{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-335",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-335.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/335",
  "kind": "regulation",
  "number": "335",
  "heading": "Contravention due to fault of another person",
  "text": "(1) This regulation applies where—\n(a) a contravention of a provision referred to in paragraph (6) constitutes an offence; and\n(b) a person (“A”) contravenes the provision by reason of the act or omission of another person (“B”).\n(2) B may be charged with and convicted of the offence, whether or not proceedings are also brought against A.\n(3) If B is convicted B is liable to the same punishment as would have been imposed on A if A had been convicted of the offence.\n(4) If A is charged with the offence it is a defence for A to prove on the balance of probabilities that—\n(a) A exercised all due diligence to avoid contravening the provision; and\n(b) the contravention was due to the act or omission of B.\n(5) A may not rely on the defence in paragraph (4) unless not later than seven clear days before the date of the hearing A serves on the prosecutor a notice in writing of any information held by A which identifies, or assists in identifying, B.\n(6) The provisions mentioned in paragraph (1) are—\n(a) regulation 251 (compliance with standards specified in certain publications);\n(b) regulations 268, 268A, 269 and 269A (offences relating to packaging and package leaflets);\n(c) regulation 273 (child resistant containers for regulated medicinal products);\n(d) regulation 275 (colouring of aspirin and paracetamol products for children);\n(e) any prohibition or requirement in Chapter 2 of Part 14 (advertising); and\n(f) regulations 305(4) and 306(7) and (8) (notices not to publish, or to cease to publish, an advertisement.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 335(6)(b) substituted (31.12.2020) by S.I. 2019/775, reg. 224ZA (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 183)"
    },
    {
      "type": "C",
      "label": "C1",
      "text": "Regs. 332-339 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/335",
    "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."
}