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

  • No public health care insures system in place (yet).

  • No reimbursement system in place (yet).

  • No reference pricing system in place (yet), however concrete steps for introduction of a relevant system are under review.

  • Limited number of essential drugs are procured directly by the Ministry of Health and distributed free of charge in public health facilities.

  • Roughly 40% (only) of the total needs are covered by public health institutions.

                           Pharmaceutical market

  • Pharmaceutical market in 2019 estimated at 120 Mio. EUR; 70 Mio. EUR in hospital segment (+47% 2019 vs. 2018).

  • Total number of wholesalers: 120

  • 900 active pharmacies.

  • Domestic manufacturers: 3 (Farmakos, GentiPharm, TrePharm)

  • Market dominated by foreign manufacturers.

  • Strong penetration of generic products.

     Demographics and key economic indicators

  • Capital City: Prishtina / Currency: EUR / Official languages: Albanian and Serbian.

  • GDP per capita (USD): 4’442 / Inflation average consumer prices: 1.9%. Unemployment rate: 26%.

  • Population: 1.8 Million, 65% younger than 30 years.

Kosovo Market Macroeconomic Data

 Pharmaceutial market – Regulatory Framework

  • Local MA is mandatory for Rx and OTC medicines, but not for medical devices and food supplements.

  • Requirement of a registered office in Kosovo as well as at least one staff member responsible for Pharmacovigilance.

  • Import during MA procedure not allowed.

  • Simplified procedure for products fully registered in Germany/ UK or EMA/FDA 30. days, no CTD, no CPP

Rr.Beqir Kastrati   Kompl.Luledielli    Nr.4/4/1  -  10000  Prishtina, Kosovo Tel. +38 344 222 051    agron.sadiku@pharma-leader.com                                                                                             www.pharma-leader.com

© 2020 Pharma Leader LLC.  created by Andre Hilton