{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-173",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-173.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/173",
  "kind": "regulation",
  "number": "173",
  "heading": "Exemption for certain radiopharmaceuticals",
  "text": "Regulation 46 (requirement for authorisation) does not apply where a radiopharmaceutical is prepared—\n(a) at the time when it is intended to be administered;\n(b) in accordance with the manufacturer's instructions and by the person by whom it is to be administered;\n(c) from radionuclide generators, radionuclide kits and radionuclide precursors in respect of which a UK marketing authorisation ... is in force; and\n(d) for administration—\n(i) in England and Wales and Scotland in accordance with a licence issued under the Ionising Radiation (Medical Exposure) Regulations 2017;\n(ii) in Northern Ireland in accordance with a licence issued under the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 173(c) substituted (31.12.2020) by S.I. 2019/775, reg. 138 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 106); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 173(c) 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), 73"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 173(d) substituted (6.2.2018) by The Ionising Radiation (Medical Exposure) Regulations 2017 (S.I. 2017/1322), reg. 1, Sch. 4 para. 2(2) (as substituted (6.2.2018) by S.I. 2018/121, regs. 1(2), 2(4)(b)(i))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/173",
    "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."
}