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Angola Angola

Official Name: Republic of Angola
Capital: Luanda
Independence Day: 11 November 1975
Currency: Kwanza (AOA)

  • Indicators

Indicators

Medicine Registration

Angola's DNME (National Directorate of Health) does not register medicines because the registration requirements require government approval that has been pending for two years. An information system, including a database, for registration applications and approved products, has not been developed and adopted yet.

Regulation and Inspection

Medicines are controlled and monitored by the General Health Inspection, which also evaluates pharmaceutical products. The DNME regulates pharmaceutical activities and oversees the application of administrative and technical regulations to the pharmaceutical sector (Global Legal Insights, 2019).

Licensing

All retail needs to be licensed. Licenses are issued for three months (provisional, pending submission of all required documents), one year (all documents submitted), or two years (all documents submitted, and requirements met).
The DNME licensing unit does not issue any other types of licenses for pharmaceutical entities, personnel, imports and exports, or products. The information system for managing data on licenses is reportedly fundamental and cannot easily monitor the status of licenses. There are plans to start Good Manufacturing Practice (GMP) inspections of manufacturers, all of which are outside the country at present, but they are not currently conducted. The country does not yet have a comprehensive or useful national pharmacovigilance system in place. It also does not have a framework to guide the development of such a system (Thumm et al., 2013).

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