Licence compulsory

Yet even in this era, aligned industry, health and social development policies did create some positive feedback mechanisms, enhancing local manufacturers innovative capabilities. This environment was instrumental in the country being one of the first in Africa to locally manufacture anti-retroviral medicines (ARVs) to address the HIV/AIDS pandemic (Banda, 2013). As Chapter 15 describes, in 2002 Zimbabwe issued a compulsory licence allowing its local manufacturers to produce ARVs. 

Under the Medicines Act, the licensing system for MAs, Manufacturer s, and Wholesale Dealer s Licences, and for Clinical Trial Certificates, allows the opportunity for an applicant or licence holder to appeal against an unfavourable recommendation or decision, right up to the High Court if necessary, although that has rarely happened. Nevertheless, appeals to the appropriate advisory committee such as the Committee on Safety of Medicines, and to the Medicines Commission, are commonplace in the process leading to grant of an MA. Appeals may also arise in connection with the suspension, revocation, or compulsory variation of MAs or certificates. Manufacturer s Licences and Wholesale Dealer s Licences are rarely subject of the need for such appeal action. 

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