{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-8/paragraph-18",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-8/paragraph-18.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/8/paragraph/18",
  "kind": "paragraph",
  "number": "18",
  "heading": null,
  "text": "Where—\n(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(b) ... an application for authorisation for the medicinal product to be placed on the market is under consideration in a country other than the United Kingdom, or by the EMA, notification of that fact.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 8 para. 18 substituted (31.12.2020) by S.I. 2019/775, regs. 1, 50(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(b))"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sch. 8 para. 18(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 137(a)(i)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Sch. 8 para. 18(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 137(a)(ii)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/8/paragraph/18",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}