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2023 Laws not yet authenticated through a Commencement Order

Revised Laws of Saint Lucia (2023)

Back to Revised Laws of Saint Lucia (2023)

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ACT

(Act No. 10 of 2016)

Act 10 of 2016 .. in force On Order

ARRANGEMENT OF SECTIONS

PRELIMINARY

1.	Short title and commencement
2.	Interpretation
3.	Act binds the Crown
4.	Application and non-application
5.	Application of other laws

PART 1
ADMINISTRATION

6.	Ethics Committee
7.	National Competent Authority
8.	Electronic database system on clinical trials
9.	Annual report

PART 2
CLINICAL TRIALS

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

PART 3
ENFORCEMENT

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

PART 4
APPEALS

30.	Establishment of Appeals Board
31.	Constitution and procedure
32.	Further appeal

PART 5
MISCELLANEOUS

33.	General penalty
34.	Amendment of Schedules
35.	Regulations
Schedule 1
Schedule 2
Schedule 3

AN ACT to establish a clinical trials framework and to institute good clinical practice principles in the design, conduct, documentation and reporting of clinical trials in Saint Lucia, and for related matters.

Commencement [ON ORDER]

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

1. Short title and commencement

2. Interpretation

3. Act binds the Crown

4. Application and non-application

5. Application of other laws

PART 1 ADMINISTRATION

6. Ethics Committee

7. National Competent Authority

8. Electronic database system on clinical trials

9. Annual report

PART 2 CLINICAL TRIALS

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

PART 3 ENFORCEMENT

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

PART 5 MISCELLANEOUS

33. General penalty

34. Amendment of Schedules

35. Regulations

PART 1 APPLICATION AND INTERPRETATION

PART 2 CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS

PART 3 CONDITIONS WHICH APPLY IN RELATION TO AN ADULT ABLE TO CONSENT OR WHO HAS GIVEN CONSENT PRIOR TO THE ONSET OF INCAPACITY

PART 4 CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO A MINOR

PART 5 CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO AN INCAPACITATED ADULT

SUBSIDIARY LEGISLATION