{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-2",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-2.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/2",
  "kind": "regulation",
  "number": "2",
  "heading": "Medicinal products",
  "text": "(1) In these Regulations “medicinal product” means—\n(a) any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or\n(b) any substance or combination of substances that may be used by or administered to human beings with a view to—\n(i) restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or\n(ii) making a medical diagnosis.\n(2) These Regulations do not apply to—\n(a) whole human blood; or\n(b) any human blood component, other than plasma prepared by a method involving an industrial process.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "C",
      "label": "C1",
      "text": "Reg. 2 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/2",
    "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."
}