{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-34/paragraph-53",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-34/paragraph-53.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/34/paragraph/53",
  "kind": "paragraph",
  "number": "53",
  "heading": null,
  "text": "In regulation 2(1) (interpretation)—\n(a) before the definition “the Act” insert the following definition—\n““the 2012 Regulations” means the Human Medicines Regulations 2012;”;\n(b) for the definition “appropriate committee” substitute—\n““appropriate committee” for the purposes of any provision of these Regulations under which a function falls to be performed means whichever the licensing authority considers to be appropriate of—\n(a)the Commission on Human Medicines; or\n(b)an expert committee appointed by the licensing authority;”;\n(c) insert in the appropriate position in alphabetical order the following definition—\n““the Commission on Human Medicines” means the Commission on Human Medicines within the meaning of regulation 9 of the 2012 Regulations;”;\n(d) in the definition “licensing authority” for “section 6 of the Act” substitute “ regulation 6 of the 2012 Regulations ”;\n(e) for sub-paragraph (a) of the definition “marketing authorisation” substitute—\n“(a) a UK marketing authorisation granted by the licensing authority under the 2012 Regulations,”; and\n(f) for the definition “medicinal product” substitute—\n““medicinal product” means a medicinal product within the meaning of regulation 2(1) of the 2012 Regulations.”",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/34/paragraph/53",
    "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."
}