{
  "url": "https://openlegislation.uk/eu-regulation-2017-556/article-11",
  "json_url": "https://openlegislation.uk/eu-regulation-2017-556/article-11.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/11",
  "kind": "article",
  "number": "11",
  "heading": "Recognition of inspection conclusions",
  "text": "Inspectors shall carry out inspections on behalf of the Union. The results of those inspections shall be recognised by all Member States.\nIn case of divergences between Member States in relation to the verification of compliance with the applicable legislation, the Member States, or the European Medicines Agency within the framework of its powers as provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council, shall inform the Commission. The Commission, after consulting those Member States and the European Medicines Agency, may request a new inspection.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2017/556/article/11",
    "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."
}