1. What policies are in place to facilitate access to the domestic market?
Since government purchases account for the majority of the Ethiopian pharmaceutical market, there are measures in place that leverage public procurement to facilitate market access.
The Pharmaceuticals Fund and Supply Agency (PFSA) manages a long-term procurement guarantee mechanism, which is available to those manufacturers operating in Ethiopia that win a PFSA tender and for those products that a manufacturer exports. This long-term guarantee is only available to exporters, and the length of the guarantee depends on the percentage of production that the manufacturer exports: up to 3 years for 30% exporters and up to 5 years for 60% exporters.
In addition, PFSA offers a 25% price preference and prepayment of 30% of the tender value to manufacturers operating in Ethiopia that have been awarded a contract by PFSA.
2. How is the registration process for companies that manufacture locally Vs importers?
Registration is straight forward for local manufacturers, taking a maximum of 2 months. Pharma companies are further advised to set up their manufacturing plants in Industrial Parks where they can have faster registration, better services and necessary infrastructure. The GoE is keen to work with other governments to facilitate and improve its quality and regulatory process.