{
  "url": "https://openlegislation.uk/blood-safety-and-quality-regulations-2005/regulation-16",
  "json_url": "https://openlegislation.uk/blood-safety-and-quality-regulations-2005/regulation-16.json",
  "legislation": "uksi/2005/50",
  "legislation_title": "The Blood Safety and Quality Regulations 2005",
  "legislation_url": "https://openlegislation.uk/blood-safety-and-quality-regulations-2005",
  "path": "regulation/16",
  "kind": "regulation",
  "number": "16",
  "heading": "Records to be kept by the Secretary of State",
  "text": "(1) The Secretary of State shall keep such records of information which he receives from, or relating to, blood establishments as he considers appropriate and shall, in particular, keep records relating to—\n(a) authorisations under regulation 4;\n(b) the designation of responsible persons under regulation 6;\n(c) notification of serious adverse events and serious adverse reactions by such establishments pursuant to regulation 12B;\n(d) inspections or requests for information under regulation 15;\n(e) the operation, during the period from 8th February 2005 to 7th November 2005, of blood establishments licensed under section 8 of the Medicines Act 1968.\n(2) The Secretary of State shall keep such records of information which he receives from persons responsible for management of hospital blood banks and facilities, or otherwise ... relating to hospital blood banks or facilities, as he considers appropriate and shall, in particular keep records relating to—\n(a) notification of serious adverse events and serious adverse reactions pursuant to regulation 12B;\n(b) the information supplied by hospital blood banks pursuant to regulation 10;\n(c) inspections or requests for information under regulation 15.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 16(1)(c) substituted (1.4.2007) by The Blood Safety and Quality (Amendment) Regulations 2007 (S.I. 2007/604), regs. 1(1), 3(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 16(1)(e) substituted (8.4.2005) by The Blood Safety and Quality (Amendment) Regulations 2005 (S.I. 2005/1098), regs. 1(1), 5"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 16(2) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 10(a)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Word in reg. 16(2) omitted (31.8.2006) by virtue of The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 10(b)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in reg. 16(2) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 10(c)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Words in reg. 16(2)(a) substituted (1.4.2007) by The Blood Safety and Quality (Amendment) Regulations 2007 (S.I. 2007/604), regs. 1(1), 3(b)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2005/50/regulation/16",
    "retrieved_at": "2026-10-29T05:11:46.706072+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."
}