{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-256M",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-256M.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/256M",
  "kind": "regulation",
  "number": "256M",
  "heading": "Offences: breach of regulations and false information",
  "text": "(1) A person is guilty of an offence if the person—\n(a) contravenes regulation 256B(1); or\n(b) offers medicinal products for sale at a distance otherwise than in accordance with the conditions in regulation 256H.\n(2) A person is guilty of an offence if the person knowingly gives false information in—\n(a) an application to be entered on the list in accordance with regulation 256C(2);\n(b) an application for a variation in accordance with regulation 256L(2); or\n(c) response to a notice under regulation 256L(4).\n(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 256F(3) or 256L(4).\n(4) A person is guilty of an offence if that person fails to inform the licensing authority—\n(a) of a falsified medicinal product in accordance with regulation 256F(1); or\n(b) about a material change of circumstances in accordance with regulation 256F(2).\n(5) It is a defence for a person charged with an offence under paragraph (4) to show that the person exercised all due diligence to avoid committing the offence.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Pt. 12A inserted (coming into force in accordance with reg. 1(2) of the amending S.I.) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(2), 28"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in regs. 256C-256M substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 197(4) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 151); 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/256M",
    "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."
}