Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance Practice

Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance Practice

The development of international regulatory practices and the accumulation of new experience in pharmacovigilance prompted the need to amend the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP Guideline), first adopted in 2016.The aim of the study was to review, fr...

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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» 2023-03-01
Series:	Безопасность и риск фармакотерапии
Subjects:	good pharmacovigilance practice of the eurasian economic union gvp pharmacovigilance pharmacovigilance system pharmacovigilance system master file marketing authorisation of medicines regulatory assessment of medicines
Online Access:	https://www.risksafety.ru/jour/article/view/350

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