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{
"id": 849883,
"url": "https://info.mzalendo.com/api/v0.1/hansard/entries/849883/?format=api",
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"type": "speech",
"speaker_name": "Garissa Township, JP",
"speaker_title": "Hon. Aden Duale",
"speaker": {
"id": 15,
"legal_name": "Aden Bare Duale",
"slug": "aden-duale"
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"content": "“investigational medicinal substance” means a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form; “medical device” means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article− (a) intended by the manufacturer to be used, alone or in combination, for humans or animals for: - (i) diagnosis, prevention, monitoring, treatment or alleviation of disease; (ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; (iii) investigation, replacement, modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) control of conception; (vi) disinfection of medical devices; or (vii) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and (b) which does not achieve its primary intended action in or on the human or animal body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means. “pharmaceutical device” includes human and veterinary medicines, medical products, medicinal substances, vaccines, diagnostics, blood products, therapeutic feeds, nutritional formulations, beauty products and related products; “pharmaceutical equipment” means equipment used in the manufacture and quality control of pharmaceutical products; “pharmaceutical product” means any material or product intended for human or veterinary use presented in its finished dosage or form, that is subject to control by or under this Act; “pharmacovigilance” means the practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions, and includes the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem; “post market surveillance” means the practice of monitoring the safety and quality of a pharmaceutical drug or medical device after it has The electronic version of the Official Hansard Report is for information purposes only. Acertified version of this Report can be obtained from the Hansard Editor."
}