SERBIA Trends and Developments Contributed by: Bisera Andrijašević, BDK Advokati
ments issued by the European Medicines Agency (EMA) and internationally recognised standards such as those of the International Council for Harmonisa- tion (ICH). Reliance mechanisms and simplified proce- dures for products already centrally authorised in the EU have gained importance in practice. This gradual alignment reflects Serbia’s EU acces- sion trajectory. Although Serbia is not formally bound by EU pharmaceutical legislation, regulatory conver- gence remains a strategic objective. The ongoing EU pharmaceutical reform package, which includes revi- sions to Directive 2001/83/EC and Regulation (EC) No 726/2004, is likely to shape future Serbian reforms. Key elements of the EU reform, such as revised regu- latory data protection periods, strengthened shortage monitoring obligations and incentives for antimicrobial development, may significantly influence the future structure of Serbian pharmaceutical legislation. In the absence of a new medicines act, much of the practical evolution of the regulatory system is taking place at the level of implementation and administra- tive practice. Digitalisation of Healthcare and Regulatory Processes Digitalisation continues to be a strategic objective within the Serbian healthcare system. ALIMS has expanded the use of its Regulatory Information Man- agement System (RIMS), which centralises regulatory submissions across the product lifecycle, including marketing authorisations, variations, clinical trial appli- cations and promotional material approvals. However, the implementation of electronic submissions for vari- ations and renewals has not yet been made fully func- tional, which in practice presents a significant problem for MAHs with medicines originally approved through RIMS. Given the length of regulatory procedures in Serbia, particularly in non-reliance marketing authorisation pathways, industry stakeholders have been increas- ingly advocating for procedural efficiencies to reduce overall time-to-market. During 2025, representatives of the pharmaceutical industry proposed that the Ministry of Health intro-
duce a procedural adjustment aimed at accelerating patient access to newly authorised medicines. The proposal suggests allowing marketing authorisation holders to submit documentation for the determina- tion of the maximum wholesale price of a medici- nal product immediately upon receipt of the post- commission report issued by ALIMS following the meeting of the Commission for Granting Marketing Authorisations. At present, the pricing procedure is typically initiated only after the marketing authorisa- tion process has been fully completed. By permitting these two processes to run in parallel, namely, the final stage of obtaining the marketing authorisation from ALIMS and the procedure for publication of the maximum price in the Ministry’s Decision on the High- est Prices of Medicinal Products for Human Use, the time required for a medicine to become commercially available on the Serbian market could be significantly reduced. The industry has framed this proposal as a pragmatic administrative improvement designed to shorten launch timelines without compromising regu- latory scrutiny. The Health Documentation and Records Act intro- duced the concept of an electronic medical record (e-File), envisaged as a centralised registry of patient medical data accessible across healthcare institu- tions. Full implementation remains ongoing. The same Act introduced a National Integrated Healthcare Infor- mation System (NIHIS), which is intended to, inter alia, integrate the records of public and private healthcare institutions. The development of NIHIS has been entrusted to the Office for Information Technologies of the Republic of Serbia. NIHIS and the eHealth Record (eKarton) have not yet been established, although their implementation was planned for 1 January 2025. These initiatives align with broader European devel- opments, particularly the recently adopted European Health Data Space (EHDS) Regulation, which seeks to facilitate secure cross-border access to health data and strengthen secondary use of health data for research and innovation. Although Serbia is not directly bound by the EHDS, eventual alignment will be necessary within the EU accession process.
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