The first applications have been submitted for registration of medicinal products under the unified rules of the Eurasian Economic Union (EAEU). This was announced by the representatives of Kazakhstan’ regulator at the EAEU and CIS Pharmaceutical Forum.
The regulators from Belarus confirmed their readiness to accept such applications.
“This marks the beginning of a very important stage in the operation of common drug market,” said Arman Shakkaliev, the Director of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission (EEC). “Previously, in EAEU member states, the medicines were registered only under the national rules. As a result, the pharmaceutical manufacturers, who wanted to trade across the Union, had to review the regulatory requirements of all five member states, prepare five dossiers for the same drug, pay for as many laboratory expert examinations (or basically for the same job), and spend too much time on registration procedures.”
Now, under the Union’s law, a manufacturer can obtain the expert report in one of EAEU member state and, after its recognition in other member states without additional laboratory expert examination, get the registration certificates for medicinal product and opportunity of free trade in the entire Union territory.
From January 2021, the pharmaceutical manufacturers must register their products only under the Union requirements. By the end of 2025, all medicines registered under the national rules must comply with EAEU regulations.