{
  "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/schedule-2/paragraph-12",
  "json_url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/schedule-2/paragraph-12.json",
  "legislation": "ukdsi/2007/9780110768342",
  "legislation_title": "The Human Tissue (Quality and Safety for Human Application) Regulations 2007",
  "legislation_url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007",
  "path": "schedule/2/paragraph/12",
  "kind": "paragraph",
  "number": "12",
  "heading": null,
  "text": "In respect of—\n(a) donation and procurement procedures, and\n(b) the reception of tissue and cells at premises specified in a licence under Schedule 1,\ndirections shall be given for the purpose of securing compliance with the requirements of Article 15(3) (selection, evaluation and procurement) and Article 19(4) to (6) (tissue and cell reception) of the first Directive and with the requirements laid down in the provisions of the second Directive listed in the right-hand column, the subject-matter of which are described in the left-hand column in respect of those provisions.\nRelevant provisions of the second Directive\n1. Donation and procurement procedures\nConsent and donor identification (record of consent, method of identification, donor interview)\nAnnex IV, point 1.1\nDonor evaluation: other than autologous donors (assessment of donor’s medical and behavioural information and physical examinations)\nAnnex IV, point 1.2\nProcurement procedures for tissue and cells (requirements relating to procurement procedures and instruments)\nAnnex IV, point 1.3\nDonor documentation (record of donor and the procurement)\nAnnex IV, point 1.4\nPackaging (requirements as to packaging and shipping containers)\nAnnex IV, point 1.5\nLabelling of the procured tissue and cells (minimum labelling requirements)\nAnnex IV, point 1.6\nLabelling of the shipping container (minimum labelling requirements)\nAnnex IV, point 1.7\n2. Reception of tissue and cells at the tissue establishment\nVerification upon arrival (procedures for verification and requirement for quarantine until verification)\nAnnex IV, point 2.1 to 2.3\nRegistration of data\nAnnex IV, point 2.4",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2007/9780110768342/schedule/2/paragraph/12",
    "retrieved_at": "2026-10-30T15:18:10.370919+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."
}