MT · S.L. 458.43
Clinical Trials Regulations (S.L. 458.43)
Inhoud
- Art. 1 Citation.
- Art. 2 Scope. Cap. 458.
- Art. 3 Definitions.
- Art. 4 Protection of clinical trial subjects. Cap. 586.
- Art. 5 Clinical trials on minors.
- Art. 6 Clinical trials on incapacitated adults not able to giveinformedlegal consent.
- Art. 7 Ethics Committee.
- Art. 8 Single opinion.
- Art. 9 Commencement of a clinical trial. Cap. 458.
- Art. 10 Conduct of a clinical trial.
- Art. 11 Exchange of information.
- Art. 12 Suspension of the trial or infringements.
- Art. 13 Authorisation for the manufacture and import of investigational medicinal products.
- Art. 14 Manufacture and import of investigational medicinal products. S.L. 458.36 S.L. 458.36
- Art. 15 Labelling.
- Art. 16 Verification of compliance of investigational medicinal products with good clinical and manufacturing practice.
- Art. 17 Notification of adverse events.
- Art. 18 Notification of serious adverse reactions.
- Art. 19 General provisions.