{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-190",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-190.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/190",
  "kind": "regulation",
  "number": "190",
  "heading": "Signal detection: holder obligation",
  "text": "(1) The holder must inform—\n(a) the licensing authority, and\n(b) in respect of a UKMA(UK)(Category 2), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the EMA,\nwithout delay if it detects any relevant changes in relation to the product.\n(2) In this regulation, “relevant changes” has the meaning given in regulation 189(5).",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 190(1) substituted (31.12.2020) by S.I. 2019/775, reg. 150 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 117)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 190(1)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 81"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/190",
    "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."
}