Bringing the medicinal products to the territory of all EAEU member states requires practical experience of working under EAEU rules for registration and expert examination of medicinal products. Until now, the pharmaceutical industry had no opportunity to acquire this necessary experience, as the legislative norms of the Union governing the registration have not yet entered into force.
Andrei Konovalov, Regulatory Affairs Director for Russia and Eurasia at Teva, commented on the intention of Teva to participate in a pilot project on the registration of drugs in accordance with EAEU procedures: „We understand that this will take some time, and we are interested in working together with professional associations and the Eurasian Economic Commission to try out new procedures in practice.“
Teva plans to include in the pilot project two of its drugs that will be submitted for registration in different countries of the Union under two procedures. The first is the mutual recognition procedure, where the drug will be submitted for registration in Belarus with its subsequent recognition in Russia. The second procedure involves bringing the dossier of registered drug in line with EAEU requirements, where a drug registered in Kazakhstan will be brought in compliance with the requirements of the Union, after which the registration will be recognized in the Russian Federation.