{
  "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-amendment-regulations-2018/regulation-9",
  "json_url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-amendment-regulations-2018/regulation-9.json",
  "legislation": "ukdsi/2018/9780111163450",
  "legislation_title": "The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018",
  "legislation_url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-amendment-regulations-2018",
  "path": "regulation/9",
  "kind": "regulation",
  "number": "9",
  "heading": "Amendments to the Act relating to the import of tissues or cells",
  "text": "(1) The Act is amended as follows.\n(2) In section 14 (remit of Human Tissue Authority)—\n(a) in subsection (1)(h)—\n(i) omit the word “preservation,”; and\n(ii) after the words “regulations 7(1)” insert “, (1A)”; and\n(b) in subsection (2A) after the words “regulation 7(1)” insert “, (1A)”.\n(3) In section 16 (licence requirement)—\n(a) in subsection (2A)—\n(i) omit the words “, preservation” and “intended for human application”; and\n(ii) after the words “regulation 7(1)” insert “, (1A)”; and\n(b) in subsection (2B) after the words “regulation 7(1)” insert “, (1A)”.\n(4) In paragraph 7(2) of Schedule 3 (revocation of licence otherwise than on application)—\n(a) omit “or” at the end of paragraph (f); and\n(b) after paragraph (g) insert—\n“or\n(h) it is not satisfied that any third country premises are suitable for carrying out activities in a manner which secures that tissues or cells imported from a third country by an importing licence holder meet standards of quality and safety equivalent to those laid down in the 2007 Regulations.”.\n(5) After paragraph 7(2) of Schedule 3 insert—\n“(3) For the purposes of sub-paragraph (2)(h), “importing licence holder”, “third country” and “third country premises” have the same meaning as in the 2007 Regulations.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Inserted by the Human Tissue (Quality and Safety for Human Application) Regulations 2007/1523, Part 6, regulation 31(2)."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Inserted by the Human Tissue (Quality and Safety for Human Application) Regulations 2007/1523, Part 6, regulation 31(2)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2018/9780111163450/regulation/9",
    "retrieved_at": "2026-10-30T15:05:39.390650+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."
}