Submission of Documents on the Pharmacovigilance System as Part of the Registration Dossier within the Framework of the EAEU Procedures: Analysis of Requirements and Typical Errors

Submission of Documents on the Pharmacovigilance System as Part of the Registration Dossier within the Framework of the EAEU Procedures: Analysis of Requirements and Typical Errors

INTRODUCTION. Documents on the pharmacovigilance system of the marketing authorisation holder (MAH), including the Pharmacovigilance System Master File (PSMF) and the PSMF-based summary of the pharmacovigilance system (SPS), are a mandatory component of the registration dossier for a medicinal produ...

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Bibliographic Details
Main Authors: N. Yu. Velts, E. O. Zhuravleva, G. V. Kutekhova, N. V. Tereshkina
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2024-10-01
Series:Безопасность и риск фармакотерапии
Subjects:
pharmacovigilance
pharmacovigilance system master file
summary of the pharmacovigilance system
registration dossier
registration of a medicinal product
examination of the registration dossier
drug safety
eurasian economic union
review
Online Access:https://www.risksafety.ru/jour/article/view/452
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