{
  "url": "https://openlegislation.uk/eu-regulation-2014-536",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-536.json",
  "id": "eur/2014/536",
  "title": "Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance)",
  "short_title": "Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use",
  "long_title": "Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance)",
  "citation": "EU Regulation No 536/2014",
  "type": "eur",
  "year": "2014",
  "number": "536",
  "version": "current",
  "date": "2014-04-16",
  "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-regulation-2014-536/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-regulation-2014-536/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-regulation-2014-536/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "General principle",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "chapter/II",
      "kind": "chapter",
      "number": "II",
      "heading": "AUTHORISATION PROCEDURE FOR A CLINICAL TRIAL",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Prior authorisation",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Submission of an application",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Assessment report — Aspects covered by Part I",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Assessment report — Aspects covered by Part II",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Decision on the clinical trial",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Persons assessing the application",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "Specific considerations for vulnerable populations",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/11",
      "kind": "article",
      "number": "11",
      "heading": "Submission and assessment of applications limited to aspects covered by Part I or Part II of the assessment report",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/12",
      "kind": "article",
      "number": "12",
      "heading": "Withdrawal",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/13",
      "kind": "article",
      "number": "13",
      "heading": "Resubmission",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-13",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/14",
      "kind": "article",
      "number": "14",
      "heading": "Subsequent addition of a Member State concerned",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-14",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "chapter/III",
      "kind": "chapter",
      "number": "III",
      "heading": "AUTHORISATION PROCEDURE FOR A SUBSTANTIAL MODIFICATION OF A CLINICAL TRIAL",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/15",
      "kind": "article",
      "number": "15",
      "heading": "General principles",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-15",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/16",
      "kind": "article",
      "number": "16",
      "heading": "Submission of application",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-16",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/17",
      "kind": "article",
      "number": "17",
      "heading": "Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-17",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/18",
      "kind": "article",
      "number": "18",
      "heading": "Assessment of a substantial modification of an aspect covered by Part I of the assessment report",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-18",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/19",
      "kind": "article",
      "number": "19",
      "heading": "Decision on the substantial modification of an aspect covered by Part I of the assessment report",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-19",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/20",
      "kind": "article",
      "number": "20",
      "heading": "Validation, assessment and decision regarding a substantial modification of an aspect covered by Part II of the assessment report",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-20",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/21",
      "kind": "article",
      "number": "21",
      "heading": "Substantial modification of aspects covered by Parts I and II of the assessment report",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-21",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/22",
      "kind": "article",
      "number": "22",
      "heading": "Assessment of a substantial modification of aspects covered by Parts I and II of the assessment report — Assessment of the aspects covered by Part II of the assessment report",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-22",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/23",
      "kind": "article",
      "number": "23",
      "heading": "Decision on the substantial modification of aspects covered by Parts I and II of the assessment report",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-23",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/24",
      "kind": "article",
      "number": "24",
      "heading": "Persons assessing the application for a substantial modification",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-24",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "chapter/IV",
      "kind": "chapter",
      "number": "IV",
      "heading": "APPLICATION DOSSIER",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/25",
      "kind": "article",
      "number": "25",
      "heading": "Data submitted in the application dossier",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-25",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/26",
      "kind": "article",
      "number": "26",
      "heading": "Language requirements",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-26",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/27",
      "kind": "article",
      "number": "27",
      "heading": "Update by way of delegated acts",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-27",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "chapter/V",
      "kind": "chapter",
      "number": "V",
      "heading": "PROTECTION OF SUBJECTS AND INFORMED CONSENT",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/28",
      "kind": "article",
      "number": "28",
      "heading": "General rules",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-28",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/29",
      "kind": "article",
      "number": "29",
      "heading": "Informed consent",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-29",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/30",
      "kind": "article",
      "number": "30",
      "heading": "Informed consent in cluster trials",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-30",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/31",
      "kind": "article",
      "number": "31",
      "heading": "Clinical trials on incapacitated subjects",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-31",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/32",
      "kind": "article",
      "number": "32",
      "heading": "Clinical trials on minors",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-32",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/33",
      "kind": "article",
      "number": "33",
      "heading": "Clinical trials on pregnant or breastfeeding women",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-33",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/34",
      "kind": "article",
      "number": "34",
      "heading": "Additional national measures",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-34",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/35",
      "kind": "article",
      "number": "35",
      "heading": "Clinical trials in emergency situations",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-35",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "chapter/VI",
      "kind": "chapter",
      "number": "VI",
      "heading": "START, END, TEMPORARY HALT, AND EARLY TERMINATION OF A CLINICAL TRIAL",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/36",
      "kind": "article",
      "number": "36",
      "heading": "Notification of the start of a clinical trial and of the end of the recruitment of subjects",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-36",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/37",
      "kind": "article",
      "number": "37",
      "heading": "End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-37",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/38",
      "kind": "article",
      "number": "38",
      "heading": "Temporary halt or early termination by the sponsor for reasons of subject safety",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-38",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/39",
      "kind": "article",
      "number": "39",
      "heading": "Update of the contents of the summary of results and summary for laypersons",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-39",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "chapter/VII",
      "kind": "chapter",
      "number": "VII",
      "heading": "SAFETY REPORTING IN THE CONTEXT OF A CLINICAL TRIAL",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/40",
      "kind": "article",
      "number": "40",
      "heading": "Electronic database for safety reporting",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-40",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII"
    },
    {
      "path": "article/41",
      "kind": "article",
      "number": "41",
      "heading": "Reporting of adverse events and serious adverse events by the investigator to the sponsor",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-41",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII"
    },
    {
      "path": "article/42",
      "kind": "article",
      "number": "42",
      "heading": "Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-42",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII"
    },
    {
      "path": "article/43",
      "kind": "article",
      "number": "43",
      "heading": "Annual reporting by the sponsor to the Agency",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-43",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII"
    },
    {
      "path": "article/44",
      "kind": "article",
      "number": "44",
      "heading": "Assessment by Member States",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-44",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII"
    },
    {
      "path": "article/45",
      "kind": "article",
      "number": "45",
      "heading": "Technical aspects",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-45",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII"
    },
    {
      "path": "article/46",
      "kind": "article",
      "number": "46",
      "heading": "Reporting with regard to auxiliary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-46",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII"
    },
    {
      "path": "chapter/VIII",
      "kind": "chapter",
      "number": "VIII",
      "heading": "CONDUCT OF A CLINICAL TRIAL, SUPERVISION BY THE SPONSOR, TRAINING AND EXPERIENCE, AUXILIARY MEDICINAL PRODUCTS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/47",
      "kind": "article",
      "number": "47",
      "heading": "Compliance with the protocol and good clinical practice",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-47",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/48",
      "kind": "article",
      "number": "48",
      "heading": "Monitoring",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-48",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/49",
      "kind": "article",
      "number": "49",
      "heading": "Suitability of individuals involved in conducting the clinical trial",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-49",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/50",
      "kind": "article",
      "number": "50",
      "heading": "Suitability of clinical trial sites",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-50",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/51",
      "kind": "article",
      "number": "51",
      "heading": "Traceability, storage, return and destruction of investigational medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-51",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/52",
      "kind": "article",
      "number": "52",
      "heading": "Reporting of serious breaches",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-52",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/53",
      "kind": "article",
      "number": "53",
      "heading": "Other reporting obligations relevant for subject safety",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-53",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/54",
      "kind": "article",
      "number": "54",
      "heading": "Urgent safety measures",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-54",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/55",
      "kind": "article",
      "number": "55",
      "heading": "Investigator's brochure",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-55",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/56",
      "kind": "article",
      "number": "56",
      "heading": "Recording, processing, handling and storage of information",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-56",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/57",
      "kind": "article",
      "number": "57",
      "heading": "Clinical trial master file",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-57",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/58",
      "kind": "article",
      "number": "58",
      "heading": "Archiving of the clinical trial master file",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-58",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/59",
      "kind": "article",
      "number": "59",
      "heading": "Auxiliary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-59",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "chapter/IX",
      "kind": "chapter",
      "number": "IX",
      "heading": "MANUFACTURING AND IMPORT OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/60",
      "kind": "article",
      "number": "60",
      "heading": "Scope of this Chapter",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-60",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/61",
      "kind": "article",
      "number": "61",
      "heading": "Authorisation of manufacturing and import",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-61",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/62",
      "kind": "article",
      "number": "62",
      "heading": "Responsibilities of the qualified person",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-62",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/63",
      "kind": "article",
      "number": "63",
      "heading": "Manufacturing and import",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-63",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/64",
      "kind": "article",
      "number": "64",
      "heading": "Modification of authorised investigational medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-64",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/65",
      "kind": "article",
      "number": "65",
      "heading": "Manufacturing of auxiliary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-65",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "chapter/X",
      "kind": "chapter",
      "number": "X",
      "heading": "LABELLING",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/66",
      "kind": "article",
      "number": "66",
      "heading": "Unauthorised investigational and unauthorised auxiliary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-66",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/67",
      "kind": "article",
      "number": "67",
      "heading": "Authorised investigational and authorised auxiliary medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-67",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/68",
      "kind": "article",
      "number": "68",
      "heading": "Radiopharmaceuticals used as investigational medicinal products or as auxiliary medicinal products for a medical diagnosis",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-68",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/69",
      "kind": "article",
      "number": "69",
      "heading": "Language",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-69",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/70",
      "kind": "article",
      "number": "70",
      "heading": "Delegated act",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-70",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "chapter/XI",
      "kind": "chapter",
      "number": "XI",
      "heading": "SPONSOR AND INVESTIGATOR",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/71",
      "kind": "article",
      "number": "71",
      "heading": "Sponsor",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-71",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XI"
    },
    {
      "path": "article/72",
      "kind": "article",
      "number": "72",
      "heading": "Co-sponsorship",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-72",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XI"
    },
    {
      "path": "article/73",
      "kind": "article",
      "number": "73",
      "heading": "Principal investigator",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-73",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XI"
    },
    {
      "path": "article/74",
      "kind": "article",
      "number": "74",
      "heading": "Legal representative of the sponsor in the Union",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-74",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XI"
    },
    {
      "path": "article/75",
      "kind": "article",
      "number": "75",
      "heading": "Liability",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-75",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XI"
    },
    {
      "path": "chapter/XII",
      "kind": "chapter",
      "number": "XII",
      "heading": "DAMAGE COMPENSATION",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/76",
      "kind": "article",
      "number": "76",
      "heading": "Damage compensation",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-76",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XII"
    },
    {
      "path": "chapter/XIII",
      "kind": "chapter",
      "number": "XIII",
      "heading": "SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/77",
      "kind": "article",
      "number": "77",
      "heading": "Corrective measures to be taken by Member States",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-77",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XIII"
    },
    {
      "path": "article/78",
      "kind": "article",
      "number": "78",
      "heading": "Member State inspections",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-78",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XIII"
    },
    {
      "path": "article/79",
      "kind": "article",
      "number": "79",
      "heading": "Union controls",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-79",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XIII"
    },
    {
      "path": "chapter/XIV",
      "kind": "chapter",
      "number": "XIV",
      "heading": "IT INFRASTRUCTURE",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/80",
      "kind": "article",
      "number": "80",
      "heading": "EU portal",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-80",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XIV"
    },
    {
      "path": "article/81",
      "kind": "article",
      "number": "81",
      "heading": "EU database",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-81",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XIV"
    },
    {
      "path": "article/82",
      "kind": "article",
      "number": "82",
      "heading": "Functionality of the EU portal and the EU database",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-82",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XIV"
    },
    {
      "path": "chapter/XV",
      "kind": "chapter",
      "number": "XV",
      "heading": "COOPERATION BETWEEN MEMBER STATES",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/83",
      "kind": "article",
      "number": "83",
      "heading": "National contact points",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-83",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XV"
    },
    {
      "path": "article/84",
      "kind": "article",
      "number": "84",
      "heading": "Support by the Agency and the Commission",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-84",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XV"
    },
    {
      "path": "article/85",
      "kind": "article",
      "number": "85",
      "heading": "Clinical Trials Coordination and Advisory Group",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-85",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XV"
    },
    {
      "path": "chapter/XVI",
      "kind": "chapter",
      "number": "XVI",
      "heading": "FEES",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/86",
      "kind": "article",
      "number": "86",
      "heading": "General principle",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-86",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XVI"
    },
    {
      "path": "article/87",
      "kind": "article",
      "number": "87",
      "heading": "One payment per activity per Member State",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-87",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XVI"
    },
    {
      "path": "chapter/XVII",
      "kind": "chapter",
      "number": "XVII",
      "heading": "IMPLEMENTING ACTS AND DELEGATED ACTS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/88",
      "kind": "article",
      "number": "88",
      "heading": "Committee procedure",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-88",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XVII"
    },
    {
      "path": "article/89",
      "kind": "article",
      "number": "89",
      "heading": "Exercise of the delegation",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-89",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XVII"
    },
    {
      "path": "chapter/XVIII",
      "kind": "chapter",
      "number": "XVIII",
      "heading": "MISCELLANEOUS PROVISIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/90",
      "kind": "article",
      "number": "90",
      "heading": "Specific requirements for special groups of medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-90",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XVIII"
    },
    {
      "path": "article/91",
      "kind": "article",
      "number": "91",
      "heading": "Relation with other Union legislation",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-91",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XVIII"
    },
    {
      "path": "article/92",
      "kind": "article",
      "number": "92",
      "heading": "Investigational medicinal products, other products and procedures, free of charge for the subject",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-92",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XVIII"
    },
    {
      "path": "article/93",
      "kind": "article",
      "number": "93",
      "heading": "Data protection",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-93",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XVIII"
    },
    {
      "path": "article/94",
      "kind": "article",
      "number": "94",
      "heading": "Penalties",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-94",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XVIII"
    },
    {
      "path": "article/95",
      "kind": "article",
      "number": "95",
      "heading": "Civil and criminal liability",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-95",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XVIII"
    },
    {
      "path": "chapter/XIX",
      "kind": "chapter",
      "number": "XIX",
      "heading": "FINAL PROVISIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/96",
      "kind": "article",
      "number": "96",
      "heading": "Repeal",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-96",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XIX"
    },
    {
      "path": "article/97",
      "kind": "article",
      "number": "97",
      "heading": "Review",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-97",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XIX"
    },
    {
      "path": "article/98",
      "kind": "article",
      "number": "98",
      "heading": "Transitional provision",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-98",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XIX"
    },
    {
      "path": "article/99",
      "kind": "article",
      "number": "99",
      "heading": "Entry into force",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/article-99",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/XIX"
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I",
      "kind": "annex",
      "number": "I",
      "heading": "APPLICATION DOSSIER FOR THE INITIAL APPLICATION",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I/division/A",
      "kind": "division",
      "number": "A",
      "heading": "INTRODUCTION AND GENERAL PRINCIPLES",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/A/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-A/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/A/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-A/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/A/division/3",
      "kind": "division",
      "number": "3",
      "heading": "The application shall be signed by the sponsor or a representative of the sponsor. This signature confirms that the sponsor is satisfied that:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-A/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/A/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-A/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/A/division/5",
      "kind": "division",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-A/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/B",
      "kind": "division",
      "number": "B",
      "heading": "COVER LETTER",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/B/division/6",
      "kind": "division",
      "number": "6",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-B/division-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/B"
    },
    {
      "path": "annex/I/division/B/division/7",
      "kind": "division",
      "number": "7",
      "heading": "However, in the cover letter it is not necessary to reproduce information already contained in the EU application form, with the following exceptions:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-B/division-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/B"
    },
    {
      "path": "annex/I/division/B/division/8",
      "kind": "division",
      "number": "8",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-B/division-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/B"
    },
    {
      "path": "annex/I/division/B/division/9",
      "kind": "division",
      "number": "9",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-B/division-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/B"
    },
    {
      "path": "annex/I/division/B/division/10",
      "kind": "division",
      "number": "10",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-B/division-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/B"
    },
    {
      "path": "annex/I/division/B/division/11",
      "kind": "division",
      "number": "11",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-B/division-11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/B"
    },
    {
      "path": "annex/I/division/B/division/12",
      "kind": "division",
      "number": "12",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-B/division-12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/B"
    },
    {
      "path": "annex/I/division/C",
      "kind": "division",
      "number": "C",
      "heading": "EU APPLICATION FORM",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/C/division/13",
      "kind": "division",
      "number": "13",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-C/division-13",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/C"
    },
    {
      "path": "annex/I/division/D",
      "kind": "division",
      "number": "D",
      "heading": "PROTOCOL",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/D/division/14",
      "kind": "division",
      "number": "14",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-14",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/15",
      "kind": "division",
      "number": "15",
      "heading": "The protocol shall be identified by:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-15",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/16",
      "kind": "division",
      "number": "16",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-16",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/17",
      "kind": "division",
      "number": "17",
      "heading": "The protocol shall at least include:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-17",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/18",
      "kind": "division",
      "number": "18",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-18",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/19",
      "kind": "division",
      "number": "19",
      "heading": "With regard to the notification of adverse events, the protocol shall identify the categories of:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-19",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/20",
      "kind": "division",
      "number": "20",
      "heading": "The protocol shall describe the procedures for:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-20",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/21",
      "kind": "division",
      "number": "21",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-21",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/22",
      "kind": "division",
      "number": "22",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-22",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/23",
      "kind": "division",
      "number": "23",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-23",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/24",
      "kind": "division",
      "number": "24",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-24",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/E",
      "kind": "division",
      "number": "E",
      "heading": "INVESTIGATOR'S BROCHURE (IB)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/E/division/25",
      "kind": "division",
      "number": "25",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-E/division-25",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/E/division/26",
      "kind": "division",
      "number": "26",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-E/division-26",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/E/division/27",
      "kind": "division",
      "number": "27",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-E/division-27",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/E/division/28",
      "kind": "division",
      "number": "28",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-E/division-28",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/E/division/29",
      "kind": "division",
      "number": "29",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-E/division-29",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/E/division/30",
      "kind": "division",
      "number": "30",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-E/division-30",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/F",
      "kind": "division",
      "number": "F",
      "heading": "DOCUMENTATION RELATING TO COMPLIANCE WITH GOOD MANUFACTURING PRACTICE (GMP) FOR THE INVESTIGATIONAL MEDICINAL PRODUCT",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/F/division/31",
      "kind": "division",
      "number": "31",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-F/division-31",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/F"
    },
    {
      "path": "annex/I/division/F/division/32",
      "kind": "division",
      "number": "32",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-F/division-32",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/F"
    },
    {
      "path": "annex/I/division/F/division/33",
      "kind": "division",
      "number": "33",
      "heading": "If the investigational medicinal product is not authorised, and does not have a marketing authorisation from a third country that is party to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and is not manufactured in the Union, the following documentation shall be submitted:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-F/division-33",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/F"
    },
    {
      "path": "annex/I/division/F/division/34",
      "kind": "division",
      "number": "34",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-F/division-34",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/F"
    },
    {
      "path": "annex/I/division/F/division/35",
      "kind": "division",
      "number": "35",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-F/division-35",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/F"
    },
    {
      "path": "annex/I/division/G",
      "kind": "division",
      "number": "G",
      "heading": "INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER (IMPD)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/G/division/36",
      "kind": "division",
      "number": "36",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-36",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G"
    },
    {
      "path": "annex/I/division/G/division/1.1",
      "kind": "division",
      "number": "1.1",
      "heading": "Data relating to the investigational medicinal product",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/1",
      "kind": "division",
      "number": null,
      "heading": "Introduction",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/1/division/37",
      "kind": "division",
      "number": "37",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-1/division-37",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1/division/1"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/1/division/38",
      "kind": "division",
      "number": "38",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-1/division-38",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1/division/1"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/1/division/39",
      "kind": "division",
      "number": "39",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-1/division-39",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1/division/1"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/2",
      "kind": "division",
      "number": null,
      "heading": "Quality data",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/2/division/40",
      "kind": "division",
      "number": "40",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-2/division-40",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1/division/2"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/3",
      "kind": "division",
      "number": null,
      "heading": "Non-clinical pharmacology and toxicology data",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/3/division/41",
      "kind": "division",
      "number": "41",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-3/division-41",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1/division/3"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/3/division/42",
      "kind": "division",
      "number": "42",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-3/division-42",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1/division/3"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/3/division/43",
      "kind": "division",
      "number": "43",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-3/division-43",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1/division/3"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/3/division/44",
      "kind": "division",
      "number": "44",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-3/division-44",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1/division/3"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/3/division/45",
      "kind": "division",
      "number": "45",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-3/division-45",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1/division/3"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/4",
      "kind": "division",
      "number": null,
      "heading": "Data from previous clinical trials and human experience",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/4/division/46",
      "kind": "division",
      "number": "46",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-4/division-46",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1/division/4"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/4/division/47",
      "kind": "division",
      "number": "47",
      "heading": "This section shall provide summaries of all available data from previous clinical trials and human experience with the investigational medicinal products.",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-4/division-47",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1/division/4"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/5",
      "kind": "division",
      "number": null,
      "heading": "Overall risk and benefit assessment",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/5/division/48",
      "kind": "division",
      "number": "48",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-5/division-48",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1/division/5"
    },
    {
      "path": "annex/I/division/G/division/1.1/division/5/division/49",
      "kind": "division",
      "number": "49",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-5/division-49",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.1/division/5"
    },
    {
      "path": "annex/I/division/G/division/1.2",
      "kind": "division",
      "number": "1.2",
      "heading": "Simplified IMPD by referring to other documentation",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G"
    },
    {
      "path": "annex/I/division/G/division/1.2/division/50",
      "kind": "division",
      "number": "50",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.2/division-50",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.2"
    },
    {
      "path": "annex/I/division/G/division/1.2/division/2",
      "kind": "division",
      "number": null,
      "heading": "Possibility of referring to the IB",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.2"
    },
    {
      "path": "annex/I/division/G/division/1.2/division/2/division/51",
      "kind": "division",
      "number": "51",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.2/division-2/division-51",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.2/division/2"
    },
    {
      "path": "annex/I/division/G/division/1.2/division/3",
      "kind": "division",
      "number": null,
      "heading": "Possibility of referring to the SmPC",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.2/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.2"
    },
    {
      "path": "annex/I/division/G/division/1.2/division/3/division/52",
      "kind": "division",
      "number": "52",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.2/division-3/division-52",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.2/division/3"
    },
    {
      "path": "annex/I/division/G/division/1.2/division/3/division/53",
      "kind": "division",
      "number": "53",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.2/division-3/division-53",
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      "status": null,
      "parent": "annex/I/division/G/division/1.2/division/3"
    },
    {
      "path": "annex/I/division/G/division/1.3",
      "kind": "division",
      "number": "1.3",
      "heading": "IMPD in cases of placebo",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G"
    },
    {
      "path": "annex/I/division/G/division/1.3/division/54",
      "kind": "division",
      "number": "54",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.3/division-54",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/G/division/1.3"
    },
    {
      "path": "annex/I/division/H",
      "kind": "division",
      "number": "H",
      "heading": "AUXILIARY MEDICINAL PRODUCT DOSSIER",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/H/division/55",
      "kind": "division",
      "number": "55",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-H/division-55",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/H"
    },
    {
      "path": "annex/I/division/I",
      "kind": "division",
      "number": "I",
      "heading": "SCIENTIFIC ADVICE AND PAEDIATRIC INVESTIGATION PLAN (PIP)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/I/division/56",
      "kind": "division",
      "number": "56",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-I/division-56",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/I"
    },
    {
      "path": "annex/I/division/I/division/57",
      "kind": "division",
      "number": "57",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-I/division-57",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/I"
    },
    {
      "path": "annex/I/division/J",
      "kind": "division",
      "number": "J",
      "heading": "CONTENT OF THE LABELLING OF THE INVESTIGATIONAL MEDICINAL PRODUCTS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/J/division/58",
      "kind": "division",
      "number": "58",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-J/division-58",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/J"
    },
    {
      "path": "annex/I/division/K",
      "kind": "division",
      "number": "K",
      "heading": "RECRUITMENT ARRANGEMENTS (INFORMATION PER MEMBER STATE CONCERNED)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/K/division/59",
      "kind": "division",
      "number": "59",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-K/division-59",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/K"
    },
    {
      "path": "annex/I/division/K/division/60",
      "kind": "division",
      "number": "60",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-K/division-60",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/K"
    },
    {
      "path": "annex/I/division/L",
      "kind": "division",
      "number": "L",
      "heading": "SUBJECT INFORMATION, INFORMED CONSENT FORM AND INFORMED CONSENT PROCEDURE (INFORMATION PER MEMBER STATE CONCERNED)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/L/division/61",
      "kind": "division",
      "number": "61",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-L/division-61",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/L"
    },
    {
      "path": "annex/I/division/L/division/62",
      "kind": "division",
      "number": "62",
      "heading": "A description of procedures relating to informed consent for all subjects, and in particular:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-L/division-62",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/L"
    },
    {
      "path": "annex/I/division/L/division/63",
      "kind": "division",
      "number": "63",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-L/division-63",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/L"
    },
    {
      "path": "annex/I/division/M",
      "kind": "division",
      "number": "M",
      "heading": "SUITABILITY OF THE INVESTIGATOR (INFORMATION PER MEMBER STATE CONCERNED)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/M/division/64",
      "kind": "division",
      "number": "64",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-M/division-64",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/M"
    },
    {
      "path": "annex/I/division/M/division/65",
      "kind": "division",
      "number": "65",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-M/division-65",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/M"
    },
    {
      "path": "annex/I/division/M/division/66",
      "kind": "division",
      "number": "66",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-M/division-66",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/M"
    },
    {
      "path": "annex/I/division/N",
      "kind": "division",
      "number": "N",
      "heading": "SUITABILITY OF THE FACILITIES (INFORMATION PER MEMBER STATE CONCERNED)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/N/division/67",
      "kind": "division",
      "number": "67",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-N/division-67",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/N"
    },
    {
      "path": "annex/I/division/O",
      "kind": "division",
      "number": "O",
      "heading": "PROOF OF INSURANCE COVER OR INDEMNIFICATION (INFORMATION PER MEMBER STATE CONCERNED)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/O/division/68",
      "kind": "division",
      "number": "68",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-O/division-68",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/O"
    },
    {
      "path": "annex/I/division/P",
      "kind": "division",
      "number": "P",
      "heading": "FINANCIAL AND OTHER ARRANGEMENTS (INFORMATION PER MEMBER STATE CONCERNED)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/P/division/69",
      "kind": "division",
      "number": "69",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-P/division-69",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/P"
    },
    {
      "path": "annex/I/division/P/division/70",
      "kind": "division",
      "number": "70",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-P/division-70",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/P"
    },
    {
      "path": "annex/I/division/P/division/71",
      "kind": "division",
      "number": "71",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-P/division-71",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/P"
    },
    {
      "path": "annex/I/division/Q",
      "kind": "division",
      "number": "Q",
      "heading": "PROOF OF PAYMENT OF FEE (INFORMATION PER MEMBER STATE CONCERNED)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/Q/division/72",
      "kind": "division",
      "number": "72",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-Q/division-72",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/Q"
    },
    {
      "path": "annex/I/division/R",
      "kind": "division",
      "number": "R",
      "heading": "PROOF THAT DATA WILL BE PROCESSED IN COMPLIANCE WITH UNION LAW ON DATA PROTECTION",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/R/division/73",
      "kind": "division",
      "number": "73",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-R/division-73",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/R"
    },
    {
      "path": "annex/II",
      "kind": "annex",
      "number": "II",
      "heading": "APPLICATION DOSSIER FOR SUBSTANTIAL MODIFICATION",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/II/division/A",
      "kind": "division",
      "number": "A",
      "heading": "INTRODUCTION AND GENERAL PRINCIPLES",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
    },
    {
      "path": "annex/II/division/A/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-A/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/division/A"
    },
    {
      "path": "annex/II/division/A/division/2",
      "kind": "division",
      "number": "2",
      "heading": "The application shall be signed by the sponsor or a representative of the sponsor. This signature shall confirm that the sponsor is satisfied that:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-A/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/division/A"
    },
    {
      "path": "annex/II/division/B",
      "kind": "division",
      "number": "B",
      "heading": "COVER LETTER",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
    },
    {
      "path": "annex/II/division/B/division/3",
      "kind": "division",
      "number": "3",
      "heading": "A cover letter with the following information:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-B/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/division/B"
    },
    {
      "path": "annex/II/division/C",
      "kind": "division",
      "number": "C",
      "heading": "MODIFICATION APPLICATION FORM",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
    },
    {
      "path": "annex/II/division/C/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-C/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/division/C"
    },
    {
      "path": "annex/II/division/D",
      "kind": "division",
      "number": "D",
      "heading": "DESCRIPTION OF THE MODIFICATION",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
    },
    {
      "path": "annex/II/division/D/division/5",
      "kind": "division",
      "number": "5",
      "heading": "The modification shall be presented and described as follows:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-D/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/division/D"
    },
    {
      "path": "annex/II/division/D/division/6",
      "kind": "division",
      "number": "6",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-D/division-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/division/D"
    },
    {
      "path": "annex/II/division/E",
      "kind": "division",
      "number": "E",
      "heading": "SUPPORTING INFORMATION",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
    },
    {
      "path": "annex/II/division/E/division/7",
      "kind": "division",
      "number": "7",
      "heading": "Where applicable, additional supporting information shall at least include:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-E/division-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/division/E"
    },
    {
      "path": "annex/II/division/F",
      "kind": "division",
      "number": "F",
      "heading": "UPDATE OF EU APPLICATION FORM",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
    },
    {
      "path": "annex/II/division/F/division/8",
      "kind": "division",
      "number": "8",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-F/division-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/division/F"
    },
    {
      "path": "annex/II/division/G",
      "kind": "division",
      "number": "G",
      "heading": "PROOF OF PAYMENT OF FEE (INFORMATION PER MEMBER STATE CONCERNED)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
    },
    {
      "path": "annex/II/division/G/division/9",
      "kind": "division",
      "number": "9",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-G/division-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/division/G"
    },
    {
      "path": "annex/III",
      "kind": "annex",
      "number": "III",
      "heading": "SAFETY REPORTING",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/III/division/1",
      "kind": "division",
      "number": "1",
      "heading": "REPORTING OF SERIOUS ADVERSE EVENTS BY THE INVESTIGATOR TO THE SPONSOR",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III"
    },
    {
      "path": "annex/III/division/1/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-1/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/1"
    },
    {
      "path": "annex/III/division/2",
      "kind": "division",
      "number": "2",
      "heading": "REPORTING OF SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS (SUSARS) BY THE SPONSOR TO THE AGENCY IN ACCORDANCE WITH ARTICLE 42",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III"
    },
    {
      "path": "annex/III/division/2/division/2.1",
      "kind": "division",
      "number": "2.1",
      "heading": "Adverse Events and Causality",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2"
    },
    {
      "path": "annex/III/division/2/division/2.1/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.1/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2/division/2.1"
    },
    {
      "path": "annex/III/division/2/division/2.1/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.1/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2/division/2.1"
    },
    {
      "path": "annex/III/division/2/division/2.1/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.1/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2/division/2.1"
    },
    {
      "path": "annex/III/division/2/division/2.2",
      "kind": "division",
      "number": "2.2",
      "heading": "Expectedness, unexpectedness and the RSI",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2"
    },
    {
      "path": "annex/III/division/2/division/2.2/division/5",
      "kind": "division",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.2/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2/division/2.2"
    },
    {
      "path": "annex/III/division/2/division/2.2/division/6",
      "kind": "division",
      "number": "6",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.2/division-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2/division/2.2"
    },
    {
      "path": "annex/III/division/2/division/2.2/division/7",
      "kind": "division",
      "number": "7",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.2/division-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2/division/2.2"
    },
    {
      "path": "annex/III/division/2/division/2.2/division/8",
      "kind": "division",
      "number": "8",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.2/division-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2/division/2.2"
    },
    {
      "path": "annex/III/division/2/division/2.2/division/9",
      "kind": "division",
      "number": "9",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.2/division-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2/division/2.2"
    },
    {
      "path": "annex/III/division/2/division/2.3",
      "kind": "division",
      "number": "2.3",
      "heading": "Information for the reporting of SUSARs",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2"
    },
    {
      "path": "annex/III/division/2/division/2.3/division/10",
      "kind": "division",
      "number": "10",
      "heading": "The information shall at least include:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.3/division-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2/division/2.3"
    },
    {
      "path": "annex/III/division/2/division/2.3/division/11",
      "kind": "division",
      "number": "11",
      "heading": "In addition, in order to properly process the report electronically, the following administrative information shall be provided:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.3/division-11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2/division/2.3"
    },
    {
      "path": "annex/III/division/2/division/2.4",
      "kind": "division",
      "number": "2.4",
      "heading": "Follow-up reports of SUSARs",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2"
    },
    {
      "path": "annex/III/division/2/division/2.4/division/12",
      "kind": "division",
      "number": "12",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.4/division-12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2/division/2.4"
    },
    {
      "path": "annex/III/division/2/division/2.4/division/13",
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      "path": "annex/III/division/2/division/2.4/division/15",
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      "path": "annex/III/division/2/division/2.5",
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      "number": "2.5",
      "heading": "Unblinding treatment allocation",
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      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III/division/2"
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      "path": "annex/III/division/2/division/2.5/division/17",
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      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.5/division-17",
      "extent": "E+W+S+N.I.",
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      "parent": "annex/III/division/2/division/2.5"
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      "path": "annex/III/division/2/division/2.5/division/18",
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      "heading": null,
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      "path": "annex/III/division/2/division/2.5/division/19",
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      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.5/division-19",
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      "path": "annex/III/division/2/division/2.5/division/20",
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      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.5/division-20",
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      "number": "3",
      "heading": "ANNUAL SAFETY REPORTING BY THE SPONSOR",
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      "path": "annex/III/division/3/division/24",
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      "path": "annex/IV",
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      "heading": "CONTENT OF THE SUMMARY OF THE RESULTS OF THE CLINICAL TRIAL",
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      "heading": "CLINICAL TRIAL INFORMATION:",
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      "heading": "SUBJECT DISPOSITION:",
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      "path": "annex/IV/division/C",
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      "heading": "BASELINE CHARACTERISTICS:",
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      "heading": "ADDITIONAL INFORMATION:",
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      "heading": "CONTENT OF THE SUMMARY OF THE RESULTS OF THE CLINICAL TRIAL FOR LAYPERSONS",
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      "extent": "E+W+S+N.I.",
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      "heading": "LABELLING OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS",
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      "extent": "E+W+S+N.I.",
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      "heading": "UNAUTHORISED INVESTIGATIONAL MEDICINAL PRODUCTS",
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      "number": "1",
      "heading": "The following particulars shall appear on the immediate and the outer packaging:",
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      "extent": "E+W+S+N.I.",
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      "heading": "When the product is provided to the subject or the person administering the medicinal product in an immediate packaging and outer packaging intended to remain together, and the outer packaging carries the particulars listed in section A.1., the following particulars shall appear on the immediate packaging (or any sealed dosing device that contains the immediate package):",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-VI/division-A/division-A.2/division-A.2.1/division-4",
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      "heading": "If the immediate packaging takes the form of blister packs or small units such as ampoules on which the particulars required in section A.1. cannot be displayed, the outer packaging provided shall bear a label with those particulars. The immediate packaging shall contain the following:",
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      "heading": "The following particulars shall appear on the immediate and the outer packaging:",
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      "extent": "E+W+S+N.I.",
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      "heading": "ADDITIONAL LABELLING FOR AUTHORISED INVESTIGATIONAL MEDICINAL PRODUCTS",
      "url": null,
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      "heading": "In accordance with Article 67(2), the following particulars shall appear on the immediate and the outer packaging:",
      "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-VI/division-C/division-7",
      "extent": "E+W+S+N.I.",
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      "heading": "REPLACING OF INFORMATION",
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      "status": null,
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      "heading": "The particulars referred to in the following points shall not be omitted from the label of a product:",
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  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
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