{
  "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-5",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-5.json",
  "legislation": "uksi/1994/3144",
  "legislation_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994",
  "path": "schedule/1/paragraph/5",
  "kind": "paragraph",
  "number": "5",
  "heading": null,
  "text": "(1) Regulations 3(1) shall not apply to a radiopharmaceutical for human use —\n(a) which is prepared at the time at which it is intended to be administered; and\n(b) which is prepared, in accordance with the manufacturer’s instructions and by the person by whom it is to be administered, exclusively from a kit, generator or precursor (or from more than one of these) in respect of which a marketing authorization is in force; and\n(c) the administration of which is not or will not be a contravention of regulation 2 of the Medicines (Administration of Radioactive Substances) Regulations 1978.\n(2) In this paragraph—\n“generator” means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and is to be used in a radiopharmaceutical;\n“kit” means any preparation to be reconstituted or combined with radionuclides in a final radiopharmaceutical, usually prior to its administration;\n“precursor” means a radionuclide produced for the radio-labelling of another substance prior to its administration, other than a radionuclide which is incorporated in or produced from a generator or is included in a radiopharmaceutical;\n“radiopharmaceutical” means any relevant medicinal product which when ready for use contains one or more radionuclides included for a medicinal purpose.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "See article 2 of Council Directive 89/343/EEC."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "S.I. 1978/1006."
    }
  ],
  "outstanding_effects": [
    {
      "type": "am",
      "affecting": "uksi/2005/768",
      "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2004/865",
      "affecting_title": "The General Medical Services and Personal Medical Services Transitional and Consequential Provisions Order 2004"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2006/562",
      "affecting_title": "The General Dental Services, Personal Dental Services and Abolition of the Dental Practice Board Transitional and Consequential Provisions Order 2006"
    },
    {
      "type": "am",
      "affecting": "uksi/2009/3063",
      "affecting_title": "The Medicines for Human Use (Miscellaneous Amendments) (No.2) Regulations 2009"
    },
    {
      "type": "words revoked",
      "affecting": "uksi/2010/1882",
      "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010"
    },
    {
      "type": "substituted",
      "affecting": "uksi/2004/1031",
      "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004"
    },
    {
      "type": "words inserted",
      "affecting": "uksi/2005/2759",
      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "substituted",
      "affecting": "uksi/2005/2759",
      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2005/2759",
      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "words substituted",
      "affecting": "wsi/2004/1016",
      "affecting_title": "The General Medical Services Transitional and Consequential Provisions (Wales) (No. 2) Order 2004"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1994/3144/schedule/1/paragraph/5",
    "retrieved_at": "2026-10-29T13:21:07.489272+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."
}