The NCEI, as a public-private dialogue enabling platform, is pleased to announce a significant regulatory change in Kosovo's pharmaceutical sector, following productive discussions and recommendations in our sectoral forums. This outcome underscores the power of collaborative dialogue between public and private stakeholders in driving meaningful change.
The existing requirement for an export permit (permit L-04) from the Kosovo Medicines Agency (KMA) was causing unnecessary delays for exporting companies. This issue was raised by private companies during sectorial forums, for a permit they were required to acquire from the KMA - a process that could have taken weeks, an unnecessary delay.
In a constructive proposal during the sectoral forums, the participants suggested that given that the law does not explicitly require an export permit for non-controlled medicinal products, the KMA should change its current practice, and notify Kosovo Customs that obtaining this permit should not be necessary. Consequently, this requirement could be removed from the "Barnatari" system.
We are thrilled to report that, following a constructive discussion between Kosovo Customs and the KMA, the latter has embraced this proposal. On May 21st, the KMA issued a formal decision, effectively removing the export permit requirement for non-controlled medicinal products.
This decision is a testament to the effectiveness of the public-private dialogue platform in addressing and resolving industry challenges.
Moving forward, the removal of the export permit requirement will:
· Accelerate the export process by eliminating administrative delays.
· Reduce the operational burden on pharmaceutical exporters.
· Enhance the competitiveness of Kosovo’s medicinal product manufacturers in the global market.
Driven by such positive outcomes, we continue to work towards identifying and resolving regulatory obstacles that impede industry growth. We extend our gratitude to all representatives who have actively contributed to discussions during the sectoral forums, the KMA and Kosovo Customs for their swift and decisive action, the Chief of Staff to the Prime Minister for championing the dialogue, as well as the SECO and EBRD for supporting the secretariat for public-private dialogue.
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The Office of the Prime Minister