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

1. Introductory Text

2. PART 1 Introductory

   1. 1. Citation and commencement

   2. 2. Interpretation

3. 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

4. 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

5. 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. 26. Change of ownership applications

   5. 26A. Consolidation onto an existing site

   6. 27. Applications for temporary listings arising out of suspensions

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

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

6. 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

7. 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

8. 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

9. 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

10. 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. 67. Conditions relating to voluntary closure of premises

    6. 67A. Condition relating to entering administration

    7. 68. Conditions relating to local resolution of disputes over terms of service

11. 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

12. 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

13. 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

14. 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

15. 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

16. Signature

17. 1. 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

    2. 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

          1. 1. Information to be included in all routine and excepted applications

          2. 2. Information to be included in all routine and excepted applications for inclusion in a pharmaceutical list

          3. 3. Fitness information about individuals: routine and excepted applications for inclusion in a pharmaceutical list

          4. 4. Fitness information about corporate bodies: routine and excepted applications for inclusion in a pharmaceutical list

          5. 5. Fitness information that has already been provided under pharmaceutical or local pharmaceutical services

          6. 5A. Updating of information about or relating to a superintendent

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

          8. 7. Additional information to be included with routine applications

          9. 8. Additional information to be included with excepted applications

          10. 9. Undertakings

          11. 10. Nature of details to be supplied

       2. PART 2 Preliminary matters

          1. 11. Relevant information or documentation

          2. 12. Failure to provide undertakings or fees

          3. 13. Functions of NHS England in relation to fitness information relevant to applications: aggregation of information

          4. 14. Deferral of notifiable applications prior to notification

          5. 15. Refusal of notifiable applications prior to notification because of the language requirement for some NHS pharmacists

          6. 16. Refusal of notifiable applications on fitness grounds prior to notification

          7. 17. Proposed new pharmacy premises in controlled localities: refusal of routine applications because of preliminary matters prior to notification

       3. PART 3 Notification of certain applications

          1. 18. Applications requiring notifications

          2. 19. Notification procedure for notifiable applications

          3. 20. Parallel notifications

          4. 21. Content of notifications

       4. PART 4 Determination and deferral of applications

          1. 22. Flexibility with regard to determining or deferring applications

          2. 23. Additional matters for consideration in relation to applications for inclusion in a pharmaceutical list

          3. 24. Action following deferrals

          4. 25. Oral hearings

          5. 26. Persons barred from taking part in decision making on routine and excepted applications

          6. 27. Timetable for determining applications

       5. PART 5 Notification, taking effect of decisions and rights of appeal to the Secretary of State

          1. 28. Notification of decisions on routine and excepted applications

          2. 29. Template notice of commencement to be included with a notice of decision

          3. 29A. Template notice of consolidation

          4. 30. Third party rights of appeal to the Secretary of State where an application is granted

          5. 31. Conditional grant of applications where the address of the premises is unknown

          6. 32. Changes to the premises specified in an application after its grant but before the listing of the premises

          7. 33. Conditional grant in cases relating to future needs or future improvements or better access

          8. 34. Taking effect of listing decisions: general

          9. 34A. Taking effect of decisions relating to business consolidations

          10. 35. Notice requiring the commencement of pharmaceutical services

          11. 36. Appeals to the Secretary of State by the applicant

    3. SCHEDULE 3

       Appeals to the Secretary of State

       1. PART 1 Preliminary matters

          1. 1. Determination of third party appeal rights in certain cases

          2. 2. Misconceived appeals

       2. PART 2 Notification of appeals

          1. 3. Notification of appeals notices under paragraph 30, 32(5) or 36 of Schedule 2

          2. 4. Notification of appeals relating to notices under regulation 45

          3. 5. Notification of appeals relating to decisions under Part 8 of these Regulations

          4. 6. Non notification of appeals relating to notices under regulation 77 or 98

       3. PART 3 Determination of appeals

          1. 7. Flexibility with regard to the manner of determining appeals

          2. 8. Oral hearings

          3. 9. Decisions of the Secretary of State

          4. 10. Notification of decisions and subsequent action by NHS England

          5. 11. Effect of decisions by the Secretary of State

    4. SCHEDULE 4

       NHS England’sTerms of service of NHS pharmacists

       1. PART 1 General

          1. 1. Responsibilities of NHS pharmacists and pharmacy staff

          2. 2. Breaches by directors and superintendents

       2. PART 2 Essential services

          1. 3. Essential services

          2. 4. Dispensing services

          3. 5. Dispensing of drugs and appliances

          4. 5A. Supply in accordance with a SSP

          5. 5B. Supply in accordance with a PTP or a PTPGD

          6. 5C. Supply in accordance with a LPIV

          7. 6. Urgent supply without a prescription

          8. 7. Preliminary matters before providing ordered drugs or appliances

          9. 8. Providing ordered drugs or appliances

          10. 9. Refusal to provide drugs or appliances ordered

          11. 10. Further activities to be carried out in connection with the provision of dispensing services

          12. 11. Additional requirements in relation to electronic prescribing

          13. 12. Additional requirements in relation to specified appliances

          14. 13. Disposal service in respect of unwanted drugs

          15. 14. Basic procedure in respect of unwanted drugs

          16. 15. Further activities to be carried out in connection with the disposal of unwanted drugs

          17. 16. Promotion of healthy lifestyles

          18. 17. Prescription linked intervention

          19. 18. ... Health campaigns

          20. 19. Signposting

          21. 20. Service outline in respect of signposting

          22. 21. Support for self-care

          23. 22. Service outline in respect of support for self-care

          24. 22A. Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.

          25. 22AA. Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

          26. 22B. Discharge medicines service

          27. 22C. Service outline in respect of the discharge medicines service

       3. PART 3 Hours of opening

          1. 23. Pharmacy opening hours: general

          2. 23A. Local hours plans

          3. 24. Matters to be considered when issuing directions in respect of pharmacy premises core opening hours

          4. 25. Determination of pharmacy premises core opening hours instigated by NHS England

          5. 26. Determination of pharmacy premises core opening hours instigated by the NHS pharmacist

          6. 27. Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical services

          7. 27A. Pharmacy opening hours: arrangements while a disease is or in anticipation of a disease being imminently pandemic etc.

          8. 27B. Flexible provision of relevant immunisation services during a pandemic etc.

       4. PART 4 Other terms of service

          1. 28. Clinical governance and the promotion of healthy living

          2. 28A. Premises requirements in respect of consultation rooms

          3. 28B. Consultations held from distance selling premises and some small pharmacy premises

          4. 28C. Distance selling premises requirements in respect of websites and health promotion zones

          5. 29. Professional Standards

          6. 29A. Accessing summary care records

          7. 29B. Electronic Prescription Service access

          8. 29C. Contact via NHSmail, pharmacy profiles and the Central Alerting System

          9. 29D. Business continuity plans to deal with temporary suspensions

          10. 30. Inducements etc.

          11. 31. Duty to provide information about fitness matters as they arise

          12. 32. Other information to be supplied

          13. 32A. Facilitating remote access to pharmaceutical services

          14. 33. Co-operation with NHS England

          15. 34. Complaints

          16. 35. Inspections and access to information

    5. 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

    6. 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. 5. Provision of Scheduled drugs

       11. 6. Refusal to provide drugs or appliances ordered

       12. 7. Dispensing doctors issuing prescription forms which may be presented to an NHS chemist

       13. 7A. Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.

       14. 7AA. Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

       15. 8. Complaints procedures

       16. 9. Inspections and access to information

       17. 10. Voluntary closure of premises

    7. 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. 6. Providing ordered drugs or appliances

       9. 7. Refusal to provide drugs or appliances ordered

       10. 8. Further activities to be carried out in connection with the provision of dispensing services

       11. 9. Additional requirements in relation to electronic prescribing

       12. 10. Further activities in connection with repeat dispensing

       13. 10A. Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.

       14. 10AA. Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

       15. 11. Information to be provided for NHS England’s lists

       16. 12. Clinical governance

       17. 13. Professional Standards

       18. 13A. Accessing summary care records

       19. 13B. Electronic Prescription Service access

       20. 13C. Contact via NHSmail and the Central Alerting System

       21. 14. Inducements etc

       22. 15. Duty to provide information about fitness to practise matters as they arise

       23. 16. Co-operation with NHS England

       24. 17. Charges for drugs, appliances and containers, and ownership of containers

       25. 18. Refunds of prescription charges

       26. 19. Remuneration, overpayments etc

       27. 20. Local resolution of disputes

       28. 21. Dispute resolution: non-NHS contracts

       29. 22. NHS dispute resolution procedure

       30. 23. Determination of dispute

       31. 24. Disputes: supplemental

       32. 25. Complaints

       33. 26. Variation of LPS schemes

       34. 27. Termination by agreement

       35. 28. Termination by serving notice

       36. 29. Termination of arrangements by NHS England on grounds of suitability etc

       37. 30. Termination by NHS England: patient safety and material financial loss

       38. 31. Termination and the NHS dispute resolution procedure

       39. 32. Third party rights

    8. 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...

    9. 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

    10. 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

18. Explanatory Note