{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004.json",
  "id": "uksi/2004/1031",
  "title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
  "short_title": "Medicines for Human Use (Clinical Trials) 2004",
  "long_title": "These Regulations implement Directive 2001/20/EC on the approximation of 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 (“the Directive”).",
  "citation": "S.I. 2004/1031",
  "type": "uksi",
  "year": "2004",
  "number": "1031",
  "version": "current",
  "date": "2004-03-31",
  "revised": true,
  "valid_from": "2026-04-28",
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 4,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/introduction",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "part/1",
      "kind": "part",
      "number": "1",
      "heading": "INTRODUCTORY PROVISIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/1",
      "kind": "regulation",
      "number": "1",
      "heading": "Citation and commencement",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-1",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/2",
      "kind": "regulation",
      "number": "2",
      "heading": "Interpretation",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/2A",
      "kind": "regulation",
      "number": "2A",
      "heading": "List of countries for the purpose of the definition of “marketing authorization”",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-2A",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/3",
      "kind": "regulation",
      "number": "3",
      "heading": "Sponsor of a clinical trial",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/3A",
      "kind": "regulation",
      "number": "3A",
      "heading": "Sponsor’s responsibility for the investigator’s brochure",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-3A",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/3B",
      "kind": "regulation",
      "number": "3B",
      "heading": "Investigator in a clinical trial",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-3B",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/4",
      "kind": "regulation",
      "number": "4",
      "heading": "Responsibility for functions under the Directive",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-4",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "part/1"
    },
    {
      "path": "part/2",
      "kind": "part",
      "number": "2",
      "heading": "ETHICS COMMITTEES",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/5",
      "kind": "regulation",
      "number": "5",
      "heading": "United Kingdom Ethics Committees Authority",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-5",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/6",
      "kind": "regulation",
      "number": "6",
      "heading": "Establishment and abolition of ethics committees",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-6",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/7",
      "kind": "regulation",
      "number": "7",
      "heading": "Recognition of ethics committees",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-7",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "part/2"
    },
    {
      "path": "regulation/8",
      "kind": "regulation",
      "number": "8",
      "heading": "Revocation of recognition",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-8",
      "extent": null,
      "status": "repealed",
      "parent": "part/2"
    },
    {
      "path": "regulation/9",
      "kind": "regulation",
      "number": "9",
      "heading": "Operation of ethics committees",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-9",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/10",
      "kind": "regulation",
      "number": "10",
      "heading": "Other functions of the Authority",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-10",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "part/3",
      "kind": "part",
      "number": "3",
      "heading": "AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/11",
      "kind": "regulation",
      "number": "11",
      "heading": "Interpretation of Part 3",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-11",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/11A",
      "kind": "regulation",
      "number": "11A",
      "heading": "Definition of notifiable trial",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-11A",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/11B",
      "kind": "regulation",
      "number": "11B",
      "heading": "Definition of Route B substantial modification",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-11B",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/12",
      "kind": "regulation",
      "number": "12",
      "heading": "Requirement for authorisation and ethics committee opinion",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/13",
      "kind": "regulation",
      "number": "13",
      "heading": "Supply of investigational medicinal products for the purpose of clinical trials",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-13",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/14",
      "kind": "regulation",
      "number": "14",
      "heading": "Request for authorisation to conduct a clinical trial",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-14",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/15",
      "kind": "regulation",
      "number": "15",
      "heading": "Application for ethics committee opinion",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-15",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/16",
      "kind": "regulation",
      "number": "16",
      "heading": "Request for approval and combined procedure",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-16",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/17",
      "kind": "regulation",
      "number": "17",
      "heading": "Assessment of request for approval",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-17",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/18",
      "kind": "regulation",
      "number": "18",
      "heading": "Approval procedure for clinical trials",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-18",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/18A",
      "kind": "regulation",
      "number": "18A",
      "heading": "Request for further information regarding a request for approval",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-18A",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/18B",
      "kind": "regulation",
      "number": "18B",
      "heading": "Approval procedure for amended requests for approval",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-18B",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/18C",
      "kind": "regulation",
      "number": "18C",
      "heading": "Approval procedure time periods in special circumstances",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-18C",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/19",
      "kind": "regulation",
      "number": "19",
      "heading": "Clinical trials conducted in countries other than the United Kingdom",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-19",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/20",
      "kind": "regulation",
      "number": "20",
      "heading": "Modifications to clinical trial approval",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-20",
      "extent": null,
      "status": null,
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    },
    {
      "path": "regulation/21",
      "kind": "regulation",
      "number": "21",
      "heading": "Modifications by the licensing authority or the ethics committee",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-21",
      "extent": null,
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    },
    {
      "path": "regulation/22",
      "kind": "regulation",
      "number": "22",
      "heading": "Modifications by the sponsor",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-22",
      "extent": null,
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    },
    {
      "path": "regulation/22A",
      "kind": "regulation",
      "number": "22A",
      "heading": "Approval procedure for substantial modifications",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-22A",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/22B",
      "kind": "regulation",
      "number": "22B",
      "heading": "Request for further information regarding proposed substantial modifications",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-22B",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/22C",
      "kind": "regulation",
      "number": "22C",
      "heading": "Approval procedure for amended requests regarding substantial modifications",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-22C",
      "extent": null,
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      "parent": "part/3"
    },
    {
      "path": "regulation/23",
      "kind": "regulation",
      "number": "23",
      "heading": "Reference to the appropriate committee or the Medicines Commission",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-23",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/24",
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      "number": "24",
      "heading": "Review and appeal relating to ethics committee opinion",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-24",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/25",
      "kind": "regulation",
      "number": "25",
      "heading": "Transparency requirements",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-25",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/26",
      "kind": "regulation",
      "number": "26",
      "heading": "Lapse of clinical trial approval",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-26",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/27",
      "kind": "regulation",
      "number": "27",
      "heading": "Conclusion of clinical trial",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-27",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/27A",
      "kind": "regulation",
      "number": "27A",
      "heading": "Information sharing",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-27A",
      "extent": null,
      "status": null,
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    },
    {
      "path": "regulation/27B",
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      "number": "27B",
      "heading": "Publication of information",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-27B",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "part/4",
      "kind": "part",
      "number": "4",
      "heading": "GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL TRIALS",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/28",
      "kind": "regulation",
      "number": "28",
      "heading": "Good clinical practice and protection of clinical trial participants",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-28",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/29",
      "kind": "regulation",
      "number": "29",
      "heading": "Conduct of trial in accordance with clinical trial authorisation etc.",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-29",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/29A",
      "kind": "regulation",
      "number": "29A",
      "heading": "Notification of serious breaches",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-29A",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/30",
      "kind": "regulation",
      "number": "30",
      "heading": "Urgent safety measures",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-30",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/31",
      "kind": "regulation",
      "number": "31",
      "heading": "Suspension or termination of clinical trial",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-31",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/31A",
      "kind": "regulation",
      "number": "31A",
      "heading": "Trial master file and archiving",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-31A",
      "extent": null,
      "status": null,
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    },
    {
      "path": "part/5",
      "kind": "part",
      "number": "5",
      "heading": "PHARMACOVIGILANCE",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/A32",
      "kind": "regulation",
      "number": "A32",
      "heading": "Record keeping",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-A32",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/32",
      "kind": "regulation",
      "number": "32",
      "heading": "Notification of adverse events",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-32",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/33",
      "kind": "regulation",
      "number": "33",
      "heading": "Notification of suspected unexpected serious adverse reactions",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-33",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/34",
      "kind": "regulation",
      "number": "34",
      "heading": "Clinical trials conducted in countries other than the United Kingdom",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-34",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/35",
      "kind": "regulation",
      "number": "35",
      "heading": "Annual ... safety report",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-35",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "part/6",
      "kind": "part",
      "number": "6",
      "heading": "MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/36",
      "kind": "regulation",
      "number": "36",
      "heading": "Requirement for authorisation to manufacture or import investigational medicinal products",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-36",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/36A",
      "kind": "regulation",
      "number": "36A",
      "heading": "Manufacture of MM investigational medicinal products",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-36A",
      "extent": null,
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    },
    {
      "path": "regulation/36B",
      "kind": "regulation",
      "number": "36B",
      "heading": "Manufacture of POC investigational medicinal products",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-36B",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/37",
      "kind": "regulation",
      "number": "37",
      "heading": "Exemption for hospitals and health centres",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-37",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/37A",
      "kind": "regulation",
      "number": "37A",
      "heading": "Exemption for radiopharmaceuticals used for diagnostic purposes",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-37A",
      "extent": null,
      "status": null,
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    },
    {
      "path": "regulation/38",
      "kind": "regulation",
      "number": "38",
      "heading": "Application for manufacturing authorisation",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-38",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/39",
      "kind": "regulation",
      "number": "39",
      "heading": "Consideration of application for manufacturing authorisation",
      "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-39",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/40",
      "kind": "regulation",
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