Background: Literature review suggested that regulatory guidelines should be harmonized
for better processing of applications and for the upliftment of the regulatory field. Therefore
it was thought worthwhile to compare the guidelines for countries where there is requirement of
harmonization. Kosovo, Ukraine and Serbia were selected because of being European countries
and still they are not a part of EU.
Introduction: Kosovo, Ukraine and Serbia are small countries of Europe but they are not members
of European Union. They have their own guidelines for the submission of MAA for marketing
of pharmaceuticals and medical devices. They are trying to obtain the EU membership and
therefore it was worthwhile to compare the guidelines of these countries.
Methods: The registration process of pharmaceuticals in Kosovo, Ukraine and Serbia was studied
throughly. Along with it, the guidelines for European Union were also studied. A comparison of
guidelines of all the three countries with the guidelines of European Union for pharmaceuticals
was carried out.
Results: The comparison of guidelines showed that there are still some changes needed in the
guidelines of Kosovo, Ukraine and Serbia before they can merge with the guidelines of European
Union. Some of the points in the guidelines are very different from the guidelines of EU.
Conclusion: It was worthwhile to study the regulatory requirements of pharmaceuticals in Non-
European Union Member States such as Kosovo, Ukraine and Serbia.