Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie...s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
Statutory Instrument 150 of 1991 | S.I. 150 of 1991 | Amended by S.I.’ s 298/93, 61/94, 319/94, 199/98, 256/98, 36/99, 24/2001 and 257/2002, 105 and 222 /2004
The resources provide both the older as well as the updated Operational Guidelines for antiretroviral therapy centres, including administrative issues, functions and establishment of centres, reporting and recording tools, measures to improve retention in HIV care, supply chain management of drugs a...nd various other aspects that are essential to ensure quality treatment for people living with HIV/AIDS.
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