SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
information stops the clock until the applicant com- pletes the application. 4.2 Regulatory Reliance Since 2023, Serbia has been progressively introducing the concept of regulatory reliance. The reliance strat- egy employed by the ALIMS is based on a risk- and science-driven approach, carefully selecting where to apply reliance while considering public health needs and priorities, available resources and expertise, the type and source of the evaluated product, and the opportunities for reliance. Regulatory reliance for centrally authorised medicinal products (CP) was introduced in January 2023, both for the issuance of initial marketing authorisations and for post-approval changes (ie, renewals and varia- tions). In 2024, ALIMS initiated a pilot project aimed at expanding the reliance framework to cover medicines previously approved in the EU via the decentralised procedure (DCP) and mutual recognition procedure (MRP). Reliance for Medicinal Products Approved Through CP in the EU As at the time of writing, no legislative amendments have been made to formally incorporate reliance into Serbia’s regulatory framework. Instead, reliance for centrally authorised medicinal products has been introduced through an interpretation of the existing provisions governing the accelerated procedure for initial marketing authorisations (which has a 150-day timeline, as outlined in 4.1 Fast Track Registration Routes ). In June 2025, ALIMS issued a Guidance on the application of the reliance approach for medicinal products authorised through the EU centralised proce- dure (CP). The Guidance provides instructions for the submission of documentation in accelerated market- ing authorisation procedures and for variations, and is grounded in the relevant regulatory framework and World Health Organization (WHO) guidance, includ- ing the WHO principles on good reliance practices, good regulatory practices and good review practices. It specifies the required documentation and includes a template Declaration of Documentation Identity. ALIMS employs the European Medicines Agency (EMA) as its reference regulatory authority, relying
on EMA assessment reports while retaining full inde- pendence, responsibility and accountability in its deci- sion-making process. The reliance procedure involves requesting various EMA assessment reports to enable an informed reliance approach, taking advantage of EMA’s transparent evaluation processes. ALIMS applies reliance to both issuance of marketing authorisations and post approval changes (renew- als and variations) for centrally authorised medicinal products. The reliance-based regulatory pathway fol- lows three key steps: (i) verification of the sameness of dossier submitted to Serbia and approved in the centralised procedure before EMA; (ii) confirmation of the applicability of the assessment outcomes of EMA for regulatory decision-making in the national context; and (iii) abridged review. The reliance pathway is detailed in the ALIMS Inter- nal procedures and Standard Operating procedures (SOPs), which outline the steps for processing reli- ance applications, the corresponding regulatory procedures, and the requirements that applicants must meet. ALIMS also employs a distinct template for abridged review applications, separate from full review applications. ALIMS is also planning to expand the reliance-based procedures to other EU-approved medicines, which is expected to enhance regulatory efficiency and pre- dictability, enabling ALIMS to meet statutory timelines in 2026. Documentation Required for Initial Marketing Authorisation Through Reliance Documentation to support reliance for initial marketing authorisations includes: • confirmation of approval (Commission Decision; Approval Letter/CHMP Opinion; eCPP); • statement regarding product sameness submitted in Serbia and approved in CP; • list of variation submitted and approved in CP; • questions and answers, interim assessment reports and unredacted final CHMP assessment report (before publishing) generated by EMA; • approvals (acknowledgement of receipt/notifica- tion/CHMP Opinion) and assessment reports (type
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