{
  "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-16",
  "json_url": "https://openlegislation.uk/eu-regulation-2017-1569/article-16.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/16",
  "kind": "article",
  "number": "16",
  "heading": "Advanced therapy investigational medicinal products",
  "text": "The good manufacturing principles shall be adapted to the specific characteristics of the advanced therapy medicinal products when used as investigational medicinal products. Investigational medicinal products, which are at the same time advanced therapy medicinal products, shall be manufactured in accordance with the guidelines referred to in Article 5 of Regulation (EC) No 1394/2007.",
  "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/16",
    "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."
}