{
  "url": "https://openlegislation.uk/patents-amendment-eu-exit-regulations-2019/regulation-54",
  "json_url": "https://openlegislation.uk/patents-amendment-eu-exit-regulations-2019/regulation-54.json",
  "legislation": "uksi/2019/801",
  "legislation_title": "The Patents (Amendment) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/patents-amendment-eu-exit-regulations-2019",
  "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 , GB or NI 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 , GB or NI 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 , GB or NI authorisation to place the product on the market as a medicinal product in the territory of the United Kingdom, the territory of England and Wales and Scotland or the territory of Northern Ireland as the case may be.”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 54 inserted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 3(4) (with reg. 7)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 54 inserted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 3(5)(a) (with reg. 7)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 54 inserted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 3(5)(b)(i) (with reg. 7)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in reg. 54 inserted (31.12.2020 immediately before IP completion day) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), regs. 1(2), 3(5)(b)(ii) (with reg. 7)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 54 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2019/801/regulation/54",
    "retrieved_at": "2026-10-28T22:41:57.386476+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."
}