Legal basis for granting a marketing authorization for drugs in Kosovo

AuthorMelisa Troshani - Arbenita Pajaziti
PositionNovartis Pharma Services Inc., Representative Office, Tirana, Albania - Ministry of Health, Pristina, Kosovo
Vol. 3 No. 1
May, 2017
Balkan Journal of Interdisciplinary Research
IIPCCL Publishing, Graz-Austria
ISSN 2410-759X
Acces online at
Legal basis for granting a marketing authorization for drugs in Kosovo
Melisa Troshani
Novartis Pharma Services Inc., Representative O ce, Tirana, Albania
Arbenita Pajaziti
Ministry of Health, Pristina, Kosovo
During the last years, Kosovo has faced many social and economic changes. These changes
have in 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 e 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.
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
ful l the criteria set by EU and to harmonize legislation with acquis communautaire.
This harmonization of legislation includes, as well, the Health and Pharmaceutical
Health system was devastated by the war and it was one of the rst focuses of the
post-war reconstruction and rebuilding e 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.

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