The Zimbabwe National Pharmacovigilance Policy serves as a handbook for pharmacovigilance activities in the country. The pharmacovigilance activities are coordinated by the Medicines Control Authority of Zimbabwe in collaboration with the Ministry of Health and Child Care and all key stakeholders both in the public and private health sector including the pharmaceutical industry. The handbook also serves as a tool for providing an enabling environment for effective planning, implementation, monitoring and evaluation of the pharmacovigilance system by all key stakeholders. The handbook address issues related to the systems and structures required for pre- and post-authorization monitoring of safety and effectiveness of medicines in Zimbabwe. If successfully implemented, the pharmacovigilance system will lead to early detection of adverse reactions, interactions and other medicine-induced problems as well as the detection of previously unknown adverse reactions (signals). Furthermore, the system ensures communication of changes in risk/benefit balance to stakeholders with a view of promoting patient safety including rational and safe use of medicines, vaccines and complimentary medicines. The handbook defined medicine as any substance or mixture of substances which is used, or is manufactured, sold or represented as suitable for use, in the diagnosis, treatment, mitigation or prevention of disease or any abnormal physical or mental state or the symptoms thereof in man or in animals; or restoring, correcting or modifying any physical, mental or organic function in man or in animals.
Zimbabwe National Pharmacovigilance Policy Handbook, 2nd Edition, 2016
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