{
  "url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-16",
  "json_url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-16.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/16",
  "kind": "regulation",
  "number": "16",
  "heading": "Directions: Great Britain",
  "text": "(1) The Authority shall give directions to licence holders or designated individuals under section 23(1) of the 2004 Act, as applied by regulation 8, in accordance with Schedule 2 for the purpose of securing compliance with the requirements of these Regulations, as they apply in relation to Great Britain.\n(2) The Authority shall give such other directions to licence holders or designated individuals under section 23(1) of that Act, as applied by regulation 8, as it considers necessary for securing compliance by licence holders and third parties with any requirements of these Regulations, as they apply in relation to Great Britain.\n(3) In this regulation, the references to securing compliance with these Regulations include a reference to securing compatibility with the principles set out in Article 12 of the first Directive as modified by section 32(3B) of the 2004 Act.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 16 heading substituted (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), 4(2)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 16(1) 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(10)(b) (as amended by S.I. 2020/1306, regs. 1, 13(b)); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 16(2) 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(10)(b) (as amended by S.I. 2020/1306, regs. 1, 13(b)); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 16(3) 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(10)(c); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Reg. 16 heading 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(10)(a) (as substituted by S.I. 2020/1306, regs. 1, 13(a)); 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/16",
    "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."
}