{
  "url": "https://openlegislation.uk/eu-regulation-2006-816",
  "json_url": "https://openlegislation.uk/eu-regulation-2006-816.json",
  "id": "eur/2006/816",
  "title": "Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems",
  "short_title": "Regulation (EC) No 816/2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical…",
  "long_title": "Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems",
  "citation": "EU Regulation No 816/2006",
  "type": "eur",
  "year": "2006",
  "number": "816",
  "version": "current",
  "date": "2006-05-17",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": "Scope",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Definitions",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Competent authority",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-3",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Eligible importing countries",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Extension to least-developed and developing countries which are not members of the WTO",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Application for a compulsory licence",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Rights of the rights-holder",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Verification",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Prior negotiation",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "Compulsory licence conditions",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/11",
      "kind": "article",
      "number": "11",
      "heading": "Refusal of the application",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/12",
      "kind": "article",
      "number": "12",
      "heading": "Notification",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/13",
      "kind": "article",
      "number": "13",
      "heading": "Prohibition of importation",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-13",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/14",
      "kind": "article",
      "number": "14",
      "heading": "Action by customs authorities",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-14",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/15",
      "kind": "article",
      "number": "15",
      "heading": "Personal luggage exception",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-15",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/16",
      "kind": "article",
      "number": "16",
      "heading": "Termination or review of the licence",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-16",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/17",
      "kind": "article",
      "number": "17",
      "heading": "Appeals",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-17",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/18",
      "kind": "article",
      "number": "18",
      "heading": "Safety and efficacy of medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-18",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/19",
      "kind": "article",
      "number": "19",
      "heading": "Review",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-19",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/20",
      "kind": "article",
      "number": "20",
      "heading": "Entry into force",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/article-20",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-regulation-2006-816/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    }
  ],
  "outstanding_effects": [],
  "made_under": [],
  "changes_made_to": 27,
  "changes_made_to_url": "https://openlegislation.uk/eu-regulation-2006-816/changes.json",
  "changes_made_by": 0,
  "changes_made_by_url": "https://openlegislation.uk/eu-regulation-2006-816/changes/by-it.json",
  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/eu-regulation-2006-816/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2006/816",
    "retrieved_at": "2026-11-01T14:53:42.913678+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."
}