{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-207",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-207.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/207",
  "kind": "regulation",
  "number": "207",
  "heading": "Offences",
  "text": "(1) A person is guilty of an offence if the person commits a breach of a provision in this Part, other than Schedule 12A (further requirements in respect of pharmacovigilance activities) and regulation 199(2) or (6) (submission of draft study protocols for required studies).\n(2) A breach of a provision in this Part includes any—\n(a) failure by a holder to comply with any requirement or obligation in this Part; or\n(b) contravention by any person of any prohibition in this Part.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 207(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 171; 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/207",
    "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."
}