SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports Although Serbia is not yet an EU member state, nor a member of the World Trade Organization (WTO), Serbia has, to a large extent, harmo- nised its legislation with the EU acquis and WTO agreements. Therefore, non-tariff restrictions are rare and imposed only in particularly justified situations, in line with the general principles of the EU and WTO to limit the use of non-tariff restrictions. Non-tariff regulations and restrictions are imposed based on the Harmonized Tariff Sched- ule (HTS) Code. The products that are subject to those restrictions (usually quotas) are listed for example in specific international agreements which Serbia has concluded. 7.5 Trade Blocs and Free Trade Agreements Serbia is a party to the Stabilisation and Asso- ciation Agreement with the EU, the Central Euro- pean Free Trade Agreement, and the Agreement with EFTA, as well as a number of bilateral free- trade agreements. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices The prices of pharmaceuticals are controlled by the government only with respect to prescrip- tion-only pharmaceuticals. The government determines the criteria for the pricing of pharma- ceuticals, and calculates their maximum prices at the joint proposal of the ministries competent for health and trade. The Ministry of Health cal- culates the maximum wholesale price for pre- scription-only pharmaceuticals.
The pricing of prescription-only medicines is governed by the Medicines Act, the Decree on Criteria for Forming of Prices of Prescription- Only Pharmaceuticals for Human Use, and the Decision on Maximum Prices of Prescription- Only Pharmaceuticals for Human Use. Prescrip- tion-only pharmaceuticals for which the govern- ment did not determine the maximum wholesale price may not be placed on the market. Once the government decides on the maximum permitted wholesale price of the pharmaceuti- cal, marketing authorisation-holders may apply to include the pharmaceutical into the positive reimbursement list of medicines ( “Positive List” ), to be prescribed and issued at the expense of the compulsory health insurance. Wholesalers of pharmaceuticals, as well as pharmacies, must align the prices of pharmaceuticals that they have in stock with the maximum prices deter- mined by the government on the same day as the relevant decision on maximum prices enters into force. However, marketing authorisation-holders are free to determine the prices of over-the-coun- ter medicines and must only notify the Ministry before March 1st of the current year of the price for the previous year. 8.2 Price Levels of Pharmaceuticals or Medical Devices The Ministry of Health calculates the maximum wholesale price for prescription-only pharma- ceuticals based on a number of criteria. One of these criteria is price parity – ie, the comparable wholesale prices of pharmaceuticals in refer- ence countries, namely, Slovenia, Greece and Italy, and the current wholesale price in Serbia, in addition to other applicable criteria.
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