{
  "url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/schedule-2/paragraph-13",
  "json_url": "https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-regulations-2007/schedule-2/paragraph-13.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/13",
  "kind": "paragraph",
  "number": "13",
  "heading": null,
  "text": "Directions shall be given for the purpose of securing compliance with the requirements laid down in the provisions of the third 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 third Directive\nOrganisation and management (requirements as to organisational structure, management systems, and third party agreements)\nAnnex I, Part A\nPersonnel (number, competence, responsibilities and training)\nAnnex I, Part B\nEquipment and materials (appropriate for use, validation, maintenance, and specifications)\nAnnex I, Part C\nFacilities and premises (suitability, environment, storage, and maintenance)\nAnnex I, Part D\nDocumentation and records (standard operating procedures, document control, record reliability)\nAnnex I, Part E\nQuality review (quality management system, investigations, corrective action, and reviews)\nAnnex I, Part F",
  "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/13",
    "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."
}