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{
"id": 1494012,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494012/?format=api",
"text_counter": 449,
"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 29: Authorization of"
},
{
"id": 1494013,
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"text_counter": 450,
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"speaker": null,
"content": "29A."
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{
"id": 1494014,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494014/?format=api",
"text_counter": 451,
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"content": "(1) A person shall not import any health product or technology health products unless— and technologies. (a) the imported health product or technology has been authorized through issuance of an import permit or a written authorization by the Authority; and (b) the imported health product or technology is inspected and verified by an inspector of the Authority at the ports of entry prior to its release. (2) A batch or lot of any registered product shall not be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such product and official batch or lot release by the Authority in cases of biological therapeutics."
},
{
"id": 1494015,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494015/?format=api",
"text_counter": 452,
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"content": "(3) Each applicable test conducted by the manufacturer under subsection (2) shall be made on each batch or lot after completion of all processes of manufacture and such test may affect compliance with the standard applicable to the product. (4) The manufacturer or marketing authorization holder of any registered biological therapeutic shall submit lot summary protocol for each lot that contains registered tests and results of tests performed and, such manufacturer or marketing authorization holder may be required to submit samples of product from the specified lot to the Authority for official batch or lot release in accordance with the prescribed regulations. (5) Every batch or lot of a registered biological therapeutic imported into Kenya or manufactured in Kenya shall be evaluated and, on being satisfied of conformity with prescribed standards and payment of prescribed fees, the Director-General shall approve its release into the market and issue a certificate of official batch or lot release in the prescribed format. (6) The Authority may recognize and accept official lot release certificates issued by other national regulatory authorities of other countries for a specific batch or lots of biological therapeutic manufactured within the territories of those national regulatory authorities, in issuance of a certificate under this section. (7) A person who contravenes this section commits an offence and shall on conviction be liable— 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": 1494016,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494016/?format=api",
"text_counter": 453,
"type": "other",
"speaker_name": "",
"speaker_title": "",
"speaker": null,
"content": "(a) in the case of a first offence, to a fine not exceeding one million shillings or to imprisonment for a term not exceeding two years, or to both; or (b) in the case of a subsequent offence, to a fine not exceeding two million shillings or to imprisonment for a term not exceeding five years, or to both."
},
{
"id": 1494017,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494017/?format=api",
"text_counter": 454,
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"speaker": null,
"content": "(The new clause was read a First Time)"
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"id": 1494018,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494018/?format=api",
"text_counter": 455,
"type": "speech",
"speaker_name": "Hon. Omboko Milemba",
"speaker_title": "The Temporary Chairman",
"speaker": {
"id": 13328,
"legal_name": "Jeremiah Omboko Milemba",
"slug": "jeremiah-omboko-milemba"
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"content": " Mover."
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"id": 1494019,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494019/?format=api",
"text_counter": 456,
"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 29A be now read a Second Time. This is to provide for authorisation of health products and technologies imported into the country, including the requirement for batch or lot release in line with World Health Organisation (WHO) requirements."
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{
"id": 1494020,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494020/?format=api",
"text_counter": 457,
"type": "speech",
"speaker_name": "Endebess, UDA",
"speaker_title": "Hon. (Dr) Robert Pukose",
"speaker": null,
"content": "Thank you, Hon. Temporary Chairman. ."
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{
"id": 1494021,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494021/?format=api",
"text_counter": 458,
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"speaker_name": "",
"speaker_title": "",
"speaker": null,
"content": "(Question, that the new clause be read a Second Time, proposed)"
}
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}