Pharmacovigilance System Master File (PSMF) – a detailed description of the pharmacovigilance system applied by the marketing authorization holder with respect to data on one or more registered medicinal products.*

*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.