{
  "url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-4E",
  "json_url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-4E.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/4E",
  "kind": "regulation",
  "number": "4E",
  "heading": "Modifications to the fourth Directive",
  "text": "(1) The modifications to the fourth Directive are as follows.\n(2) The Directive is to be read as if references to a third country were references to any country other than the United Kingdom.\n(3) Article 2 is to be read as if for “the Union”, in each place where it occurs, there were substituted “Great Britain”.\n(4) Article 5(1) is to be read as if—\n(a) for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;\n(b) the references to the competent authority or authorities were references to the Authority.\n(5) Article 6 is to be read as if—\n(za) in paragraph 1, the reference to the competent authority or authorities were a reference to the Authority;\n(a) in paragraph 2—\n(i) the reference to the competent authority or authorities were a reference to the Authority;\n(ii) the words from “The information laid out” to the end were omitted;\n(b) in paragraph 3—\n(i) the first reference to the competent authority or authorities were a reference to the Authority;\n(ii) the reference to the competent authority or authorities in subparagraph (b) were a reference to the authority in the third country concerned responsible for regulating tissue establishments in that country.\n(6) Article 7 is to be read as if—\n(a) in paragraph 1—\n(i) in the first subparagraph, for “the Union”, in each place where it occurs, there were substituted “Great Britain”;\n(ii) for the second subparagraph, there were substituted “ This requirement does not apply to one-off imports as defined in regulation 11(4C)(a) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 provided that the requirements in regulation 11(4B) of those regulations are met. ”;\n(b) in paragraph 2, for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;\n(c) in paragraph 3, the reference to the competent authority or authorities were a reference to the Authority;\n(d) in paragraph 4, the reference to the competent authority or authorities were a reference to the Authority.\n(7) Article 8(1) is to be read as if the word “annual” were omitted.\n(8) Annex 1 is to be read as if—\n(a) in paragraph A.4, for “TE compendium code” there were substituted “ reference number previously allocated to the tissue establishment by the Authority ”;\n(b) in paragraph B.4, the reference to the Responsible Person were a reference to the designated individual in accordance with regulations 11 and 12 of these Regulations;\n(c) in paragraph C.2, the words “(where applicable, in accordance with the EU generic list)” were omitted;\n(d) in paragraph F.3, the references to a third country competent authority or authorities were references to the authority in the third country responsible for regulating tissue establishments in that country.\n(9) Annex 3 is to be read as if—\n(a) in the first paragraph, the reference to the competent authority or authorities were a reference to the Authority;\n(b) in paragraph A.1, for “as laid down in Directive 2004/23/EC” there were substituted “ in accordance with regulations 11 and 12 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;\n(c) in paragraph A.3, the words “applying the Single European Code,” were omitted;\n(d) in paragraph B.7, the reference to a third country competent authority or authorities were a reference to the authority in the third country responsible for regulating tissue establishments in that country.\n(10) Annex 4 is to be read as if—\n(a) in paragraph 1, for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;\n(b) in paragraph 4, the reference to a third country competent authority or authorities were a reference to the authority in the third country responsible for regulating tissue establishments in that country;\n(c) in paragraph 5, the reference to the competent authority or authorities were a reference to the Authority;\n(d) in paragraph 7, for “EU data protection rules” there were substituted “ data protection legislation within the meaning of section 3(9) of the Data Protection Act 2018 ”;\n(e) in paragraph 8, for the words from “requirements” to the end there were substituted “ quality and safety standards required by 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/4E",
    "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."
}