{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-205",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-205.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/205",
  "kind": "regulation",
  "number": "205",
  "heading": "Obligations on holders in relation to public announcements",
  "text": "(1) This regulation applies where the holder intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product.\n(2) The holder must inform the bodies listed in paragraph (3) where the product is subject to a UKMA(NI), UKMA(UK)(Category 2), THR(NI), THR(UK) or Article 126a authorisation, or the licensing authority where the product is subject to a UKMA(GB) , UKMA(UK)(Category 1) or THR(GB), of its intention to make the public announcement—\n(a) as soon as is practicable once it forms that intention; and\n(b) in any event no later than at the same time as, or before, the public announcement is made.\n(3) The bodies listed in this paragraph are—\n(a) the licensing authority;\n(b) the EMA; and\n(c) the European Commission.\n(4) The holder must ensure that the information in the public announcement—\n(a) is presented objectively; and\n(b) is not misleading.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 205(2) inserted (31.12.2020) by S.I. 2019/775, reg. 166(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 133(a)); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 205(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 95(a)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 205(2) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 95(b)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/205",
    "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."
}