{
  "url": "https://openlegislation.uk/eu-regulation-2006-816/article-2",
  "json_url": "https://openlegislation.uk/eu-regulation-2006-816/article-2.json",
  "legislation": "eur/2006/816",
  "legislation_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",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2006-816",
  "path": "article/2",
  "kind": "article",
  "number": "2",
  "heading": "Definitions",
  "text": "For the purposes of this Regulation, the following definitions shall apply:\n(1)‘pharmaceutical product’ means any product of the pharmaceutical sector, including medicinal products as defined in Article 1(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, active ingredients and diagnostic kits ex vivo;\n(2)‘rights-holder’ means the holder of any patent or supplementary protection certificate in relation to which a compulsory licence has been applied for under this Regulation;\n(3)‘importing country’ means the country to which the pharmaceutical product is to be exported;\n(4) “competent authority” for the purposes of Articles 1 to 11, 16 and 17 means the Comptroller-General of Patents, Designs and Trade Marks;\n(5)“patent” means “a patent under the Patents Act 1977;\n(6)“supplementary protection certificate” means a supplementary protection certificate issued under Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Art. 2(4) substituted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 39(2); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Art. 2(5)(6) inserted (31.12.2020) by The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801), regs. 1, 39(3); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2006/816/article/2",
    "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."
}