Kosovo Market
Medicines Medical devices
Lead time 30 – 210 days N/A
Documentation CTD file mandatory CE mark
Packages Local Foreign with label
Pharmaceutial market – Reimbursement system and pricing policy
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No public health care insures system in place (yet).
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No reimbursement system in place (yet).
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No reference pricing system in place (yet), however concrete steps for introduction of a relevant system are under review.
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Limited number of essential drugs are procured directly by the Ministry of Health and distributed free of charge in public health facilities.
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Roughly 40% (only) of the total needs are covered by public health institutions.
Pharmaceutical market
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Pharmaceutical market in 2019 estimated at 120 Mio. EUR; 70 Mio. EUR in hospital segment (+47% 2019 vs. 2018).
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Total number of wholesalers: 120
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900 active pharmacies.
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Domestic manufacturers: 3 (Farmakos, GentiPharm, TrePharm)
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Market dominated by foreign manufacturers.
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Strong penetration of generic products.
Demographics and key economic indicators
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Capital City: Prishtina / Currency: EUR / Official languages: Albanian and Serbian.
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GDP per capita (USD): 4’442 / Inflation average consumer prices: 1.9%. Unemployment rate: 26%.
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Population: 1.8 Million, 65% younger than 30 years.
Kosovo Market Macroeconomic Data
Pharmaceutial market – Regulatory Framework
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Local MA is mandatory for Rx and OTC medicines, but not for medical devices and food supplements.
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Requirement of a registered office in Kosovo as well as at least one staff member responsible for Pharmacovigilance.
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Import during MA procedure not allowed.
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Simplified procedure for products fully registered in Germany/ UK or EMA/FDA 30. days, no CTD, no CPP