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The Human Tissue (Quality and Safety for Human Application) Regulations 2007

S.I. 2007/1523 · Made 24 May 2007 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 21 March 2024.

human tissue

Made 24th May 2007

Coming into force

for the purposes of regulation 1(3) 25th May 2007

for all other purposes 5th July 2007

The Secretary of State is a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 M1 in relation to health protection measures regulating the use of material of human origin M2;

A draft of this instrument was laid before Parliament in accordance with paragraph 2(2) of Schedule 2 to that Act and approved by a resolution of each House of Parliament;

Accordingly the Secretary of State, in exercise of the powers conferred by section 2(2) of that Act, makes the following Regulations:—

Annotations to the whole text

Marginal citations

M1

1972 c.68.

M2

SI 2004/3037. In relation to measures in these Regulations relating to health protection measures regulating the use of material of human origin, the power of the Secretary of State under section 2(2) of the European Communities Act 1972 is exercisable in relation to Scotland by virtue of section 57(1) of the Scotland Act 1998 (c.46).

Contents

  1. Part 1: CITATION, COMMENCEMENT, EXTENT AND INTERPRETATION
  2. 1Citation and commencement
  3. 2Extent and application
  4. 3Designation of the competent authority
  5. 4References to Directives
  6. 4AModifications to the first, second, third and fourth Directives: general
  7. 4BModifications to the first Directive
  8. 4CModifications to the second Directive
  9. 4DModifications to the third Directive
  10. 4EModifications to the fourth Directive
  11. 5Interpretation of other terms
  12. 6References to third party agreements etc
  13. Part 2: LICENSING OF ACTIVITIES RELATING TO THE USE OF TISSUE FOR HUMAN APPLICATION
  14. 7Licensing requirement
  15. 7AImport into Northern Ireland from the EEA
  16. 8Application of the 2004 Act in relation to licences under Schedule 1
  17. 9Extension of other provisions of the 2004 Act to Scotland
  18. 10Breach of requirement to hold a licence or to act under a third party agreement
  19. 11Preconditions to grant of licence
  20. 12Duty of designated individual
  21. 13Information and confidentiality
  22. 14Breach of confidentiality requirement
  23. Part 3: REGULATION OF LICENSED ACTIVITIES
  24. 15Import and export of tissue and cells Repealed
  25. 16Directions: Great Britain
  26. 16ADirections: compliance with first, second, third and fourth Directives as they apply in relation to Northern Ireland
  27. Part 4: OBLIGATIONS OF THE AUTHORITY
  28. 17Requirement for the Authority to provide information
  29. 18Register of licences
  30. 19Register of serious adverse events and serious adverse reactions
  31. 20Duties of the Authority in relation to serious adverse events and serious adverse reactions
  32. 20ADuties of the Authority in relation to application of the Single European Code in relation to Northern Ireland
  33. 20BInspection of third country premises etc , Northern Ireland
  34. 20CThird country premises and third country suppliers: report of inspections etc , Northern Ireland
  35. Part 5: INSPECTION, ENTRY, SEARCH AND SEIZURE
  36. 21Inspection of documents
  37. 21AInspection of documents to be held by an importing licence holder , Northern Ireland
  38. 22Entry and inspection of premises
  39. 22AImporting licence holders: requests for inspections , Northern Ireland
  40. 23Entry and search in connection with suspected offence
  41. 24Execution of warrants
  42. 25Seizure in the course of inspection or search
  43. 26Powers: supplementary
  44. 27Requirements when exercising power of inspection or search
  45. 28Enforcement
  46. 29Meaning of duly authorised person
  47. Part 6: AMENDMENTS TO THE 2004 ACT
  48. 30Remit of the Authority
  49. 31Exclusion from licensing requirement of section 16
  50. 32Interpretation of Part 2 of the 2004 Act
  51. 33Applications under Schedule 3 to the 2004 Act
  52. Part 7: GENERAL
  53. 34ZAPowers to make regulations in relation to standards of quality and safety, Great Britain
  54. 34ZBScope and nature of powers
  55. 34ZCScrutiny of regulations
  56. 34Offences by bodies corporate
  57. 35Transitional arrangements: storage licences
  58. Signature
  59. Schedule 1: Licences for the purposes of regulation 7
  60. Part: Power to grant licence
  61. 1Paragraph 1
  62. Part: Characteristics of licences
  63. 2Paragraph 2
  64. 3Paragraph 3
  65. 4Paragraph 4
  66. 5Paragraph 5
  67. 5AParagraph 5A
  68. Part: Fees
  69. 6Paragraph 6
  70. Schedule 2: Directions for securing compliance with the first, second, third and fourth Directives
  71. Part: Traceability and coding system
  72. 1Paragraph 1
  73. 1ZAParagraph 1ZA
  74. 1AParagraph 1A
  75. 2Paragraph 2
  76. Part: Reporting obligations
  77. 3Paragraph 3
  78. Part: Serious adverse events and serious adverse reactions
  79. 4Paragraph 4
  80. 4ZAParagraph 4ZA
  81. 4AParagraph 4A
  82. Part: Third party agreements and termination of licensed activities
  83. 5Paragraph 5
  84. Part: Procurement and use of tissue or cells
  85. 6Paragraph 6
  86. 7Paragraph 7
  87. 7AParagraph 7A
  88. 8Paragraph 8
  89. Part: Selection criteria and laboratory tests required for donors of tissues and cells
  90. 9Paragraph 9
  91. 10Paragraph 10
  92. 11Paragraph 11
  93. Part: Donation and procurement procedures and reception at the tissue establishment
  94. 12Paragraph 12
  95. Part: Requirements for holding a licence under Schedule 1
  96. 13Paragraph 13
  97. Part: Requirements for holding a licence under Schedule 1 for tissue and cell preparation processes
  98. 14Paragraph 14
  99. 15Updated information
  100. 16Written agreements
  101. Schedule 3: Appropriate statements
  102. Paragraph
  103. Explanatory note