{
  "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-19",
  "json_url": "https://openlegislation.uk/eu-regulation-2017-1569/article-19.json",
  "legislation": "eur/2017/1569",
  "legislation_title": "Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2017-1569",
  "path": "article/19",
  "kind": "article",
  "number": "19",
  "heading": "Recognition of inspection conclusions",
  "text": "1. The conclusions reached in the inspection report referred to in Article 17(5) shall be valid throughout the Union.\nHowever, in exceptional cases, where a competent authority is unable, for reasons relating to public health, to recognise the conclusions reached following an inspection under Article 63(4) of Regulation (EU) No 536/2014, that competent authority shall forthwith inform the Commission and the Agency. The Agency shall inform the other competent authorities concerned.\n2. When the Commission is informed in accordance with the second subparagraph of paragraph 1, it may, after consulting the competent authority which was unable to accept the report, request the inspector who performed the inspection to perform a new inspection. The inspector may be accompanied by two inspectors from other competent authorities which are not parties to the disagreement.",
  "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/2017/1569/article/19",
    "retrieved_at": "2026-11-01T14:44:34.669471+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."
}