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

Contents

5,236 provisions, too many to show on one page. Open a part or section to read it with its history and connections, or search inside the text.

1. Part 1 · Introductory
   1. 1 Citation and commencement
   2. 2 Interpretation
2. Part 2 · Pharmaceutical needs assessments
   1. 3 Pharmaceutical needs assessments
   2. 4 Information to be contained in pharmaceutical needs assessments
   3. 5 Date by which the first HWB pharmaceutical needs assessments are to be published
   4. 6 Subsequent assessments and later first assessments
   5. 7 Temporary extension of earlier pharmaceutical needs assessments and access by NHS England and HWBs to pharmaceutical needs assessments
   6. 8 Consultation on pharmaceutical needs assessments
   7. 9 Matters for consideration when making assessments
3. Part 3 · General matters relating to pharmaceutical lists and applications in respect of them
   1. 10 Pharmaceutical lists ...
   2. 11 Terms of service of NHS chemists: general
   3. 12 Routine applications for inclusion in or amendments to a pharmaceutical list
   4. 13 Current needs: additional matters to which NHS England must have regard
   5. 14 Current needs: consequences of additional matters
   6. 15 Future needs: additional matters to which NHS England must have regard
   7. 16 Future needs: consequences of additional matters
   8. 17 Improvements or better access to the current service: additional matters to which NHS England must have regard
   9. 18 Unforeseen benefits applications: additional matters to which NHS England must have regard
   10. 19 Applications to which regulation 17 or 18 applies: consequences of additional matters
   11. 20 Future improvements or better access: additional matters to which NHS England must have regard
   12. 21 Future improvements or better access: consequences of additional matters
   13. 21A PNA based applications for new premises offering additional or different opening hours
   14. 22 Refusal of routine applications that are based on neither a pharmaceutical needs assessment nor unforeseen benefits
4. Part 4 · Excepted applications
   1. 23 Applications from NHS chemists in respect of providing directed services
   2. 24 Relocations that do not result in significant change to pharmaceutical services provision
   3. 25 Distance selling premises applications
   4. 25A Transitional provision: distance selling premises applications for new inclusions made before 23rd June 2025
   5. 26 Change of ownership applications
   6. 26A Consolidation onto an existing site
   7. 27 Applications for temporary listings arising out of suspensions
   8. 28 Applications from persons exercising a right of return to a pharmaceutical list
   9. 29 Temporary arrangements during emergencies or because of circumstances beyond the control of NHS chemists
5. Part 5 · Specific grounds for refusal or deferral of applications under Parts 3 and 4 which are not linked to fitness grounds
   1. 30 Refusal: language requirement for some NHS pharmacists
   2. 31 Refusal: same or adjacent premises
   3. 32 Deferrals arising out of LPS designations
6. Part 6 · Refusal, deferral and conditional inclusion in pharmaceutical lists of chemists on fitness grounds
   1. 33 Refusal of applications for inclusion in a pharmaceutical list on fitness grounds
   2. 34 Deferral of consideration of applications for inclusion in a pharmaceutical list on fitness grounds
   3. 35 Granting applications for inclusion in a pharmaceutical list subject to efficiency conditions and conditions to combat fraud
7. Part 7 · Areas that are controlled localities or reserved locations, and new pharmacies within them
   1. 36 Determination that an area is a controlled locality
   2. 37 Process for determining controlled localities: preliminary matters
   3. 38 Process for determining controlled localities: local notification and deferment of routine applications
   4. 39 Process of determining controlled localities: formulation of NHS England’s decision
   5. 40 Applications for new pharmacy premises in controlled localities: refusals because of preliminary matters
   6. 41 Applications for new pharmacy premises in controlled localities: reserved locations
   7. 42 Second and subsequent determinations of reserved location status
   8. 43 Determinations of reserved locations: supplemental matters
   9. 44 Prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved location
   10. 45 Appeals against decisions under Part 7
8. Part 8 · Dispensing doctors
   1. 46 Dispensing doctor lists
   2. 47 Terms of service of dispensing doctors: general
   3. 48 Arrangements for the provision of pharmaceutical services by doctors: applications by patients
   4. 49 Necessary services for temporary patients
   5. 50 Discontinuation of arrangements for the provision of pharmaceutical services by doctors
   6. 51 Outline consent and premises approval: applications by doctors
   7. 52 Notification of applications for outline consent and premises approval
   8. 53 Decisions on outline consent and premises approval applications and the taking effect of grants
   9. 54 Premises approval: relocations of practice premises which are not significant before outline consent takes effect
   10. 55 Premises approval: relocations of practice premises which are not significant after outline consent has taken effect
   11. 56 Taking effect of premises approval where there is no related application for outline consent
   12. 57 Gradual introduction of premises approval
   13. 58 Temporary provision in cases of relocations or additional premises where premises approval has not taken effect
   14. 59 Practice amalgamations
   15. 60 Lapse of outline consent and premises approval
   16. 61 Temporary arrangements during emergencies or circumstances beyond the control of a dispensing doctor
   17. 62 Persons barred from taking part in decision making with regard to applications for outline consent or premises approval
   18. 63 Appeals against decisions under Part 8
9. Part 9 · Conditional inclusion in pharmaceutical lists: certain specific conditions that do not relate to fitness or performance
   1. 64 Distance selling premises: specific conditions
   2. 65 Core opening hours conditions
   3. 65A Continuity in respect of opening hours directions
   4. 66 Conditions relating to providing directed services
   5. 66A Conditions relating to independent prescribing
   6. 67 Conditions relating to voluntary closure of premises
   7. 67A Condition relating to entering administration
   8. 68 Conditions relating to local resolution of disputes over terms of service
10. Part 10 · Performance related sanctions and market exit
    1. 69 Local dispute resolution before serving remedial notices or breach notices
    2. 70 Breaches of terms of service: remedial notices
    3. 71 Breaches of terms of service: breach notices
    4. 71A Issuing breach or remedial notices while a disease is or in anticipation of a disease being imminently pandemic etc.
    5. 72 Payment withholdings: supplementary matters
    6. 73 Removal of listings: cases relating to remedial notices and breach notices
    7. 74 Removal of listings: cases relating to death, incapacity or cessation of service
    8. 75 Voluntary and automatic removal of listings: change of ownership, relocation, temporary provision and voluntary closure
    9. 76 Limitation on withdrawal from pharmaceutical lists while fitness investigations or proceedings are ongoing
    10. 77 Appeals against decisions under Part 10
11. Part 11 · Enforcement, reviews and appeals relating to fitness matters
    1. 78 Extended meaning of “health scheme” in fraud cases
    2. 79 Review of decisions to impose fitness conditions originally imposed on grants of applications
    3. 80 Removal for breach of fitness conditions imposed under regulation 35 or 79
    4. 81 Mandatory removal in suitability cases
    5. 82 Fitness cases: procedures for removal or contingent removal from pharmaceutical lists
    6. 83 Procedure for suspensions in fitness cases
    7. 84 Procedure for reviewing some suspensions and contingent removal conditions
    8. 85 General power to revoke suspensions in appropriate circumstances
    9. 86 Internal handling of fitness information by NHS England or an agent of NHS England
    10. 87 Review periods for national disqualifications
    11. 88 Wider notifications of fitness decisions
12. Part 12 · Remuneration, charges and refunds
    1. 89 The Drug Tariff and section 164: general provisions
    2. 90 Data to be provided to assist Drug Tariff determinations
    3. 91 Remuneration of NHS chemists: instruments of appointment of NHS England
    4. 91A Zero or nominal product reimbursement for ... vaccines and antivirals
    5. 92 Dispensing doctor remuneration
    6. 93 The taking effect of determinations
    7. 94 Overpayments
    8. 95 Free supply of drugs, appliances and containers where the drug or appliance is supplied under pharmaceutical services
    9. 96 Refunds of prescription charges
    10. 97 Reward scheme
    11. 98 Payments to suspended chemists
13. Part 13 · Local Pharmaceutical Services
    1. 99 Designation of areas, premises or descriptions of premises
    2. 100 Review of designations
    3. 101 Cancellation of designations
    4. 102 Terms of service for LPS schemes: general
    5. 102A Suspension of terms of schemes or of enforcement of terms of schemes while a disease is or in anticipation of a disease being imminently pandemic etc.
    6. 103 LPS schemes: health service body status
    7. 104 Development of LPS schemes
    8. 105 Persons permitted to be parties to LPS schemes: fitness criteria
    9. 106 LPS proposals: fitness information to be supplied
    10. 107 Notification of proposals
    11. 108 Right of return to pharmaceutical lists: LPS contractors
    12. 109 LPS pilot schemes: health service body status
    13. 110 LPS pilot schemes: termination
    14. 111 Emergencies requiring the flexible provision of local pharmaceutical services
    15. 112 Sharing of information about LPS chemists and their employees with the General Pharmaceutical Council
    16. 113 Directions to the First-tier Tribunal relating to local pharmaceutical services
    17. 114 Lists of LPS chemists
14. Part 14 · Miscellaneous
    1. 115 Notification by NHS England of changes to its lists
    2. 116 Authorised persons to apply for services
    3. 117 Functions of the Secretary of State to be exercised by the NHS Litigation Authority
    4. 118 Proceedings relating to overridden arrangements
    5. 119 Transitional provisions
    6. 119A Transitional provisions in respect of drugs or appliances supplied in accordance with SSPs
    7. 120 Amendments and revocations
    8. 121 Review of these Regulations
15. Schedule 1 · Information to be contained in pharmaceutical needs assessments
    1. (1) Necessary services: current provision
    2. (2) Necessary services: gaps in provision
    3. (3) Other relevant services: current provision
    4. (4) Improvements and better access: gaps in provision
    5. (5) Other NHS services
    6. (6) How the assessment was carried out
    7. (7) Map of provision
16. Schedule 2 · Applications in respect of pharmaceutical lists and the procedures to be followed
    1. Part 1 Information to be included in routine and excepted applications
    2. Part 2 Preliminary matters
    3. Part 3 Notification of certain applications
    4. Part 4 Determination and deferral of applications
    5. Part 5 Notification, taking effect of decisions and rights of appeal to the Secretary of State
17. Schedule 3 · Appeals to the Secretary of State
    1. Part 1 Preliminary matters
    2. Part 2 Notification of appeals
    3. Part 3 Determination of appeals
18. Schedule 4 · NHS England’sTerms of service of NHS pharmacists
    1. Part 1 General
    2. Part 2 Essential services
    3. Part 3 Hours of opening
    4. Part 4 Other terms of service
19. Schedule 5 · Terms of service of NHS appliance contractors
    1. (1) Division of responsibilities between individuals and corporate bodies
    2. (2) Breaches by directors
    3. (3) Dispensing services
    4. (4) Dispensing of appliances
    5. (4A) Supply in accordance with a SSP
    6. (5) Urgent supply without a prescription
    7. (6) Preliminary matters before providing appliances
    8. (7) Providing appliances
    9. (8) Refusal to provide appliances ordered
    10. (9) Further activities to be carried out in connection with the provision of dispensing services
    11. (10) Additional requirements in relation to electronic prescribing
    12. (11) Additional requirements in relation to specified appliances
    13. (12) Signposting
    14. (13) Opening hours: general
    15. (14) Matters to be considered when issuing directions in respect of core opening hours
    16. (15) Determination of core opening hours instigated by NHS England
    17. (16) Determination of core opening hours instigated by the NHS appliance contractor
    18. (17) Temporary open hours and closures during an emergency requiring the flexible provision of pharmaceutical services
    19. (18) Clinical governance
    20. (19) Professional Standards
    21. (20) Inducements etc.
    22. (21) Duty to provide information about fitness matters as they arise
    23. (22) Other information to be supplied
    24. (23) Co-operation with NHS England
    25. (24) Complaints
    26. (25) Inspections and access to information
20. Schedule 6 · Terms of service of dispensing doctors
    1. (1) Persons duly authorised to dispense on behalf of dispensing doctors
    2. (2) Dispensing of drugs and appliances ordered by another prescriber
    3. (3) Dispensing of drugs and appliances ordered by the dispensing doctor
    4. (3A) Supply in accordance with a SSP
    5. (3B) Supply in accordance with a PTP or a PTPGD
    6. (3C) Supply in accordance with a LPIV
    7. (4) Preliminary matters before providing ordered drugs or appliances
    8. (4A) Charge exemption and remission of charges: declarations and checks
    9. (4B) Checks and records in the case of supply in accordance with a SSP
    10. (4ZA) Sub-contracting aspects of dispensing under “hub and spoke” arrangements
    11. (4ZB) Objection to and termination of hub and spoke arrangements
    12. (4ZC) Hub and spoke arrangements: sharing of “relevant data” between different businesses
    13. (5) Provision of Scheduled drugs
    14. (6) Refusal to provide drugs or appliances ordered
    15. (7) Dispensing doctors issuing prescription forms which may be presented to an NHS chemist
    16. (7A) Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.
    17. (7AA) Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.
    18. (8) Complaints procedures
    19. (9) Inspections and access to information
    20. (10) Voluntary closure of premises
21. Schedule 7 · Mandatory terms for LPS schemes
    1. (1) General provisions
    2. (2) Restrictions in an LPS scheme on supply
    3. (3) Dispensing
    4. (3A) Supply in accordance with a SSP
    5. (3B) Supply in accordance with a LPIV
    6. (4) Urgent supply without a prescription
    7. (5) Preliminary matters before providing ordered drugs or appliances
    8. (5A) Sub-contracting aspects of dispensing under “hub and spoke” arrangements
    9. (5B) Objection to and discontinuation of hub and spoke arrangements
    10. (5C) Hub and spoke arrangements: sharing of “relevant data” between different businesses
    11. (6) Providing ordered drugs or appliances
    12. (7) Refusal to provide drugs or appliances ordered
    13. (8) Further activities to be carried out in connection with the provision of dispensing services
    14. (9) Additional requirements in relation to electronic prescribing
    15. (10) Further activities in connection with repeat dispensing
    16. (10A) Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.
    17. (10AA) Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.
    18. (11) Information to be provided for NHS England’s lists
    19. (12) Clinical governance
    20. (13) Professional Standards
    21. (13A) Accessing summary care records
    22. (13B) Electronic Prescription Service access
    23. (13C) Contact via NHS.net Connect and the Central Alerting System
    24. (14) Inducements etc
    25. (15) Duty to provide information about fitness to practise matters as they arise
    26. (16) Co-operation with NHS England
    27. (17) Charges for drugs, appliances and containers, and ownership of containers
    28. (18) Refunds of prescription charges
    29. (19) Remuneration, overpayments etc
    30. (20) Local resolution of disputes
    31. (21) Dispute resolution: non-NHS contracts
    32. (22) NHS dispute resolution procedure
    33. (23) Determination of dispute
    34. (24) Disputes: supplemental
    35. (25) Complaints
    36. (26) Variation of LPS schemes
    37. (27) Termination by agreement
    38. (28) Termination by serving notice
    39. (29) Termination of arrangements by NHS England on grounds of suitability etc
    40. (30) Termination by NHS England: patient safety and material financial loss
    41. (31) Termination and the NHS dispute resolution procedure
    42. (32) Third party rights
22. Schedule 8 · Service remuneration determined by NHS England
    1. (1) (1) Any fees and allowances payable to NHS pharmacists for...
    2. (2) (1) Any fees and allowances payable to NHS appliance contractors...
23. Schedule 9 · Transitional provisions
    1. (1) The continuity principles
    2. (2) Listing applications under the 2005 Regulations: NHS chemists
    3. (3) Listing applications under the 2012 Regulations: NHS chemists
    4. (4) Listing applications under the 2005 Regulations: dispensing doctors
    5. (5) Listing applications under the 2012 Regulations: dispensing doctors
    6. (6) Outstanding cases relating to dispensing contractor lists
    7. (7) Controlled localities
    8. (8) Reserved locations
    9. (9) Gradual discontinuation of the provision of pharmaceutical services by doctors
    10. (10) Gradual introduction of the provision of pharmaceutical services by doctors
    11. (11) Giving effect to listing decisions: pharmaceutical lists and dispensing doctor lists
    12. (12) Pharmaceutical lists, EPS lists and dispensing doctor lists: continuity of entries and decisions
    13. (13) Service provision issues: NHS chemists
    14. (14) Service provision issues: dispensing doctors
    15. (15) LPS schemes: replacement of Primary Care Trusts with NHS England and service provision issues
    16. (16) Notification of LPS designations and completion of reviews
    17. (17) The application of Group 12 of Schedule 8 to the Value Added Tax Act 1994
24. Schedule 10 · Amendments and revocations
    1. (1) Amendment of the National Health Service (Charges for Drugs and Appliances) Regulations 2000
    2. (2) Revocation of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002
    3. (3) Revocation of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002
    4. (4) Revocation of the National Health Service (Pharmaceutical Services) Amendment Regulations 2005
    5. (5) Revocation of the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 and amendments to those Regulations
    6. (6) Revocation of the National Health Service (Pharmaceutical Services) (Amendment) Regulations 2006
    7. (7) Amendments to the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009
    8. (8) Revocation of the National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) Amendment Regulations 2009
    9. (9) Revocation of the National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) (Amendment) Regulations 2010
    10. (10) Revocation of the National Health Service (Local Pharmaceutical Services) Amendment Regulations 2012
    11. (11) Revocation of the National Health Service (Pharmaceutical Services) Regulations 2012 and of amendments to those Regulations
    12. (12) Amendment of the Local Authorities (Partnership Arrangements, Care Trusts, Public Health and Local Healthwatch Arrangements etc.) Regulations 2012