Legal basis for granting a marketing authorization for drugs in Kosovo

• Author: Melisa Troshani - Arbenita Pajaziti
• Position: Novartis Pharma Services Inc., Representative Office, Tirana, Albania - Ministry of Health, Pristina, Kosovo
• Pages: 283-289

283

Vol. 3 No. 1

May, 2017

Balkan Journal of Interdisciplinary Research

IIPCCL Publishing, Graz-Austria

ISSN 2410-759X

Acces online at www.iipccl.org

Legal basis for granting a marketing authorization for drugs in Kosovo

Melisa Troshani

Novartis Pharma Services Inc., Representative Offi ce, Tirana, Albania

Arbenita Pajaziti

Ministry of Health, Pristina, Kosovo

Abstract

During the last years, Kosovo has faced many social and economic changes. These changes

have infl uenced directly the healthcare system, the pharmaceutical market, as well. The

implementation of laws and regulations has given the possibility to create a challenging, and

quite competitive environment, which is developing in a rapid way. Actually in Kosovo, there

are present with their drugs many research and development pharmaceutical companies,

generic companies as well as local manufacturers.

In this project, it is introduced the legal regulatory basis in Kosovo, including the main law

provisions and regulations requirements. It is also described in detail, the procedure for

granting a marketing authorization of a medicinal product from the local health authority.

All the eff orts have been made in order to harmonise, till now, partially the new requirements

with the EU directives, as the future objective of Kosovo is to be part of the European Union.

Keywords: marketing authorization, drugs, Kosovo, legal basis, requirements, harmanisation

with EU.

Introduction

Kosovo, as the newest country in Europe has faced establishing of the state institutions

from the scratch. A er the war of 1999, Kosovo was under the UN administration. UN

and local institutions of provisional government had to build governing institutions,

at the same time they to dra the new laws. In 2008, Kosovo declared independence

and UN gradually transferred competences to local institutions. Today, Kosovo

aspires to become member of the European Union. In order to do so, there is need to

fulfi l the criteria set by EU and to harmonize legislation with acquis communautaire.

This harmonization of legislation includes, as well, the Health and Pharmaceutical

system.

Health system was devastated by the war and it was one of the fi rst focuses of the

post-war reconstruction and rebuilding eff orts. Adequate legislation had to be

dra ed, capacities had to be built and institutions had to be established so that the

whole health system can serve welfare and wellbeing of the Kosovo citizens.

Establishment of the Health Insurance Fund together with the harmonization of the

legislation with the EU are now the biggest challenges that the health system is facing

in our country. Creating a new health insurance structure in Kosovo will start a new

challenging phase of healthcare system reform. During dra ing of the legislation,

it is a “must” to look at the lessons learned and the best practices shared from the

countries that have similar infrastructure and number of residents, compared to

Kosovo. Welfare of the citizens is the essence of any successful reform.