Market Authorization Process for Medicinal Products in Eurasian Economic Union Council

Abstract

The study aims to discuss about history and structure of the Eurasian Economic Union (EAEU) has been shaped by numerous agreements and treaties aimed at promoting economic cooperation among member states. The EAEU is an international organization comprising the countries of the Eurasian region. Its major treaties and agreements, such as the Partnership and Cooperation Agreement (PCA) of 1997, passed the way for further integration. The Treaty establishing the Eurasian Economic Union, signed on May 29, 2014, marked an important step forward. This treaty established the framework for the EAEU, with its provisions entering into force on 1 January 2015. The treaty covers several key aspects, including the creation of four common spaces: Economy and environment, freedom, security and justice, foreign security, research and education, including cultural cooperation among Member States. The main objective of the EAEU is to facilitate the movement of goods, services, capital and labor within its borders, and to coordinate policies in specific economic sectors as defined by the EAEU. It aims to promote sustainable economic development, improve living standards, create a single market and enhance competitiveness in the global economy. The structure of the EAEU includes key agencies responsible for decision-making and implementation. The Supreme Eurasian Economic Council, composed of the heads of member states, is the highest governing body. The executive functions are performed by the Eurasian Economic Commission, which is responsible for the practical aspects of the EAEU's operations. One notable aspect is the agreement on the general principles and rules of drug marketing within the EAEU. This agreement underscores the EAEU's commitment to ensuring access to safe, high-quality medicines, with an emphasis on distribution coordination and consumer protection. The agreement defines the principles of drug regulation in the member states. The EAEU drug registration procedure includes several routes: mutual recognition, decentralized procedure and national procedure. These procedures are designed to harmonize registration requirements and streamline the delivery process in compliance with EAEU standards. The mutual recognition procedure includes the selection of a Reference Member State (RM) and a Member State of Concern (EMC) for the assessment of the application. Decentralized process allows RMS and CMS to evaluate simultaneously. The national procedure is available to those who wish to register in only one country. Adaptation of old records to EAEU requirements related to RMS selection, followed by assessment and feasibility testing. Successful compliance leads to a harmonized registration certificate and, if eligible, the registration certificate is valid indefinitely