Council of the European Union and European Parliament 7 July 2010, Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation

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European Union · · · Cited by 506 · 06-08-2010

CHAPTER I. SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1. Subject Matter
Article 2. Scope
Article 3. Definitions
CHAPTER II. THE QUALITY AND SAFETY OF ORGANS
Article 4. Framework for quality and safety
Article 5. Procurement organisations
Article 6. Organ procurement
Article 7. Organ and donor characterisation
Article 8. Transport of organs
Article 9. Transplantation centres
Article 10. Traceability
Article 11. Reporting system and management concerning serious adverse events and reactions
Article 12. Healthcare personnel
CHAPTER III. DONOR AND RECIPIENT PROTECTION AND DONOR SELECTION AND EVALUATION
Article 13. Principles governing organ donation
Article 14. Consent requirements
Article 15. Quality and safety aspects of living donation
Article 16. Protection of personal data, confidentiality and security of processing
CHAPTER IV. OBLIGATIONS OF COMPETENT AUTHORITIES AND EXCHANGE OF INFORMATION
Article 17. Designation and tasks of competent authorities
Article 18. Records and reports concerning procurement organisations and transplantation centres
Article 19. Exchange of information
CHAPTER V. ORGAN EXCHANGE WITH THIRD COUNTRIES AND EUROPEAN ORGAN EXCHANGE ORGANISATIONS
Article 20. Organ exchange with third countries
Article 21. European organ exchange organisations
CHAPTER VI. GENERAL PROVISIONS
Article 22. Reports concerning this Directive
Article 23. Penalties
Article 24. Adaptation of the Annex
Article 25. Exercise of the delegation
Article 26. Revocation of the delegation
Article 27. Objection to delegated acts
Article 28. Urgency procedure
Article 29. Implementing measures
Article 30. Committee
Article 31. Transposition
CHAPTER VII. FINAL PROVISIONS
Article 32. Entry into force
Article 33. Addressees

6.8.2010

Official Journal of the European Union

L 207/14

DIRECTIVE 2010/45/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 7 July 2010

on standards of quality and safety of human organs intended for transplantation

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular

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