Clinical Trials Regulations (S.L. 458.43)

Содержание

1. ст. 1 Citation.
2. ст. 2 Scope. Cap. 458.
3. ст. 3 Definitions.
4. ст. 4 Protection of clinical trial subjects. Cap. 586.
5. ст. 5 Clinical trials on minors.
6. ст. 6 Clinical trials on incapacitated adults not able to giveinformedlegal consent.
7. ст. 7 Ethics Committee.
8. ст. 8 Single opinion.
9. ст. 9 Commencement of a clinical trial. Cap. 458.
10. ст. 10 Conduct of a clinical trial.
11. ст. 11 Exchange of information.
12. ст. 12 Suspension of the trial or infringements.
13. ст. 13 Authorisation for the manufacture and import of investigational medicinal products.
14. ст. 14 Manufacture and import of investigational medicinal products. S.L. 458.36 S.L. 458.36
15. ст. 15 Labelling.
16. ст. 16 Verification of compliance of investigational medicinal products with good clinical and manufacturing practice.
17. ст. 17 Notification of adverse events.
18. ст. 18 Notification of serious adverse reactions.
19. ст. 19 General provisions.