Russian and foreign legislation on regulation of post approval variations in the dossier for the medicinal products

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Russian and foreign legislation on regulation of post approval variations in the dossier for the medicinal products

Drug licensing is the most crucial factor for effective market regulation of pharmaceuticals. The rapid development of the pharmaceutical industry, emergence of new scientific data, and changes in composition of medicinal products drive the need for introduction of variations in original registratio...

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Bibliographic Details
Main Authors:	Yu. V. Olefir, V. A. Merkulov, E. A. Soloviev, E. A. Ustyugova, L. V. Sayapina, V. P. Bondarev
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’) 2018-02-01
Series:	Регуляторные исследования и экспертиза лекарственных средств
Subjects:	лекарственные препараты пострегистрационные изменения классификация изменений руководства нормативные документы drugs post-approval variations classification guidelines normative documents
Online Access:	https://www.vedomostincesmp.ru/jour/article/view/58
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