{
  "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007",
  "json_url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007.json",
  "id": "ukdsi/2007/9780110768342",
  "title": "The Human Tissue (Quality and Safety for Human Application) Regulations 2007",
  "short_title": "Human Tissue (Quality and Safety for Human Application) 2007",
  "long_title": "These Regulations implement in part Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, as well as Commission Directive 2006/17/EC and Commission Directive 2006/86/EC laying down technical requirements in relation to Directive 2004/23/EC (“the Directives”). These Regulations impose safety and quality requirements in relation to human tissue and cells intended for human application, including stem cells and cell lines grown outside the body. These Regulations do not apply to reproductive cells, embryos outside the human body, organs and blood.",
  "citation": "Draft 2007, ISBN 9780110768342",
  "type": "ukdsi",
  "year": "2007",
  "number": "9780110768342",
  "version": "current",
  "date": null,
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/introduction",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "part/1",
      "kind": "part",
      "number": "1",
      "heading": "CITATION, COMMENCEMENT, EXTENT AND INTERPRETATION",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/1",
      "kind": "regulation",
      "number": "1",
      "heading": "Citation and commencement",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-1",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/2",
      "kind": "regulation",
      "number": "2",
      "heading": "Extent and application",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-2",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/3",
      "kind": "regulation",
      "number": "3",
      "heading": "Designation of the competent authority",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-3",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/4",
      "kind": "regulation",
      "number": "4",
      "heading": "References to Directives",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-4",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/5",
      "kind": "regulation",
      "number": "5",
      "heading": "Interpretation of other terms",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-5",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/6",
      "kind": "regulation",
      "number": "6",
      "heading": "References to third party agreements etc",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-6",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "part/2",
      "kind": "part",
      "number": "2",
      "heading": "LICENSING OF ACTIVITIES RELATING TO THE USE OF TISSUE FOR HUMAN APPLICATION",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/7",
      "kind": "regulation",
      "number": "7",
      "heading": "Licensing requirement",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-7",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/8",
      "kind": "regulation",
      "number": "8",
      "heading": "Application of the 2004 Act in relation to licences under Schedule 1",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-8",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/9",
      "kind": "regulation",
      "number": "9",
      "heading": "Extension of other provisions of the 2004 Act to Scotland",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-9",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/10",
      "kind": "regulation",
      "number": "10",
      "heading": "Breach of requirement to hold a licence or to act under a third party agreement",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-10",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/11",
      "kind": "regulation",
      "number": "11",
      "heading": "Preconditions to grant of licence",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-11",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/12",
      "kind": "regulation",
      "number": "12",
      "heading": "Duty of designated individual",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-12",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/13",
      "kind": "regulation",
      "number": "13",
      "heading": "Information and confidentiality",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-13",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/14",
      "kind": "regulation",
      "number": "14",
      "heading": "Breach of confidentiality requirement",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-14",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "part/3",
      "kind": "part",
      "number": "3",
      "heading": "REGULATION OF LICENSED ACTIVITIES",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/15",
      "kind": "regulation",
      "number": "15",
      "heading": "Import and export of tissue and cells",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-15",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/16",
      "kind": "regulation",
      "number": "16",
      "heading": "Directions: compliance with the first, second and third Directives",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-16",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "part/4",
      "kind": "part",
      "number": "4",
      "heading": "OBLIGATIONS OF THE AUTHORITY",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/17",
      "kind": "regulation",
      "number": "17",
      "heading": "Requirement for the Authority to provide information",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-17",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/18",
      "kind": "regulation",
      "number": "18",
      "heading": "Register of licences",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-18",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/19",
      "kind": "regulation",
      "number": "19",
      "heading": "Register of serious adverse events and serious adverse reactions",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-19",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/20",
      "kind": "regulation",
      "number": "20",
      "heading": "Duties of the Authority in relation to serious adverse events and serious adverse reactions",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-20",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "part/5",
      "kind": "part",
      "number": "5",
      "heading": "INSPECTION, ENTRY, SEARCH AND SEIZURE",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/21",
      "kind": "regulation",
      "number": "21",
      "heading": "Inspection of documents",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-21",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/22",
      "kind": "regulation",
      "number": "22",
      "heading": "Entry and inspection of premises",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-22",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/23",
      "kind": "regulation",
      "number": "23",
      "heading": "Entry and search in connection with suspected offence",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-23",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/24",
      "kind": "regulation",
      "number": "24",
      "heading": "Execution of warrants",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-24",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/25",
      "kind": "regulation",
      "number": "25",
      "heading": "Seizure in the course of inspection or search",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-25",
      "extent": null,
      "status": null,
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    },
    {
      "path": "regulation/26",
      "kind": "regulation",
      "number": "26",
      "heading": "Powers: supplementary",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-26",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/27",
      "kind": "regulation",
      "number": "27",
      "heading": "Requirements when exercising power of inspection or search",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-27",
      "extent": null,
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    },
    {
      "path": "regulation/28",
      "kind": "regulation",
      "number": "28",
      "heading": "Enforcement",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-28",
      "extent": null,
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    },
    {
      "path": "regulation/29",
      "kind": "regulation",
      "number": "29",
      "heading": "Meaning of duly authorised person",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-29",
      "extent": null,
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    },
    {
      "path": "part/6",
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      "number": "6",
      "heading": "AMENDMENTS TO THE 2004 ACT",
      "url": null,
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    },
    {
      "path": "regulation/30",
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      "number": "30",
      "heading": "Remit of the Authority",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-30",
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    },
    {
      "path": "regulation/31",
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      "number": "31",
      "heading": "Exclusion from licensing requirement of section 16",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-31",
      "extent": null,
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    },
    {
      "path": "regulation/32",
      "kind": "regulation",
      "number": "32",
      "heading": "Interpretation of Part 2 of the 2004 Act",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-32",
      "extent": null,
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    },
    {
      "path": "regulation/33",
      "kind": "regulation",
      "number": "33",
      "heading": "Applications under Schedule 3 to the 2004 Act",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-33",
      "extent": null,
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    },
    {
      "path": "part/7",
      "kind": "part",
      "number": "7",
      "heading": "GENERAL",
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    },
    {
      "path": "regulation/34",
      "kind": "regulation",
      "number": "34",
      "heading": "Offences by bodies corporate",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-34",
      "extent": null,
      "status": null,
      "parent": "part/7"
    },
    {
      "path": "regulation/35",
      "kind": "regulation",
      "number": "35",
      "heading": "Transitional arrangements: storage licences",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-35",
      "extent": null,
      "status": null,
      "parent": "part/7"
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/signature",
      "extent": null,
      "status": null,
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    },
    {
      "path": "schedule/1",
      "kind": "schedule",
      "number": "1",
      "heading": "Licences for the purposes of regulation 7",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/1/crossheading/power-to-grant-licence",
      "kind": "crossheading",
      "number": null,
      "heading": "Power to grant licence",
      "url": null,
      "extent": null,
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      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/1",
      "kind": "paragraph",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/schedule-1/paragraph-1",
      "extent": null,
      "status": null,
      "parent": "schedule/1/crossheading/power-to-grant-licence"
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    {
      "path": "schedule/1/crossheading/characteristics-of-licences",
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      "number": null,
      "heading": "Characteristics of licences",
      "url": null,
      "extent": null,
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      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/schedule-1/paragraph-2",
      "extent": null,
      "status": null,
      "parent": "schedule/1/crossheading/characteristics-of-licences"
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    {
      "path": "schedule/1/paragraph/3",
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      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/schedule-1/paragraph-3",
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      "parent": "schedule/1/crossheading/characteristics-of-licences"
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    {
      "path": "schedule/1/paragraph/4",
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    {
      "path": "schedule/1/paragraph/5",
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    {
      "path": "schedule/1/crossheading/fees",
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    },
    {
      "path": "schedule/1/paragraph/6",
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    {
      "path": "schedule/2/crossheading/traceability-and-coding-system",
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      "number": null,
      "heading": "Traceability and coding system",
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    },
    {
      "path": "schedule/2/paragraph/1",
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    {
      "path": "schedule/2/paragraph/2",
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    {
      "path": "schedule/2/crossheading/reporting-obligations",
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      "heading": "Reporting obligations",
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    },
    {
      "path": "schedule/2/paragraph/3",
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    {
      "path": "schedule/2/crossheading/serious-adverse-events-and-serious-adverse-reactions",
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      "heading": "Serious adverse events and serious adverse reactions",
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    },
    {
      "path": "schedule/2/paragraph/4",
      "kind": "paragraph",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/schedule-2/paragraph-4",
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      "status": null,
      "parent": "schedule/2/crossheading/serious-adverse-events-and-serious-adverse-reactions"
    },
    {
      "path": "schedule/2/crossheading/third-party-agreements-and-termination-of-licensed-activities",
      "kind": "crossheading",
      "number": null,
      "heading": "Third party agreements and termination of licensed activities",
      "url": null,
      "extent": null,
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      "parent": "schedule/2"
    },
    {
      "path": "schedule/2/paragraph/5",
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      "parent": "schedule/2/crossheading/third-party-agreements-and-termination-of-licensed-activities"
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    {
      "path": "schedule/2/crossheading/procurement-and-use-of-tissue-or-cells",
      "kind": "crossheading",
      "number": null,
      "heading": "Procurement and use of tissue or cells",
      "url": null,
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      "parent": "schedule/2"
    },
    {
      "path": "schedule/2/paragraph/6",
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