{
  "url": "https://openlegislation.uk/eu-regulation-2014-536/article-54",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-536/article-54.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": "article/54",
  "kind": "article",
  "number": "54",
  "heading": "Urgent safety measures",
  "text": "1. Where an unexpected event is likely to seriously affect the benefit-risk balance, the sponsor and the investigator shall take appropriate urgent safety measures to protect the subjects.\n2. The sponsor shall notify the Member States concerned, through the EU portal, of the event and the measures taken.\nThat notification shall be made without undue delay but no later than seven days from the date the measures have been taken.\n3. This Article is without prejudice to Chapters III and VII.",
  "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/article/54",
    "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."
}