Entry Instance

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{
    "id": 1493931,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1493931/?format=api",
    "text_counter": 368,
    "type": "other",
    "speaker_name": "",
    "speaker_title": "",
    "speaker": null,
    "content": "(3) The application made under subsection (1) shall be accompanied by— (a) a proposed label for use on the health product or technology; (b) a copy of the manufacturing licence of the health product or technology, where applicable; (c) a copy of the good manufacturing practice certificate from the Authority and the regulatory authority of the country where the health product or technology is manufactured; (d) a copy of a certificate of analysis from a quality control laboratory recognized by the Authority, where applicable; (e) a copy of the marketing authorization or certificate of registration of the health product or technology from the regulatory authority of the country where the health product or technology is sold; (f) the available data on the quality, safety, efficacy and performance of the health product or technology submitted in a common technical dossier format; (g) a sample of the health product or technology; (h) proof of ownership of the site for the manufacture of the health product or technology, where applicable; (i) 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; (j) where the application relates to a health product or technology which is registered with a foreign regulatory body— (i) a copy of the certificate of registration; (ii) the professional information relating to the health product or technology; and (iii)the conditions of the registration of the health product or technology; 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."
}