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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."
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"content": "(i) a valid practising licence issued by the body responsible for the profession of pharmacy; (ii) a valid wholesale dealer’s licence issued in accordance with this Act; (iii)a valid licence to sell health products or technologies issued in accordance with this Act; or (iv) a valid manufacturing licence issued in accordance with this Act; and (v) proof of payment of the application fees as prescribed by the Authority. (6) Where the Authority issues an authorization under subsection (1), the person to whom the authorization is issued shall submit to the Authority— (a) progress reports after every six months from the date of issuance of the authorization; (b) any adverse event report, where an adverse event occurred; and (c) a progress report within thirty days after the completion or termination of the use of the health product or technology. (7) The Authority may, where it is of the opinion that the safety of any patient is compromised or where the scientific reasons for administering the unregistered health product or technology have changed— (a) impose any additional conditions; (b) request additional information; (c) inspect the site where the unregistered health product or technology is manufactured, stored or administered; or (d) withdraw the authorization to treat the patient. (8) The Authority may, by notice in writing withdraw the authorization issued under subsection (1) if any of the purposes or the manner specified in subsection (2) is contravened. (9) A health product or technology authorized under this section shall be labelled in accordance with this Act. (10) An applicant shall notify the Authority of any variation to the agreement appointing the local representative within seven days of the variation. (11) The requirements in this section shall apply to applications for donations of health products and technologies."
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"content": "(The new clause was read a First Time)"
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"speaker_name": "Hon. Omboko Milemba",
"speaker_title": "The Temporary Chairman",
"speaker": {
"id": 13328,
"legal_name": "Jeremiah Omboko Milemba",
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"content": " Mover."
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"speaker_name": "Endebess, UDA",
"speaker_title": "Hon. (Dr) Robert Pukose",
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"content": " Hon. Temporary Chairman, I beg to move that the New Clause 27D be now read a Second Time. This is to provide new clauses to guide the handling of applications or product licences by the Authority. Thank you, Hon. Chairman."
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"content": "(Question, that the new clause"
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"type": "speech",
"speaker_name": "Endebess, UDA",
"speaker_title": "Hon. (Dr) Robert Pukose",
"speaker": null,
"content": "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."
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"id": 1494009,
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"speaker": null,
"content": "be read a Second Time, proposed)"
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"content": "(Question, that the new clause be read a Second Time, put and agreed to)"
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"speaker": null,
"content": "(Question, that the new clause be added to the Bill, put and agreed to) New Clause 29A"
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