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{
    "id": 1494040,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1494040/?format=api",
    "text_counter": 477,
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    "content": "(2) An approval under subsection (1) shall only be granted by the Authority after approval by the relevant ethics body has been granted. (3) A person who intends to commence a clinical trial on a health product or technology shall make an application to the Authority in the prescribed form and the application shall be accompanied by the study protocol in the prescribed format and the prescribed fee. (4) The study protocol submitted under subsection (2) shall include a post-trial access programme to ensure access of investigational medicinal substances by participants in the trial before grant of marketing authorization by the Authority. (5) The Authority shall prescribe guidelines for evaluation of applications made under subsection (2) to be implemented for accelerated evaluations during emergency situations, epidemics and outbreaks. (6) A person granted an approval under this section shall put in place a robust quality assurance system to ensure that the clinical trial is The electronic version of the Official Hansard Report is for information purposesonly. A certified version of this Report can be obtained from the Hansard Editor."
}