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{
    "id": 1494015,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1494015/?format=api",
    "text_counter": 452,
    "type": "other",
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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."
}