{
  "url": "https://openlegislation.uk/eu-regulation-2017-556/article-1",
  "json_url": "https://openlegislation.uk/eu-regulation-2017-556/article-1.json",
  "legislation": "eur/2017/556",
  "legislation_title": "Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2017-556",
  "path": "article/1",
  "kind": "article",
  "number": "1",
  "heading": "Scope",
  "text": "This Regulation applies to inspections of:\n(a) clinical trials conducted in the Union, including clinical trial sites related to those trials but located outside the Union;\n(b) clinical trials referred to in the applications for clinical trial authorisations pursuant to Article 25(5) of Regulation (EU) No 536/2014;\n(c) clinical trials conducted in third countries and referred to in marketing authorisation applications in the Union.",
  "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/2017/556/article/1",
    "retrieved_at": "2026-11-01T14:45:06.073231+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."
}