Типовая форма периодического отчета по безопасности лекарственного препарата

The results of evaluating information in the Periodic safety update reports (PSUR) submitted by marketing-authorisation holder indicate a lack of understanding of regulatory requirements for the preparation of this document. As a result PSURs submitted by some marketing authorisation holders are returned to them for correction. The purpose of this article is to present the standard forms of PSUR, which will allow you to adequately prepare this reporting document.