{
  "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-IV/division-F",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-536/annex-IV/division-F.json",
  "legislation": "eur/2014/536",
  "legislation_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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2014-536",
  "path": "annex/IV/division/F",
  "kind": "division",
  "number": "F",
  "heading": "ADDITIONAL INFORMATION:",
  "text": "1.. Global Substantial Modifications;\n2.. Global Interruptions and re-starts;\n3.. Limitations, addressing sources of potential bias and imprecisions and Caveats;\n4.. A declaration by the submitting party on the accuracy of the submitted information.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2014/536/annex/IV/division/F",
    "retrieved_at": "2026-11-01T14:47:39.363123+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}