SERBIA Trends and Developments Contributed by: Bisera Andrijašević, BDK Advokati
and potential barriers to market entry. As part of the inquiry, the Commission has already begun sending out questionnaires to larger pharmacy chains to gather the necessary data for its analy- sis. The inquiry follows a growing concern about market practices in the pharmaceutical sector, which had also been expressed by the Serbian Prime Minister in October 2024. Additionally, the inquiry may be spurred by the ongoing consoli- dation in the retail pharmacy market, as larger pharmacy chains acquire smaller ones, poten- tially fostering an environment where price col- lusion could occur. The goal of the inquiry is to identify measures and recommendations to improve market competition, which the Com- mission may present to relevant authorities and market participants. The inquiry might also result in initiation of concrete infringement proceed- ings, which often follow sector inquiries con- ducted by the Commission. Centre for the Fourth Industrial Revolution and BIO4 Campus A significant step in positioning Serbia as a regional and European biotechnology hub was the establishment of the Centre for the Fourth Industrial Revolution in Serbia, launched in March 2022 as a joint initiative between the government and the World Economic Forum. This Centre is the first of its kind in the region and only the third in Europe, following Oslo and Moscow. Its primary objective is to advance biotechnology and AI applications in healthcare by fostering collaboration between science and industry. The Centre will support research in biotechnology, molecular biology and medicine, ensuring their practical implementation in healthcare solutions. To further strengthen Serbia’s biotechnology sector, construction of the BIO4 Campus in
Belgrade began in late December 2023, with completion expected by the end of 2026. This state-of-the-art hub will facilitate the develop- ment of innovative therapies by bringing togeth- er research centres from companies working in biomedicine, biotechnology, bioinformatics and biodiversity. The government has already signed memoranda of understanding with several lead- ing global pharmaceutical companies to encour- age investment and collaboration. Additionally, the Campus will include a start-up accelerator to support Serbian biotech companies. Digitalisation of Healthcare ALIMS is continuing to expand the use of the Regulatory Information Management Sys- tem (RIMS) for the regulatory applications and requests from its competence. RIMS is a cen- tralised software platform designed to stream- line the management of regulatory information throughout a product’s lifecycle and enables efficient tracking of regulatory activities, includ- ing product applications, registrations and sub- missions, thereby enhancing compliance and operational efficiency. Requests are now being submitted through the RIMS system for a range of pharmaceutical and clinical trial-related procedures. This includes applications for the issuance of marketing authorisations for medicines, such as drug cat- egorisation, expert opinions on packaging and approval of promotional materials for both the general and professional public. Also included are requests for the importation of unregistered medicines, reference standards and expert opinions on the country of origin of a medicine. The system facilitates requests for clinical trial approvals, including registration, amendments and notifications on the completion of clinical trials. Requests for the importation of medicines and medical devices for clinical trial purposes,
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