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{
    "id": 1494081,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1494081/?format=api",
    "text_counter": 518,
    "type": "speech",
    "speaker_name": "Endebess, UDA",
    "speaker_title": "Hon. (Dr) Robert Pukose",
    "speaker": null,
    "content": "THAT, the Bill be amended by inserting the following new Part immediately after the new Clause 59A— Pharmacovigilance. 59B. (1) The Authority shall establish a National Pharmacovigilance Centre which shall set up and manage the national pharmacovigilance and post marketing surveillance system. (2) The Centre established under subsection (1) shall receive and maintain all relevant information about suspected adverse drug reactions and adverse events to health products or technologies which have been authorized by the Authority. (3) The Authority shall conduct both passive surveillance and active surveillance of health products and technologies. (4) The Authority shall carry out pharmacovigilance audits and inspections in order to ensure compliance with good pharmacovigilance practices and the prescribed requirements. (5) All entities responsible for placing a health product or technology in the market shall establish and maintain a pharmacovigilance system for managing safety information of health products and technologies. (6) The entities referred to in subsection (5) shall submit safety information to the Authority in the prescribed manner. (7) The consumers, general public and health care professionals shall report adverse reactions and adverse events to the Authority in the prescribed manner."
}