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Revised Laws of Saint Lucia (2021)

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PRELIMINARY

1. Short title and commencement

(1) This Act may be cited as the Clinical Trials Act, 2016.

(2) This Act shall come into operation on a day to be fixed by the Minister by Order published in the Gazette.

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1. Short title and commencement

2. Interpretation

3. Act binds the Crown

4. Application and non-application

5. Application of other laws

6. Ethics Committee

7. National Competent Authority

8. Electronic database system on clinical trials

9. Annual report

10. Restriction on clinical trial

11. Application for opinion of Ethics Committee

12. Opinion of Ethics Committee

13. Application for authorization

14. Consideration of application for authorization

15. Grant or refusal of application for authorization

16. Withdrawal of application

17. Notice of substantial modification

18. Withdrawal, revocation and suspension

19. Conditions and principles of good clinical practice

20. Urgent safety measures

21. Notification of serious adverse events

22. Notification of suspected unexpected serious adverse reactions

23. Annual list of suspected serious adverse reactions and safety report

24. Infringement notice

25. Sale or supply of investigational medicinal product or investigational medical device

26. False or misleading information

27. Limitation on prosecution

28. Prosecution of offences

29. Payment of compensation

30. Establishment of Appeals Board

31. Constitution and procedure

32. Further appeal

33. General penalty

34. Amendment of Schedules

35. Regulations