SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
IB i II) for all variations implemented in submitted dossier; • the complete product dossier (CTD M2-5) as approved by EMA; and • the latest set of documents approved in the cen- tralised 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 prod- uct specifications, 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 variation documen- tation approved in the centralised procedure, variation approval in centralised procedure, and assessment report in centralised 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 medicines approved under the DCP and MRP. This project focuses on initial marketing authorisations 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, upcoming 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 Regulatory Systems Strengthening (RSS) programme for National Regulatory Authorities (NRAs) under WHO Resolution
67.20. Serbia’s regulatory system underwent bench- marking in 2019 and was classified as Maturity Level 3 (stable, well-functioning, 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 evalu- ation 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 perfor- mance as globally trusted authorities for reliance and work-sharing procedures. As part of these efforts, in 2024, ALIMS participated in its first pilot project for post-approval changes (CMC variation), with the objective of reducing global approval and implemen- tation timelines while minimising country-specific regulatory requirements. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants 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 manufacturing licence must contain information and documents regarding the location and premises of the manufacturing site, equipment, personnel, medicines to be produced, relevant procedures, as well as other information required by the law. The Ministry issues a licence for a particular manufacturing site and certain forms of pharmaceutical manufactured at that site. The licence may include an entire manufacturing process or only a part of the process. The licence is valid for an indefi- nite period. Manufacturing of Medical Devices Manufacturers of medical devices may be both legal entities and individuals. A manufacturing licence is necessary only for class I medical devices (other than Is and Im class), other in vitro diagnostic medi- cal devices, medical devices for which no conformity assessment has been performed, those not covered by the sign of conformity, custom-made devices for a
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