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

• Main Authors: N. Yu. Velts (Author), E. O. Zhuravleva (Author), G. V. Kutekhova (Author), N. V. Tereshkina (Author)
• Format: Book
• Published: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2023-03-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...