Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (c. 23)

1. Introductory Text

2. CHAPTER I GENERAL PROVISIONS

   1. Article 1. Objective

   2. Article 2. Scope

   3. Article 3. Definitions

   4. Article 4. Implementation

3. CHAPTER II OBLIGATIONS ON MEMBER STATES' AUTHORITIES

   1. Article 5. Supervision of human tissue and cell procurement

   2. Article 6. Accreditation, designation, authorisation or licensing of tissue establishments and tissue and cell preparation processes

   3. Article 7. Inspections and control measures

   4. Article 8. Traceability

   5. Article 9. Import/export of human tissues and cells

   6. Article 10. Register of tissue establishments and reporting obligations

   7. Article 11. Notification of serious adverse events and reactions

4. CHAPTER III DONOR SELECTION AND EVALUATION

   1. Article 12. Principles governing tissue and cell donation

   2. Article 13. Consent

   3. Article 14. Data protection and confidentiality

   4. Article 15. Selection, evaluation and procurement

5. CHAPTER IV PROVISIONS ON THE QUALITY AND SAFETY OF TISSUES AND CELLS

   1. Article 16. Quality management

   2. Article 17. Responsible person

   3. Article 18. Personnel

   4. Article 19. Tissue and cell reception

   5. Article 20. Tissue and cell processing

   6. Article 21. Tissue and cell storage conditions

   7. Article 22. Labelling, documentation and packaging

   8. Article 23. Distribution

   9. Article 24. Relations between tissue establishments and third parties

6. CHAPTER V EXCHANGE OF INFORMATION, REPORTS AND PENALTIES

   1. Article 25. Coding of information

   2. Article 26. Reports

   3. Article 27. Penalties

7. CHAPTER VI CONSULTATION OF COMMITTEES

   1. Article 28. Technical requirements and their adaptation to scientific and technical progress

   2. Article 29. Committee

   3. Article 30. Consultation of one or more scientific committees

8. CHAPTER VII FINAL PROVISIONS

   1. Article 31. Transposition

   2. Article 32. Entry into force

   3. Article 33. Addressees

9. 1. ANNEX

      INFORMATION TO BE PROVIDED ON THE DONATION OF CELLS AND/OR TISSUES

      1. A. Living donors

         1. 1. The person in charge of the donation process shall ensure...

         2. 2. The information must be given by a trained person able...

         3. 3. The information must cover: the purpose and nature of the...

         4. 4. The donor must be informed that he/she has the right...

         5. 5. Information must be given on the necessity for requiring the...

      2. B. Deceased donors

         1. 1. All information must be given and all necessary consents and...

         2. 2. The confirmed results of the donor's evaluation must be communicated...