The National Health Service (Pharmaceutical Services) Regulations 2012

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

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 and 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 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 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 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 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. 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 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 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 Miscellaneous

    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

       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. Providing fitness information instead to a home Primary Care Trust

          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

          3. 13. Functions of a home Primary Care Trust in relation to certain applications

          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 Primary Care Trust

          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 Primary Care Trust

          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. Home Primary Care Trust of bodies corporate

          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 Primary Care Trust

       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. Home Primary Care Trust of bodies corporate

       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

       Transitional provisions

       1. 1. Pharmaceutical needs assessments

       2. 2. Listing applications: NHS chemists

       3. 3. Listing applications: dispensing doctors

       4. 4. Approved retail areas

       5. 5. Controlled localities

       6. 6. Reserved locations

       7. 7. Gradual discontinuation of the provision of pharmaceutical services by doctors

       8. 8. Gradual introduction of the provision of pharmaceutical services by doctors

       9. 9. Giving effect to listing decisions taken under the 2005 Regulations

       10. 10. Dispensing contractor lists

       11. 11. Continuing matters: periods of time

       12. 12. Other continuing matters: NHS chemists

       13. 13. Other continuing matters: dispensing doctors

       14. 14. Continuing operation of SCAT arrangements

       15. 15. The application of Group 12 of Schedule 8 to the Value Added Tax Act 1994

       16. 16. Terms of service for distance selling premises

    8. SCHEDULE 8

       Amendments and revocations

       1. 1. Revocation of the National Health Service (Service Committees and Tribunal) Regulations 1992, and of amendments to and measures relating to those Regulations

       2. 2. Amendment to the National Health Service (Indicative Amounts) Regulations 1997

       3. 3. Amendment to the National Health Service (Payments by Local Authorities to NHS Bodies) (Prescribed Functions) Regulations 2000

       4. 4. Amendments to the National Health Service (Charges for Drugs and Appliances) Regulations 2000

       5. 5. Amendments to the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002

       6. 6. Amendments to the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002

       7. 7. Amendments to the National Health Service (General Medical Services Contracts) Regulations 2004

       8. 8. Amendments to the National Health Service (Personal Medical Services Agreements) Regulations 2004

       9. 9. Revocation of the National Health Service (Pharmaceutical Services) Regulations 2005 and of amendments to those Regulations

       10. 10. Amendments to the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006

       11. 11. Amendments to the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009

17. Explanatory Note