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The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020

W.S.I. 2020/1073 · Made 29 September 2020 · Extends to England and Wales

Up to date with all changes known to legislation.gov.uk, revised to 2 June 2026.

National Health Service, Wales

Made 29 September 2020

Coming into force in accordance with regulation 1(2) and (3)

The Welsh Ministers, in exercise of the powers conferred on them by sections 15, 80, 82A, 83, 84, 86, 88, 104, 107, 110, 115, 116, 118, 203(9) and (10) and 205 of the National Health Service (Wales) Act 2006f1, make the following Regulations.

A draft of these Regulations has been approved by a resolution of Senedd Cymru in accordance with section 203(6A) of that Act.

Annotations to the whole text

Footnotes

f1

2006 c. 42. See section 206(1) for the definitions of “prescribed” and “regulations”. Section 82A and section 203(6A) were inserted by section 111 of the Public Health (Wales) Act 2017 (anaw 2). Sections 83 and 84 were amended by section 112 of the Public Health (Wales) Act 2017.

Contents

  1. Part 1: Introductory
  2. 1Title, commencement and application
  3. 2Interpretation
  4. Part 2: Pharmaceutical needs assessments
  5. 3Pharmaceutical needs assessments
  6. 4Information to be contained in pharmaceutical needs assessments
  7. 5Date by which the first pharmaceutical needs assessment is to be published
  8. 6Subsequent assessments
  9. 7Consultation on pharmaceutical needs assessments
  10. 8Matters for consideration when making assessments
  11. 9Publication of pharmaceutical needs assessments
  12. Part 3: Pharmaceutical lists and dispensing doctor lists
  13. 10Preparation and maintenance of pharmaceutical lists
  14. 11Preparation and maintenance of dispensing doctor lists
  15. 12Terms of service
  16. Part 4: Determination of controlled localities
  17. 13Areas that are controlled localities
  18. 14Appeals against decisions under Part 4
  19. Part 5: Applications by NHS pharmacists and NHS appliance contractors for inclusion in or amendment to pharmaceutical lists
  20. 15Applications to be included in or make amendment to a pharmaceutical list
  21. 16Determination of applications to be included in or to make amendment to a pharmaceutical list
  22. 17Locations in controlled localities that are reserved locations
  23. 18Applications for preliminary consent and effect of preliminary consent
  24. 19Applications involving relocation within a Local Health Board’s area
  25. 20Applications involving relocation between neighbouring Local Health Board areas
  26. 21Applications involving temporary relocation
  27. 22Applications involving a change of ownership
  28. 23Procedure following grant of an application
  29. 24Application to extend the relevant period
  30. 25Appeals
  31. Part 6: Applications by doctors for inclusion in or amendment to dispensing doctors lists
  32. 26Arrangements for the provision of pharmaceutical services by doctors
  33. 27Necessary services for temporary patients
  34. 28Provision of pharmaceutical services for immediate treatment or personal administration
  35. 29Discontinuation of arrangements for the provision of pharmaceutical services by doctors
  36. 30Outline consent and premises approval
  37. 31Taking effect of outline consent and premises approval
  38. 32Lapse of outline consent and premises approval
  39. 33Premises approval: change of premises before outline consent takes effect
  40. 34Premises approval: additional and new premises after outline consent has taken effect
  41. 35Premises approval: practice amalgamations
  42. Part 7: Fitness grounds and inclusion in and removal from pharmaceutical lists
  43. 36Deferral of applications on fitness grounds
  44. 37Refusal of applications on fitness grounds
  45. 38Conditional inclusion on fitness grounds
  46. 39Removal from a pharmaceutical list for breach of conditions on fitness grounds or imposition or variation or imposition of new conditions under section 108 of the 2006 Act
  47. 40Removal from a pharmaceutical list for other reasons
  48. 41Suspension from a pharmaceutical list
  49. 42Notification of a decision to impose conditions
  50. 43Review of decision to impose a suspension under section 110 of the 2006 Act or a contingent removal under section 108 of the 2006 Act
  51. 44Review of a decision to impose conditions
  52. 45Appeals
  53. Part 8: Conditional inclusion in pharmaceutical lists: certain specific conditions that do not relate to fitness or performance
  54. 46Core opening hours conditions
  55. 47Conditions relating to providing directed services
  56. 48Conditions relating to local resolution of disputes over terms of service
  57. Part 9: Performance related sanctions and Market Exit
  58. 49Local dispute resolution before serving remedial notices or breach notices
  59. 50Breaches of terms of service: remedial notices
  60. 51Breaches of terms of service: breach notices
  61. 52Payment withholdings: supplementary matters
  62. 53Removal of listings: cases relating to remedial notices and breach notices
  63. 54Appeals against decisions under Part 9
  64. Part 10: Payments to NHS pharmacists and NHS appliance contractors
  65. 55The Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors
  66. 55AZero or nominal product reimbursement for coronavirus vaccines, coronavirus antivirals and influenza virus vaccines
  67. 56Local Health Boards as determining authorities
  68. 57Overpayments
  69. 58Reward scheme
  70. 59Payments to suspended NHS pharmacists and NHS appliance contractors
  71. Part 11: Miscellaneous
  72. 60Home Local Health Board
  73. 61Publication of particulars
  74. 62Exercise of choice in certain cases
  75. 63Transitional provisions
  76. 64Minor and consequential amendments
  77. 65Revocation
  78. Signature
  79. Schedule 1: Information to be contained in pharmaceutical needs assessments
  80. 1Current provision of pharmaceutical services
  81. 2Other NHS services
  82. 3Gaps in provision of pharmaceutical services
  83. 4How the assessment was carried out
  84. 5Map of provision
  85. Schedule 2: Information to be included in applications to provide pharmaceutical services
  86. Part 1: Application for inclusion in or for amendment to a pharmaceutical list
  87. Information required from all applicants
  88. 1Details of the application
  89. 2Paragraph 2
  90. 3Paragraph 3
  91. 4Details of the applicant
  92. 5Paragraph 5
  93. 6Paragraph 6
  94. 7Details of the premises and opening hours
  95. 8Paragraph 8
  96. 9Paragraph 9
  97. 10Pharmaceutical services to be provided
  98. 11Paragraph 11
  99. 12Paragraph 12
  100. Information relating to applications to be included in, or amend, a pharmaceutical list
  101. 13Paragraph 13
  102. Information relating to the prejudice test
  103. 14Paragraph 14
  104. Information relating to applications involving relocations
  105. 15Paragraph 15
  106. 16Paragraph 16
  107. 17Paragraph 17
  108. 18Paragraph 18
  109. Information relating to applications involving a change of ownership
  110. 19Paragraph 19
  111. 20Paragraph 20
  112. Applicant’s undertaking
  113. 21Paragraph 21
  114. Part 2: Information and undertakings for applications for inclusion in a pharmaceutical list
  115. 22Applicant’s details
  116. 23Investigation, proceedings and convictions
  117. 24Paragraph 24
  118. 25Pharmaceutical qualifications, referees etc.
  119. 26Paragraph 26
  120. 27Paragraph 27
  121. 28Paragraph 28
  122. 29Paragraph 29
  123. 30Undertakings
  124. Part 3: Notification of commencement date
  125. 31Information to be provided prior to the commencement of the provision of pharmaceutical services
  126. Part 4: Applications for outline consent and premises approval
  127. 32Details of the application
  128. 33Paragraph 33
  129. 34Details of the applicant
  130. 35Paragraph 35
  131. 36Application for outline consent
  132. 37Paragraph 37
  133. 38Application for premises approval
  134. 39Paragraph 39
  135. 40Paragraph 40
  136. 41Paragraph 41
  137. 42Paragraph 42
  138. 43Paragraph 43
  139. 44Pharmaceutical services to be provided
  140. 45Prejudice test
  141. 46Meeting identified needs
  142. 47Applicant’s undertaking
  143. Schedule 3: Procedures to be followed by Local Health Boards to determine applications under the Regulations
  144. Part 1: Preliminary matters
  145. 1General principles
  146. 2Timetable for determining applications
  147. 3Persons prohibited from taking part in decision-making on applications
  148. Part 2: Determination of controlled localities
  149. 4Notice of proposed determination in respect of controlled localities
  150. 5Deferral of applications
  151. 6Imposition of conditions
  152. 7Notification of determination and action following determination
  153. Part 3: Applications for inclusion in or amendment to pharmaceutical lists and dispensing doctor lists
  154. 8Notice of certain applications
  155. 9Persons and bodies to be notified
  156. 10Content of notification
  157. 11Oral hearings
  158. 12Information to which a Local Health Board must have regard
  159. 13Imposition of conditions
  160. 14Notification of decisions: applications for inclusion in or to make an amendment to a pharmaceutical list
  161. 15Notification of decisions: applications for inclusion in or amendment to dispensing doctor lists
  162. 16Notification of decisions: applications under regulation 24 for extension of the relevant period
  163. 17Notification of decisions: applications under regulation 17(2)
  164. 18Action following determination in respect of reserved locations
  165. Schedule 4: Appeals to the Welsh Ministers
  166. Part 1: Preliminary matters
  167. 1General principles
  168. 2Oral hearings
  169. Part 2: Appeals against decisions determining controlled localities
  170. 3Right of appeal to the Welsh Ministers
  171. 4Notification of appeals
  172. 5Decision on appeals
  173. Part 3: Appeals against decisions for inclusion in or amendment to pharmaceutical lists and dispensing doctor lists
  174. 6Right of appeal to the Welsh Ministers
  175. 7Notification of appeals
  176. 8Decision on appeals
  177. 9Effect of decisions by the Welsh Ministers
  178. Schedule 5: Terms of service for NHS pharmacists who provide pharmaceutical services in particular by the provisions of drugs
  179. Part 1: General
  180. 1Interpretation
  181. 2Incorporation of provisions
  182. 2AParagraph 2A
  183. Part 2: Essential services
  184. 3Essential services
  185. 4Dispensing services
  186. 5Dispensing of drugs and appliances
  187. 5ADispensing ophthalmic listed appliances and ophthalmic listed medicines ordered by qualifying optometrists
  188. 6Supply in accordance with a SSP
  189. 7Urgent supply without a prescription
  190. 8Preliminary matters before providing ordered drugs or appliances
  191. 9Providing ordered drugs or appliances
  192. 10Refusal to provide drugs or appliances ordered
  193. 11Further activities to be carried out in connection with the provision of dispensing services
  194. 12Additional requirements in relation to specified appliances
  195. 13Disposal service in respect of unwanted drugs
  196. 14Basic procedure in respect of unwanted drugs
  197. 15Further activities to be carried out in connection with the disposal of unwanted drugs
  198. 16Promotion of healthy lifestyles
  199. 17Prescription linked intervention
  200. 18Public health campaigns
  201. 19Signposting
  202. 20Service outline in respect of signposting
  203. 21Support for self-care
  204. 22Service outline in respect of support for self-care
  205. Part 3: Pharmacy opening hours
  206. 23Pharmacy opening hours: general
  207. 24Matters to be considered when issuing directions in respect of pharmacy opening hours
  208. 25Determination of pharmacy opening hours instigated by the Local Health Board
  209. 26Determination of pharmacy opening hours instigated by the NHS pharmacist
  210. 27Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical services
  211. Part 4: Clinical governance and complaints
  212. 28Clinical governance
  213. 29Professional standards
  214. 30Inducements
  215. 31Duty to provide information about fitness to practice matters as they arise
  216. 32Home Local Health Board of bodies corporate
  217. 33Complaints
  218. Part 5: Other terms of service
  219. 34Directed services
  220. 35Information to be supplied
  221. 36Withdrawal from pharmaceutical lists
  222. 37Charges for drugs and refunds
  223. 38Inspections and access to information
  224. 39Welsh language
  225. 40Workforce reporting
  226. Schedule 6: Terms of service for NHS appliance contractors who provide pharmaceutical services only by the provision of appliances
  227. 1Incorporation of provisions
  228. 1AParagraph 1A
  229. 2Division of responsibilities between individuals and corporate bodies
  230. 3Dispensing services
  231. 4Dispensing of appliances
  232. 5Supply in accordance with a SSP
  233. 6Urgent supply without a prescription
  234. 7Preliminary matters before providing appliances
  235. 8Providing appliances
  236. 9Refusal to provide appliances ordered
  237. 10Further activities to be carried out in connection with the provision of dispensing services
  238. 11Additional requirements in relation to specified appliances
  239. 12Signposting
  240. 13Opening hours: general
  241. 14Matters to be considered when issuing directions in respect of opening hours
  242. 15Determination of opening hours instigated by the Local Health Board
  243. 16Determination of opening hours instigated by the NHS appliance contractor
  244. 17Clinical governance
  245. 18Professional standards
  246. 19Inducements
  247. 20Duty to provide information about fitness to practise matters as they arise
  248. 21Home Local Health Board of bodies corporate
  249. 22Complaints
  250. 23Directed services
  251. 24Information to be supplied
  252. 25Withdrawal from pharmaceutical services
  253. 26Charges for appliances
  254. 27Inspections and access to information
  255. 28Welsh language
  256. Schedule 7: Terms of service for doctors providing pharmaceutical services
  257. 1Interpretation
  258. 2Incorporation of provisions
  259. 2AParagraph 2A
  260. 3Persons duly authorised to dispense on behalf of dispensing doctors
  261. 4Dispensing of drugs and appliances ordered by another prescriber
  262. 5Dispensing of drugs and appliances ordered by the dispensing doctor
  263. 6Preliminary matters before providing ordered drugs or appliances
  264. 7Provision of Scheduled drugs
  265. 8Refusal to provide drugs or appliances ordered
  266. 9Fees and charges
  267. 10Complaints and concerns
  268. 11Inspections and access to information
  269. 12Welsh language
  270. Schedule 8: Minor and consequential amendments
  271. 1The National Health Service (Service Committees and Tribunal) Regulations 1992
  272. 2The National Health Service (Indicative Amounts) Regulations 1997
  273. 3The National Health Service (Payments by Local Authorities to Health Authorities) (Prescribed Functions) (Wales) Regulations 2001
  274. 4The National Health Service (General Medical Services Contracts) (Wales) Regulations 2004
  275. 5The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007
  276. 6The Single Use Carrier Bags Charge (Wales) Regulations 2010
  277. Explanatory note