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The Blood Safety and Quality Regulations 2005

S.I. 2005/50 · Made 13 January 2005 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 16 July 2025.

HEALTH AND SAFETY

Made 13th January 2005

Laid before Parliament 18th January 2005

Coming into force

For all purposes other than regulation 25(1) 8th February 2005

For the purposes of regulation 25(1) 8th November 2005

The Secretary of State for Health, being a Minister designated M1 for the purposes of section 2(2) of the European Communities Act 1972 M2 in relation to health protection measures regulating the use of material of human origin, in exercise of the powers conferred on him by the said section 2(2) and, with the consent of the Treasury, of the powers conferred by section 56(1) and (2) of the Finance Act 1973 M3, hereby makes the following Regulations:—

Annotations to the whole text

Marginal citations

M1

S.I. 2004/3037.

M2

1972 c. 68. Under section 57(1) of the Scotland Act 1998 (c. 46), despite the transfer to Scottish Ministers of functions in relation to implementing obligations under Community law in relation to devolved matters, the functions of the Secretary of State in relation to implementing these obligations continues to be exercisable by him as regards Scotland.

M3

1973 c. 51.

Contents

  1. 1Citation, commencement and interpretation
  2. 1AModification of provisions of the Annex to Commission Directive 2005/62/EC
  3. 1BReferences to the requirements set out in the Annex to Commission Directive 2005/62/EC
  4. 2Designation of the competent authority for Northern Ireland and scope of the Regulations
  5. 3Requirement for authorisation
  6. 4Authorisation of a blood establishment
  7. 5Suspension or revocation of authorisation
  8. 6The responsible person for a blood establishment
  9. 7Blood establishment requirements
  10. 8Labelling of blood and blood components and traceability
  11. 9Hospital blood bank requirements
  12. 10Requirement for hospital blood banks to provide information to the Secretary of State
  13. 11Service of notices relating to hospital blood banks
  14. 12Objections to suspensions, revocations etc
  15. 12ARequirement that facilities retain certain data
  16. 12BRequirement to report serious adverse reactions and events
  17. 13Import of blood and blood components into Great Britain
  18. 13AImport of blood and blood components into Northern Ireland
  19. 14Disclosure of information by blood establishments and hospital blood banks
  20. 15Inspections, etc.
  21. 16Records to be kept by the Secretary of State
  22. 16ARequirement that the Secretary of State communicate certain information in respect of Northern Ireland to other competent authorities
  23. 17Powers of entry, etc.
  24. 18Criminal offences
  25. 19Penalties
  26. 20Defence of due diligence
  27. 21Offences by bodies corporate and Scottish partnerships
  28. 22Fees
  29. 23Specific epidemiological situations in relation to Great Britain
  30. 23ZASpecific epidemiological situations in relation to Northern Ireland
  31. 23ARegulations relating to the quality and safety of blood and blood components
  32. 23BScope and nature of powers
  33. 23CScrutiny of regulations made by the Secretary of State
  34. 23DScrutiny of regulations made by the Welsh Ministers
  35. 23EScrutiny of regulations made by the Scottish Ministers
  36. 24Transitional provisions
  37. 25Consequential amendments
  38. Signature
  39. Schedule
  40. Part 1
  41. Definitions
  42. 1Paragraph 1
  43. 2Paragraph 2
  44. 3Paragraph 3
  45. 4Paragraph 4
  46. 5Paragraph 5
  47. 6Paragraph 6
  48. 7Paragraph 7
  49. 8Paragraph 8
  50. 9Paragraph 9
  51. 10Paragraph 10
  52. 11Paragraph 11
  53. 12Paragraph 12
  54. 13Paragraph 13
  55. 14Paragraph 14
  56. 15Paragraph 15
  57. 16Paragraph 16
  58. 17Paragraph 17
  59. 18Paragraph 18
  60. 19Paragraph 19
  61. 20Paragraph 20
  62. 21Paragraph 21
  63. 22Paragraph 22
  64. 23Paragraph 23
  65. 24Paragraph 24
  66. 25Paragraph 25
  67. 26Paragraph 26
  68. 27Paragraph 27
  69. Part 2: INFORMATION REQUIREMENTS FOR DONORS
  70. Part A – Information to be provided to prospective donors of blood or blood components Repealed
  71. 1Paragraph 1
  72. 2Paragraph 2
  73. 3Paragraph 3
  74. 4Paragraph 4
  75. 5Paragraph 5
  76. 6Paragraph 6
  77. 7Paragraph 7
  78. 8Paragraph 8
  79. 9Paragraph 9
  80. 10Paragraph 10
  81. 11Paragraph 11
  82. 12Paragraph 12
  83. 13Paragraph 13
  84. Part B – Information to be obtained from donors by blood establishments at every donation Repealed
  85. 14Identification of the donor
  86. 15Health and medical history of the donor
  87. 16Signature of the donor
  88. Part 3: ELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS
  89. 1Acceptance criteria for donors of whole blood and blood components
  90. 1.1Paragraph 1.1
  91. 1.2Paragraph 1.2
  92. 1.3Paragraph 1.3
  93. 1.4Paragraph 1.4
  94. 2.1Deferral criteria for donors of whole blood and blood components
  95. 2.2Paragraph 2.2
  96. 2.2.1Paragraph 2.2.1
  97. Duration of deferral period
  98. Paragraph
  99. 2.2.2Paragraph 2.2.2
  100. 2.2.3Paragraph 2.2.3
  101. 2.2.4Paragraph 2.2.4
  102. 2.3Paragraph 2.3
  103. 2.4Paragraph 2.4
  104. Part 4: STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS
  105. 1Paragraph 1
  106. 1.1Paragraph 1.1
  107. 1.2Paragraph 1.2
  108. 2TRANSPORT AND DISTRIBUTION
  109. 3ADDITIONAL REQUIREMENTS FOR AUTOLOGOUS DONATIONS Repealed
  110. 3.1Paragraph 3.1
  111. 3.2Paragraph 3.2
  112. Part 5: QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS
  113. 1Paragraph 1
  114. 2Paragraph 2
  115. 2.1Paragraph 2.1
  116. 2.2Paragraph 2.2
  117. 2.3Paragraph 2.3
  118. Part 6: RECORD OF DATA ON TRACEABILITY
  120. 1Paragraph 1
  121. 2Paragraph 2
  122. 3Paragraph 3
  123. 4Paragraph 4
  124. 5Paragraph 5
  125. 6Paragraph 6
  127. 1Paragraph 1
  128. 2Paragraph 2
  129. 3Paragraph 3
  130. 4Paragraph 4
  131. 5Paragraph 5
  132. 6Paragraph 6
  133. Part 7: NOTIFICATION OF SERIOUS ADVERSE REACTIONS
  134. SECTION ARapid notification format for suspected serious adverse reactions
  135. SECTION BSerious adverse reactions – imputability levels
  136. SECTION CConfirmation format for serious adverse reactions
  137. SECTION DAnnual notification format for serious adverse reactions
  138. Part 8: NOTIFICATION OF SERIOUS ADVERSE EVENTS
  139. SECTION ARapid Notification Format for Serious Adverse Events
  140. SECTION BConfirmation Format for Serious Adverse Events
  141. SECTION CAnnual Notification Format for Serious Adverse Events
  142. Explanatory note