Source: http://remedium-journal.ru/arhiv/detail.php?ID=54272&num=%E2%84%967-8
Timestamp: 2019-08-25 10:31:17
Document Index: 297691653

Matched Legal Cases: ['art 314', '§314', 'art 314', '§314', 'art 314', '§314']

Р.Р. Ниязов1, Д.А. Рождественский2, А.Н. Васильев1, Е.В. Гавришина1, М.А. Драницына1, Д.А. Куличев1
R. R. Niyazov1 , D. A. Rozhdestvenskiy2 , A. N. Vasiliev1 , E. V. Gavrishina1 , М. А. Dranitsyna1 , D. A. Kulichev1
1 Center for Scientific Advice LLC
2 Eurasian Economic Commission
A robust methodological basis for 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.
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Ключевые слова: воспроизведенный лекарственный препарат, гибридный лекарственный препарат, биоэквивалентность, биодоступность, регистрация, фармацевтическая эквивалентность, терапевтическая эквивалентность, взаимозаменяемость, международный компаратор, Generic medicinal
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