SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
reports (type IB i II) for all variations imple- mented in submitted dossier; • the complete product dossier (CTD M2-5) as approved by EMA; and • the latest set of documents approved in the centralised procedure for the initial MA or variations, including the composition of the medicinal product with specification for the active substance(s), SPC, PIL, text for inner and outer packaging, EURMP (European Risk Management Plan), finished product specifi- cations, specification release and shelf-life for the product, and flow chart approved in the centralised procedure). Documentation Required for Post-Approval Changes Through Reliance Documentation to support reliance for post approval changes incudes the package of vari- ation documentation approved in the centralised procedure, variation approval in centralised pro- cedure, and assessment report in centralsied procedure for variations type IB and II. Reliance Pathway on DCP/MRP Approved Medicines Pilot Project In 2024, ALIMS launched a pilot project to refine and expand the reliance strategy to cover medi- cines approved under the DCP and MRP. This project focuses on initial marketing authorisa- tions and post-approval changes for recently approved medicines (no later than 2022) to incorporate the latest scientific and regulatory requirements, such as risk assessments for nitrosamine and elemental impurities. Currently, there are no national regulations explicitly governing reliance for medicines approved via the DCP/MRP. However, upcom- ing legislative changes in Serbia’s medicinal product regulations are expected to introduce formal provisions for this type of reliance. In the
meantime, the documentation required for reli- ance on DCP/MRP-approved medicines aligns with that for CP-approved medicines. Other Projects Regarding Reliance and International Co-Operation ALIMS actively participates in the WHO Regula- tory Systems Strengthening (RSS) programme for National Regulatory Authorities (NRAs) under WHO Resolution 67.20. Serbia’s regulatory sys- tem underwent benchmarking in 2019 and was classified as Maturity Level 3 (stable, well-func- tioning, and integrated) for vaccines. By the end of 2025, ALIMS aims to achieve Maturity Level 4 (advanced level of performance and continu- ous improvement) for vaccines and expand this evaluation to cover other medicines. ALIMS is also striving to be designated as a WHO Listed Authority (WLA), which recognises regulatory agencies operating at an advanced level of performance as globally trusted authori- ties for reliance and work-sharing procedures. As part of these efforts, in 2024, ALIMS partici- pated in its first pilot project for post-approval changes (CMC variation), with the objective of reducing global approval and implementation timelines while minimising country-specific reg- ulatory requirements. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices Manufacturing of Pharmaceuticals The manufacturing of pharmaceuticals is subject to a licence issued by the Ministry of Health to legal entities. The application for a manufactur-
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