Preparation of Module 1 of the Registration Dossier According to the EAEU Procedure

The legislation of the Eurasian Economic Union (EAEU) includes all the necessary requirements and tools to implement a unified approach to preparing Module 1 of the electronic Common Technical Document (eCTD) for the concerned member states (CMSs). However, the approaches to the matter and the recom...

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Bibliographic Details
Main Author: E. M. Rychikhina
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2022-10-01
Series:Регуляторные исследования и экспертиза лекарственных средств
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Online Access:https://www.vedomostincesmp.ru/jour/article/view/484
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