Risk Management Plan: Expert Review of Applications for Marketing Authorisation in the EAEU Depending on the Type of Medicinal Product (Review)

Risk Management Plan: Expert Review of Applications for Marketing Authorisation in the EAEU Depending on the Type of Medicinal Product (Review)

INTRODUCTION. A risk management plan (RMP) is an important document for assessing and managing risks when using a medicinal product. An RMP is provided as part of the marketing authorisation application for a medicinal product. The requirements for the need to submit an RMP and the information in it...

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Bibliographic Details
Main Authors: T. M. Bukatina, E. V. Shubnikova
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2024-07-01
Series:Безопасность и риск фармакотерапии
Subjects:
risk management plan
pharmacovigilance
risk management system
identified risks
potential risks
risk assessment
drug safety
safety specification
marketing authorisation
eurasian economic union
Online Access:https://www.risksafety.ru/jour/article/view/438
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