HTTP 200 OK
Allow: GET, POST, HEAD, OPTIONS
Content-Type: application/json
Vary: Accept
{
"count": 1608389,
"next": "http://info.mzalendo.com/api/v0.1/hansard/entries/?format=api&page=147585",
"previous": "http://info.mzalendo.com/api/v0.1/hansard/entries/?format=api&page=147583",
"results": [
{
"id": 1494032,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494032/?format=api",
"text_counter": 469,
"type": "speech",
"speaker_name": "Endebess, UDA",
"speaker_title": "Hon. (Dr) Robert Pukose",
"speaker": null,
"content": " Hon. Temporary Chairman, I beg to move that the New Clause 29B be now read a Second Time. This is to make provision for parallel importation of health products and technologies."
},
{
"id": 1494033,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494033/?format=api",
"text_counter": 470,
"type": "scene",
"speaker_name": "",
"speaker_title": "",
"speaker": null,
"content": "(Question, that the new clause be read a Second Time, proposed)"
},
{
"id": 1494034,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494034/?format=api",
"text_counter": 471,
"type": "scene",
"speaker_name": "",
"speaker_title": "",
"speaker": null,
"content": "(Question, that the new clause be read a Second Time, put and agreed to)"
},
{
"id": 1494035,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494035/?format=api",
"text_counter": 472,
"type": "scene",
"speaker_name": "",
"speaker_title": "",
"speaker": null,
"content": "(Question, that the new clause be added to the Bill, put and agreed to)"
},
{
"id": 1494036,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494036/?format=api",
"text_counter": 473,
"type": "scene",
"speaker_name": "",
"speaker_title": "",
"speaker": null,
"content": "New Clause 36A"
},
{
"id": 1494037,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494037/?format=api",
"text_counter": 474,
"type": "speech",
"speaker_name": "Endebess, UDA",
"speaker_title": "Hon. (Dr) Robert Pukose",
"speaker": null,
"content": "THAT, the Bill be amended by inserting the following new clause immediately after Clause 36: Clinical trials. 36A"
},
{
"id": 1494038,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494038/?format=api",
"text_counter": 475,
"type": "heading",
"speaker_name": "",
"speaker_title": "",
"speaker": null,
"content": "."
},
{
"id": 1494039,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494039/?format=api",
"text_counter": 476,
"type": "other",
"speaker_name": "",
"speaker_title": "",
"speaker": null,
"content": "(1) A health product or technology shall not be used for clinical trial unless an approval is granted by the Authority."
},
{
"id": 1494040,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494040/?format=api",
"text_counter": 477,
"type": "other",
"speaker_name": "",
"speaker_title": "",
"speaker": null,
"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."
},
{
"id": 1494041,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494041/?format=api",
"text_counter": 478,
"type": "other",
"speaker_name": "",
"speaker_title": "",
"speaker": null,
"content": "carried out in a manner that ensures the integrity of data generated and the safety and well-being of the participants of the study. (7) The Authority shall carry out inspection of the clinical trials and monitor compliance of the clinical trials with the prescribed requirements. (8) Any amendments to clinical trials protocols shall be submitted to the Authority for approval before implementation."
}
]
}