{
  "url": "https://openlegislation.uk/draft-patents-amendment-eu-exit-regulations-2018/regulation-54",
  "json_url": "https://openlegislation.uk/draft-patents-amendment-eu-exit-regulations-2018/regulation-54.json",
  "legislation": "ukdsi/2018/9780111175347",
  "legislation_title": "The Patents (Amendment) (EU Exit) Regulations 2018",
  "legislation_url": "https://openlegislation.uk/draft-patents-amendment-eu-exit-regulations-2018",
  "path": "regulation/54",
  "kind": "regulation",
  "number": "54",
  "heading": null,
  "text": "For Articles 2 (scope) and 3 (conditions for obtaining a certificate), substitute—\n“Article 2\nScope\nA product may, under the terms and conditions provided for in this Regulation, be the subject of a certificate if it is—\n(a) protected by a patent; and\n(b) the subject of a UK authorisation prior to being placed on the market as a medicinal product.\nArticle 3\nConditions for obtaining a certificate\nWhere an application is submitted under Article 7, a certificate shall be granted if, at the date of submission of that application—\n(a) the product is protected by a basic patent in force;\n(b) there is a valid UK authorisation to place the product on the market;\n(c) the product has not already been the subject of a certificate;\n(d) the authorisation referred to in point (b) is the first UK authorisation to place the product on the market as a medicinal product.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2018/9780111175347/regulation/54",
    "retrieved_at": "2026-10-30T15:03:09.348932+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."
}