{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-51",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-51.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/51",
  "kind": "regulation",
  "number": "51",
  "heading": "Application for UKMA(NI) relating to generic medicinal products",
  "text": "(1) An applicant for a UKMA(NI) for a relevant medicinal product that is a generic medicinal product may provide information in relation to the application in accordance with Article 10(1), (5) and (6) of the 2001 Directive.\n(2) If the licensing authority grants a UKMA(NI) for the generic medicinal product in accordance with paragraph (1), it is a term of the authorisation that the product must not be sold or supplied, or offered for sale or supply, in Northern Ireland before the time at which it may be placed on the market in accordance with Article 10(1) of the 2001 Directive ....\n(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 51-51B substituted for reg. 51 (31.12.2020) by S.I. 2019/775, regs. 1, 56 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 41)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 51(2) 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), 34(a)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 51(3) 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), 34(b)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 51(4) 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), 34(b)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/51",
    "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."
}