{
  "url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-4C",
  "json_url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-4C.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/4C",
  "kind": "regulation",
  "number": "4C",
  "heading": "Modifications to the second Directive",
  "text": "(1) The modifications to the second Directive are as follows.\n(2) Article 2 is to be read as if, in paragraph 1, the reference to Member States were a reference to the Authority.\n(3) Articles 3, 4 and 5 are to be read as if any reference to the competent authority or authorities were a reference to the Authority.\n(4) Annex 1 is to be read as if, in the first paragraph, for “responsible person as defined in Article 17 of Directive 2004/23/EC” there were substituted “ designated individual in accordance with regulations 11 and 12 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;\n(5) Annex 2 is to be read as if, in paragraph 2.1 the reference to the competent authority in the Member State were a reference to the Authority.\n(6) Annex 3 is to be read as if, in paragraph 3.6, for “in force in Member States” there were substituted “ of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”.\n(7) Annex 4 is to be read as if—\n(a) in paragraphs 1.1.1 and 1.2.1, the reference to an authorised person were to—\n(i) the designated individual in accordance with regulations 11 and 12 of these Regulations, or\n(ii) a person authorised to carry out the specified tasks by—\n(aa) the designated individual, or\n(bb) the Authority;\n(b) in paragraph 1.1.1(a), for “Article 13 of Directive 2004/23/EC” there were substituted “ the Human Tissue Act 2004, the Human Tissue (Scotland) Act 2006 or the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ”;\n(c) in paragraph 1.4.4 the reference to the competent authority were a reference to the Authority.",
  "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/4C",
    "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."
}