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The Pharmacy Order 2010

S.I. 2010/231 · Made 10 February 2010 · Extends to England, Wales and Scotland

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Health Care And Associated Professions

Made 10th February 2010

Coming into force in accordance with article 1

At the Court at Buckingham Palace, the 10th day of February 2010

Present,

The Queen’s Most Excellent Majesty in Council

This Order in Council is made in exercise of the powers conferred by sections 60 and 62(4) and (4A) of, and Schedule 3 to, the Health Act 1999f1 as read with paragraph 1A of Schedule 2 to the European Communities Act 1972f2.

This Order makes provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to Her Majesty, with the advice of Her Privy Council, that it is necessary for the reference to Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualificationsf3 to be construed as a reference to that Directive as amended from time to time.

The Secretary of State and the Scottish Ministers published a draft Order and invited representations as required by paragraph 9(1) and (3) of Schedule 3 to the Health Act 1999.

The period of three months mentioned in paragraph 9(4) of that Schedule expired before a draft of this Order in Council was laid before Parliament and the Scottish Parliament.

A draft of this Order in Council has been approved by resolution of each House of Parliament and the Scottish Parliament in accordance with section 62(10) of the Health Act 1999.

Accordingly, Her Majesty is pleased, by and with the advice of Her Privy Council, to make the following Order in Council:

Annotations to the whole text

Footnotes

f1

1999 c.8. Section 60 was amended by section 26(9) of the National Health Service Reform and Health Care Professions Act 2002 (c.17) (“the 2002 Act”), by paragraph 1 of Schedule 8, paragraph 10 of Schedule 10 and Part 2 of Schedule 15 to the Health and Social Care Act 2008 (c.14) (“the 2008 Act”) and by S.I.2002/253 and 254. Subsection (4) of section 62 of the Act was substituted by subsections (4) and (4A) as inserted by paragraph 11 of Schedule 10 to the 2008 Act. Schedule 3 has been amended as follows: by section 26(10) of the 2002 Act; by paragraph 67 of Schedule 11, and Part 4 of Schedule 14, to the Health and Social Care (Community Health and Standards) Act 2003 (c.43); by Schedule 9 to the Health Act 2006 (c.28); by paragraphs 3 to 10 of Schedule 8, paragraph 12 of Schedule 10 and Part 2 of Schedule 15, to the 2008 Act; and by S.I.2002/254.

f2

1972 c.68. Paragraph 1A of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 (c.51) and amended by S.I.2007/1388.

f3

OJ No. L255, 30.09.2005, p22, as amended by Council Directive 2006/100/EEC of 20 November 2006, OJ No. L363 of 20.12.2006, p141.

Contents

  1. Part 1: Preliminary
  2. 1Citation and commencement
  3. 2Extent
  4. 3Interpretation
  5. Part 2: The Council and its Committees
  6. 4The Council and its Committees
  7. 5Standards and requirements: consultation and review
  8. 6The Council’s general duties
  9. Part 3: Registered Pharmacies: Standards in retail pharmacies
  10. 7Standards: general
  11. 8The Inspectorate
  12. 9Inspection and enforcement
  13. 10Power of entry
  14. 11Powers of an inspector
  15. 12Obstruction: offences
  16. 13Improvement notices
  17. 14Non-compliance with improvement notices
  18. 15Offences committed by partnerships
  19. 16Appeals against improvement notices
  20. 17Powers of a court on appeal
  21. Part 4: Registration
  22. 18The Registrar
  23. 19Establishment, maintenance of and access to the Register
  24. 20Entitlement to entry in Part 1 or 2 of the Register: pharmacists and pharmacy technicians
  25. 20AArticle 20: further provision relating to specified state professionals
  26. 21Pre-entry requirements in respect of qualifications and additional education, training or experience: pharmacists
  27. 21AEuropean qualifications: pharmacists
  28. 22Pre-entry requirements in respect of qualifications and additional education, training or experience: pharmacy technicians
  29. 23Form, manner and content of applications for entry or for renewal of an entry in the Register: pharmacists and pharmacy technicians
  30. 23ASupplementary provisions as to necessary knowledge of English
  31. 24Notification by the Registrar: entry and renewal
  32. 25Duration of entry
  33. 26Notice of entry in the Register
  34. 27Specialisations: registrants and registered pharmacies
  35. 28Registrants’ duties with regard to their entries
  36. 29Corrections to the Register
  37. 30Fitness to practise matters before entry or renewal of an entry
  38. 31Voluntary removal from the Register
  39. 32Indemnity arrangements
  40. 33Visiting pharmacists and pharmacy technicians from relevant European States Repealed
  41. 33AEuropean professional card Repealed
  42. 34Temporary entry with regard to emergencies involving loss of human life or human illness etc.
  43. 35Temporary annotations with regard to emergencies involving loss of human life or human illness etc.
  44. 36Fees in connection with entry
  45. 36AAdditional requirements for specified state professionals
  46. 37Restoration to the Register of persons or premises removed from the Register
  47. 38Offences relating to the Register
  48. 39Appealable decisions
  49. 40Appeals to the Appeals Committee
  50. 41Appeals from the Appeals Committee
  51. Part 5: Education, training and acquisition of experience and continuing professional development
  52. 42Education, training and acquisition of experience
  53. 42AProfessional traineeships carried out in other relevant European States, etc. Repealed
  54. 43Continuing professional development
  55. 44Specific obligations and powers of the Council in respect of education and training
  56. 45Visitors
  57. 46Information to be given by institutions or other providers
  58. 47Refusal or withdrawal of approval of courses, qualifications and institutions
  59. Part 6: Fitness to practise
  60. 48Standards of conduct and performance
  61. 48AInformation for specified state professionals
  62. 49Disclosure of information: general
  63. 50Disclosure of fitness to practise matters in the public interest
  64. 51Impairment of fitness to practise
  65. 52Initial action in respect of allegations
  66. 53Consideration by the Investigating Committee
  67. 54Consideration by the Fitness to Practise Committee
  68. 55Professional performance assessments
  69. 55AKnowledge of English assessments
  70. 56Interim orders
  71. 57Restoration of names to the Register: fitness to practise
  72. 58Appeals against appealable fitness to practise decisions
  73. 59The taking effect of directions in respect of appealable fitness to practise decisions
  74. 60Interim measures pending a direction taking effect
  75. Part 7: Proceedings
  76. 61Rules in respect of proceedings
  77. 62Procedure for the Fitness to Practise Committee and the Appeals Committee
  78. 63Legal advisers
  79. 64Clinical and other specialist advisers
  80. Part 8: Miscellaneous
  81. 65General fees
  82. 66Rules
  83. 67The Directive: designation of competent authority etc. Repealed
  84. 68Amendments, repeals and revocations
  85. 69Transitional, transitory and saving provisions
  86. 70Privy Council procedures etc.
  87. 71Review Repealed
  88. Signature
  89. Schedule 1: Constitution of the General Pharmaceutical Council
  90. 1Membership: general
  91. 2Matters for the order of the Privy Council under article 4(2)
  92. 3Powers of the Council
  93. 4Registration of members’ private interests
  94. 5The statutory committees
  95. 6The Council’s duties in respect of publications
  96. 7Accounts
  97. 8Annual reports, statistical information and strategic plans
  98. Schedule 2: Visiting Practitioners from relevant European States Repealed
  99. Part 1: Pharmacists Repealed
  100. 1Application and interpretation Repealed
  101. 2Registration in respect of provision of occasional pharmacy services Repealed
  102. 3Entitlement to provide occasional pharmacy services: first year Repealed
  103. 4First provision of services: required documents Repealed
  104. 4AFirst provision of services: visiting practitioners from Northern Ireland Repealed
  105. 5First provision of services: supplementary Repealed
  106. 6Entitlement to provide occasional pharmacy services after the first year: renewals Repealed
  107. 7Duration of entitlement to provide occasional pharmacy services Repealed
  108. 8Conditions Repealed
  109. Part 2: Pharmacy technicians Repealed
  110. 9Application and interpretation Repealed
  111. 10Registration in respect of the provision of occasional services Repealed
  112. 11Entitlement to provide occasional pharmacy services: first year Repealed
  113. 12First provision of services: required documents Repealed
  114. 13First provision of services: supplementary Repealed
  115. 14Entitlement to provide occasional pharmacy services after the first year: renewals Repealed
  116. 15Duration of entitlement to provide occasional pharmacy services Repealed
  117. 16Conditions Repealed
  118. Schedule 2A: Directive 2005/36/EC: European professional card Repealed
  119. Part 1: General Repealed
  120. 1Introductory Repealed
  121. 2Interpretation Repealed
  122. Part 2: General functions of the Council in relation to European professional cards Repealed
  123. 3Council not to request resubmission of valid documents Repealed
  124. 4Power to revoke a European professional card Repealed
  125. 5Rectification of the European professional card or the IMI file Repealed
  126. 6Duty to give reasons and to notify of right of appeal Repealed
  127. 7Updating the IMI file: disciplinary action or criminal sanctions Repealed
  128. 8Access to data Repealed
  129. 9Processing data Repealed
  130. Part 3: European professional cards for establishment in the United Kingdom or another relevant European State Repealed
  131. 10European professional cards for establishment in a host State other than the United Kingdom Repealed
  132. 11Issue of European professional card for establishment in Great Britain Repealed
  133. Part 4: European professional cards for the provision of occasional pharmacy services in a relevant European State other than the United Kingdom Repealed
  134. 12Issue of European professional card for the provision of occasional pharmacy services in a host State other than the United Kingdom Repealed
  135. 13Variation of a European professional card for the provision of occasional pharmacy services in a host State other than the United Kingdom Repealed
  136. Part 5: European professional card: requirements and entitlements as to registration Repealed
  137. 14Requirement to register: establishment cases Repealed
  138. 15Entitlement to registration: provision of occasional pharmacy services Repealed
  139. Part 6: Conditions in relation to fitness to practise Repealed
  140. 16Conditions in relation to fitness to practise: providers of occasional pharmacy services Repealed
  141. Schedule 3The Directive: Designation of competent authority etc. Repealed
  142. Schedule 4: Amendments, repeals and revocations
  143. Part 1: Primary legislation
  144. 1Amendment of the Medicines Act 1968
  145. 2Amendment of the Poisons Act 1972
  146. 3Amendment of the Race Relations Act 1976
  147. 4Amendment of the National Health Service (Scotland) Act 1978
  148. 5Amendment of the Value Added Tax Act 1994
  149. 6Amendment of the Data Protection Act 1998
  150. 7Amendment of the Health Act 1999
  151. 8Amendment of the Regulation of Investigatory Powers Act 2000
  152. 9Amendment of the Freedom of Information Act 2000
  153. 10Amendment of the National Health Service Reform and Health Care Professions Act 2002
  154. 11Amendment of the Income Tax (Earnings and Pensions) Act 2003
  155. 12Amendment of the Health Act 2006
  156. 13Amendment of the National Health Service Act 2006
  157. 14Amendment of the National Health Service (Wales) Act 2006
  158. 15Amendment of the Safeguarding Vulnerable Groups Act 2006
  159. 16Amendment of the Protection of Vulnerable Groups (Scotland) Act 2007
  160. Part 2: Secondary legislation
  161. 17Amendment of the Medicines (Pharmacies) (Applications for Registration and Fees) Regulations 1973
  162. 18Amendment of the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975
  163. 19Amendment of the Medicines (Bal Jivan Chamcho Prohibition) (No 2) Order 1977
  164. 20Amendment of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980
  165. 21Amendment of the Medicines (Pharmacy and General Sale – Exemption) Order 1980
  166. 22Amendment of the Employment Agencies Act 1973 (Exemption) (No 2) Regulations 1984
  167. 23Amendment of the Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989
  168. 24Amendment of the National Health Service (Pharmaceutical Services) Regulations 1992
  169. 25Amendment of the National Health Service (Service Committees and Tribunal) Regulations 1992 Repealed
  170. 26Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
  171. 27Amendment of the Prescription Only Medicines (Human Use) Order 1997
  172. 28Amendment of the Building Societies (Business Names) Regulations 1998
  173. 29Amendment of the Feeding Stuffs (Enforcement) Regulations 1999
  174. 30Amendment of the National Health Service (Charges for Drugs and Appliances) Regulations 2000
  175. 31Amendment of the Representation of the People (England and Wales) Regulations 2001
  176. 32Amendment of the Representation of the People (Scotland) Regulations 2001
  177. 33Amendment of the Family Health Services Appeal Authority (Procedure) Rules 2001
  178. 34Amendment of the Misuse of Drugs Regulations 2001
  179. 35Amendment of the Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002
  180. 36Amendment of the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002
  181. 37Amendment of the Rehabilitation of Offenders Act 1974 (Exclusions and Exceptions) (Scotland) Order 2003 Repealed
  182. 38Amendment of the Medicines (Child Safety) Regulations 2003
  183. 39Amendment of the National Health Service (Tribunal) (Scotland) Regulations 2004
  184. 40Amendment of the National Health Service (General Medical Services Contracts) Regulations 2004 Repealed
  185. 41Amendment of the National Health Service (General Medical Services Contracts) (Wales) Regulations 2004
  186. 42Amendment of the National Health Service (Personal Medical Services Agreements) Regulations 2004 Repealed
  187. 43Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
  188. 44Amendment of the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004
  189. 45Amendment of the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004
  190. 46Amendment of the Regulation of Care (Social Service Workers) (Scotland) Order 2005
  191. 47Amendment of the National Health Service (Pharmaceutical Services) Regulations 2005 Repealed
  192. 48Amendment of the Medicines for Human Use (Prescribing) Order 2005
  193. 49Amendment of the Gender Recognition (Disclosure of Information) (England, Wales and Northern Ireland) (No. 2) Order 2005
  194. 50Amendment of the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005
  195. 51Amendment of the Gender Recognition (Disclosure of Information) (Scotland) Order 2005
  196. 52Amendment of the National Health Service (Discipline Committees) (Scotland) Regulations 2006
  197. 53Amendment of the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 Repealed
  198. 54Amendment of the Controlled Drugs (Supervision of Management and Use) Regulations 2006
  199. 55Amendment of the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007
  200. 56Diwygio Rheoliadau’r Gwasanaeth Iechyd Gwladol (Presgripsiynau am Ddim a Ffioedd am Gyffuriau a Chyfarpar) (Cymru) 2007
  201. 57Amendment of the National Assembly for Wales (Representation of the People) Order 2007
  202. 58Revocation of the Pharmacists and Pharmacy Technicians Order 2007
  203. 59Amendment of the Licensing (Relevant Offences) (Scotland) Regulations 2007
  204. 60Amendment of the Regulation of Investigatory Powers (Authorisations Extending to Scotland) Order 2007
  205. 61Amendment of the Scottish Parliament (Elections etc.) Order 2007
  206. 62Amendment of the European Communities (Recognition of Professional Qualifications) Regulations 2007
  207. 63Amendment of the National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2008
  208. 64Amendment of the Controlled Drugs (Drug Precursors) (Intra-Community Trade) Regulations 2008
  209. 65Amendment of the Cosmetic Products (Safety) Regulations 2008 Repealed
  210. 66Amendment of the Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 Repealed
  211. 67Amendment of the Council for Healthcare Regulatory Excellence (Appointment, Procedure etc.) Regulations 2008
  212. 68Amendment of the Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008
  213. 69Diwygio Rheoliadau Cyffuriau a Reolir (Goruchwylio Rheolaeth a Defnydd) (Cymru) 2008
  214. 70Amendment of the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009
  215. 71Amendment of the Veterinary Medicines Regulations 2009 Repealed
  216. Schedule 5: Transitional Provisions
  217. 1Interpretation
  218. 2Members of committees
  219. 3Transfer of information to the Register
  220. 4The register
  221. 5Appealable registration decisions
  222. 6Appealable registration decisions
  223. 7Transitional arrangements: pharmacy technicians
  224. 8Offences relating to the Register: pharmacy technicians
  225. 9Education and training
  226. 10Premises
  227. 11Fees
  228. 12Fitness to practise proceedings
  229. 13Fitness to practise proceedings
  230. 14Proceedings under section 80 of the 1968 Act
  231. 15Supply of information
  232. 16Application of TUPE
  233. 17Transfer of property, rights and liabilities
  234. 18Grants and loans
  235. 19Cancellation of elections to, and transitional measures relating to, the Council of the Society
  236. Schedule 6: Savings
  237. Part 1: Primary legislation
  238. 1Medicines Act 1968
  239. 2Income Tax (Earnings and Pensions) Act 2003
  240. Part 2: Secondary legislation
  241. 3Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975
  242. 4National Health Service (Pharmaceutical Services) Regulations 1992
  243. 5Rehabilitation of Offenders Act 1974 (Exclusions and Exceptions) (Scotland) Order 2003
  244. 6National Health Service (Pharmaceutical Services) Regulations 2005 Repealed
  245. Explanatory note