This publication presents the data and findings of the risk assessment on methyl 2-{[1-(5-fluoropentyl)-1H-indazole-3-carbonyl]amino}-3,3-dimethylbutanoate (5F-MDMB-PINACA), carried out by the extended Scientific Committee of the EMCDDA on 7-8 November 2017. In March 2018, at its 61st regular session, the Commission on Narcotic Drugs (CND) decided to place 5F-MDMB-PINACA in Schedule II of the Convention on Psychotropic Substances of 1971 based on a recommendation by the World Health Organization. This recommendation was substantially supported by European data provided by the EMCDDA.