COMPANY OVERVIEW

Santefarm ltd was founded in 2006 , as a private limited liability company for wholesale and distribution of pharmaceuticals and healthcare products in Kosovo.

Santefarm's  market activities are oriented towards satisfying the demand of the public healthcare within the segment of public tender  procurement (medium and small values) for hospitals and medical centers.

In the same time , the assortment   includes a  range   of imported branded and generic prescription and over-the –counter medicines for supply to public and private pharmacies.  We represent world famous companies like: Bayer Schering Pharma-Germany, Innotech-France, Medochemie-Cyprus etc, Dade Behring-Germany.

The company is managed by Mr Milaim Abdulahu, B.pharm , whose extensive experience and knowledge of the local pharmaceutical infrastructure will ensure a  positioning of the company as a reliable partner to  pharmaceutical manufacturers seeking  efficient distribution of their products in the market , while offering a reliable support to further  development of the pharmaceutical sector of Kosovo.

Mr Milaim Abdullahu , formerly engaged in a private retail pharmaceutical business, joined the JCC Group (UNMIK) in 2000, as member of the Commission for civil coordination whose duty was to regulate the pharmaceutical sector in Kosovo, within a project implemented  by WHO ( World Health Organisation) and EAR   (European Agency for Reconstruction).  During this time, Mr Abdulahu attended several courses on various topics concerning public drugs and quality management issues such as :

1. Drug rational Use – management course , Boston University , conducted by Prof. Rechard Laing
2. Management in Essential Drugs for Public Health , in Volendam- Netherlands, organised by IDA
3. Quality Issues and Quality Control for Marketing Authorization, at AFSAPS Institute – Paris

MARKET OVERVIEW

Kosovo' s  pharmaceutical market is small , valued at  approx. EUR 100 mio in 2005. As a result of political and economic instability , the market has fluctuated significantly over the last decade.   The low per capita drug expenditure of about 21,4 EUR  in   2004 signifies the under-developed nature of the market.

Kosovo Macroeconomic & Medicine Market data (2005)

Population (mio)2,5

Nominal GDP (EUR bn)1,9

GDP per capita (EUR)800,00

Public sector health expenditure (EUR mio)60

Out-of pocket medicines expenditure (EUR mio)35

Pursuant to the Administrative Instruction No. 2003/09 on the Transitional Marketing Authorization of Medicinal Products Placed in Kosovo,   transitional marketing authorisations are granted for 2896  pharmaceutical forms / dosages to 160 domestic and foreign manufacturers of medicinal products from 30 different countries.      

Generics play a significant role in the market , owing largely to the low spending power of both the government and consumers. Generics produced by manufacturers from former Yugoslav countries   have a significant share in the market and are estimated at a turnover of approx. EUR 25 mio.

REGULATORY REGIME

The principal market regulator in Kosovo is the Kosovo Medicines Agency (KMA). The body which is responsible for marketing approval , was established in 2003 as a non-independent agency of the Ministry of Health.

Kosovo' s main pharmaceuticals legislation is the Law on medicines supplemented by a set of Adminstrative Instructions and Guidelines adopted in December 2005.

Drug registration is officially the sole responsibility of the KMA, and all applicants must  either  be a local manufacturer or a representative of a foreign company legally present in Kosovo.

Under the current legislation framework drug registration requirements are as follows:
registration  file ( entirely in the EU CTD dossier format or CTD Module 1 and 2 and the rest of the dossier in the «Old EU» dossier format or in a mixed dossier format that combines both the «Old EU « and CTD formats in accordance with the Kosovo dossier guidelines or entirely in the «Old EU» format ) and corresponding certificates and licenses. All the documentation must be submitted in English , while a few parts are required in local language ( proposals for patient information leaflets and outer and immediate packaging texts ). The EU 's Mutual Recognition Procedure is recently upheld in Kosovo , while a simplified procedure was established by the Guidelines on   Unilateral recognition. There is also an abridged application procedure for generic products.

HEALTHCARE SECTOR         

Kosovo Macroeconomic & Medicine Market data (2005)
Regional Hospitals ( Prishtina, Peja, Mitrovica, Prizren, Djakova, Vushtri,Ferizaj,Gnjilan)
Municipal Health Centres 50
Private MD Practices 420
Private policlinics  20
Microbiology and biochemistry laboratories 50
Public pharmacies 50
Private pharmacies  350

The requirements of the public health sector are served on a centralised procurement and distribution system basis . Medicines are procured by ways of annual public tenders for public procurement announced by the Ministry of Health.

In 2005, the Ministry of Health disposed with  a budget of EUR 60 mio  , with allocation of approx. EUR 15mio for medicines supply ( including approx. 300 medicines from the Essential drugs list); while EUR 25-30 mio were allocated for supply of medical equipment , reagents , instruments , infrastructure investment etc.
These figures do not take account of pharmaceuticals and medical supplies procured by hospitals and health houses independently from the central budget, as the inadequate classification does not currently allow the tracking of such expenditure. 

The private sector  consisting of about 350 private pharmacies and 45 wholesale companies  serves a medicines market valued at approx. EUR 35-40 mio in 2005.

Company Annual Report 2006-2008