{
  "url": "https://openlegislation.uk/eu-directive-2015-566",
  "json_url": "https://openlegislation.uk/eu-directive-2015-566.json",
  "id": "eudr/2015/566",
  "title": "Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (Text with EEA relevance)",
  "short_title": "Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the…",
  "long_title": "Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (Text with EEA relevance)",
  "citation": "EU Directive 2015/566",
  "type": "eudr",
  "year": "2015",
  "number": "566",
  "version": "current",
  "date": "2015-04-08",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-directive-2015-566/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "chapter/I",
      "kind": "chapter",
      "number": "I",
      "heading": "GENERAL PROVISIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": "Scope",
      "url": "https://openlegislation.uk/eu-directive-2015-566/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Definitions",
      "url": "https://openlegislation.uk/eu-directive-2015-566/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "chapter/II",
      "kind": "chapter",
      "number": "II",
      "heading": "OBLIGATIONS ON MEMBER STATES' AUTHORITIES",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Accreditation, designation, authorisation or licensing of importing tissue establishments",
      "url": "https://openlegislation.uk/eu-directive-2015-566/article-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Inspections and other control measures",
      "url": "https://openlegislation.uk/eu-directive-2015-566/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "chapter/III",
      "kind": "chapter",
      "number": "III",
      "heading": "OBLIGATIONS ON IMPORTING TISSUE ESTABLISHMENTS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Applications for accreditation, designation, authorisation or licensing as an importing tissue establishment",
      "url": "https://openlegislation.uk/eu-directive-2015-566/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Updated information",
      "url": "https://openlegislation.uk/eu-directive-2015-566/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Written agreements",
      "url": "https://openlegislation.uk/eu-directive-2015-566/article-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Register of importing tissue establishments",
      "url": "https://openlegislation.uk/eu-directive-2015-566/article-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "chapter/IV",
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      "heading": "FINAL PROVISIONS",
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      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/9",
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      "number": "9",
      "heading": "Transposition",
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      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/10",
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      "number": "10",
      "heading": "Entry into force",
      "url": "https://openlegislation.uk/eu-directive-2015-566/article-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/11",
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      "number": "11",
      "heading": "Addresses",
      "url": "https://openlegislation.uk/eu-directive-2015-566/article-11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-directive-2015-566/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I",
      "kind": "annex",
      "number": "I",
      "heading": "Minimum requirements concerning the information and documentation to be provided by importing tissue establishment applicants when applying to be accredited, designated, authorised or licensed for the purpose of import activities",
      "url": "https://openlegislation.uk/eu-directive-2015-566/annex-I",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I/division/A",
      "kind": "division",
      "number": "A",
      "heading": "General Information on the Importing Tissue Establishment (ITE)",
      "url": "https://openlegislation.uk/eu-directive-2015-566/annex-I/division-A",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/B",
      "kind": "division",
      "number": "B",
      "heading": "Contact Details for the Application",
      "url": "https://openlegislation.uk/eu-directive-2015-566/annex-I/division-B",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/C",
      "kind": "division",
      "number": "C",
      "heading": "Details of Tissues and Cells to be Imported",
      "url": "https://openlegislation.uk/eu-directive-2015-566/annex-I/division-C",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/D",
      "kind": "division",
      "number": "D",
      "heading": "Location of Activities",
      "url": "https://openlegislation.uk/eu-directive-2015-566/annex-I/division-D",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/E",
      "kind": "division",
      "number": "E",
      "heading": "Details of Third Country Suppliers",
      "url": "https://openlegislation.uk/eu-directive-2015-566/annex-I/division-E",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/F",
      "kind": "division",
      "number": "F",
      "heading": "Documentation to Accompany the Application",
      "url": "https://openlegislation.uk/eu-directive-2015-566/annex-I/division-F",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/II",
      "kind": "annex",
      "number": "II",
      "heading": "Certificate of Accreditation, Designation, Authorisation or Licence to be issued by the competent authority or authorities to importing tissue establishments",
      "url": "https://openlegislation.uk/eu-directive-2015-566/annex-II",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/III",
      "kind": "annex",
      "number": "III",
      "heading": "Minimum requirements concerning the documentation to be made available to the competent authority or authorities by tissue establishments intending to import tissues and cells from third countries",
      "url": "https://openlegislation.uk/eu-directive-2015-566/annex-III",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/III/division/A",
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      "number": "A",
      "heading": "Documentation relating to the importing tissue establishment",
      "url": "https://openlegislation.uk/eu-directive-2015-566/annex-III/division-A",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III"
    },
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      "path": "annex/III/division/B",
      "kind": "division",
      "number": "B",
      "heading": "Documentation relating to the third country supplier or suppliers",
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      "extent": "E+W+S+N.I.",
      "status": null,
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    },
    {
      "path": "annex/IV",
      "kind": "annex",
      "number": "IV",
      "heading": "Minimum requirements concerning the contents of written agreements between importing tissue establishments and their third country suppliers",
      "url": "https://openlegislation.uk/eu-directive-2015-566/annex-IV",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    }
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    "retrieved_at": "2026-11-01T15:21:39.843576+00:00"
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  "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."
}