{
  "url": "https://openlegislation.uk/eu-directive-2001-20/article-19",
  "json_url": "https://openlegislation.uk/eu-directive-2001-20/article-19.json",
  "legislation": "eudr/2001/20",
  "legislation_title": "Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use",
  "legislation_url": "https://openlegislation.uk/eu-directive-2001-20",
  "path": "article/19",
  "kind": "article",
  "number": "19",
  "heading": "General provisions",
  "text": "This Directive is without prejudice to the civil and criminal liability of the sponsor or the investigator. To this end, the sponsor or a legal representative of the sponsor must be established in the Community.\nUnless Member States have established precise conditions for exceptional circumstances, investigational medicinal products and, as the case may be, the devices used for their administration shall be made available free of charge by the sponsor.\nThe Member States shall inform the Commission of such conditions.",
  "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/eudr/2001/20/article/19",
    "retrieved_at": "2026-11-01T15:23:00.807576+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."
}