{
  "url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/schedule-2/paragraph-4",
  "json_url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/schedule-2/paragraph-4.json",
  "legislation": "uksi/2007/1523",
  "legislation_title": "The Human Tissue (Quality and Safety for Human Application) Regulations 2007",
  "legislation_url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007",
  "path": "schedule/2/paragraph/4",
  "kind": "paragraph",
  "number": "4",
  "heading": null,
  "text": "In relation to Great Britain, directions shall require licence holders to adopt such—\n(a) systems to report, investigate, register and transmit information about serious adverse events and serious adverse reactions, and\n(b) accurate, rapid and verifiable procedures for recalling from distribution any product which may be related to a serious adverse event or serious adverse reaction,\nas the Authority considers appropriate.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 2 para. 4 substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(c)(i) (as substituted by S.I. 2020/1306, regs. 1, 25(d)); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Sch. 2 para. 4 substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(c)(ii) (as substituted by S.I. 2020/1306, regs. 1, 25(d)); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2007/1523/schedule/2/paragraph/4",
    "retrieved_at": "2026-10-29T03:52:01.998683+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."
}