SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices The import and export of pharmaceuticals and medi- cal devices is subject to a prior issuance of a medici- nal product wholesale licence, subject to exceptions described under 7.2 Importer of Record of Pharma- ceuticals and Medical Devices . A legal entity that performs only the activities of import and export may perform these activities without a medicinal product wholesale licence if it conducts the import and customs clearance activities on behalf of and for the account of a wholesale licence-holder to the site of the goods’ free marketing, in accordance with the customs regulations. Generally, only medicinal products with a valid mar- keting authorisation and medical devices registered in the ALIMS’s registry of medical devices may be imported. Exceptionally, the ALIMS may approve import of medicinal products without a marketing authorisation in Serbia or unregistered medical devic- es under conditions prescribed for compassionate- use programmes, donation or humanitarian aid, or the emergency situations described in 3.5 Access to Pharmaceuticals and Medical Devices Without Mar- keting Authorisations . Persons entering or leaving Serbia may carry medici- nal products in the amount not exceeding their six- month requirement within one calendar year, for their personal usage or for an animal travelling with them, depending on the type and length of the underlying illness. They have to provide to the Customs Author- ity the approval of a competent Serbian ministry for bringing in or carrying out medicinal products for per- sonal use. The transfer of medicinal products across the border in the amount not exceeding the 15-day requirement of an individual is not subject to any approval. 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), Ser- bia has, to a large extent, harmonised 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 Schedule (HTS) Code. The products that are subject to those restric- tions (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 Association Agreement with the EU, the Central European 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 prescription-only pharmaceuticals. The government determines the cri- teria for the pricing of pharmaceuticals, and calculates their maximum prices at the joint proposal of the min- istries competent for health and trade. The Ministry of Health calculates the maximum wholesale price for prescription-only pharmaceuticals. The pricing of prescription-only medicines is governed by the Medicines Act, the Decree on Criteria for Form- ing of Prices of Prescription-Only Pharmaceuticals for Human Use, and the Decision on Maximum Prices of Prescription-Only Pharmaceuticals for Human Use. Prescription-only pharmaceuticals for which the gov- ernment did not determine the maximum wholesale price may not be placed on the market. Once the government decides on the maximum per- mitted wholesale price of the pharmaceutical, mar- keting 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
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