{
  "url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-4D",
  "json_url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-4D.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/4D",
  "kind": "regulation",
  "number": "4D",
  "heading": "Modifications to the third Directive",
  "text": "(1) The modifications to the third Directive are as follows.\n(2) Annex 1 is to be read as if—\n(a) in paragraph A.1—\n(i) for “responsible person” there were substituted “ designated individual ”;\n(ii) for “as provided in Article 17 of Directive 2004/23/EC there were substituted “ in accordance with the requirements of regulations 11 and 12 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;\n(b) in paragraph A.4, for “laid down in this Directive” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;\n(c) in paragraph C.6, for the words from “the requirements of Council” to the end there were substituted “ the requirements of the Medical Devices Regulations 2002 ”;\n(d) in paragraph D.1, for “laid down in this Directive” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;\n(e) in paragraph E.1, for “laid down in this Directive” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;\n(f) in paragraph E.8, the reference to the competent authority were a reference to the Authority.\n(3) Annex 2 is to be read as if—\n(a) in the first paragraph the reference to the competent authority were a reference to the Authority;\n(b) in paragraph A, for the words from “the tissues and cells must” to the end there were substituted “ tissue establishment procedures must ensure that the licence conditions in paragraph 12 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 are met ”;\n(c) in paragraph B.3, for the words from “the standards” to the end there were substituted “ the requirements of paragraph 13 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;\n(d) in paragraph B.8, the second sentence were omitted;\n(e) in paragraph C.2, for “laid down in this Directive” there were substituted “ of paragraph 14 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;\n(f) in paragraphs C.4 and C.5, any reference to the responsible person as defined or specified in Article 17 of Directive 2004/23/EC were a reference to the designated individual in accordance with regulations 11 and 12 of these Regulations;\n(g) in paragraph D.5, the reference to the competent authority were a reference to the Authority;\n(h) in paragraph E.2(h), for “as set out in Articles 5 to 6” there were substituted “ in accordance with paragraph 4 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 4A-4E inserted (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(4) (as amended by S.I. 2020/1306, regs. 1, 6); 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/regulation/4D",
    "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."
}