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Statutory Instrument 2005 No. 641
The National Health Service (Pharmaceutical Services) Regulations 2005
(The document as of February, 2008)
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STATUTORY INSTRUMENTS
2005 No. 641
NATIONAL HEALTH SERVICE, ENGLAND
The National Health Service (Pharmaceutical Services) Regulations 2005
| | Made | 10th March 2005 | | | | Laid before Parliament | 11th March 2005 | | | | Coming into force | 1st April 2005 | |
ARRANGEMENT OF REGULATIONSPART 1General
| 1. | Citation, commencement and extent |
PART 2Pharmaceutical Lists and Applications for Admission to a Pharmaceutical List
| 5. | Applications for inclusion in or amendment to a pharmaceutical list |
| 6. | Applications involving a minor relocation within a Primary Care Trust's area |
| 7. | Applications involving a minor relocation between neighbouring Primary Care Trusts |
| 8. | Applications involving a change of ownership |
| 9. | Applications following suspension from the list |
| 10. | Right of return to pharmaceutical lists |
| 11. | Refusal: general provisions |
| 12. | Necessary or desirable test |
| 13. | Exemption from the necessary or desirable test |
| 14. | Variation of directed services in respect of exempted premises |
| 16. | New one-stop primary care centres |
| 17. | Refusal: distance selling premises |
| 18. | Refusal: premises which are in a controlled locality but not in a reserved location |
| 19. | Refusal: fitness to practise grounds |
| 20. | Imposition of conditions |
| 21. | Conditional inclusion relating to fitness to practise matters |
| 22. | Relevant procedures for applications |
| 23. | Notification of applications |
| 24. | Determination of applications |
| 25. | Deferral of consideration of certain applications |
| 26. | Deferral of consideration of applications on fitness to practise grounds |
| 27. | Notification of decision |
| 28. | Notifications by Primary Care Trusts to other persons |
| 30. | Appeals against imposition of conditions and related decisions |
| 31. | Determination that an area is a controlled locality |
| 32. | Appeals relating to rurality of an area |
| 33. | Notification of an application in respect of premises in a controlled locality |
| 34. | Decision not to consider an application in respect of premises in a controlled locality |
| 35. | Pharmaceutical services in reserved locations |
| 36. | Determination of applications in respect of controlled localities |
| 37. | Notification of decision in respect of applications in controlled localities |
| 38. | Appeals in connection with determinations in respect of controlled localities etc |
| 39. | Procedure after grant of application |
| 40. | Preliminary consent to be included in a pharmaceutical list |
| 41. | Effect of preliminary consent |
PART 3Conditional inclusion, suspension and removal from pharmaceutical lists
| 42. | Review of decision to impose conditions |
| 43. | Appeals following a review |
| 44. | Removal for breach of conditions |
| 45. | Removal from pharmaceutical lists |
| 46. | Criteria for decisions on removal |
| 47. | Cases where the Primary Care Trust must remove a chemist |
| 49. | Supplementary matters relating to removal |
| 50. | Procedure on suspension |
| 51. | Procedure on review of Primary Care Trust decision |
| 52. | Review periods on national disqualification |
| 53. | Withdrawals from the list |
| 54. | Temporary provision of services during a period of suspension |
PART 4Payments to chemists
| 56. | Standards of, and payments for, drugs and appliances |
| 57. | Claims and overpayments |
| 58. | Payments to suspended chemists |
PART 5Provision of Pharmaceutical Services by Doctors
| 60. | Arrangements for provision of pharmaceutical services by doctors |
| 61. | Outline consent and premises approval |
| 62. | Taking effect of outline consent and premises approval |
| 63. | Lapse of outline consent and premises approval |
| 64. | Premises approval: change of premises before outline consent takes effect |
| 65. | Premises approval: additional and new premises after outline consent has taken effect |
| 66. | Premises approval: practice amalgamations |
| 67. | Premises approval - transitional provisions |
| 68. | Dispensing doctor lists |
| 69. | Removal of entries from dispensing doctor lists |
PART 6Miscellaneous
| 70. | Publication of particulars |
| 71. | List of chemists providing an ETP service |
| 72. | Exercise of choice of chemist in certain cases |
| 73. | Transitional provisions |
| 74. | Transitional arrangements in respect of terms of service |
| 75. | Minor and consequential amendments and revocations |
| | SCHEDULE 1 | TERMS OF SERVICE OF PHARMACISTS |
| 1. | Incorporation of provisions |
| 2. | Division of responsibilities between individuals and corporate bodies |
| 5. | Dispensing of drugs and appliances |
| 6. | Urgent supply without a prescription |
| 7. | Preliminary matters before providing ordered drugs or appliances |
| 8. | Providing ordered drugs or appliances |
| 9. | Refusal to provide drugs or appliances ordered |
| 10. | Further activities to be carried out in connection with the provision of dispensing services |
| 11. | Additional requirements in relation to electronic prescribing |
| 12. | Disposal service in respect of unwanted drugs |
| 13. | Basic procedure in respect of unwanted drugs |
| 14. | Further activities to be carried out in connection with the disposal of unwanted drugs |
| 15. | Promotion of healthy lifestyles |
| 16. | Prescription linked intervention |
| 17. | Public health campaigns |
| 19. | Service outline in respect of signposting |
| 21. | Service outline in respect of support for self-care |
| 22. | Pharmacy opening hours: general |
| 23. | Matters to be considered when issuing directions in respect of pharmacy opening hours |
| 24. | Determination of pharmacy opening hours instigated by the Primary Care Trust |
| 25. | Determination of pharmacy opening hours instigated by the pharmacist |
| | PART 4 | CLINICAL GOVERNANCE, FITNESS TO PRACTISE AND COMPLAINTS |
| 27. | Professional Standards |
| 29. | Duty to provide information about fitness to practise matters: pharmacists on pharmaceutical lists on 1st April 2005 |
| 30. | Duty to provide information about fitness to practise matters as they arise |
| 31. | Home Primary Care Trust of bodies corporate |
| | PART 5 | OTHER TERMS OF SERVICE |
| 34. | Information to be supplied |
| 35. | Withdrawal from pharmaceutical lists |
| 36. | Charges for drugs and refunds |
| 37. | Inspections and access to information |
| | SCHEDULE 2 | TERMS OF SERVICE OF DISPENSING DOCTORS |
| 1. | Incorporation of provisions |
| 2. | Persons duly authorised to dispense on behalf of dispensing doctors |
| 3. | Dispensing of drugs and appliances ordered by another prescriber |
| 4. | Dispensing of drugs and appliances ordered by the dispensing doctor |
| 5. | Preliminary matters before providing ordered drugs or appliances |
| 6. | Provision of Scheduled drugs |
| 7. | Refusal to provide drugs or appliances ordered |
| 10. | Inspections and access to information |
| | SCHEDULE 3 | TERMS OF SERVICE OF SUPPLIERS OF APPLIANCES |
| 1. | Incorporation of provisions |
| 2. | Division of responsibilities between individuals and corporate bodies |
| 4. | Dispensing of appliances |
| 5. | Preliminary matters before providing appliances |
| 7. | Refusal to provide appliances ordered |
| 8. | Further activities to be carried out in connection with the provision of dispensing services |
| 9. | Additional requirements in relation to electronic prescribing |
| 10. | Opening hours: general |
| 11. | Matters to be considered when issuing directions in respect of opening hours |
| 12. | Determination of opening hours instigated by the Primary Care Trust |
| 13. | Determination of opening hours instigated by the supplier of appliances |
| 14. | Professional Standards |
| 16. | Duty to provide information about fitness to practise matters: suppliers of appliances on pharmaceutical lists on 1st April 2005 |
| 17. | Duty to provide information about fitness to practise matters as they arise |
| 18. | Home Primary Care Trust of bodies corporate |
| 21. | Information to be supplied |
| 22. | Withdrawal from pharmaceutical lists |
| 23. | Charges for appliances |
| 24. | Inspections and access to information |
| | Part 1 | INFORMATION TO BE INCLUDED IN AN APPLICATION FOR INCLUSION IN A PHARMACEUTICAL LIST OR INCLUSION IN A LIST IN RESPECT OF DIFFERENT SERVICES OR PREMISES |
| | Part 2 | NOTIFICATIONOF COMMENCEMENT DATE |
| | Part 3 | INFORMATION AND UNDERTAKINGS TO BE GIVEN BY AN APPLICANT IN CONNECTION WITH AN APPLICATION FOR INCLUSION (OR TEMPORARY INCLUSION) IN A PHARMACEUTICAL LIST |
| | SCHEDULE 5 | MINOR AND CONSEQUENTIAL AMENDMENTS |
The Secretary of State for Health, in exercise of the powers conferred upon him by sections 41, 42, 43, 43ZA, 49F, 49I, 49N, 49O, 49P, 49Q and 126(4) of the National Health Service Act 1977[1] hereby makes the following Regulations: - PART 1GeneralCitation, commencement and extent 1. - (1) These Regulations may be cited as the National Health Service (Pharmaceutical Services) Regulations 2005 and shall come into force on 1st April 2005. (2) Subject to paragraph (3), these Regulations shall apply in relation to England only[2]. (3) The amendments and revocations of enactments made by regulation 75 and Schedules 5 and 6 have, subject to paragraph (4), no application to Wales but, subject to that, the extent of those provisions is the same as that of the enactment amended or revoked. (4) The amendments made by regulation 75 and paragraph 4 of Schedule 5 apply to Wales. Interpretation 2. - (1) In these Regulations - "the Act" means the National Health Service Act 1977; "the 1992 Regulations" means the National Health Service (Pharmaceutical Services) Regulations 1992[3], as in force on 31st March 2005; "the 1997 Act" means the National Health Service (Primary Care) Act 1997[4]; "the 2001 Act" means the Health and Social Care Act 2001[5]; "the 2002 Act" means the National Health Service Reform and Health Care Professions Act 2002[6]; "Abolition of the Tribunal Regulations" means the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2001[7]; "Abolition of the Tribunal (Wales) Regulations" means the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2002[8]; "advanced electronic signature" means an electronic signature which is - (a) uniquely linked to the signatory;
(b) capable of identifying the signatory;
(c) created using means that the signatory can maintain under his sole control; and
(d) linked to the data to which it relates in such a manner that any subsequent change of data is detectable;
"APMS" means primary medical services provided in accordance with an APMS contract; "APMS contract" means an arrangement to provide primary medical services made under section 16CC(2)(b) (primary medical services)[9] of the Act; "APMS contractor" means a party to an APMS contract other than a Primary Care Trust; "appliance" means an appliance which is included in a list for the time being approved by the Secretary of State for the purposes of section 41 (arrangements for pharmaceutical services) of the Act; "appropriate non-proprietary name" means a non-proprietary name which is not mentioned in Schedule 1 (drugs, medicines and other substances not to be ordered under a general medical services contract) to the Prescription of Drugs Regulations or, except where the conditions in paragraph 42(2) of Schedule 6 to the GMS Regulations are satisfied, in Schedule 2 (drugs, medicines and other substances that may be ordered only in certain circumstances) to the Prescription of Drugs Regulations; "associated batch issue" means, in relation to a non-electronic repeatable prescription, one of the batch issues relating to that prescription and containing the same date as that prescription; "bank holiday" means any day that is specified or proclaimed as a bank holiday in England pursuant to section 1 of the Banking and Financial Dealings Act 1971[10]; "batch issue" means a form provided by a Primary Care Trust and issued by a repeatable prescriber at the same time as a non-electronic repeatable prescription to enable a chemist to receive payment for the provision of repeat dispensing services which is in the format specified in Part 2 of Schedule 1 to the GMS Regulations, and which - (a) is generated by a computer and not signed by a repeatable prescriber;
(b) relates to a particular non-electronic repeatable prescription and contains the same date as that prescription;
(c) 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
(d) specifies a number denoting its place in the sequence referred to in sub-paragraph (c);
"Charges Regulations" means the National Health Service (Charges for Drugs and Appliances) Regulations 2000[11]; "chemical reagent" means a chemical reagent included in a list for the time being approved by the Secretary of State for the purposes of section 41 of the Act; "chemist", except in the expression "LPS chemist", means - (a) a registered pharmacist;
(b) a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968[12]; or
(c) a supplier of appliances,
who is included in the list of a Primary Care Trust under section 42 (regulations as to pharmaceutical services) of the Act, and includes a person suspended from such a list;
"child" means a person who has not attained the age of 16 years; "Community Health Council" means a body of that name established in accordance with section 20 of the Act; "conditional inclusion" means inclusion in a pharmaceutical list (or the grant of preliminary consent to be included in a pharmaceutical list) subject to conditions imposed under regulation 21, 30, 42 or 43 and "conditionally include" shall be construed accordingly; "contingent removal" means removal from a pharmaceutical list contingently, within the meaning of section 49G (contingent removal)[13] of the Act, and "contingently remove" shall be construed accordingly; "controlled locality" means an area which the Primary Care Trust, or on appeal, the Secretary of State, has determined is rural in character in accordance with regulation 31 or, as the case may be, regulation 32; "dentist" means a dental practitioner; "directed services" means additional pharmaceutical services provided in accordance with a direction under section 41A[14] (arrangements for providing additional pharmaceutical services) of the Act; (a) a director of a body corporate; or
(b) a member of the body of persons controlling a body corporate (whether or not a limited liability partnership);
"dispensing contractor" means a chemist, doctor, GMS contractor or PMS contractor whom a patient wishes to dispense his electronic prescriptions; "dispensing doctor" means a doctor who provides pharmaceutical services under arrangements with a Primary Care Trust under Part 5; "dispensing doctor list" shall be construed in accordance with regulation 68; "distance selling chemist" means a chemist who provides pharmaceutical services from distance selling premises; "distance selling premises" has the meaning given to it in regulation 13(1)(d); "doctor" means a medical practitioner; "drugs" includes medicines; "Drug Tariff" has the meaning given to it in regulation 56; "electronic communication" has the same meaning as in section 15 of the Electronic Communications Act 2000[15]; "electronic prescription" means an electronic prescription form or an electronic repeatable prescription; "electronic prescription form" means a prescription which falls within paragraph (b) of the definition of "prescription form"; "electronic repeatable prescription" means a prescription which falls within paragraph (a)(ii) of the definition of "repeatable prescription"; "employment" means any employment whether paid or unpaid and whether under a contract for services or a contract of service, and "employed" and "employer" shall be construed accordingly; "equivalent body" means a Local Health Board in Wales, a Health Board or an NHS trust in Scotland, a Health and Social Services Board in Northern Ireland, (in relation to any time prior to 1st October 2002) a Health Authority in England or (in relation to any time prior to 1st April 2003) a Health Authority in Wales; "equivalent lists" means lists kept by an equivalent body; "essential services" has the meaning given to it in paragraph 3 of Schedule 1 (essential services); "ETP list" means the list prepared, maintained and published by a Primary Care Trust pursuant to regulation 71. "ETP service" means the electronic prescription service which forms part of the NHS Care Record Service; "FHSAA" means the Family Health Services Appeal Authority constituted under section 49S of the Act[16]; "finally granted" and "final grant" (except in regulations 40 and 41) have the meaning given to them in regulation 39(14) and "finally refused" and "finally determined" shall be construed accordingly; "fraud case" means a case where a person satisfies the second condition for removal from the pharmaceutical list, set out in section 49F(3) (disqualification of practitioners) of the Act, or by virtue of section 49H (fraud and unsuitability cases: supplementary)[17] of the Act is treated as doing so; "GMS contract" means a general medical services contract[18]; "GMS contractor" means a party to a GMS contract other than a Primary Care Trust; "the GMS Regulations" means the National Health Service (General Medical Services Contracts) Regulations 2004[19]; "Health and Social Services Board" means a Health and Social Services Board established under the Health and Personal Social Services (Northern Ireland) Order 1972[20]; "Health Board" means a Health Board established under section 2 of the National Health Service (Scotland) Act 1978[21]; "health care professional" means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the 2002 Act; "independent nurse prescriber" means a person - "joint discipline committee" shall have the same meaning as in the National Health Service (Service Committees and Tribunal) Regulations 1992[22]; "licensing or regulatory body" means a body that licenses or regulates any profession of which the person is or has been a member, and includes any body which licenses or regulates any such profession in a country other than the United Kingdom; "list", unless the context otherwise requires, means - (a) a list referred to in section 49N(1)(a) to (c)(national disqualification) of the Act[23];
(b) a list of persons undertaking to provide general medical services prepared in accordance with regulations made under section 29 (arrangements and regulations for general medical services)[24] of the Act, as the list existed on or before 31st March 2004;
(c) a list of persons approved by a Primary Care Trust for the purpose of assisting in the provision of general medical services prepared in accordance with regulations made under section 43D(1) (supplementary lists)[25] of the Act as the list existed on or before 31st March 2004; or
(d) a services list referred to in section 8ZA(1)(a) (lists of persons who may perform personal medical services or personal dental services)[26] of the 1997 Act as the list existed on or before 31st March 2004;
"listed premises" means premises in relation to which premises approval has been granted and has effect and from which a doctor may dispense, being premises specified in relation to the doctor in the dispensing doctors list pursuant to regulation 68(4); "Local Dental Committee" means a committee recognised under section 44 (Local Optical Committees and Local Pharmaceutical Committees)[27] of the Act as being representative of persons providing general dental services or personal dental services in an area; and in this definition, "personal dental services" has the meaning assigned to it in section 1 (pilot schemes) of the 1997 Act; "Local Medical Committee" means a committee recognised under section 45A (Local Medical Committees) of the Act[28]; "Local Pharmaceutical Committee" means a committee recognised under section 44 of the Act as being representative of persons providing pharmaceutical services or local pharmaceutical services in a locality; "local pharmaceutical services" has the meaning given in regulation 2 of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002[29]; (a) a registered pharmacist,
(b) a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968, or
(c) a supplier of appliances,
who provides local pharmaceutical services under a pharmacy pilot scheme;
"medical performers list" means a list of doctors prepared and published pursuant to regulation 3(1) (performers lists) of the National Health Service (Performers Lists) Regulations 2004[30]; "national disqualification" means - (a) a decision made by the FHSAA under section 49N (national disqualification) of the Act in relation to a person who has been removed from a pharmaceutical list;
(b) a decision under provisions in force in Scotland or Northern Ireland corresponding to section 49N of the Act; or
(c) a decision by the Tribunal which is treated as a national disqualification by the FHSAA by virtue of regulation 4 (national disqualification decisions made before the relevant date) or 6(4)(b) (other cases under the 1977 Act not disposed of by the relevant date) of the Abolition of the Tribunal Regulations or regulation 4 (national disqualification decisions made before the relevant date) or 6(4)(b) (other cases under the 1977 Act not disposed of by the relevant date) of the Abolition of the Tribunal (Wales) Regulations;
"National Health Service Counter Fraud and Security Management Service" means the Special Health Authority of that name with responsibility for policy and operational matters relating to the prevention, detection and investigation of fraud or corruption and the management of security in the National Health Service[31]; "NHS Care Record" means the records relating to an individual patient held by the NHS Care Record Service; "NHS Care Record Service" means the information technology systems procured by the Department of Health and used by the health service to hold medical records relating to patients; "NHS services" means services provided as part of the health service; "nominated dispensing contractor" means a chemist, doctor, GMS contractor or PMS contractor whom a patient has nominated in his NHS Care Record to dispense his electronic prescriptions; "non-electronic prescription form" means a prescription form which falls within paragraph (a) of the definition of "prescription form"; "non-electronic repeatable prescription" means a prescription which falls within paragraph (a)(i) of the definition of repeatable prescription; "non-proprietary name", in relation to a drug, means - (a) where the drug is described in a monograph in the current edition (as defined in section 103(5) (construction of references to specified publications)[32] of the Medicines Act 1968), as in force at the time of the supply of the drug, of the European Pharmacopoeia, the British Pharmacopoeia, the British Pharmaceutical Codex, the British National Formulary, the International Pharmacopoeia, the Cumulative List of Recommended International Non-proprietary Names or the Dental Practitioners' Formulary, any name, or abbreviation of the name, at the head of that monograph or, where the name consists of two or more words, any name derived from a suitable inversion of such words which is permitted by that publication; or
(b) where the drug is not so described but has an approved name, being the name which appears in the current edition (as defined in section 103(5) of the Medicines Act 1968) of the list of names prepared and published under section 100 (lists of names) of that Act, as in force at the time of the supply of the drug, its approved name;
"notice" means a notice in writing (including electronic) and "notify" shall be construed accordingly; "Nursing and Midwifery Register" means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001[33]; "originating events" means the events that gave rise to the conviction, investigation, proceedings, suspension, refusal to admit, conditional inclusion, removal or contingent removal that took place; "outstanding application" except where the context otherwise requires has the meaning given to it in regulation 62(5); "outline consent" has the meaning given to it in regulation 61(1)(a); "patient" in relation to - (a) a GMS contract has the same meaning as in regulation 2 of the GMS Regulations (interpretation);
(b) a PMS agreement has the same meaning as in regulation 2 of the PMS Regulations (interpretation); and
(c) an arrangement made under section 16CC(2)(b) of the Act or a PCTMS practice means any person to whom primary medical services are or are to be provided under those arrangements or by that practice;
"patient list" means a list of patients kept by a Primary Care Trust - (a) in respect of a GMS contractor, in accordance with paragraph 14 (list of patients) of Schedule 6 to the GMS Regulations;
(b) in respect of a PMS contractor, in accordance with paragraph 13 (list of patients) of Schedule 5 to the PMS Regulations; or
(c) in respect of an APMS contractor or PCTMS practice, in accordance with directions given by the Secretary of State under section 17 of the Act in respect of an APMS contract or a PCTMS practice[34];
"Patients' Forum" means a body established under section 15(1) (establishment of Patients' forums) of the 2002 Act; "PCTMS" means primary medical services provided by a Primary Care Trust under section 16CC(2)(a) of the Act; "PCTMS practice" means a practice established by a Primary Care Trust to provide PCTMS; "pharmaceutical discipline committee" has the same meaning as in the National Health Service (Service Committees and Tribunal) Regulations 1992[35]; "pharmaceutical list" shall be construed in accordance with regulation 4; "pharmaceutical services" means pharmaceutical services other than directed services; "pharmacist" means, except where the context otherwise requires - (a) a registered pharmacist; or
(b) a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968,
whose name is included in the list of a Primary Care Trust under section 42 (regulations as to pharmaceutical services) of the Act, but does not include a supplier of appliances only,;
"pharmacy" means any premises where drugs are provided by a pharmacist - (a) as part of pharmaceutical services under section 41 (arrangements for pharmaceutical services) of the Act; or
(b) in accordance with a pharmacy pilot scheme -
(i) where the range of local pharmaceutical services provided under that scheme is the same or comparable to the range of pharmaceutical services provided by a pharmacy falling within paragraph (a) of this definition, and
(ii) where the local pharmaceutical services provided under that scheme are provided at the same or similar hours as pharmaceutical services provided by a pharmacy falling within paragraph (a) of this definition;
"pharmacy pilot scheme" has the same meaning as the term "pilot scheme" in section 28(2) (pilot schemes)[36] of the 2001 Act; "PMS agreement" means an agreement made under section 28C (personal medical or dental services) of the Act[37]; "PMS contractor" means a party to a PMS agreement, other than a Primary Care Trust or a Strategic Health Authority; "the PMS Regulations" means the National Health Service (Personal Medical Services Agreements) Regulations 2004[38]; "practice amalgamation" has the meaning given to it in regulation 66(1); "practice premises", in relation to a provider of primary medical services, means the address specified in the contract (in the case of a GMS, PMS or APMS contractor) or practice statement (in the case of a PCTMS practice) as one at which services are to be provided under the contract or practice statement; "preliminary consent" has the meaning given to it in regulation 40; "premises approval" has the meaning given to it in regulation 61(1)(b) and includes temporary premises approval granted under regulation 65(9) or 66(4) and residual premises approval under regulation 66(9); "prescriber" means a doctor, dentist, independent nurse prescriber or a supplementary prescriber; "prescription form" means - (a) a form provided by a Health Board, a Health and Social Services Board, a Local Health Board, a Primary Care Trust, an NHS Trust or NHS Foundation Trust, and issued by a prescriber; or
(b) data that are created in an electronic form, signed with a prescriber's advanced electronic signature and transmitted as an electronic communication to a nominated dispensing contractor by the ETP service,
to enable a person to obtain pharmaceutical services or local pharmaceutical services, and does not include a repeatable prescription;
"the Prescription of Drugs Regulations" means the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc) Regulations 2004[39]; "primary carer" means, in relation to an adult, the adult or organisation primarily caring for him; "professional conduct" includes matters relating both to professional conduct and professional performance; "professional registration number" means the number against the pharmacist's name in the register maintained by the Royal Pharmaceutical Society of Great Britain and in the case of a person who is not a pharmacist, means the number against that person's name in the register of any body that licenses or regulates any profession of which he is a member; "provisional date" shall be interpreted in accordance with regulation 62(6) to (8); "provider of primary medical services" means a GMS contractor, PMS contractor, APMS contractor or a PCTMS practice; "relevant APMS contractor", in relation to any doctor, means the APMS contractor, where the doctor is an APMS contractor, or where he is not, the APMS contractor by whom he is employed or engaged; "relevant GMS contractor", in relation to any doctor, means the GMS contractor, where the doctor is a GMS contractor or, where he is not, the GMS contractor by whom the doctor is employed or engaged; "relevant patient list" means, in relation to a doctor who is (or is a legal and beneficial shareholder in a company which is) a GMS contractor, PMS contractor or APMS contractor, the patient list for that contractor or, where he is not a contractor, means the patient list for the GMS contractor, PMS contractor or APMS contractor by whom he is employed or engaged or for the PCTMS practice within which the doctor provides primary medical services; "relevant PCTMS practice", in relation to any doctor, means the PCTMS practice within which he provides primary medical services; "relevant PMS contractor", in relation to any doctor, means the PMS contractor, where the doctor is a PMS contractor or, where he is not, the PMS contractor by whom the doctor is employed or engaged; "relevant register" means - (a) in relation to a nurse or midwife, the Nursing and Midwifery Register; and
(b) in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954[40] (the registers and registration) or the register maintained in pursuance of Articles 6 (the registers) and 9 (the registrar) of the Pharmacy (Northern Ireland) Order 1976[41];
"Remission of Charges Regulations" means the National Health Service (Travel Expenses and Remission of Charges) Regulations 2003[42]; "repeat dispensing services" means pharmaceutical services which involve the provision of drugs or appliances by a chemist in accordance with a repeatable prescription; "repeatable prescriber" means a person who is - (a) a GMS contractor who provides repeatable prescribing services under the terms of its contract which give effect to paragraph 40 (repeatable prescribing services) of Schedule 6 to the GMS Regulations;
(b) a PMS contractor who provides repeatable prescribing services under the terms of its agreement which give effect to paragraph 39 (repeatable prescribing services) of Schedule 5 to the PMS Regulations;
(c) an APMS contractor who provides repeatable prescribing services under the terms of its agreement which give effect to a provision in directions made by the Secretary of State under section 17 of the Act in relation to APMS contracts which is the equivalent provision to paragraph 39 of Schedule 5 to the PMS Regulations; or
(d) employed or engaged by -
(i) a GMS contractor who provides repeatable prescribing services under the terms of a contract which give effect to paragraph 40 of Schedule 6 to the GMS Regulations,
(ii) a PMS contractor who provides repeatable prescribing services under the terms of an agreement which give effect to paragraph 39 of Schedule 5 to the PMS Regulations,
(iii) an APMS contractor who provides repeatable prescribing services under the terms of an agreement which give effect to a provision in directions made by the Secretary of State under section 17 of the Act in relation to APMS contracts which is the equivalent provision to paragraph 39 of Schedule 5 to the PMS Regulations, or
(iv) a Primary Care Trust for the purposes of providing primary medical services within a PCTMS practice which provides repeatable prescribing services in accordance with a provision in directions made by the Secretary of State under section 17 of the Act in relation to PCTMS which is the equivalent provision to paragraph 39 of Schedule 5 to the PMS Regulations;
"repeatable prescription" means a prescription which - (a) either -
(i) is contained in a form provided by a Primary Care Trust and issued by a repeatable prescriber which is in the format specified in Part 1 of Schedule 1 (repeat dispensing forms) to the GMS Regulations, and which is generated by a computer and signed in ink by a repeatable prescriber, or
(ii) consists of data that are created in an electronic form, signed with a repeatable prescriber's advanced electronic signature and transmitted as an electronic communication to a nominated dispensing contractor by the ETP service;
(b) is issued or created to enable a person to obtain pharmaceutical services or local pharmaceutical services; and
(c) indicates that the drugs or appliances ordered on that prescription may be provided more than once, and specifies the number of occasions on which they may be provided;
"reserved location" has the meaning given to it in regulation 35(2); "restricted availability appliance" means an appliance which is approved for particular categories of persons or particular purposes only; "Scheduled drug" means a drug or other substance specified in Schedule 1 to the Prescription of Drugs Regulations or, except where the conditions in paragraph 42(2) of Schedule 6 to the GMS Regulations are satisfied, Schedule 2 to the Prescription of Drugs Regulations; "superintendent" has the same meaning as it has in section 71 (bodies corporate)[43] of the Medicines Act 1968; "supplementary prescriber" means a person - (a) whose name is registered in -
(i) the Nursing and Midwifery Register,
(ii) the Register of Pharmaceutical Chemists maintained in pursuance of section 2(1) (the registers and registration) of the Pharmacy Act 1954,
(iii) the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976. or
(iv) the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001[44] relating to -
(aa) chiropodists and podiatrists,
(bb) physiotherapists, or
(cc) radiographers: diagnostic or therapeutic; and
(b) against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs and appliances as a supplementary prescriber;
(a) suspended by a Primary Care Trust or equivalent body under sections 49I (suspension) or 49J (suspension pending appeal)[45] of the Act, regulations made under section 28DA (lists of persons who may perform personal medical services or personal dental services)[46] or 43D(supplementary lists) of the Act, or under section 8ZA (lists of persons who may perform personal medical services or personal dental services) of the 1997 Act; or
(b) in relation to Scotland or Northern Ireland, suspended under provisions in force corresponding to those in or made under sections 28DA, 43D, 49I or 49J of the Act or under section 8ZA of the 1997 Act,
and shall be treated as including a case where a person is treated as suspended by a Primary Care Trust or, prior to 1st October 2002, by a Health Authority by virtue of regulation 6(2) of the Abolition of the Tribunal Regulations, or, in Wales, by a Local Health Board, or prior to 1st April 2003, by a Health Authority by virtue of regulation 6(2) of the Abolition of the Tribunal (Wales) Regulations, and "suspends" and "suspension" shall be construed accordingly;
"temporary chemist" means a chemist whose application has been granted under regulation 54 and who is included in a pharmaceutical list pursuant to that regulation; "terms of service" shall be construed in accordance with regulation 3; and "Tribunal" means the Tribunal constituted under section 46 of the Act[47] for England and Wales, and which, except for prescribed cases, had effect in relation to England only until 14th December 2001, and in relation to Wales only until 26th August 2002[48]. (2) In these Regulations -
(a) the term "pharmaceutical services", in relation to a doctor, means those services referred to in regulation 60; and
(b) the term "dispensing services", in relation to a doctor or to a GMS contractor or PMS contractor, means any corresponding service provided, not as pharmaceutical services, but under the terms of a GMS contract which give effect to paragraphs 47 to 51 of Schedule 6 to the GMS Regulations or under the terms of a PMS agreement which give effect to paragraph 45 to 51 of Schedule 5 to the PMS Regulations.
(3) Except where expressly provided to the contrary, any document which is required or authorised to be given or sent to a person or body under these Regulations may be given or sent by delivering it to the person or, in the case of a body, to the secretary or general manager of that body, or by sending it in a pre-paid letter addressed to that person or, in the case of a body, to the secretary or general manager of that body at his usual or last known address, and delivering it includes sending it electronically to an electronic address which that person has notified for the purpose.
(4) For as long as there are in existence -
(a) contracts entered into under article 13 (entitlement to a contract under section 176(3) of the Act) of the General Medical Services Transitional and Consequential Provisions Order 2004[49] ("default contracts"), in respect of such contracts any reference to a GMS contract shall be read as including a reference to a contract entered into under that article, and any reference to a term of a GMS contract shall be read as including a reference to the equivalent term in the default contract; and
(b) transitional agreements as defined in article 1(4) of the General Medical Services and Personal Medical Services Transitional and Consequential Provisions Order 2004, any reference in these Regulations to a PMS agreement shall be read as including a reference to any equivalent term in the transitional agreement.
Terms of service
3.The arrangements for the provision of pharmaceutical services which it is the duty of a Primary Care Trust to make under sections 41 to 43 of the Act, and to administer under section 15(1) of the Act, shall incorporate -
(a) in the case of arrangements with a pharmacist, the terms of service in Schedule 1;
(b) in the case of arrangements with a doctor who provides pharmaceutical services, the terms of Service in Schedule 2; and
(c) in the case of arrangements with a supplier of appliances, the terms of service in Schedule 3.
PART 2Pharmaceutical Lists and Applications for Admission to a Pharmaceutical ListPreparation of lists 4. - (1) A Primary Care Trust shall prepare and publish lists, to be called pharmaceutical lists, of the persons, other than doctors and dentists - (a) whose applications to be included in a pharmaceutical list have been granted by the Primary Care Trust, subject to and in accordance with the provisions of these Regulations, and who accordingly undertake to provide pharmaceutical services from premises in the Primary Care Trust's area, in particular, by way of the provision of drugs; and
(b) whose applications to be included in a pharmaceutical list have been granted by the Primary Care Trust, subject to and in accordance with the provisions of these Regulations, and who accordingly undertake to provide pharmaceutical services from premises in the Primary Care Trust's area by way of the provision of appliances.
(2) Each such list shall contain -
(a) the addresses of premises in the Primary Care Trust's area from which those services are provided;
(b) the days on which and times at which pharmaceutical services are provided at that address (including times at which those services are provided when the person is not obliged to do so); and
(c) in the case of a list referred to in paragraph (1)(a), shall indicate whether or not the chemist has undertaken to provide directed services, and if he has, which services.
(3) The pharmaceutical lists shall be available for public inspection.
Applications for inclusion in or amendment to a pharmaceutical list
5. - (1) Subject to paragraph (4), a person, other than a doctor or dentist -
(a) who wishes to be included in a pharmaceutical list for the provision of pharmaceutical services from premises in a Primary Care Trust's area;
(b) who is already included in a pharmaceutical list but wishes -
(i) to open, within a Primary Care Trust's area, additional premises from which to provide the same or different pharmaceutical services,
(ii) to change the premises from which he provides pharmaceutical services to other premises within that area from which he wishes to provide the same or different pharmaceutical services, or
(iii) to provide from his existing premises in that area pharmaceutical services other than those already listed in relation to him; or
(c) who is already included in a pharmaceutical list of a neighbouring Primary Care Trust but wishes to change the premises within the neighbourhood from which he provides pharmaceutical services to other premises in the area of the Primary Care Trust to which he makes an application under this Regulation and -
(i) the change is a minor relocation, and
(ii) the same pharmaceutical services will be provided,
shall apply, in accordance with this regulation, to the Primary Care Trust, providing the information set out in Part 1 of Schedule 4.
(2) A person applying in accordance with paragraph (1)(a) shall provide the information and undertakings specified in Part 3 of Schedule 4.
(3) A person who wishes to be included in a Primary Care Trust's pharmaceutical list -
(a) pursuant to a determination made by the Secretary of State under regulation 4 of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002[50]; or
(b) as a temporary chemist,
shall apply under regulation 10 or 54 (as the case may be), and not under this regulation.
(4) In this Part and in regulation 54 and Schedule 4 and unless the context otherwise requires, "applicant" and "application" shall be construed accordingly.
(5) Where an application has been granted under regulation 6 or 7, no further application may be granted under regulation 6 or 7 in relation to those new premises for a period of 12 months beginning with the date on which the applicant commenced the provision of pharmaceutical services from the new premises unless the Primary Care Trust for good cause allows him to make an application before the end of that period.
Applications involving a minor relocation within a Primary Care Trust's area
6. - (1) In the case of an application under regulation 5(1)(b), where the applicant intends to change within the neighbourhood the premises from which he provides pharmaceutical services, being the same services as he intends to provide from the new premises, and the Primary Care Trust is satisfied that -
(a) the change is a minor relocation; and
(b) the provision of pharmaceutical services will not be interrupted (except for such period as the Primary Care Trust may for good cause allow),
the Primary Care Trust shall grant the application, subject to regulations 9(2) and 21(10) (and accordingly regulations 11 to 20 shall not apply).
(2) Except where paragraph (3) applies, a Primary Care Trust shall determine an application to which paragraph (1) relates in accordance with the procedures set out in, regulations 23, 24(1) and (3) to (6), 25, 26, 27 and 29.
(3) Where the minor relocation is to premises which are less than 500 metres by the most practicable route by foot from the applicant's existing premises ("a minor relocation of less than 500 metres"), the Primary Care Trust shall -
(a) determine the application without giving notice of the application under regulation 23 or hearing any oral representations under regulation 24; and
(b) grant the application,
unless, within the period of 30 days beginning with the date of receipt of the application it notifies the applicant that it considers that it is desirable that the application be determined as if it were a minor relocation to premises which are 500 metres or more by the most practicable route by foot from the applicant's existing premises ("a minor relocation of 500 metres or more").
(4) Where the Primary Care Trust determines under paragraph (3) that an application for a minor relocation of less than 500 metres should be determined as if it were a minor relocation of 500 metres or more, it shall send the applicant a statement in writing setting out -
(a) its decision and its reasons for it; and
(b) the applicant's right of appeal under paragraph (5).
(5) The applicant may within the period of 30 days beginning with the date of receipt of the notification under paragraph (4), appeal in writing to the Secretary of State against the decision notified to him under that paragraph.
(6) A notice of appeal under paragraph (5) shall contain a concise statement of the grounds of appeal.
(7) The Secretary of State may, when determining the appeal under paragraph (5) -
(a) confirm the decision of the Primary Care Trust;
(b) grant the appeal; or
(c) grant the application.
(8) The Secretary of State shall notify the applicant and the Primary Care Trust in writing of his determination and shall include with the notification a written statement of the reasons for his determination.
(9) Where the determination of the Secretary of State is to grant the appeal, the Primary Care Trust shall within the period of 30 days beginning with the date of receipt of the notification under paragraph (8) determine the application in accordance with paragraph (3)(a).
Applications involving a minor relocation between neighbouring Primary Care Trusts
7. - (1) In the case of an application under regulation 5(1)(c), where -
(a) the Primary Care Trust is satisfied that -
(i) the change is a minor relocation, and
(ii) the provision of pharmaceutical services will not be interrupted (except for such period as the Primary Care Trust may for good cause allow); and
(b) the applicant consents to the removal of his name from the pharmaceutical list of the Primary Care Trust in which his existing premises are located in respect of those premises with effect from the date on which he commences to provide pharmaceutical services from his new premises,
the Primary Care Trust shall grant the application, subject to regulations 9(2) and 21(10) (and accordingly regulations 11 to 20 shall not apply).
(2) Subject to paragraph (3), a Primary Care Trust shall determine an application to which paragraph (1) relates in accordance with the procedures set out in, regulations 23, 24(1) and (3) to (6), 25, 26, 27 and 29.
(3) Where the minor relocation is to premises which are less than 500 metres by the most practicable route by foot from the applicant's existing premises ("a minor relocation of less than 500 metres"), the Primary Care Trust shall -
(a) determine the application without giving notice of the application under regulation 23 or hearing any oral representations under regulation 24; and
(b) grant the application,
unless within the period of 30 days beginning with the date of receipt of the application it notifies the applicant that it considers that it is desirable that the application be determined as if it were a minor relocation to premises which are 500 metres or more by the most practicable route by foot from the applicant's existing premises ("a minor relocation of 500 metres or more").
(4) Where the Primary Care Trust determines under paragraph (3) that an application for a minor relocation of less than 500 metres should be determined as if it were a minor relocation of 500 metres or more, it shall send the applicant a statement in writing setting out -
(a) its decision and its reasons for it; and
(b) the applicant's right of appeal under paragraph (5).
(5) The applicant may within the period of 30 days beginning with the date of receipt of the notification under paragraph (4), appeal in writing to the Secretary of State against the decision notified to him under that paragraph.
(6) A notice of appeal under paragraph (5) shall contain a concise statement of the grounds of appeal.
(7) The Secretary of State may, when determining the appeal under paragraph (5) -
(a) confirm the decision of the Primary Care Trust;
(b) grant the appeal; or
(c) grant the application.
(8) The Secretary of State shall notify the applicant and the Primary Care Trust in writing of his determination and shall include with the notification a written statement of the reasons for his determination.
(9) Where the determination of the Secretary of State is to grant the appeal, the Primary Care Trust shall within the period of 30 days beginning with the date of receipt of the notification under paragraph (8) determine the application in accordance with paragraph (3)(a).
Applications involving a change of ownership
8. - (1) Where the applicant intends to provide pharmaceutical services at premises from which those services are, at the time of the application, provided by a person who is included in a pharmaceutical list, and the Primary Care Trust is satisfied that -
(a) the same services will be provided from those premises; and
(b) the provision of pharmaceutical services will not be interrupted (except for such period as the Primary Care Trust may for good cause allow),
the Primary Care Trust shall grant the application, subject to -
(i) where the applicant is not already on that Primary Care Trust's pharmaceutical list, paragraph (2) and regulations 11, 19 and 21 (and accordingly regulations 12 to 18 and 20 shall not apply), or
(ii) where the applicant is already on that Primary Care Trust's pharmaceutical list, paragraph (2) (and accordingly regulations 11 to 21 shall not apply).
(2) Where a temporary chemist wishes to make an application under regulation 5(1)(b) on behalf of the suspended chemist in whose place he is providing pharmaceutical services, and that application is to relate to his provision of those services as a temporary chemist, and the application is one falling within paragraph (1), he must, before making the application, obtain the written consent of the Primary Care Trust to the application.
(3) A Primary Care Trust shall determine an application to which paragraph (1) relates in accordance with the procedures set out in regulations 24(1) and (3) to (7), 26, 27, 28 and 29 and where paragraph (1)(i) applies, in addition regulation 24(2).
Applications following suspension from the list
9. - (1) Where -
(a) the applicant intends to provide pharmaceutical services (otherwise than as a temporary chemist) from premises from which, at the time of the application, no services are being provided because the person who had undertaken to provide services from those premises is suspended from the pharmaceutical list; and
(b) the Primary Care Trust is satisfied that the applicant will provide the same services as were provided by that person prior to his suspension,
the Primary Care Trust shall grant the application, subject to -
(i) where the applicant is not already on that Primary Care Trust's pharmaceutical list, regulations 11, 19 and 21 (and accordingly regulations 12 to 18 and 20 shall not apply), or
(ii) where the applicant is already on that Primary Care Trust's pharmaceutical list, regulation 11(2) (and accordingly regulations 11(1) and 12 to 21 shall not apply).
(2) A Primary Care Trust shall determine an application to which paragraph (1) relates in accordance with the procedures set out in regulations 24(1) and (3) to (7), 26, 27, 28 and 29 and where paragraph (1)(i) applies, in addition regulation 24(2).
(3) Where a temporary chemist wishes to make an application under regulation 5(1)(b) on behalf of the suspended chemist in whose place he is providing pharmaceutical services, that application shall be dealt with as if the application had been made by the suspended chemist whilst not suspended from the pharmaceutical list (except that regulation 8(2) shall also apply in the case of an application falling within regulation 8(1)).
Right of return to pharmaceutical lists
10. - (1) This regulation applies if the Secretary of State makes a determination under regulation 4 of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002 that a person is to be given a right of return to a Primary Care Trust's pharmaceutical list on making an application for his name to be included in that list after ceasing to provide local pharmaceutical services under a pharmacy pilot scheme, and the conditions mentioned in paragraph (2) are satisfied.
(2) The conditions are that -
(a) the period of time between the cessation of provision of local pharmaceutical services by the applicant and the commencement of provision of pharmaceutical services by the applicant will be such that the provision of such services will be continuous (except for such period as the Primary Care Trust may for good cause allow); and
(b) the determination or determinations relevant to the application have not been invalidated by any subsequent determination, and that any conditions specified in the determination or determinations are satisfied.
(3) A person making an application under this regulation for inclusion of his name in a pharmaceutical list must apply to the Primary Care Trust giving the information set out in Part 1 of Schedule 4 while he is still providing local pharmaceutical services under a pharmacy pilot scheme, and in addition he must -
(a) make clear that the application is made by virtue of this regulation; and
(b) attach copies of all determinations relevant to the application.
(4) A person who meets the conditions specified in paragraph (7) must, in addition to the requirements of paragraph (3), provide the information, declarations and undertakings specified in Part 3 of Schedule 4.
(5) If a person has made an application in the manner described in paragraph (3) and (if applicable) (4) to a Primary Care Trust for his name to be included in its pharmaceutical list, the Primary Care Trust shall grant the application, subject to paragraph (6) and regulation 11(2).
(6) Notwithstanding the determination relevant to his application, if an applicant meets the conditions specified in paragraph (7), the provisions of regulations 19, 21, 26, 28 and 30 apply to his application under this regulation.
(7) The conditions referred to in paragraphs (4) and (6) are that -
(a) the applicant is not, at the time of his application to a Primary Care Trust, already included in that Primary Care Trust's pharmaceutical list; and
(b) the applicant was not, immediately before the date on which he commenced the provision of local pharmaceutical services, included in that Primary Care Trust's pharmaceutical list.
(8) Any conditions imposed by a Primary Care Trust under regulation 20 or by the Secretary of State under regulation 29(18)(b), 32(10)(b) or 38(14)(b) which are still in force by virtue of regulation 20(3) shall be unaffected by the grant of an application under this regulation.
(9) A Primary Care Trust must, as soon as is practicable, and in any event within the period of four months beginning with the date of receipt of the application unless the Primary Care Trust has good cause to require a longer period, give notice in writing of its decision on an application under this regulation to those persons or bodies listed in regulation 27(1)(a).
(10) Where a Primary Care Trust grants an application under this regulation, the applicant must be included in the relevant pharmaceutical list or lists only if, not less than 14 days before the expiry of six months after the date on which the grant was notified to him by the Primary Care Trust in accordance with paragraph (9), he notifies the Primary Care Trust, in the form set out in Part 2 of Schedule 4, that he will, within the next 14 days, commence the provision of services in respect of which the application was made at the premises to which the application related.
(11) Where, at any time after making an application under this regulation, but before the expiry of the six months referred to in paragraph (10), the applicant notifies the Primary Care Trust that he intends to change within the neighbourhood the premises from which he intends to provide pharmaceutical services, being the same services as those named in the application, and the Primary Care Trust is satisfied that the change is a minor relocation, it may amend the premises named in the original application.
(12) For the purposes of paragraph (10), the date of the notification of a grant of an application is the day after the expiry of the period of 30 days beginning on the date on which notice of that decision is given under paragraph (9).
(13) Except as specified in paragraphs (6) and (8), regulations 5 to 9, 11(1) and 12 to 28 and 30 to 42 do not apply to an application under this regulation.
Refusal: general provisions
11. - (1) An application, other than one to which regulation 6, 7, 8(1)(b)(ii) or 9(3) applies, which is made by a person who qualified to have his name registered under the Pharmacy Act 1954[51] by virtue of section 4A[52] of that Act (qualification by European diploma) shall not be granted unless the applicant satisfies the Primary Care Trust that he has the knowledge of English which, in the interests of himself and persons making use of the services to which the application relates, is necessary for the provision of pharmaceutical services in the Primary Care Trust's area.
(2) A Primary Care Trust shall refuse an application in which a pharmacist does not offer to provide all of the essential services.
Necessary or desirable test
12. - (1) Subject to regulations 13, 19, 21, 25 and 26, an application shall be granted by the Primary Care Trust only if it is satisfied that it is necessary or desirable to grant the application in order to secure, in the neighbourhood in which the premises from which the applicant intends to provide the services are located, the adequate provision, by persons included in a pharmaceutical list, of the services, or some of the services, specified in the application ("the necessary or desirable test").
(2) Subject to regulations 25 and 26 and paragraph (4), in considering whether the necessary or desirable test is satisfied, a Primary Care Trust shall have regard in particular to -
(a) whether or not any of the following services are already provided by persons in the neighbourhood in which the premises named in the application are located -
(i) any pharmaceutical services specified in the application provided by persons included in a pharmaceutical list, or any directed services the applicant agrees to provide if his name is included in the pharmaceutical list, or
(ii) any local pharmaceutical services provided under a pharmacy pilot scheme which are of the same description as any pharmaceutical services specified in the application;
(b) whether the recipients of pharmaceutical services already have a reasonable choice with regard to -
(i) the pharmaceutical services provided in the neighbourhood in which the premises named in the application are located, by persons included in a pharmaceutical list, and
(ii) the persons included in a pharmaceutical list from whom such recipients may obtain pharmaceutical services in the neighbourhood in which the premises named in the application are located;
(c) any other information available to the Primary Care Trust which, in its opinion, is relevant to the consideration of the application; and
(d) any representations received by the Primary Care Trust -
(i) under regulation 23(2) or (3), or
(ii) where the application is in respect of premises in a controlled locality, under regulation 33(4) from a person mentioned in regulation 33(2)(a) to (d) or (f) to (j) or (3)(a) to (d), (f) or (g).
(3) In considering whether the necessary or desirable test is satisfied, a Primary Care Trust may also have regard to any pharmaceutical services that the applicant proposes to provide in that neighbourhood in circumstances where he is not obliged to provide those services.
(4) The Primary Care Trust shall not take into account pharmaceutical services provided from premises at which pharmaceutical services are provided by a distance selling chemist when considering the pharmaceutical services already provided in the neighbourhood.
Exemption from the necessary or desirable test
13. - (1) Unless the applicant requests otherwise, or the premises to which his application relates are in a neighbourhood in which local pharmaceutical services are or are to be provided, regulation 12 shall not apply to an application in respect of -
(a) premises which are in an approved retail area (within the meaning of regulation 15);
(b) premises which the applicant is willing to keep open for at least 100 hours per week for the provision of pharmaceutical services;
(c) premises which are in a new one-stop primary care centre (within the meaning of regulation 16); or
(d) premises at which essential services are to be provided but the means of providing those services are such that all persons receiving them do so otherwise than at those premises ("distance selling premises").
(2) As regards an application to which paragraph (1)(b) applies, if the application is granted -
(a) it is a condition of the applicant's inclusion in a pharmaceutical list (and so a term of service) that the premises to which the application relates are kept open for at least 100 hours per week for the provision of pharmaceutical services, and the Primary Care Trust may not vary or remove that condition; and
(b) the Primary Care Trust may only remove a person from the pharmaceutical list for breach of that condition if -
(i) that person has repeatedly breached the condition, or is likely to breach the condition repeatedly, without good cause, or
(ii) the breach is, in all the circumstances, a serious breach and as a consequence of it the safety of a patient has been or may be put at serious risk.
(3) As regards an application to which paragraph (1)(a), (b) or (c) applies -
(a) the application may only be granted if the applicant agrees to a condition of his inclusion in the pharmaceutical list that he will provide, where requested to do so by the Primary Care Trust, and at the premises to which the application relates, such directed services as the Primary Care Trust may specify; and
(b) if the application is granted, it is a condition of the applicant's inclusion in a pharmaceutical list (and so a term of service) that he provides, where requested to do so by the Primary Care Trust and at the premises to which the application relates, the directed services specified by the Primary Care Trust for the purposes of this paragraph (read with regulation 14).
(4) As regards an application to which paragraph (1)(d) applies, if the application is granted it is a condition of the applicant's inclusion in a pharmaceutical list (and so a term of service) that -
(a) he does not offer to provide pharmaceutical services to persons who are present at the premises to which the application relates; and
(b) the means by which he provides pharmaceutical services are such that the person receiving them does so otherwise than at the premises to which the application relates,
and the Primary Care Trust may not vary or remove those conditions.
Variation of directed services in respect of exempted premises
14. - (1) A person in respect of whom a condition is imposed by virtue of regulation 13(3)(b) may apply to a Primary Care Trust for it to vary the directed services that it has specified as regards him for the purposes of that condition, but he may only do so after at least three years have elapsed -
(a) since the condition was imposed in respect of him; or
(b) during which the Primary Care Trust has not required him to provide the directed services.
(2) An application under paragraph (1) shall include the applicant's reasons for asking the Primary Care Trust to vary the condition concerned.
(3) The Primary Care Trust shall determine an application under paragraph (1) within 60 days of receiving it.
(4) In determining an application under paragraph (1), the Primary Care Trust shall -
(a) specify, as regards the applicant, different or no directed services for the purposes of the condition imposed by virtue of regulation 13(3)(b) in respect of the premises to which the application relates, if this has the effect of either granting the application under paragraph (1) or granting it only in part; or
(b) confirm that, as regards the applicant, the directed services that it has previously specified for the purposes of the condition imposed by virtue of regulation 13(3)(b) in respect of the premises to which the application relates are to remain unchanged.
(5) Where the Primary Care Trust is considering taking action under paragraph (4)(a), it shall consult the Local Pharmaceutical Committee before determining the application.
(6) A Primary Care Trust shall notify the applicant in writing of any action taken under paragraph (4), and where this has the effect of refusing an application under paragraph (1) or granting it in part, it shall send the applicant a statement in writing setting out -
(a) the reasons for the refusal or, as the case may be, for granting the application only in part; and
(b) the applicant's right of appeal under paragraph (7).
(7) The applicant may, within 30 days of receiving a notification pursuant to paragraph (6), appeal in writing to the Secretary of State against any action under paragraph (4) which has the effect of refusing an application under paragraph (1) or granting it only in part.
(8) A notice of appeal under paragraph (7) shall contain a concise statement of the grounds of appeal.
(9) The Secretary of State may, when determining an appeal, either confirm the action taken by the Primary Care Trust or take any action that the Primary Care Trust could have taken under paragraph (4).
(10) The Secretary of State shall notify the applicant in writing of his determination and shall in every case include with the notification a written statement of the reasons for the determination.
Approved retail areas
15. - (1) For the purposes of these Regulations, premises are in an approved retail area if they are in a retail area that has been approved by the Secretary of State under this paragraph for the purposes of the exemption in regulation 13(1)(a).
(2) Approval of an area under paragraph(1) shall only be granted if the Secretary of State is satisfied that it is in respect of -
(a) an area -
(i) which comprises a discrete site or building which is a shopping centre, a retail park or retail premises, or
(ii) for which is planned a discrete site or building which, if the permitted development is carried out (and it may, at the time of the approval, be part carried out), will be a shopping centre, a retail park or retail premises,
and such an area, for the purposes of these Regulations, is a "retail area";
(b) a retail area which is not or will not be part of -
(i) a primary shopping area which is or is part of -
(aa) a city, metropolitan or town centre; or
(bb) a district centre which performs the role of a city, metropolitan or town centre, or
(ii) an edge of centre location which relates to -
(aa) a city, metropolitan or town centre; or
(bb) a district centre which performs the role of a city, metropolitan or town centre,
and in determining whether or not an area is a "primary shopping area" or an "edge of centre" location for the purposes of this sub-paragraph, regard shall be had to any relevant national planning policy guidance; and
(c) a retail area which exceeds or will exceed the minimum size,
but approval under paragraph (1) shall otherwise be granted by the Secretary of State as he sees fit.
(3) For the purposes of paragraph (2)(c) a retail area exceeds or will exceed the minimum size if -
(a) in the case of a shopping centre or retail premises, it is or will be, or incorporates or will incorporate, leasehold retail premises the gross floor space of which exceeds or will exceed 15,000 square metres; or
(b) in the case of a retail park, it, together with any adjacent retail area, incorporates or will incorporate leasehold retail premises the gross floor space of which exceeds or will exceed 15,000 square metres.
(4) The Secretary of State shall publish, in such manner and at such intervals as he sees fit, a list of retail areas which are for the time being approved by him under paragraph (1).
(5) The Secretary of State may withdraw his approval under paragraph (1) of a retail area in appropriate circumstances.
New one-stop primary care centres
16. - (1) For the purposes of these Regulations, premises are in a new one-stop primary care centre if they are in a one-stop primary care centre which a Primary Care Trust on or after 1st April 2005 has for the first time included in its strategic service development plan (or if it has no such plan, in a written plan that achieves the same purpose as a strategic service development plan), at which on or after 1st April 2005 -
(a) the services of health care professionals will be provided for the first time; or
(b) as a consequence of substantial new development or redevelopment, the services of a broad range of health care professionals will be provided for the first time.
(2) For the purposes of these Regulations, premises are a "one-stop primary care centre" if they are in a discrete site or building -
(a) at which the services of a broad range of health care professionals is, or will be, regularly and frequently provided (together, where appropriate, with other health or social services);
(b) at which there is, or will be, a provider of primary medical services with a patient list which comprises at least 18,000 patients; and
(c) which is under the management or control of a consortium, and for these purposes a "consortium" is an association of persons or undertakings carrying on a business together with -
(i) a single management and equity structure, and
(ii) agreed written articles of association which commit them to running a one-stop primary care centre.
(3) In determining whether the requirements of paragraph (2)(a) are met, a Primary Care Trust shall have regard to the range and number of health care professionals (apart from those who are, or who are engaged or employed by, other chemists) who are available to provide services within its area.
Refusal: distance selling premises
17.A Primary Care Trust shall not grant an application to which regulation 13(1)(d) applies if the premises to which the application relates are on the same site or in the same building as the premises of a provider of primary medical services with a patient list.
Refusal: premises which are in a controlled locality but not in a reserved location
18. - (1) Paragraph (2) applies where the application is in respect of premises in a controlled locality and -
(a) the Primary Care Trust has determined under regulation 35; or
(b) on appeal it is determined,
that the premises from which the applicant wishes to provide pharmaceutical services are not in a reserved location.
(2) Subject to regulations 25 and 26 the Primary Care Trust -
(a) shall refuse an application to the extent that it is of the opinion that to grant it would prejudice the proper provision of primary medical services, dispensing services, local pharmaceutical services or pharmaceutical services in any locality;
(b) shall refuse an application under regulation 61 in relation to any part of the area specified in the application -
(i) which is not in a controlled locality, or
(ii) which is within 1.6 kilometres of any pharmacy;
(c) shall refuse an application under regulation 61 in relation to any premises from which the doctor wishes to be authorised to dispense and which are within 1.6 kilometres of any pharmacy; and
(d) may refuse an application in a case to which regulation 36(9) applies (notwithstanding that it would, if determining that application in isolation, grant it) where the number of applications is such, or the circumstances in which they are made are such, that to grant all of them or more than one of them would prejudice the proper provision of primary medical services, dispensing services, local pharmaceutical services or pharmaceutical services in any locality,
and any refusal of such an application may relate to all or any part of the area within the controlled locality.
Refusal: fitness to practise grounds
19. - (1) This regulation applies to an application to a Primary Care Trust -
(a) under regulation 5, 40 or 54, where the applicant is not already on that Primary Care Trust's pharmaceutical list; and
(b) under regulation 10, where the applicant meets the conditions specified in paragraph (7) of that regulation.
(2) A Primary Care Trust may refuse to grant an application to which this regulation applies if -
(a) having considered the undertakings and declarations required by paragraphs 1, 2 and 3 of Part 3 of Schedule 4 and any other information in its possession in relation to the application, it considers that the applicant is unsuitable to be included in the list;
(b) having checked the information provided by the applicant in accordance with paragraphs 4, 5 and 6 of Part 3 of Schedule 4, and any further information provided pursuant to the undertaking given in accordance with paragraph 12 of Part 3 of Schedule 4, it considers the applicant is unsuitable to be included in the list;
(c) having contacted the referees nominated by the applicant in accordance with paragraph 7 of Part 3 of Schedule 4, it is not satisfied with the references given;
(d) having checked with the National Health Service Counter Fraud and Security Management Service for any facts that it considers relevant relating to past or current fraud investigations involving or related to the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant), and having considered these and any other facts in its possession relating to fraud involving or relating to the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant), it considers these justify such refusal;
(e) having checked with the Secretary of State for any facts that he considers relevant relating to past or current investigations or proceedings involving or relating to the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) and, having considered these and any other facts in its possession involving or relating to the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant), it considers these justify such refusal; or
(f) it considers that admitting the applicant to the list would be prejudicial to the efficiency of the service which he would undertake to provide.
(3) A Primary Care Trust must refuse to grant an application to which this regulation applies if -
(a) the applicant (or where the applicant is a body corporate, any director or superintendent of the applicant) has been convicted in the United Kingdom of murder;
(b) the applicant (or where the applicant is a body corporate, any director or superintendent of the applicant) has been convicted in the United Kingdom of a criminal offence, other than murder, which was committed after the date on which these Regulations come into force and has been sentenced to a term of imprisonment of over six months;
(c) the applicant is the subject of a national disqualification;
(d) the applicant has not updated his application in accordance with regulation 26(4); or
(e) in a case to which regulation 30 applies, he does not notify the Primary Care Trust under regulation 30(4) that he wishes to be included in its pharmaceutical list subject to the specified conditions.
(4) Where the Primary Care Trust is considering refusal of an application under paragraph (2), it shall consider all facts which appear to it to be relevant and shall in particular take into consideration in relation to paragraph (2)(a), (b), (d) and (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 the applicant 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[53] applies, or if it had been committed in England and Wales, would have applied;
(g) whether the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) has been refused admittance to, conditionally included in, removed, contingently removed or is currently suspended from any list or equivalent list on fitness to practise grounds, and if so, the facts relating to the matter which led to such action and the reasons given by the Primary Care Trust or equivalent body for such action; or
(h) whether the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) was, at the time of the originating events, or has in the preceding six months been, a director or superintendent of a body corporate which has been refused admittance to, conditionally included in, removed or contingently removed from any list or equivalent list, or is currently suspended from any such list, on fitness to practise grounds, and if so, what the facts were in each such case and the reasons given by the Primary Care Trust or equivalent body in each case.
(5) When the Primary Care Trust takes into consideration the matters set out in paragraph (4), it shall consider the overall effect of all the matters being considered.
(6) An applicant may appeal to the FHSAA against a decision of the Primary Care Trust to refuse to grant his application -
(a) to be included in the pharmaceutical list (including an application to be included as a temporary chemist); or
(b) for preliminary consent to be included in that list,
on grounds specified in paragraph (2).
(7) An appeal must be made within the period of 28 days beginning with the date on which the Primary Care Trust notified the applicant of the decision under regulation 10(9), 27(1), 37(1) or 54(14) (as the case may be), and such an appeal shall be by way of redetermination of the Primary Care Trust's decision.
Imposition of conditions
20. - (1) Subject to regulations 22(4), 25 and 26 where -
(a) the premises specified in an application under regulation 5(1) are in a controlled locality, or are not in a controlled locality but are within 1.6 kilometres of any part of any controlled locality in which reside patients for whom a doctor provides pharmaceutical services or for whom a GMS contractor or PMS contractor provides dispensing services; and
(b) the granting of the application would, in the view of the Primary Care Trust, result in a significant change in the arrangements for the provision of pharmaceutical services, local pharmaceutical services or dispensing services in any part of a controlled locality,
the Primary Care Trust shall, where it grants the application, consider the conditions (if any) which are to be imposed in relation to that grant under paragraph (2), and pending the final determination of such conditions, shall not in consequence of the grant give notice to any doctor to discontinue the provision of pharmaceutical services or dispensing services to any patient.
(2) Where the Primary Care Trust considers that the provision of primary medical services by any provider of such services (other than itself) or pharmaceutical services by any chemist or local pharmaceutical services by any LPS chemist is likely to be adversely affected in consequence of a grant under paragraph (1), it may impose conditions to postpone, for such period as it thinks fit, the making or termination of arrangements under regulation 60 (or equivalent provision under the GMS Regulation or PMS Regulations) for the provision by a doctor or a GMS contractor or PMS contractor of pharmaceutical services or dispensing services to patients on the relevant patient list.
(3) Where a Primary Care Trust has imposed any conditions under paragraph (2), or the Secretary of State has imposed any conditions under regulation 29(18)(b), 32(10)(b) or 38(14)(b), those conditions shall be unaffected by the commencement or continuation of a pharmacy pilot scheme for the provision of local pharmaceutical services by the person whose application was granted subject to such conditions (or by a successor to that person who likewise provides local pharmaceutical services under that scheme).
Conditional inclusion relating to fitness to practise matters
21. - (1) This regulation applies to an application to a Primary Care Trust -
(a) under regulation 5(1)(a), except an application in respect of which preliminary consent has previously been granted, where the premises specified in the application have the same location as that in respect of which preliminary consent has previously been granted;
(b) under regulation 40 or 54, where the applicant is not already included in that Primary Care Trust's pharmaceutical list; or
(c) under regulation 10, where the applicant meets the conditions specified in paragraph (7) of that regulation.
(2) Where a person makes an application to which this regulation applies, a Primary Care Trust may determine that, while he remains included in the pharmaceutical list,or while his preliminary consent has effect, he is to be subject to the imposition of conditions, having regard to the requirements in section 43ZA (conditional inclusion in medical, dental, ophthalmic and pharmaceutical lists) of the Act.
(3) A Primary Care Trust may vary the terms of service in relation to an applicant for the purpose of, or in connection with, the imposition of those conditions.
(4) A Primary Care Trust shall notify the applicant in writing as soon as is practicable of any conditions it intends to impose.
(5) When the Primary Care Trust notifies the applicant of any decision under this regulation, it shall inform him that if he wishes to exercise a right of appeal he must do so within the period of 28 days beginning with the date on which it gave him the notice informing him of its decision, and shall tell him how to make an appeal.
(6) A Primary Care Trust shall require the applicant to notify it, within 28 days of the date of the notification under paragraph (4) -
(a) whether he agrees to the imposition of the conditions; or
(b) whether he is appealing against that imposition of conditions under regulation 30.
(7) Paragraph (8) applies where -
(a) a Primary Care Trust has granted an application for inclusion in its pharmaceutical list but imposed conditions on that grant; and
(b) the applicant is considering whether to appeal, or has notified the Primary Care Trust that he wishes to appeal, but wishes to be included in the pharmaceutical list during the period until the time for appeal has expired or the appeal is decided.
(8) A Primary Care Trust shall include the applicant in its pharmaceutical list if -
(a) it has received notification from him that he agrees to the imposition of the conditions during the period until the time for appeal has expired or the appeal is decided; and
(b) the requirements of regulation 39 are satisfied.
(9) Where no notification is received from the applicant in accordance with paragraph (5), the Primary Care Trust shall deem him to have withdrawn his application.
(10) In the case of an application under regulation 5(1)(b) or (c), where an applicant is subject to conditions imposed in accordance with this regulation, or regulation 30, 42 or 43 a grant of his application shall be subject to those same conditions.
Relevant procedures for applications
22. - (1) An application which -
(a) does not concern a controlled locality, or does concern a controlled locality but falls within paragraph (2); and
(b) does not fall within regulations 6 to 10 or 54 (the procedures for which are referred to in regulation 6(2), 7(2), 8(3), 9(2), 10 and 54),
shall be dealt with in accordance with the procedures set out in paragraph (4) and regulations 12(2) to (4), 23 to 30.
(2) An application falls within this paragraph -
(a) where the application is made under regulation 5(1)(b)(iii) except where the additional services which the person wishes to be able to provide include the provision of drugs; or
(b) where -
(i) the applicant is seeking only to change within a controlled locality the premises at which he provides pharmaceutical services; and
(ii) the granting of the application would not, in the opinion of the Primary Care Trust, result in a significant change in the arrangements for the provision of pharmaceutical services (including by a person on the dispensing doctor list) or of local pharmaceutical services in any part of the locality.
(3) An application which -
(a) concerns a controlled locality; and
(b) does not fall within regulations 6 to 10 or 54 (the procedures for which are referred to in regulation 6(2), 7(2), 8(3), 9(2), 10 and 54), shall, unless it falls within paragraph (2), be dealt with in accordance with the procedures set out in -
(i) paragraph (4) and regulations 12(2) to (4), 25, 26, 28 and 30, and
(ii) regulations 31 to 38.
(4) Subject to regulations 25 and 26, where the premises specified in an application under regulation 5(1) are within 1.6 kilometres of the locality of another Primary Care Trust, the Primary Care Trust shall make enquiries as to controlled localities in that locality in order to determine -
(a) whether the application is of the description specified in regulation 20(1); and
(b) which controlled localities are to be considered for the purposes of paragraph (2)(b)(ii) or regulation 20(1)(b),
and where it is satisfied that there is a relevant controlled locality in that locality, it shall consult that other Primary Care Trust before forming a view for the purposes of paragraph (2)(b)(ii) or regulation 20(1)(b).
Notification of applications
23. - (1) This regulation applies where a Primary Care Trust receives an application which falls to be dealt with as mentioned in regulation 6, 7 or 22(1).
(2) Subject to regulations 25 and 26, the Primary Care Trust shall, as soon as is practicable, give notice in writing of the application to -
(a) the Local Pharmaceutical Committee;
(b) the Local Medical Committee;
(c) any person who is included in a pharmaceutical list and whose interests might, in the opinion of the Primary Care Trust, be significantly affected if the application were granted;
(d) any LPS chemist whose interests might, in the opinion of the Primary Care Trust, be significantly affected if the application were granted;
(e) any Primary Care Trust or Local Health Board any part of whose area is within two kilometres of the premises;
(f) any Patients' Forum serving the area of the Primary Care Trust; and
(g) any other patient, consumer or community groups in the area of the Primary Care Trust that the Primary Care Trust considers has an interest in the provision of pharmaceutical services in the neighbourhood,
and any person so notified may, within 45 days from the date on which the notification was sent, or such longer period as the Primary Care Trust may allow in its notification, make representations in writing to the Primary Care Trust.
(3) A Primary Care Trust or Local Health Board which is notified under paragraph (2)(e) shall, as soon as is practicable, give notice in writing of the application to -
(a) the Local Pharmaceutical Committee for its area;
(b) the Local Medical Committee for its area;
(c) any person whose name is included in a pharmaceutical list and whose interests might, in the opinion of that Primary Care Trust or Local Health Board, be significantly affected if the application were granted;
(d) any LPS chemist whose interests might, in the opinion of that Primary Care Trust, be significantly affected if the application were granted;
(e) any Patients' Forum or Community Health Council serving its area; and
(f) any other patient, consumer or community groups in the area that the Primary Care Trust or Local Health Board considers has an interest in the provision of pharmaceutical services in the neighbourhood,
and any person so notified may, within 45 days from the date on which the notification was sent, make representations in writing to the Primary Care Trust to which the application was made.
(4) Any notice given under paragraph (2) or (3) shall include a notification of the right to make representations in accordance with that paragraph.
Determination of applications
24. - (1) Subject to the following paragraphs and regulations 25 and 26, the Primary Care Trust may determine an application in such manner as it thinks fit and may, if it considers that oral representations are unnecessary, determine the application without hearing any oral representations.
(2) Subject to regulations 25 and 26, in considering any application from an applicant who is not already included in that Primary Care Trust's pharmaceutical list (except an applicant who has applied under regulation 5(1)(c)), a Primary Care Trust shall -
(a) check as far as reasonably practicable the information provided by the applicant, particularly that provided in accordance with paragraphs 1 to 6 of Part 3 of Schedule 4;
(b) check with the National Health Service Counter Fraud and Security Management Service whether the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) has any record of fraud;
(c) check with the Secretary of State as to any information held by him as to any record about past or current investigations or proceedings involving or related to the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant);
(d) take up and check the references provided under paragraph 7 of Part 3 of Schedule 4; and
(e) consider whether there are grounds -
(i) for refusing the application under regulation 19, or
(ii) for imposing conditions in accordance with regulation 21.
(3) In any case where the Primary Care Trust decides to hear oral representa |
