SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
4.2 Regulatory Reliance Since 2023, Serbia has been progressively introducing the concept of regulatory reliance. The reliance strategy 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 oppor- tunities 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 variations). In 2024, ALIMS initiated a pilot project aimed at expand- ing the reliance framework to cover medicines previously approved in the EU via the decen- tralised 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 amend- ments have been made to formally incorporate reliance into Serbia’s regulatory framework. Instead, reliance for centrally authorised medici- nal products has been introduced through an interpretation of the existing provisions govern- ing the accelerated procedure for initial market- ing authorisations (which has a 150-day time- line, as outlined in 4.1 Fast Track Registration Routes ). ALIMS employs the European Medicines Agency (EMA) as its reference regulatory authority, rely- ing on EMA assessment reports while retaining full independence, responsibility and account- ability in its decision-making process. The reli- ance 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 mar- keting authorisations and post approval changes (renewals and variations) for centrally authorised medicinal products. The reliance-based regula- tory pathway follows three key steps: (i) verifi- cation of the sameness of dossier submitted to Serbia and approved in the centralised proce- dure before EMA; (ii) confirmation of the appli- cability of the assessment outcomes of EMA for regulatory decision-making in the national con- text; and (iii) abridged review. The reliance pathway is detailed in the ALIMS Internal procedures and Standard Operating pro- cedures (SOPs), which outline the steps for pro- cessing reliance applications, the correspond- ing regulatory procedures, and the requirements that applicants must meet. ALIMS also employs a distinct template for abridged review applica- tions, separate from full review applications. Documentation Required for Initial Marketing Authorisation Through Reliance Documentation to support reliance for initial marketing authorisations includes: • confirmation of approval (Commission Deci- sion; Approval Letter/CHMP Opinion; eCPP); • statement regarding product sameness sub- mitted in Serbia and approved in CP; • list of variation submitted and approved in CP; • questions and answers, interim assessment reports and unredacted final CHMP assess- ment report (before publishing) generated by EMA; • approvals (acknowledgement of receipt/ notification/CHMP Opinion) and assessment
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