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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Bibliografische gegevens
Hoofdauteurs: Yu. V. Olefir, V. A. Merkulov, E. A. Soloviev, E. A. Ustyugova, L. V. Sayapina, V. P. Bondarev
Formaat: Artigo
Taal:Russo
Gepubliceerd in: OOO “Vashe Tsifrovoe Izdatelstvo” 2018-02-01
Reeks:Ведомости Научного центра экспертизы средств медицинского применения
Onderwerpen:
лекарственные препараты
пострегистрационные изменения
классификация изменений
руководства
нормативные документы
drugs
post-approval variations
classification
guidelines
normative documents
Online toegang:https://www.vedomostincesmp.ru/jour/article/view/58
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