{
  "url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/schedule-2/paragraph-15",
  "json_url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/schedule-2/paragraph-15.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": "schedule/2/paragraph/15",
  "kind": "paragraph",
  "number": "15",
  "heading": "Updated information",
  "text": "(1) Directions must require that importing licence holders must not make any substantial changes in connection with any qualifying import made by that licence holder unless the requirement in sub-paragraph (2) or (3) is met.\n(2) The requirement of this sub-paragraph is where the substantial change would require the variation of a condition of the licence authorising the qualifying import—\n(a) the importing licence holder has made an application to the Authority to vary the licence under paragraph 8(2) of Schedule 3 to the 2004 Act, as applied by regulation 8, to reflect the change; and\n(b) the Authority has made that variation.\n(3) The requirement in this sub-paragraph is where the substantial change does not fall within sub-paragraph (2), the Authority has approved the change in writing.\n(4) Directions must require that importing licence holders must notify the Authority—\n(a) if the licence holder ceases to make qualifying imports; and\n(b) of any changes in circumstances of the importing licence holder’s third country supplier of which the importing licence holder is aware.\n(5) In this paragraph—\n“changes of circumstances” means any changes in circumstances of the description specified in the direction in question in accordance with the provision made in Article 6(3) of the fourth Directive (notification of revocation of third country’s authorisation);\n“qualifying import” means the import ... from a third country of tissues or cells intended for human application;\n“qualifying tissues or cells” means tissues or cells intended for human application; and\n“substantial changes” means changes of the description specified in the direction in question in accordance with the provision as to the meaning of substantial changes made in Article 3(3) of the fourth Directive (requirements where substantial changes made to import activities).",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 2 paras. 15, 16 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), 8(1)(g)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Sch. 2 para. 15(5) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(f) (as inserted by S.I. 2020/1306, regs. 1, 25(g)); 2020 c. 1, Sch. 5 para. 1(1); 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/schedule/2/paragraph/15",
    "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."
}