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Zimbabwe Zimbabwe

Official Name: Republic of Zimbabwe
Capital: Harare
Independence Day: 18 April 1980
Currency: Zimbabwe Dollar (ZW$)

  • Indicators

Indicators

Medicine Regulation

The Medicines Control Authority of Zimbabwe (MCAZ) oversees regulation of medicines entering Zimbabwe. The is responsible for protecting public and animal health by ensuring that accessible medicines, allied substances, and medical devices are safe, effective and of good quality through enforcement and adherence to standards by manufacturers and distributors. The website outlines information on the needed procedure to distribute medicines in the Zimbabwean market. The website provides stakeholders with the necessary for forms for applications to register medicines with the MCAZ and with Zazibona.
There are various documents and forms covering aspects that include Legal and Corporate Affairs, Licensing and Enforcement, Evaluations and Regulations, Pharmacovigilance and Clinical Trials, Approved fees, Quality Assurance, among others. There is also an online register where users can find details of approved medicines, licensed persons, and premises. The platform is yet to include the register for approved medical devices.

Inspection

In Zimbabwe, legal provisions exist allowing for appointment of government pharmaceutical inspectors. Local manufacturers are inspected every two years. Private wholesalers, retail distributors, retail distributors, public pharmacies and stores, and pharmacies and dispensing points of health facilities are inspected once a year.

Pharmacovigilance

A pharmacovigilance centre linked to the NMRA. The centre did not publish analysis reports in 2009 and 2010 but it publishes an ADR bulletin which is not online. 2045 reports were submitted in 2009 and 2010 combined. These reports are sent to the WHO collaborating centre in Uppsala. There is usually a backlog to submit ADR reports to the Uppsala Monitoring Centre due to lack of availability of high-speed internet for the database (World Health Organization, 2011).

Information Management System

The website explains the need for pharmacovigilance to identify and observe the various risks medicines pose to the public and animals. The platform introduced a new platform available for Adverse Drug Reaction reporting. This portal is available as a mobile app and Desktop app for various operating systems available. The platform provides news on safety regulations and the latest news regarding happenings on regulating medicines in the country. Other sections on the website regulated by the authority include contact, vaccine safety, publications, and re-core training.

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