{
  "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012",
  "json_url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012.json",
  "id": "uksi/2012/1501",
  "title": "The Quality and Safety of Organs Intended for Transplantation Regulations 2012",
  "short_title": "Quality and Safety of Organs Intended for Transplantation 2012",
  "long_title": "These Regulations implement Directive 2010/53/EC of the European Parliament and of the Council of 7th July 2010 on standards of quality and safety of human organs intended for transplantation (“the Directive”). These Regulations impose quality and safety requirements in relation to the procurement and transplantation of organs intended for transplantation.",
  "citation": "S.I. 2012/1501",
  "type": "uksi",
  "year": "2012",
  "number": "1501",
  "version": "current",
  "date": "2012-06-11",
  "revised": true,
  "valid_from": "2020-12-31",
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/introduction",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "part/1",
      "kind": "part",
      "number": "1",
      "heading": "Citation, commencement and extent",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/1",
      "kind": "regulation",
      "number": "1",
      "heading": "Citation and commencement",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-1",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/2",
      "kind": "regulation",
      "number": "2",
      "heading": "Extent",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-2",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "part/2",
      "kind": "part",
      "number": "2",
      "heading": "Interpretation and designation of the competent authority",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/3",
      "kind": "regulation",
      "number": "3",
      "heading": "Interpretation",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/4",
      "kind": "regulation",
      "number": "4",
      "heading": "Designation of the competent authority",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-4",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "part/3",
      "kind": "part",
      "number": "3",
      "heading": "Licensing",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/5",
      "kind": "regulation",
      "number": "5",
      "heading": "Licensing requirement",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-5",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/6",
      "kind": "regulation",
      "number": "6",
      "heading": "Application of the 2004 Act in relation to licences under Schedule 1",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/7",
      "kind": "regulation",
      "number": "7",
      "heading": "Extension of other provisions of the 2004 Act to Scotland",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-7",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/8",
      "kind": "regulation",
      "number": "8",
      "heading": "Breach of requirement to hold a licence",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-8",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/9",
      "kind": "regulation",
      "number": "9",
      "heading": "Preconditions to grant of a licence",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-9",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/10",
      "kind": "regulation",
      "number": "10",
      "heading": "Duty of the licence holder",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-10",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/11",
      "kind": "regulation",
      "number": "11",
      "heading": "Directions",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-11",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/12",
      "kind": "regulation",
      "number": "12",
      "heading": "Guidance",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "part/4",
      "kind": "part",
      "number": "4",
      "heading": "Other obligations of the Authority",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/13",
      "kind": "regulation",
      "number": "13",
      "heading": "Framework and compliance with licensing conditions and directions",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-13",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/14",
      "kind": "regulation",
      "number": "14",
      "heading": "Records and reports",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-14",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/15",
      "kind": "regulation",
      "number": "15",
      "heading": "Living donors",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-15",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/16",
      "kind": "regulation",
      "number": "16",
      "heading": "Serious adverse events and serious adverse reactions",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-16",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/17",
      "kind": "regulation",
      "number": "17",
      "heading": "Traceability",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-17",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/18",
      "kind": "regulation",
      "number": "18",
      "heading": "Organs sent to or received from another country",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-18",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/19",
      "kind": "regulation",
      "number": "19",
      "heading": "European Union network of competent authorities",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-19",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/20",
      "kind": "regulation",
      "number": "20",
      "heading": "Requirement for the Authority to provide information",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-20",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "part/5",
      "kind": "part",
      "number": "5",
      "heading": "General",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/21",
      "kind": "regulation",
      "number": "21",
      "heading": "Arrangements by the Authority for assistance with functions",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-21",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/22",
      "kind": "regulation",
      "number": "22",
      "heading": "Offences by bodies corporate",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-22",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/23",
      "kind": "regulation",
      "number": "23",
      "heading": "Licences: transitional arrangements",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-23",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/24",
      "kind": "regulation",
      "number": "24",
      "heading": "Review",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-24",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "part/5A",
      "kind": "part",
      "number": "5A",
      "heading": "Power to amend data sets specified in Schedule 1A in relation to Great Britain",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/24A",
      "kind": "regulation",
      "number": "24A",
      "heading": "Power for appropriate authority to amend Schedule 1A in relation to Great Britain",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-24A",
      "extent": null,
      "status": null,
      "parent": "part/5A"
    },
    {
      "path": "regulation/24B",
      "kind": "regulation",
      "number": "24B",
      "heading": "Scope and nature of powers",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-24B",
      "extent": null,
      "status": null,
      "parent": "part/5A"
    },
    {
      "path": "regulation/24C",
      "kind": "regulation",
      "number": "24C",
      "heading": "Scrutiny of regulations",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-24C",
      "extent": null,
      "status": null,
      "parent": "part/5A"
    },
    {
      "path": "part/6",
      "kind": "part",
      "number": "6",
      "heading": "Amendments to other legislation",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/25",
      "kind": "regulation",
      "number": "25",
      "heading": "Amendment of the 2004 Act",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-25",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/26",
      "kind": "regulation",
      "number": "26",
      "heading": "Amendment of the 2006 Regulations",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-26",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/27",
      "kind": "regulation",
      "number": "27",
      "heading": "Amendment of the Human Tissue Act 2006 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2004",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-27",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/28",
      "kind": "regulation",
      "number": "28",
      "heading": "Amendment of the 2007 Regulations",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-28",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/29",
      "kind": "regulation",
      "number": "29",
      "heading": "Amendment of the 2006 Scotland Regulations",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/regulation-29",
      "extent": "S",
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/signature",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/1",
      "kind": "schedule",
      "number": "1",
      "heading": "Licences for the purposes of regulation 5",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/1/paragraph/1",
      "kind": "paragraph",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-1/paragraph-1",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": "Licensing conditions",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-1/paragraph-2",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/3",
      "kind": "paragraph",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-1/paragraph-3",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/4",
      "kind": "paragraph",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-1/paragraph-4",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/5",
      "kind": "paragraph",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-1/paragraph-5",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/6",
      "kind": "paragraph",
      "number": "6",
      "heading": null,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-1/paragraph-6",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/7",
      "kind": "paragraph",
      "number": "7",
      "heading": null,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-1/paragraph-7",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/8",
      "kind": "paragraph",
      "number": "8",
      "heading": null,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-1/paragraph-8",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/9",
      "kind": "paragraph",
      "number": "9",
      "heading": null,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-1/paragraph-9",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/10",
      "kind": "paragraph",
      "number": "10",
      "heading": "Fees",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-1/paragraph-10",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1A",
      "kind": "schedule",
      "number": "1A",
      "heading": "Organ and Donor Characterisation",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/1A/part/A",
      "kind": "part",
      "number": "A",
      "heading": "Minimum data set",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/1A"
    },
    {
      "path": "schedule/1A/paragraph/1",
      "kind": "paragraph",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-1A/paragraph-1",
      "extent": null,
      "status": null,
      "parent": "schedule/1A/part/A"
    },
    {
      "path": "schedule/1A/part/B",
      "kind": "part",
      "number": "B",
      "heading": "Complementary data set",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/1A"
    },
    {
      "path": "schedule/1A/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-1A/paragraph-2",
      "extent": null,
      "status": null,
      "parent": "schedule/1A/part/B"
    },
    {
      "path": "schedule/2",
      "kind": "schedule",
      "number": "2",
      "heading": "Directions of the Authority",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/2/paragraph/1",
      "kind": "paragraph",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-2/paragraph-1",
      "extent": null,
      "status": null,
      "parent": "schedule/2"
    },
    {
      "path": "schedule/2/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-2/paragraph-2",
      "extent": null,
      "status": null,
      "parent": "schedule/2"
    },
    {
      "path": "schedule/2/paragraph/3",
      "kind": "paragraph",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/schedule-2/paragraph-3",
      "extent": null,
      "status": null,
      "parent": "schedule/2"
    },
    {
      "path": "note",
      "kind": "note",
      "number": null,
      "heading": "Explanatory note",
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/note",
      "extent": null,
      "status": null,
      "parent": null
    }
  ],
  "has_text": true,
  "pdfs": [
    {
      "title": "Printed copy",
      "main": true,
      "language": null,
      "date": "2012-06-14",
      "size": 105015,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/pdf/uksi_20121501_en.pdf",
      "source_url": "https://www.legislation.gov.uk/uksi/2012/1501/pdfs/uksi_20121501_en.pdf"
    },
    {
      "title": "Explanatory Memorandum",
      "main": false,
      "language": null,
      "date": "2012-06-14",
      "size": 218049,
      "url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/pdf/uksiem_20121501_en.pdf",
      "source_url": "https://www.legislation.gov.uk/uksi/2012/1501/pdfs/uksiem_20121501_en.pdf"
    }
  ],
  "outstanding_effects": [],
  "made_under": [],
  "changes_made_to": 62,
  "changes_made_to_url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/changes.json",
  "changes_made_by": 39,
  "changes_made_by_url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/changes/by-it.json",
  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/quality-and-safety-of-organs-intended-for-transplantation-regulations-2012/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1501",
    "retrieved_at": "2026-10-29T01:29:20.897638+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}