This article examines the Eurasian Economic Union (EAEU) regulatory pathway following the completion of the transition period in December 2025, after which all medicinal products on the union's market must comply with unified registration rules. It provides a practical guide to the key regulatory institutions, the hierarchy of normative documents, registration procedures, and electronic common technical document (eCTD) dossier requirements. Particular attention is paid to document preparation, common applicant mistakes, and strategies to optimize the regulatory process. The recommendations are based on an analysis of the EAEU regulatory framework and the author’s extensive hands-on experience.
