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The National Health Service (Pharmaceutical Services) Regulations 2005

S.I. 2005/641 · Made 10 March 2005

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NATIONAL HEALTH SERVICE, ENGLAND

Made 10th March 2005

Laid before Parliament 11th March 2005

Coming into force 1st April 2005

The Secretary of State for Health, in exercise of the powers conferred upon him by sections 41, 42, 43, 43ZA, 49F, 49I, 49N, 49O, 49P, 49Q and 126(4) of the National Health Service Act 1977f1 hereby makes the following Regulations:—

Annotations to the whole text

Footnotes

f1

1977 c. 49; section 41 was substituted by the Health and Social Care Act 2001 (c. 15) (“the 2001 Act”), section 42(1), and amended by the National Health Service Reform and Healthcare Professions Act 2002 (c. 17) (“the 2002 Act”), Schedule 2, Part 1, paragraphs 1 and 13; and by the Health Professions Order 2001 (Consequential Amendments) Order 2003 (S.I. 2003/1590) article 3, Schedule, Part 1, paragraph 3 and the Health Act 1999 (Consequential Amendments) (Nursing and Midwifery) Order 2004 (S.I. 2004/1771) article 8. Section 42 was substituted by the National Health Service (Amendment) Act 1986 (c. 66), section 3(1); extended by the Health and Medicines Act 1988 (c. 49), section 17; and amended by S.I. 1987/2202, article 4; by the National Health Service and Community Care Act 1990 (c. 19) (“the 1990 Act”), section 12(3); by the Health Authorities Act 1995 (c. 17) (“the 1995 Act”), Schedule 1, paragraph 30; by the Pharmacists (Fitness to Practice) Act 1997 (c. 19), Schedule, paragraph 6; by the 2001 Act, sections 20(6), 43(2), (3) and (4) and by Schedule 6 Part 1; and by the 2002 Act, Schedule 2, paragraph 16. Section 43 was amended by the 1995 Act, Schedule 1, paragraph 31; by the Health Services Act 1980 (c. 53), section 21(2); by the National Health Service (Primary Care) Act 1997 (c. 46) (“the 1997 Act”), section 29(1) and Schedule 2, paragraphs 3 and 14; by the 1990 Act, Schedule 9, paragraph 18(2); by the 2001 Act, sections 20(7), 42(2) and 43(5); and by the 2002 Act, Schedule 2, paragraph 17. Section 43ZA was inserted by the 2001 Act, section 21, and amended by the 2002 Act, section 2(5) and Schedule 2, Part 1, paragraphs 1 and 18, and by the Health and Social Care (Community Health and Standards) Act 2003 (c. 43) (“the 2003 Act”), Schedule 14, Part 4. Sections 49F, 49I, 49N, 49O and 49Q were inserted by the 2001 Act, section 25 and amended by the 2002 Act, Schedule 2, paragraphs 1, 21, 23, 24, 25, 26, 27 and 28. Section 126(4) was amended by the Health Act 1999 (“the 1999 Act”), section 65(1), Schedule 4, paragraphs 3 and 37. See section 128(1) of the National Health Service Act 1977 as amended by the 1990 Act, section 26(2)(g) and (i), for the definitions of “prescribed” and “regulations”.

Contents

  1. Part 1: General
  2. 1Citation, commencement and extent
  3. 2Interpretation
  4. 3Terms of service
  5. Part 2: Pharmaceutical Lists and Applications for Admission to a Pharmaceutical List
  6. 4Preparation of lists
  7. 5Applications for inclusion in or amendment to a pharmaceutical list
  8. 6Applications involving a minor relocation within a Primary Care Trust’s area
  9. 7Applications involving a minor relocation between neighbouring Primary Care Trusts
  10. 8Applications involving a change of ownership
  11. 9Applications following suspension from the list
  12. 10Right of return to pharmaceutical lists
  13. 11Refusal: general provisions
  14. 12Necessary or desirable test
  15. 13Exemption from the necessary or desirable test
  16. 14Variation of directed services in respect of exempted premises
  17. 15Approved retail areas
  18. 16New one-stop primary care centres
  19. 17Refusal: distance selling premises
  20. 18Refusal: premises which are in a controlled locality but not in a reserved location
  21. 19Refusal: fitness to practise grounds
  22. 20Imposition of conditions
  23. 21Conditional inclusion relating to fitness to practise matters
  24. 22Relevant procedures for applications
  25. 23Notification of applications
  26. 24Determination of applications
  27. 25Deferral of consideration of certain applications
  28. 26Deferral of consideration of applications on fitness to practise grounds
  29. 27Notification of decision
  30. 28Notifications by Primary Care Trusts to other persons
  31. 29Appeals
  32. 30Appeals against imposition of conditions and related decisions
  33. 31Determination that an area is a controlled locality
  34. 32Appeals relating to rurality of an area
  35. 33Notification of an application in respect of premises in a controlled locality
  36. 34Decision not to consider an application in respect of premises in a controlled locality
  37. 35Pharmaceutical services in reserved locations
  38. 36Determination of applications in respect of controlled localities
  39. 37Notification of decision in respect of applications in controlled localities
  40. 38Appeals in connection with determinations in respect of controlled localities etc
  41. 39Procedure after grant of application
  42. 40Preliminary consent to be included in a pharmaceutical list
  43. 41Effect of preliminary consent
  44. Part 3: Conditional inclusion, suspension and removal from pharmaceutical lists
  45. 42Review of decision to impose conditions
  46. 43Appeals following a review
  47. 44Removal for breach of conditions
  48. 45Removal from pharmaceutical lists
  49. 46Criteria for decisions on removal
  50. 47Cases where the Primary Care Trust must remove a chemist
  51. 48Procedure on removal
  52. 49Supplementary matters relating to removal
  53. 50Procedure on suspension
  54. 51Procedure on review of Primary Care Trust decision
  55. 52Review periods on national disqualification
  56. 53Withdrawals from the list
  57. 54Temporary provision of services during a period of suspension
  58. 55Notifications
  59. Part 4: Payments to chemists
  60. 56Standards of, and payments for, drugs and appliances
  61. 57Claims and overpayments
  62. 58Payments to suspended chemists
  63. 59Reward Scheme
  64. Part 5: Provision of Pharmaceutical Services by Doctors
  65. 60Arrangements for provision of pharmaceutical services by doctors
  66. 61Outline consent and premises approval
  67. 62Taking effect of outline consent and premises approval
  68. 63Lapse of outline consent and premises approval
  69. 64Premises approval: change of premises before outline consent takes effect
  70. 65Premises approval: additional and new premises after outline consent has taken effect
  71. 66Premises approval: practice amalgamations
  72. 67Premises approval – transitional provisions
  73. 68Dispensing doctor lists
  74. 69Removal of entries from dispensing doctor lists
  75. Part 6: Miscellaneous
  76. 70Publication of particulars
  77. 71List of chemists providing an ETP service
  78. 72Exercise of choice of chemist in certain cases
  79. 73Transitional provisions
  80. 74Transitional arrangements in respect of terms of service
  81. 75Minor and consequential amendments and revocations
  82. Signature
  83. Schedule 1: TERMS OF SERVICE OF PHARMACISTS
  84. Part 1: GENERAL
  85. 1Incorporation of provisions
  86. 2Division of responsibilities between individuals and corporate bodies
  87. Part 2: ESSENTIAL SERVICES
  88. 3Essential services
  89. 4Dispensing services
  90. 5Dispensing of drugs and appliances
  91. 6Urgent supply without a prescription
  92. 7Preliminary matters before providing ordered drugs or appliances
  93. 8Providing ordered drugs or appliances
  94. 9Refusal to provide drugs or appliances ordered
  95. 10Further activities to be carried out in connection with the provision of dispensing services
  96. 11Additional requirements in relation to electronic prescribing
  97. 12Disposal service in respect of unwanted drugs
  98. 13Basic procedure in respect of unwanted drugs
  99. 14Further activities to be carried out in connection with the disposal of unwanted drugs
  100. 15Promotion of healthy lifestyles
  101. 16Prescription linked intervention
  102. 17Public health campaigns
  103. 18Signposting
  104. 19Service outline in respect of signposting
  105. 20Support for self-care
  106. 21Service outline in respect of support for self-care
  107. Part 3: HOURS OF OPENING
  108. 22Pharmacy opening hours: general
  109. 23Matters to be considered when issuing directions in respect of pharmacy opening hours
  110. 24Determination of pharmacy opening hours instigated by the Primary Care Trust
  111. 25Determination of pharmacy opening hours instigated by the pharmacist
  112. Part 4: CLINICAL GOVERNANCE, FITNESS TO PRACTISE AND COMPLAINTS
  113. 26Clinical governance
  114. 27Professional Standards
  115. 28Inducements etc.
  116. 29Duty to provide information about fitness to practise matters: pharmacists on pharmaceutical lists on 1st April 2005
  117. 30Duty to provide information about fitness to practise matters as they arise
  118. 31Home Primary Care Trust of bodies corporate
  119. 32Complaints
  120. Part 5: OTHER TERMS OF SERVICE
  121. 33Directed Services
  122. 34Information to be supplied
  123. 35Withdrawal from pharmaceutical lists
  124. 36Charges for drugs and refunds
  125. 37Inspections and access to information
  126. Schedule 2: TERMS OF SERVICE OF DISPENSING DOCTORS
  127. 1Incorporation of provisions
  128. 2Persons duly authorised to dispense on behalf of dispensing doctors
  129. 3Dispensing of drugs and appliances ordered by another prescriber
  130. 4Dispensing of drugs and appliances ordered by the dispensing doctor
  131. 5Preliminary matters before providing ordered drugs or appliances
  132. 6Provision of Scheduled drugs
  133. 7Refusal to provide drugs or appliances ordered
  134. 8Fees and charges
  135. 9Complaints procedures
  136. 10Inspections and access to information
  137. Schedule 3: TERMS OF SERVICE OF SUPPLIERS OF APPLIANCES
  138. 1Incorporation of provisions
  139. 2Division of responsibilities between individuals and corporate bodies
  140. 3Dispensing services
  141. 4Dispensing of appliances
  142. 5Preliminary matters before providing appliances
  143. 6Providing appliances
  144. 7Refusal to provide appliances ordered
  145. 8Further activities to be carried out in connection with the provision of dispensing services
  146. 9Additional requirements in relation to electronic prescribing
  147. 10Opening hours: general
  148. 11Matters to be considered when issuing directions in respect of opening hours
  149. 12Determination of opening hours instigated by the Primary Care Trust
  150. 13Determination of opening hours instigated by the supplier of appliances
  151. 14Professional Standards
  152. 15Inducements etc.
  153. 16Duty to provide information about fitness to practise matters: suppliers of appliances on pharmaceutical lists on 1st April 2005
  154. 17Duty to provide information about fitness to practise matters as they arise
  155. 18Home Primary Care Trust of bodies corporate
  156. 19Complaints
  157. 20Directed Services
  158. 21Information to be supplied
  159. 22Withdrawal from pharmaceutical lists
  160. 23Charges for appliances
  161. 24Inspections and access to information
  162. Schedule 4
  163. Part 1: INFORMATION TO BE INCLUDED IN AN APPLICATION FOR INCLUSION IN A PHARMACEUTICAL LIST OR INCLUSION IN A LIST IN RESPECT OF DIFFERENT SERVICES OR PREMISES
  164. 1APPLICATION
  165. 2DETAILS OF APPLICANT
  166. 3DETAILS OF PREMISES AND OPENING HOURS
  167. 4PHARMACEUTICAL SERVICES TO BE PROVIDED
  168. 5NECESSARY OR DESIRABLE TEST
  169. 6APPLICATIONS MADE UNDER REGULATION 5(1)(b)(ii) OR 5(1)(c)
  170. 7APPLICATIONS MADE UNDER REGULATION 5(1)(b)(iii)
  171. 8APPLICATIONS MADE IN ACCORDANCE WITH REGULATION 8
  172. 2NOTIFICATION OF COMMENCEMENT DATE
  173. Part 3: INFORMATION AND UNDERTAKINGS TO BE GIVEN BY AN APPLICANT IN CONNECTION WITH AN APPLICATION FOR INCLUSION (OR TEMPORARY INCLUSION) IN A PHARMACEUTICAL LIST
  174. 1Paragraph 1
  175. 2Paragraph 2
  176. 3Paragraph 3
  177. 4Paragraph 4
  178. 5Paragraph 5
  179. 6Paragraph 6
  180. 7Paragraph 7
  181. 8Paragraph 8
  182. 9Paragraph 9
  183. 10Paragraph 10
  184. 11Paragraph 11
  185. 12Paragraph 12
  186. Schedule 5: MINOR AND CONSEQUENTIAL AMENDMENTS
  187. 1The National Health Service (General Medical Services Contracts) (Personal Medical Services Agreements) and (Pharmaceutical Services) (Amendment) Regulations 2005
  188. 2The Health Act 1999 (Consequential Amendments) (Nursing and Midwifery) Order 2004
  189. 3The Health and Social Care (Community Health and Standards) Act 2003 (Supplementary and Consequential Provision) (NHS Foundation Trusts) Order 2004
  190. 4The Nurses and Midwives (Parts of and Entries in the Register) Order of Council 2004
  191. 5The National Health Service (General Medical Services etc) (Patients' Forums) Amendment Regulations 2003
  192. 6The National Health Service (Pharmaceutical Services) (General Medical Services) and (Charges for Drugs and Appliances) Amendment Regulations 2003
  193. 7The National Health Service (Amendments Relating to Prescribing by Nurses and Pharmacists etc) (England) Regulations 2003
  194. 8The National Health Service (Local Pharmaceutical Services Etc) Regulations 2002
  195. 9The National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc Provisions) Regulations 2002
  196. 10The National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002
  197. 11The National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002
  198. 12The National Health Service (Pharmaceutical Services) and (Misuse of Drugs) (Electronic Communications) Order 2001
  199. 13The National Health Service (Charges for Drugs and Appliances) Regulations 2000
  200. 14The National Health Service (Payments by Local Authorities to NHS Bodies) (Prescribed Functions) Regulations 2000
  201. 15The National Health Service (Pilot Schemes for Personal Dental Services: Miscellaneous Provisions and Consequential Amendments) Regulations 1998
  202. 16The National Health Service (Indicative Amounts) Regulations 1997
  203. 17The National Health Service (Service Committees and Tribunal) Regulations 1992
  204. 18The National Health Service (General Dental Services) Regulations 1992
  205. Schedule 6REVOCATIONS
  206. Explanatory note