, to P's knowledge, become subject to any investigation by the NHS BSA in relation to fraud or is notified of the outcome of such an investigation where it is adverse;

k

has, 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; or

l

either—

i

has been removed or contingently removed from, refused admission to, or conditionally included in, any relevant list of another primary care organisation,

ii

has been suspended from such a list, on fitness to practise grounds, and if so, why and the name of that other primary care organisation, or

iii

has 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.

2

P is a “relevant person” in relation to C for these purposes, in the case of a contractor that is—

a

an individual, if P is C;

b

a partnership, if P is a partner in C;

c

a body corporate, if P is a director, the chief executive, the company secretary or the superintendent pharmacist of C.

3

C or any relevant person must consent to a request being made by F427NHS 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.

Co-operation with F379NHS England16

The LPS contractor must co-operate with F379NHS England in the discharge by F379NHS England of the duty under section 1F(1) of the 2006 Act M165 (duty as to education and training).

Charges for drugs, appliances and containers, and ownership of containers17

1

Subject 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.

2

Where 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.

Refunds of prescription charges18

1

Where 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.

2

For the purposes of sub-paragraph (1), a claim for repayment is only valid if duly made—

a

in such form and manner as the Secretary of State has determined for an application for such a repayment under F74regulation 18(2)(b) of the Charges Regulations M166 (repayment of charges); or

b

on the equivalent form issued in Scotland, Wales or Northern Ireland.

Remuneration, overpayments etc19

1

F427NHS 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.

2

F427NHS 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.

3

For 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 M167 (remuneration for persons providing pharmaceutical services).

4

Where 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 F427NHS England, that fee, allowance or other item of remuneration must be determined by F427NHS England.

5

F427NHS England must ensure that the LPS scheme—

a

allows it to recover any payment made to C which should not have been made;

b

provides that any such recovery of an overpayment is without prejudice to any investigation of any alleged breach of the scheme; and

c

provides that the remuneration arrangements under the scheme, referred to in sub-paragraphs (1) to (4), are subject to any right F427NHS England may have to set off against any amount payable to C, any amount—

i

owed by C to it, or

ii

which it is entitled to withhold under the terms of the scheme (including terms of the Drug Tariff applied by the scheme).

Local resolution of disputes20

In the case of any dispute arising out of, or in connection with, the LPS scheme, the LPS contractor and F427NHS 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).

Dispute resolution: non-NHS contracts21

F631

In 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—

a

if it relates to a period when the contractor was treated as a health service body, by the contractor or by F427NHS England; or

b

in any other case, by the contractor or, if the contractor agrees in writing, by F427NHS England.

2

In the case of a dispute referred to the Secretary of State under sub-paragraph (1)—

a

the procedure to be followed is the NHS dispute resolution procedure; and

b

the parties must agree to be bound by any determination made by the adjudicator.

a

is 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; and

b

notifies 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.

3

During an emergency requiring the flexible provision of pharmaceutical services, F427NHS England may, on application from C—

a

permit C a temporary change to the days on which or times at which C is obliged to provide local pharmaceutical services at the scheme premises, or permit temporary closure of those premises, if—

i

C gives at least 24 hours notice of the change or closure, and

ii

the reasons given by C for the request are, in the opinion of F427NHS England adequate reasons; or

b

permit C any other temporary variation to C's LPS scheme that, in the opinion of F427NHS 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 M169 (arrangements for pharmaceutical services and additional pharmaceutical services) during the emergency.

4

F427NHS 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 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.

Termination by agreement27

F427NHS 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.

Termination by serving notice28

1

Either the LPS contractor or F427NHS 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.

2

Where a notice is served pursuant to sub-paragraph (1), the LPS scheme must terminate on the expiry of the notice period.

3

This paragraph is without prejudice to any other rights to terminate the agreement which the LPS contractor and F427NHS England may have.

Termination of arrangements by F427NHS England on grounds of suitability etc29

1

F427NHS 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—

a

with an individual as a party, that individual;

b

with more than one individual (whether or not practising in partnership), any of those individuals; or

c

with a body corporate—

i

the body corporate, or

ii

ii

Schedule 1 to the Criminal Procedure (Scotland) Act 1995 M171 (offences against children under the age of 17 years to which special provisions apply),

which was committed on or after 1st April 2006;

g

X—

i

has been F88made bankrupt, or sequestration of X's estate has been ordered, unless X has been discharged from the bankruptcy or the order has been annulled,

ii

has become a person in relation to whom a moratorium period under a debt relief order (under Part 7A of the Insolvency Act 1986 M172 (debt relief orders)) applies,

iii

has 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 M173 or Schedule 2A of the Insolvency (Northern Ireland) Order 1989 M174 (which relate to bankruptcy and debt relief restrictions orders and undertakings), which has not been annulled,

iv

if X is a body corporate, has been wound up under Part 4 of the Insolvency Act 1986;

v

has 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;

X (in the case of an individual) has refused to comply with a request by F427NHS 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; or

l

it comes to the attention of F427NHS England that information provided to it pursuant to—

i

regulation 12 or 17 of the 2006 Regulations,

ii

a term of the scheme required by paragraph 16 of Schedule 2 to the 2006 Regulations,

iii

regulation 106, or

iv

b

C's financial situation is such that F427NHS England considers that F427NHS England is at risk of material financial loss.

Termination and the NHS dispute resolution procedure31

1

Where F427NHS 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 F427NHS England has served that notice on C, unless sub-paragraph (2) applies.

2

This sub-paragraph applies if F427NHS England is satisfied that a period less than 28 days, or termination with immediate effect, is necessary in order to—

a

protect the safety of the C's patients; or

b

protect itself from material financial loss.

3

In a case falling within sub-paragraph (1), where—

a

the exceptions in sub-paragraph (2) do not apply;

b

C invokes the NHS dispute resolution procedure before the end of the period of notice referred to in sub-paragraph (1); and

c

C notifies F427NHS 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).

4

Subject to paragraph (5), the LPS scheme (or C's participation in it) is only to terminate if and when—

a

there has been a determination of the dispute pursuant to paragraph 23 and that determination permits F427NHS England to terminate the scheme; or

b

C ceases to pursue the NHS dispute resolution procedure,

whichever is the sooner.

5

If F427NHS England is satisfied that it is necessary to terminate the scheme before the NHS dispute resolution procedure is concluded in order to—

a

protect the safety of the C's patients; or

b

protect itself from material financial loss,

sub-paragraphs (3) and (4) shall not apply and F427NHS 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.

Third party rights32

The LPS scheme shall not create any right enforceable by any person not a party to it.

SCHEDULE 8Service remuneration determined by F427NHS England

Regulation 91(1)(a)

1

Any fees and allowances payable to NHS pharmacists for professional services provided as part of the provision of pharmaceutical services.

2

Without prejudice to the generality of sub-paragraph (1), those fees and allowances may include—

a

fees in connection with the dispensing of drugs and appliances, including any additional fees relating to the dispensing of particular types of drug or appliance;

b

payments 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; and

c

payments 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).

3

For the purposes of sub-paragraph (1), “professional services” does not include providing pre-registration training experience for pharmacy graduates or undergraduates.

2

1

Any fees and allowances payable to NHS appliance contractors for professional services provided as part of the provision of pharmaceutical services.

2

Without prejudice to the generality of sub-paragraph (1), those fees and allowances may include—

a

dealing with the matter justly, or

ii

ii

adding to, modifying or removing functions that are to be performed by F427NHS England or a HWB under these Regulations or the 2006 Act.

8

In this Schedule, “the continuity principles” means the provisions of sub-paragraphs (1) to (7).

Listing applications under the 2005 Regulations: NHS chemists2

1

An 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—

a

has not been determined before the appointed day; and

b

by 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 F427NHS England in accordance with the 2005 Regulations.

2

Where an application made under the 2005 Regulations for preliminary consent has been finally granted under those Regulations—

a

determination 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 F427NHS 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.

3

Where an excepted application has been made to a Primary Care Trust before the appointed day under the 2012 Regulations—

a

if that application—

i

is not a notifiable application, and

ii

has not been determined by the Primary Care Trust before the appointed day,

it is to be dealt with by F427NHS England in accordance with these Regulations;

b

if that application—

i

is a notifiable application, and

ii

has 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; and

c

if that application—

i

is a notifiable application, and

ii

has 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.

4

Where 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—

a

the arrangements for bringing an appeal in relation to that application; and

b

the determination of any appeal validly brought,

a Primary Care Trust has required a doctor to provide pharmaceutical services under regulation 60(4)(a) of the 2005 Regulations M182 (arrangements for provision of pharmaceutical services by doctors); and

b

the 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.

Listing applications under the 2012 Regulations: dispensing doctors5

1

Where 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—

a

if 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 F427NHS England in accordance with these Regulations; and

the 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.

Outstanding cases relating to dispensing contractor lists6

1

If, 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 F427NHS England in accordance with paragraph 10 of Schedule 7 to the 2012 Regulations (transitional provisions – dispensing contractor lists).

2

Where—

a

F427NHS England grants an application for premises approval by virtue of this paragraph; and

b

F427NHS 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, F427NHS 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.

3

Conditions 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.

Controlled localities7

1

F427NHS England must—

a

in 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);

b

publish that map; and

c

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

2

Where—

a

before 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; or

b

F427NHS 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.

3

Where—

a

consideration 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—

i

the consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by F427NHS England in accordance with the 2005 Regulations, and

ii

the arrangements for bringing an appeal in relation to the decision of F427NHS England, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations;

b

consideration 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)—

i

the consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by F427NHS England in accordance with the 2012 Regulations, and

ii

the arrangements for bringing an appeal in relation to the decision of F427NHS 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 F427NHS England in accordance with these Regulations;

c

an application referred to in sub-paragraph (2)(b) is to be dealt with under the 2012 Regulations (by virtue of paragraphs 3 or 5)—

i

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 F427NHS England in accordance with the 2012 Regulations, and

ii

the arrangements for bringing an appeal in relation to the decision of F427NHS England, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations;

d

an 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 F427NHS England in accordance with these Regulations.

4

Where, by virtue of sub-paragraph (3), it is determined (whether by F427NHS 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, F427NHS England must—

a

delineate precisely the boundary of any resulting controlled locality on a map;

b

publish that map; and

c

make that map available as soon as is practicable to any HWB that has all or part of 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).

Reserved locations8

1

Where—

i

that decision has been appealed before the appointed day, or

ii

the 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.

4

Where, when granting an application which by virtue of paragraph 3 is finally determined in accordance with the 2012 Regulations, F427NHS 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)—

a

any termination of arrangements with any person on its dispensing doctor list; and

b

any postponement of any such termination,

arising out of that grant, that consideration and its decision are to be in accordance with the 2012 Regulations.

5

Where 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—

a

the termination of arrangements with a dispensing doctor; or

b

the postponement of the termination of arrangements with a dispensing doctor,

that matter is to be dealt with by F427NHS England, in accordance with the 2012 Regulations.

6

Where, under the 2012 Regulations—

a

a 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); or

b

i

that decision has been appealed before the appointed day, or

ii

the 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.

7

Regulation 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.

8

Conditions imposed by virtue of—

a

regulation 20(2) or 35(6)(b) (pharmaceutical services in reserved locations) of the 2005 Regulations; or

b

regulation 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.

Gradual introduction of the provision of pharmaceutical services by doctors10

1

Where, when granting an application which by virtue of paragraph 4 is finally determined in accordance with the 2005 Regulations, F427NHS 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.

2

Where 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 F427NHS England, in accordance with the 2005 Regulations.

3

Where, under the 2005 Regulations—

postponement of the making of arrangements with a dispensing doctor, or

ii

limiting the patients to whom a dispensing doctor is able to provide pharmaceutical services,

is made by virtue of sub-paragraph (1) or (2); or

b

before 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—

i

that decision has been appealed before the appointed day, or

ii

the 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.

7

Conditions imposed by virtue of—

a

regulation 20(2) of the 2005 Regulations relating to postponement of the making of arrangements with a dispensing doctor; or

b

regulation 57(1) of the 2012 Regulations relating to—

i

the postponement of the making of arrangements with a dispensing doctor, or

ii

limiting 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.

Giving effect to listing decisions: pharmaceutical lists and dispensing doctor lists11

1

Where, 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 F427NHS England, or on appeal)—

a

to be included F51in a pharmaceutical list but has not been included in that list;

b

to have listed in relation to their entry in a pharmaceutical list premises that have not been listed in relation to them;

c

to be included in a dispensing doctor list but has not been included in that list;

d

to have listed in relation to their entry in a dispensing doctor list premises that have not been listed in relation to them; or

e

to 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.

2

Where, 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 F427NHS England, or on appeal)—

a

to be included F52in a pharmaceutical list but has not been included in that list;

b

to have listed in relation to their entry in a pharmaceutical list premises that have not been listed in relation to them;

c

to be included in a dispensing doctor list but has not been included in that list;

d

to have listed in relation to their entry in a dispensing doctor list premises that have not been listed in relation to them; or

e

to 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.

Pharmaceutical lists, EPS lists and dispensing doctor lists: continuity of entries and decisions12

1

Subject 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 F427NHS England on the appointed day under regulations 10 and 46 (albeit that the lists may be maintained by reference to different geographical areas).

2

Where 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, F427NHS England is required or entitled (unless the context requires otherwise) to give effect to that decision on or after the appointed day.

3

If, as regards a decision to which paragraph (2) applies, before the appointed day—

a

removal of an entry in a pharmaceutical list, EPS list or dispensing doctor list—

i

would have resulted in removal of a person from a pharmaceutical list, EPS list or dispensing doctor list but no longer does so, or

ii

would 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; or

b

inclusion of an entry in a pharmaceutical list, EPS list or dispensing doctor list—

i

would have required the new inclusion of a person in a pharmaceutical list, EPS list or dispensing doctor list but no longer does so, or

ii

would 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,

to 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);

b

to 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); or

c

to 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).

7

Decisions and reviews of decisions in any proceedings commenced under Chapter 6 of Part 7 of the 2006 Act before the appointed day—

a

which 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; or

b

were 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).

8

c

iii

any 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.

Notification of LPS designations and completion of reviews16

1

The 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 F427NHS England as if it were made, varied or notified under Part 13 of these Regulations.

2

Any 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 F427NHS England.

The application of Group 12 of Schedule 8 to the Value Added Tax Act 199417

Pending amendment of Group 12 of Schedule 8 to the Value Added Tax Act 1994 M185 (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—

j
Part 8 of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013.

SCHEDULE 10Amendments and revocations

Regulation 120

Amendment of the National Health Service (Charges for Drugs and Appliances) Regulations 2000F751

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocation of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 20022

The National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002 M186 are revoked.

Revocation of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 20023

The National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002 M187 are revoked.

Revocation of the National Health Service (Pharmaceutical Services) Amendment Regulations 20054

The National Health Service (Pharmaceutical Services) Amendment Regulations 2005 M188 are revoked.

Revocation of the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 and amendments to those Regulations5

1

The National Health Service (Local Pharmaceutical Services etc.) Regulations M189 are revoked.

2

The following provisions are revoked—

a

regulation 4 of the National Health Service (Miscellaneous Amendments Relating to Independent Prescribing) Regulations 2006 M190;

b

regulation 8 of the National Health Service (Pharmaceutical Services) (Remuneration for Persons Providing Pharmaceutical Services) (Amendment) Regulations 2007 M191;

c

Part 2 of the National Health Service (Miscellaneous Amendments Relating to Community Pharmaceutical Services and Optometrist Prescribing) Regulations 2009 M192;

d

paragraphs 134 to 136 of Schedule 3 to the Transfer of Tribunal Functions Order 2010 M193; and

e

paragraph 53 of Schedule 4 to the Pharmacy Order 2010 M194.

Revocation of the National Health Service (Pharmaceutical Services) (Amendment) Regulations 20066

The National Health Service (Pharmaceutical Services) (Amendment) Regulations 2006 M195 are revoked.

Amendments to the Local Authority Social Services and National Health Service Complaints (England) Regulations 20097

In the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 M196—

a

in the definition of “relevant complaints procedure” in regulation 2 (interpretation), for paragraphs (i) to (iii) of sub-paragraph (a) substitute the following paragraphs—

i
paragraph 34 of Schedule 4 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013;
ia
paragraph 24 of Schedule 5 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013;
ii
paragraph 8 of Schedule 6 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013; or
iii
paragraph 25 of Schedule 7 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013; or

b

paragraph 2 of the Schedule is revoked.

Revocation of the National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) Amendment Regulations 20098

The National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) Amendment Regulations 2009 M197 are revoked.

Revocation of the National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) (Amendment) Regulations 20109

The National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) (Amendment) Regulations 2010 M198 are revoked.

Revocation of the National Health Service (Local Pharmaceutical Services) Amendment Regulations 201210

The National Health Service (Local Pharmaceutical Services) Amendment Regulations 2012 M199 are revoked.

Revocation of the National Health Service (Pharmaceutical Services) Regulations 2012 and of amendments to those Regulations11

1

The following Regulations are revoked—

a

the National Health Service (Pharmaceutical Services) Regulations 2012 M200; and

b

National Health Service (Pharmaceutical Services) Regulations 2012 (Amendment) Regulations 2012 M201.

Amendment of the Local Authorities (Partnership Arrangements, Care Trusts, Public Health and Local Healthwatch Arrangements etc.) Regulations 201212

In regulation 12(3)(d) of the Local Authorities (Partnership Arrangements, Care Trusts, Public Health and Local Healthwatch Arrangements etc.) Regulations 2012 M202 (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).