Medicinal product incident – a situation in which an event occurs or new information becomes available regarding a registered medicinal product, regardless of whether it is or is not publicly available, which may have a serious impact on public health.*

*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.