REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot127610.21518/1561-5936-2018-7-8-6-19Original ArticleRegulatory aspects of marketing authorization of generic and hybrid medicinal products in the Eurasian Economic UnionNiyazovR. R.noemail@neicon.ruRozhdestvenskiyD. A.noemail@neicon.ruVasilievA. N.noemail@neicon.ruGavrishinaE. V.noemail@neicon.ruDranitsynaМ. А.noemail@neicon.ruKulichevD. A.noemail@neicon.ruCenter for Scientific Advice LLCEurasian Economic Commission071220187-861918032022Copyright © 2018,2018A robust methodological basis for the placing generic and hybrid medicinal products on the market has been established in the Eurasian Economic Union (EAEU). Since the concepts of generic medicinal products and hybrid medicinal products are regulatory in their nature and serve as a tool for the simplified access on the pharmaceutical market for medicinal products with established safety and efficacy, it is worth discussing the terms and definitions, criteria for recognizing generic or hybrid products, considering regulatory conditions for the development, and applying for the marketing authorization, of generics and hybrids as well as comparing U. S., EU and EAEU legal provisions governing granting marketing authorization for these two group of products that are important for the healthcare.Generic medicinal producthybrid medicinal productbioequivalencebioavailabilitymarketing authorizationpharmaceutical equivalencetherapeutic equivalenceinterchangeinternational comparatorвоспроизведенный лекарственный препаратгибридный лекарственный препаратбиоэквивалентностьбиодоступностьрегистрацияфармацевтическая эквивалентностьтерапевтическая эквивалентностьвзаимозаменяемостьмеждународный компаратор[Правила проведения исследований биоэквивалентности лекарственных препаратов в рамках Евразийского экономического союза. Утв. Решением Совета Евразийской экономической комиссии от 3 ноября 2016 года № 85. Справочно-правовая система «Электронный фон правовой и нормативно-технической документации». URL: http://docs.cntd.ru/document/456026107 (дата обращения: 06.04.2018).][Номенклатура лекарственных форм. Утв. 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