Extending to the south from central Europe into the Mediterranean Sea, the region of the Balkans includes the countries of Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Romania, Serbia, Slovenia, The Former Yugoslav Republic of Macedonia (FYR Macedonia), Montenegro. Some of these countries are Member States of the European Union (EU): Slovenia since 2004, Bulgaria and Romania since 2007 and Croatia since 2013. All other Balkan countries are EU candidate countries, with the exception of Bosnia and Herzegovina, which is a potential candidate for EU membership. There are also differences in the performance of health systems among them. All countries in the past 20 years have been faced with different problems in financing healthcare and trying to implement different reforms in order to assure a sustainable and efficient healthcare system.
There is a strong political will in the non-EU Balkan states to align the region’s pharmaceutical legislation and practice with that of the European Union. Accordingly the efforts of the local regulatory authorities are aimed at harmonization of policies with other European countries. Pharma registration in Balkan countries advances towards simplification of drug registration requirements, licensing of professionals and businesses in the sector, implementation of ethics standards, price controls and reimbursement of drugs through national health insurance systems.
The output of the European Medicines Agency (EMA), a London-based EU agency for the evaluation of medicinal products, has been a key part of the medicine registration process for new medicines in the Balkan region, allowing its smaller and poorer member countries to avoid costly duplication of efforts. By contrast, the process of drug pricing and reimbursement remains a national responsibility. In many countries in the region pharma product can be authorised either by the national agency or centrally through the EMA. In Serbia, manufacturers can only apply for local marketing authorisation if their product already has marketing authorisation in its country of origin, the EU or the US. In theory, authorisation should take 210 days for medicines not registered through the EU, but in practice it is closer to 300 days.