{
  "url": "https://openlegislation.uk/eu-decision-2010-453",
  "json_url": "https://openlegislation.uk/eu-decision-2010-453.json",
  "id": "eudn/2010/453",
  "title": "Commission Decision of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council (notified under document C(2010) 5278) (Text with EEA relevance) (2010/453/EU)",
  "short_title": "Commission Decision of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council (notified under document C(2010) 5278) (2010/453/EU)",
  "long_title": "Commission Decision of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council (notified under document C(2010) 5278) (Text with EEA relevance) (2010/453/EU)",
  "citation": "EU Decision 2010/453",
  "type": "eudn",
  "year": "2010",
  "number": "453",
  "version": "current",
  "date": "2010-08-03",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-decision-2010-453/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-decision-2010-453/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-decision-2010-453/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-decision-2010-453/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex",
      "kind": "annex",
      "number": null,
      "heading": "GUIDELINES CONCERNING INSPECTIONS AND CONTROL MEASURES, AND ON THE TRAINING AND QUALIFICATION OF OFFICIALS, IN THE FIELD OF HUMAN TISSUES AND CELLS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/division/1",
      "kind": "division",
      "number": "1",
      "heading": "Purpose of the guidelines",
      "url": "https://openlegislation.uk/eu-decision-2010-453/annex/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex"
    },
    {
      "path": "annex/division/2",
      "kind": "division",
      "number": "2",
      "heading": "Responsibilities of the inspectors",
      "url": "https://openlegislation.uk/eu-decision-2010-453/annex/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex"
    },
    {
      "path": "annex/division/3",
      "kind": "division",
      "number": "3",
      "heading": "Qualifications of inspectors",
      "url": "https://openlegislation.uk/eu-decision-2010-453/annex/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex"
    },
    {
      "path": "annex/division/4",
      "kind": "division",
      "number": "4",
      "heading": "Training of inspectors",
      "url": "https://openlegislation.uk/eu-decision-2010-453/annex/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex"
    },
    {
      "path": "annex/division/5",
      "kind": "division",
      "number": "5",
      "heading": "Types of inspections",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex"
    },
    {
      "path": "annex/division/5/division/5.1",
      "kind": "division",
      "number": "5.1",
      "heading": "Different types of inspection may be carried out:",
      "url": "https://openlegislation.uk/eu-decision-2010-453/annex/division-5/division-5.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/5"
    },
    {
      "path": "annex/division/5/division/5.2",
      "kind": "division",
      "number": "5.2",
      "heading": "In addition some particular inspections can be done:",
      "url": "https://openlegislation.uk/eu-decision-2010-453/annex/division-5/division-5.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/5"
    },
    {
      "path": "annex/division/6",
      "kind": "division",
      "number": "6",
      "heading": "Inspections scheduling",
      "url": "https://openlegislation.uk/eu-decision-2010-453/annex/division-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex"
    },
    {
      "path": "annex/division/7",
      "kind": "division",
      "number": "7",
      "heading": "Conduct of inspections",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex"
    },
    {
      "path": "annex/division/7/division/7.1",
      "kind": "division",
      "number": "7.1",
      "heading": "Where resources allow, the team should be composed of members with different competences.",
      "url": "https://openlegislation.uk/eu-decision-2010-453/annex/division-7/division-7.1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/7"
    },
    {
      "path": "annex/division/7/division/7.2",
      "kind": "division",
      "number": "7.2",
      "heading": "An inspection report should be sent after the inspection to the tissue establishment or third party inspected. The conclusions of the report should clearly identify the deficiencies observed.",
      "url": "https://openlegislation.uk/eu-decision-2010-453/annex/division-7/division-7.2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/division/7"
    },
    {
      "path": "annex/division/8",
      "kind": "division",
      "number": "8",
      "heading": "Inspectorate quality management system",
      "url": "https://openlegislation.uk/eu-decision-2010-453/annex/division-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2010/453",
    "retrieved_at": "2026-10-31T18:05:35.024671+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."
}