{
  "url": "https://openlegislation.uk/eu-directive-2001-20",
  "json_url": "https://openlegislation.uk/eu-directive-2001-20.json",
  "id": "eudr/2001/20",
  "title": "Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use",
  "short_title": "Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use",
  "long_title": "Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use",
  "citation": "EU Directive 2001/20",
  "type": "eudr",
  "year": "2001",
  "number": "20",
  "version": "current",
  "date": "2001-04-04",
  "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-2001-20/introduction",
      "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-2001-20/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Definitions",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/3",
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      "number": "3",
      "heading": "Protection of clinical trial subjects",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Clinical trials on minors",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Clinical trials on incapacitated adults not able to give informed legal consent",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Ethics Committee",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Single opinion",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Detailed guidance",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Commencement of a clinical trial",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "Conduct of a clinical trial",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/11",
      "kind": "article",
      "number": "11",
      "heading": "Exchange of information",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/12",
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      "number": "12",
      "heading": "Suspension of the trial or infringements",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-12",
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      "status": null,
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    },
    {
      "path": "article/13",
      "kind": "article",
      "number": "13",
      "heading": "Manufacture and import of investigational medicinal products",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-13",
      "extent": "E+W+S+N.I.",
      "status": null,
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    },
    {
      "path": "article/14",
      "kind": "article",
      "number": "14",
      "heading": "Labelling",
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      "status": null,
      "parent": null
    },
    {
      "path": "article/15",
      "kind": "article",
      "number": "15",
      "heading": "Verification of compliance of investigational medicinal products with good clinical and manufacturing practice",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-15",
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      "path": "article/16",
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      "heading": "Notification of adverse events",
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      "status": null,
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    },
    {
      "path": "article/18",
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      "heading": "Guidance concerning reports",
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      "path": "article/19",
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      "heading": "General provisions",
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    },
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      "path": "article/20",
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      "url": "https://openlegislation.uk/eu-directive-2001-20/article-20",
      "extent": "E+W+S+N.I.",
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      "path": "article/21",
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    },
    {
      "path": "article/22",
      "kind": "article",
      "number": "22",
      "heading": "Application",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-22",
      "extent": "E+W+S+N.I.",
      "status": null,
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    {
      "path": "article/23",
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      "heading": "Entry into force",
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    },
    {
      "path": "article/24",
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      "number": "24",
      "heading": "Addressees",
      "url": "https://openlegislation.uk/eu-directive-2001-20/article-24",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    }
  ],
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  "changes_made_to_url": "https://openlegislation.uk/eu-directive-2001-20/changes.json",
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  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2001/20",
    "retrieved_at": "2026-11-01T15:23:00.807576+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."
}