{
  "url": "https://openlegislation.uk/eu-directive-2015-565/annex-I",
  "json_url": "https://openlegislation.uk/eu-directive-2015-565/annex-I.json",
  "legislation": "eudr/2015/565",
  "legislation_title": "Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2015-565",
  "path": "annex/I",
  "kind": "annex",
  "number": "I",
  "heading": null,
  "text": "The Annexes to Directive 2006/86/EC are amended as follows:\n(1) Annex II, Part E, is amended as follows:\n(a) in point 1 the following point (g) is added:\n‘(g)\nSingle European Code as applicable to the tissues and cells being distributed for human application or the donation identification sequence as applicable to the tissues and cells released for circulation, other than distributed for human application’;\n(b) the second subparagraph of point 1 is replaced by the following:\n‘If any of the information under points (d), (e) and (g) above cannot be included on the primary container label, it must be provided on a separate sheet accompanying the primary container. This sheet must be packaged with the primary container in a manner that ensures that they remain together.’;\n(c) in point 2, the following point (j) is added:\n‘(j)\nfor imported tissues and cells, the country of procurement and the exporting country (if different from the procurement country)’.\n(2) Annexes III and IV are replaced by the following:\nANNEX III\nNOTIFICATION OF SERIOUS ADVERSE REACTIONS\nPART A\nRapid notification for suspected serious adverse reactions\nTissue establishment\nEU tissue establishment code (if applicable)\nReport identification\nReporting date (year/month/day)\nIndividual affected (recipient or donor)\nDate and place of procurement or human application (year/month/day)\nUnique donation identification number\nDate of suspected serious adverse reaction (year/month/day)\nType of tissues and cells involved in the suspected serious adverse reaction\nSingle European Code of tissues or cells involved in the suspected serious adverse reaction (if applicable)\nType of suspected serious adverse reaction(s)\nPART B\nConclusions of Serious Adverse Reactions Investigation\nTissue establishment\nEU tissue establishment code (if applicable)\nReport identification\nConfirmation date (year/month/day)\nDate of serious adverse reaction (year/month/day)\nUnique donation identification number\nConfirmation of serious adverse reaction (Yes/No)\nSingle European Code of tissues or cells involved in the confirmed serious adverse reaction (if applicable)\nChange of type of serious adverse reaction (Yes/No) If YES, specify\nClinical outcome (if known)\nComplete recovery\nMinor sequelae\nSerious sequelae\nDeath\nOutcome of the investigation and final conclusions\nRecommendations for preventive and corrective actions\nANNEX IV\nNOTIFICATION OF SERIOUS ADVERSE EVENTS\nPART A\nRapid notification for suspected serious adverse events\nTissue establishment\nEU tissue establishment code (if applicable)\nReport identification\nReporting date (year/month/day)\nDate of serious adverse event (year/month/day)\nSerious adverse event, which may affect quality and safety of tissues and cells due to a deviation in:\nSpecification\nTissues and cells defect\nEquipment failure\nHuman error\nOther (specify)\nProcurement\nTesting\nTransport\nProcessing\nStorage\nDistribution\nMaterials\nOthers (specify)\nPART B\nConclusions of Serious Adverse Events investigation\nTissue establishment\nEU tissue establishment code (if applicable)\nReport identification\nConfirmation date (year/month/day)\nDate of serious adverse event (year/month/day)\nRoot cause analysis (details)\nCorrective measures taken (details)\n(3) Annexes VI and VII are replaced by the following:\nANNEX VI\nMinimum data to be kept in accordance with Article 9(2)\nA.\nBY TISSUE ESTABLISHMENTS\n(1)\nDonor identification\n(2)\nDonation identification that will include at least:\nIdentification of the procurement organisation (including contact details) or the tissue establishment\nUnique donation number\nDate of procurement\nPlace of procurement\nType of donation (e.g. single v multi-tissue; autologous v allogenic; living v deceased)\n(3)\nProduct identification that will include at least:\nIdentification of the tissue establishment\nType of tissue and cell/product (basic nomenclature)\nPool number (in case of pooling)\nSplit number (if applicable)\nExpiry date (if applicable)\nTissue/cell status (i.e. quarantined, suitable for use, etc.)\nDescription and origin of the products, processing steps applied, materials and additives coming into contact with tissues and cells and having an effect on their quality and/or safety.\nIdentification of the facility issuing the final label\n(4)\nSingle European Code (if applicable)\n(5)\nHuman application identification that will include at least:\nDate of distribution/disposal\nIdentification of the clinician or end-user/facility\nB.\nBY ORGANISATIONS RESPONSIBLE FOR HUMAN APPLICATION\n(1)\nIdentification of the supplier tissue establishment\n(2)\nIdentification of the clinician or end-user/facility\n(3)\nType of tissues and cells\n(4)\nProduct identification\n(5)\nIdentification of the recipient\n(6)\nDate of application\n(7)\nSingle European Code (if applicable)\nANNEX VII\nTHE STRUCTURE OF THE SINGLE EUROPEAN CODE\nDONATION IDENTIFICATION SEQUENCE\nPRODUCT IDENTIFICATION SEQUENCE\nEU TISSUE ESTABLISHMENT CODE\nUNIQUE DONATION NUMBER\nPRODUCT CODE\nSPLIT NUMBER\nEXPIRY DATE\n(YYYYMMDD)\nISO country code\nTissue establishment number\nProduct Coding System identifier\nProduct number\n2 alphabetic characters\n6 alpha-numeric characters\n13 alpha-numeric characters\n1 alphabetic character\n7 alpha-numeric characters\n3 alpha-numeric characters\n8 numeric characters",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2015/565/annex/I",
    "retrieved_at": "2026-11-01T15:21:39.894922+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."
}