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{
    "id": 1336294,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1336294/?format=api",
    "text_counter": 451,
    "type": "speech",
    "speaker_name": "Endebess, UDA",
    "speaker_title": "Hon. (Dr) Robert Pukose",
    "speaker": null,
    "content": "(ga) approve the use of any unregistered medicinal substance for purposes of clinical trials, emergency use and compassionate use; (gb) carry out pharmacovigilance audits and inspections in order to ensure compliance with good pharmacovigilance practices and the prescribed requirements‖; (e) deleting paragraph (n) and substituting therefor the following new paragraph (n)— (n) appoint inspectors and order inspection of manufacturing premises, medical devices establishments, importing and exporting agents, wholesalers, distributors, pharmacies, including those in health facilities and clinics, retail outlets and any other premises and vessels subject to regulation under this Act‖; (f) inserting the following new paragraphs after paragraph (o)— (oa) conduct national regulatory authority lot release, official authority batch release of specified biologicals to ensure the quality, safety and efficacy of biological products through a regulatory release system in compliance with established approaches, policies, guidelines, procedures and in line with World Health Organization and internationally recognized guidelines; (ob) carry out and promote research related to medicines and health products‖; (g) inserting the following paragraphs after paragraph (q)— (qa) ensure that all health products and technologies manufactured in, imported into or exported from the country including through parallel importation conform to prescribed standards of quality, safety and efficacy; (qb) enforce the prescribed standards of quality, safety and efficacy of health products and technologies manufactured, imported into or exported out of the country; (qc) grant or revoke licenses and permits for the manufacture, importation, exportation, distribution and sale of health products and technologies; (qd) maintain a register of all authorized health products and technologies manually or electronically; (qe) regulate licit use of narcotic, psychotropic substances and precursor chemical substances in accordance with the Single Convention on Narcotic Drugs, 1961, the Convention on Psychotropic substances,1971 or the United Nations Convention against Illicit Traffic of Precursor Chemical Substances, 1988; (qf) inspect and license all manufacturing premises, importing and exporting agents, wholesalers, distributors, pharmacies including those in hospitals and clinics and other retail outlets;” Hon. Temporary Chairlady, in (d) this is to provide for approval of health products and technologies during emergencies and for pharmacovigilance which checks the safety of health products and technologies."
}