Minimum requirements for information in an adverse reaction report – the minimum set of data to be submitted to the competent authorities in the field of pharmacovigilance regarding suspected adverse reaction cases (including an identifiable reporter, an identifiable patient, the adverse reaction, and the suspected medicinal product).*

*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.