Entry Instance

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{
    "id": 1494002,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1494002/?format=api",
    "text_counter": 439,
    "type": "other",
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    "content": "(2) A health product or technology distributed pursuant to authorization granted under subsection (1) may be used for such purposes and in such manner and during such period as the Authority may in writing determine. (3) A person who intends to obtain the authorization under subsection (1), for purposes other than a clinical trial, shall apply to the Authority in the prescribed form. (4) Where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya, the applicant shall appoint a local representative who shall be a citizen of Kenya, a person who is or has permanent residence or a company incorporated in Kenya. (5) The application made under subsection (3) shall be accompanied by— (a) a product brochure containing relevant chemical, pharmaceutical, pre-clinical pharmacological and toxicological data and where applicable, human pharmacological and clinical data related to the health product or technology for which authority is sought; (b) written consent of the applicant, where applicable; (c) details of registration or pending registration of the health product or technology with any other regulatory authority, where applicable; (d) evidence of compliance by the manufacturer of the health product or technology with good manufacturing practice standards as determined by the Authority; (e) reasons why a registered health product or technology cannot be used; (f) where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya, a copy of the agreement appointing the local representative; (g) proof that the applicant holds— 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."
}