{
  "url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-4",
  "json_url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-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": "regulation/4",
  "kind": "regulation",
  "number": "4",
  "heading": "References to Directives",
  "text": "In these Regulations—\n“the first Directive” means Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells ,\n“the second Directive” means Commission Directive 2006/17/EC implementing Directive 2004/23/EC of the European Parliament and of the Council of 8 February 2006 as regards certain technical requirements for the donation, procurement and testing of human tissues and cells , as amended by Commission Directive 2012/39/EU, and\n“the third Directive” means Commission Directive 2006/86/EC implementing Directive 2004/23/EC of the European Parliament and of the Council of 24 October 2006 as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells—\n(a)in relation to Great Britain, as it had effect immediately before 29th April 2015 (the date on which the amendments made by Commission Directive 2015/565/EU came into force); and\n(b)in relation to Northern Ireland, as amended by Commission Directive 2015/565/EU;\n“the fourth Directive” means Commission Directive 2015/566 of 8th April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 4 inserted (15.12.2014) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2014 (S.I. 2014/2883), regs. 1, 2"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 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(3) (as substituted by S.I. 2020/1306, regs. 1, 5); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 4 inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 2(3)(b)"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "OJ L102, 7.4.2004, p.48."
    },
    {
      "type": "M",
      "label": "M2",
      "text": "OJ L38, 9.2.2006, p.40."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2007/1523/regulation/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."
}