{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-98",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-98.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/98",
  "kind": "regulation",
  "number": "98",
  "heading": "General offence of breach of provision of this Part",
  "text": "(1) A person is guilty of an offence if that person commits a breach of a provision in this Part.\n(2) A breach of a provision in this Part includes any—\n(a) failure by the holder of a marketing authorisation or parallel import licence to comply with any requirement or obligation in this Part:\n(b) contravention by any person of any prohibition in this Part; or\n(c) failure to comply with any requirement imposed on a person by the licensing authority pursuant to this Part.\n(3) Paragraph (1) is without prejudice to any offence established by any other provision in this Part.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 98(2)(a) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 98(2)(a) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(p)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/98",
    "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."
}