Medicinal products

Draft amendments to the Rules of Good Pharmacovigilance Practice (GVP) of the Eurasian Economic Union (507 page(s), in Russian)

Harmonization with the current version of the European Pharmacovigilance Regulations 2014-2019, generalization and use of experience in assessing actual issues of safety and

efficacy of medicinal products being in circulation on the pharmaceutical market from 2005 to 2019. Clarification of approaches to the preparation of risk management plans and of periodically updated reports on the safety of medicines.