Revised Laws of Saint Lucia (2023)

• 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

• Schedule 1

• Schedule 2

• Schedule 3