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

   5. 7. Temporary extension of Primary Care Trust pharmaceutical needs assessments and access by the NHSCB 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 and EPS 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 the NHSCB must have regard

   5. 14. Current needs: consequences of additional matters

   6. 15. Future needs: additional matters to which the NHSCB 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 the NHSCB must have regard

   9. 18. Unforeseen benefits applications: additional matters to which the NHSCB 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 the NHSCB must have regard

   12. 21. Future improvements or better access: consequences of additional matters

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

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

   7. 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 the NHSCB'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. 66. Conditions relating to providing directed services

    4. 67. Conditions relating to voluntary closure of premises

    5. 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. 72. Payment withholdings: supplementary matters

    5. 73. Removal of listings: cases relating to remedial notices and breach notices

    6. 74. Removal of listings: cases relating to death, incapacity or cessation of service

    7. 75. Voluntary and automatic removal of listings: change of ownership, relocation, temporary provision and voluntary closure

    8. 76. Limitation on withdrawal from pharmaceutical lists while fitness investigations or proceedings are ongoing

    9. 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 the NHSCB or an agent of the NHSCB

    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 the NHSCB

    4. 92. Dispensing doctor remuneration

    5. 93. The taking effect of determinations

    6. 94. Overpayments

    7. 95. Free supply of drugs, appliances and containers where the drug or appliance is supplied under pharmaceutical services

    8. 96. Refunds of prescription charges

    9. 97. Reward scheme

    10. 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. 103. LPS schemes: health service body status

    6. 104. Development of LPS schemes

    7. 105. Persons permitted to be parties to LPS schemes: fitness criteria

    8. 106. LPS proposals: fitness information to be supplied

    9. 107. Notification of proposals

    10. 108. Right of return to pharmaceutical lists: LPS contractors

    11. 109. LPS pilot schemes: health service body status

    12. 110. LPS pilot schemes: termination

    13. 111. Emergencies requiring the flexible provision of local pharmaceutical services

    14. 112. Sharing of information about LPS chemists and their employees with the General Pharmaceutical Council

    15. 113. Directions to the First-tier Tribunal relating to local pharmaceutical services

    16. 114. Lists of LPS chemists

15. PART 14 Miscellaneous

    1. 115. Notification by the NHSCB 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. 120. Amendments and revocations

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

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

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

          9. 9. Undertakings

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

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

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

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

          7. 34. Taking effect of listing decisions: general

          8. 35. Notice requiring the commencement of pharmaceutical services

          9. 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 the NHSCB

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

    4. SCHEDULE 4

       Terms 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. 6. Urgent supply without a prescription

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

          6. 8. Providing ordered drugs or appliances

          7. 9. Refusal to provide drugs or appliances ordered

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

          9. 11. Additional requirements in relation to electronic prescribing

          10. 12. Additional requirements in relation to specified appliances

          11. 13. Disposal service in respect of unwanted drugs

          12. 14. Basic procedure in respect of unwanted drugs

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

          14. 16. Promotion of healthy lifestyles

          15. 17. Prescription linked intervention

          16. 18. Public health campaigns

          17. 19. Signposting

          18. 20. Service outline in respect of signposting

          19. 21. Support for self-care

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

       3. PART 3 Hours of opening

          1. 23. Pharmacy opening hours: general

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

          3. 25. Determination of pharmacy premises core opening hours instigated by the NHSCB

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

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

       4. PART 4 Other terms of service

          1. 28. Clinical governance

          2. 29. Professional Standards

          3. 30. Inducements etc.

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

          5. 32. Other information to be supplied

          6. 33. Co-operation with Health Education England

          7. 34. Complaints

          8. 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. 5. Urgent supply without a prescription

       6. 6. Preliminary matters before providing appliances

       7. 7. Providing appliances

       8. 8. Refusal to provide appliances ordered

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

       10. 10. Additional requirements in relation to electronic prescribing

       11. 11. Additional requirements in relation to specified appliances

       12. 12. Signposting

       13. 13. Opening hours: general

       14. 14. Matters to be considered when issuing directions in respect of core opening hours

       15. 15. Determination of core opening hours instigated by the NHSCB

       16. 16. Determination of core opening hours instigated by the NHS appliance contractor

       17. 17. Temporary open hours and closures during an emergency requiring the flexible provision of pharmaceutical services

       18. 18. Clinical governance

       19. 19. Professional Standards

       20. 20. Inducements etc.

       21. 21. Duty to provide information about fitness matters as they arise

       22. 22. Other information to be supplied

       23. 23. Co-operation with Health Education England

       24. 24. Complaints

       25. 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. 4. Preliminary matters before providing ordered drugs or appliances

       5. 5. Provision of Scheduled drugs

       6. 6. Refusal to provide drugs or appliances ordered

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

       8. 8. Complaints procedures

       9. 9. Inspections and access to information

       10. 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. 4. Urgent supply without a prescription

       5. 5. Preliminary matters before providing ordered drugs or appliances

       6. 6. Providing ordered drugs or appliances

       7. 7. Refusal to provide drugs or appliances ordered

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

       9. 9. Additional requirements in relation to electronic prescribing

       10. 10. Further activities in connection with repeat dispensing

       11. 11. Information to be provided for the NHSCB's lists

       12. 12. Clinical governance

       13. 13. Professional Standards

       14. 14. Inducements etc

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

       16. 16. Co-operation with Health Education England

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

       18. 18. Refunds of prescription charges

       19. 19. Remuneration, overpayments etc

       20. 20. Local resolution of disputes

       21. 21. Dispute resolution: non-NHS contracts

       22. 22. NHS dispute resolution procedure

       23. 23. Determination of dispute

       24. 24. Disputes: supplemental

       25. 25. Complaints

       26. 26. Variation of LPS schemes

       27. 27. Termination by agreement

       28. 28. Termination by serving notice

       29. 29. Termination of arrangements by the NHSCB on grounds of suitability etc

       30. 30. Termination by the NHSCB: patient safety and material financial loss

       31. 31. Termination and the NHS dispute resolution procedure

       32. 32. Third party rights

    8. SCHEDULE 8

       Service remuneration determined by the NHSCB

       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 the NHSCB 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