The Common Pharmaceutical Market of the Eurasian Economic Union: A Regulatory Review

Abstract

According to the Treaty on the Eurasian Economic Union, a common pharmaceutical market was supposed to become operational on January 1, 2016. Nevertheless, the responsible parties did not meet the deadline. Although a majority of the draft guidelines regulating this process were already known in 2014 and 2015, the anticipated process itself caused anxiety among representatives of the foreign pharma industry, who tried to prepare for coming challenges. Among other possible issues, the ambiguity of transitional periods and a lack of approved legislation were noted. Now only a few months remain until the end of 2016, but the market is still not functional. Furthermore, key documents relevant to the market still require approval by the Eurasian Economic Commission, and some of them even require discussion by representatives of member states. The present review provides readers with basic knowledge about regulatory procedures within the EAEU and the document approval process. It analyzes essential legislative acts and consequences for the pharma industry to take into account, including marketing authorization pathways, specific dossier requirements, and dates of their implementation. At the same time, reasons for the delay in the market's opening and future perspectives are discussed.

Impact on the Availability of Food Supplements and Medicines in the Russian Federation during Legislative Changes in 2010: A Case Study

“…To address such issues in the future, common EAEU legislation was introduced. However, there were almost no legal obstacles to implementing common EAEU pharmaceutical legislation to start a common market [24]. However, at the end of 2017, despite an enormous workload with the intention of an easy market entrance and overall unification, all the efforts led nowhere, and the Russian MA system proceeded to function autonomously [24].…”