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Section 14: Refusal of application

Clinical Trials Act · PART V: TRIAL LICENCE

consolidated text (as at 2017, amended since). juris shows the text as it was consolidated; it does not confirm that this is the law in force today.

14. Refusal of application (1) The Council may, after consideration of the opinion of the Ethics Committee, refuse an application made under section 12— (a) where it considers that— (i) any requirement set out under section 13 (1) is not satisfied; (ii) the health, welfare, safety or protection of a subject is likely to be compromised; or (iii) the proposed trial is of limited or no scientific benefit; or (b) for any other good cause. [Issue 10] C25A – 12 Revised Laws of Mauritius (2) Where the Council refuses an application under subsection (1), it shall give written notice of its decision to the sponsor.

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