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The Pharmacy Order 2010

Draft. This instrument was laid in draft and may differ from the one made. Look for the made version under its title.

Draft 2010, ISBN 9780111487358

Original text. legislation.gov.uk does not revise statutory instruments, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Draft Order laid before Parliament and the Scottish Parliament under section 62(10) of the Health Act 1999, for approval by resolution of each House of Parliament and of the Scottish Parliament.

Health Care And Associated Professions

Pharmacy

Made 000

Coming into force 000

At the Court at Buckingham Palace, the 000 day of 000

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