The National Health Service (Pharmaceutical Services) Regulations 2012

1. Introductory Text

2. PART 1

   1. 1. Citation and commencement

   2. 2. Interpretation

3. PART 2

   1. 3. Pharmaceutical needs assessments

   2. 4. Information to be contained in pharmaceutical needs assessments

   3. 5. Date by which the first pharmaceutical needs assessment is to be published

   4. 6. Subsequent assessments

   5. 7. Temporary extension of pharmaceutical needs assessments

   6. 8. Consultation on pharmaceutical needs assessments

   7. 9. Matters for consideration when making assessments

4. PART 3

   1. 10. Pharmaceutical lists and EPS lists

   2. 11. Terms of service of NHS chemists: general

   3. 12. Routine applications for inclusion in or amendment to a pharmaceutical list

   4. 13. Current needs: additional matters to which the Primary Care Trust must have regard

   5. 14. Current needs: consequences of additional matters

   6. 15. Future needs: additional matters to which the Primary Care Trust must have regard

   7. 16. Future needs: consequences of additional matters

   8. 17. Improvements or better access in the pharmaceutical needs assessment: additional matters to which the Primary Care Trust must have regard

   9. 18. Unforeseen benefits applications: additional matters to which the Primary Care Trust 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 Primary Care Trust 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

   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. Applications relating to emergencies requiring the flexible provision of pharmaceutical services

6. PART 5

   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

   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

   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 Primary Care Trust’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

   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 an emergency requiring the flexible provision of pharmaceutical services

   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

    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

    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

    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. Evidence of unsuitability, fraud or inefficiency in service provision: specific matters

    10. 87. Review periods for national disqualifications

    11. 88. Wider notifications of fitness decisions

13. PART 12

    1. 89. The Drug Tariff and section 164: general provisions

    2. 90. Data to be provided to assist Drug Tariff determinations

    3. 91. Remuneration in respect of enhanced services

    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

    1. 99. Sharing of information by home Primary Care Trusts

    2. 100. Notification by a Primary Care Trust of changes to its pharmaceutical lists

    3. 101. Proceedings with regard to overridden arrangements during an emergency requiring the flexible provision of pharmaceutical services

    4. 102. Authorised persons to apply for services

    5. 103. Transitional provisions

    6. 104. Amendments and revocations

    7. 105. Review of these Regulations

15. Signature

16. 1. SCHEDULE 1

       Information to be contained in pharmaceutical needs assessments

    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

       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

    3. 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

    4. SCHEDULE 4

       Terms 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

    5. SCHEDULE 5

       Terms of service of NHS appliance contractors

    6. SCHEDULE 6

       Terms of service of dispensing doctors

    7. SCHEDULE 7

       Transitional provisions

    8. SCHEDULE 8

       Amendments and revocations

17. Explanatory Note