Directive 2001/20/EC of the European Parliament and of the CouncilShow full title

1. Introductory Text

2. Article 1. Scope

3. Article 2. Definitions

4. Article 3. Protection of clinical trial subjects

5. Article 4. Clinical trials on minors

6. Article 5. Clinical trials on incapacitated adults not able to give informed legal consent

7. Article 6. Ethics Committee

8. Article 7. Single opinion

9. Article 8. Detailed guidance

10. Article 9. Commencement of a clinical trial

11. Article 10. Conduct of a clinical trial

12. Article 11. Exchange of information

13. Article 12. Suspension of the trial or infringements

14. Article 13. Manufacture and import of investigational medicinal products

15. Article 14. Labelling

16. Article 15. Verification of compliance of investigational medicinal products with good clinical and manufacturing practice

17. Article 16. Notification of adverse events

18. Article 17. Notification of serious adverse reactions

19. Article 18. Guidance concerning reports

20. Article 19. General provisions

21. Article 20. The Commission shall adapt this Directive to take account of...

22. Article 21. (1) The Commission shall be assisted by the Standing Committee...

23. Article 22. Application

24. Article 23. Entry into force

25. Article 24. Addressees