Periodic Safety Update Report (PSUR) – a report for presenting the benefit-risk assessment of a medicinal product by the marketing authorization holder during a defined period of time during the post‑authorisation phase.*
*Decision No. 87 of the Council of the Eurasian Economic Commission dated November 3, 2016 “On Approval of the Good Pharmacovigilance Practice Rules of the Eurasian Economic Union” (as amended by Decision No. 81 of the Council of the Eurasian Economic Commission dated May 19, 2022). Effective date — December 6, 2022.
