Entry Instance

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{
    "id": 1494003,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1494003/?format=api",
    "text_counter": 440,
    "type": "other",
    "speaker_name": "",
    "speaker_title": "",
    "speaker": null,
    "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."
}