{
  "url": "https://openlegislation.uk/eu-regulation-2017-556/article-13",
  "json_url": "https://openlegislation.uk/eu-regulation-2017-556/article-13.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/13",
  "kind": "article",
  "number": "13",
  "heading": "Inspection reports and records",
  "text": "Without prejudice to the obligation to submit the inspection reports via the EU Portal in accordance with Article 78(6) of Regulation (EU) No 536/2014, Member States shall keep for at least 25 years relevant records of national inspections as well as of the inspections performed outside their territory, including information on the outcome of the inspection as regards good clinical practice compliance status as well as any action taken by the sponsor or Member State in the follow-up of the inspection. The inspection reports submitted through the EU portal shall not contain personal data of clinical trials' subjects.",
  "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/13",
    "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."
}