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