Classifying harm associated with a medication error can be time consuming and labour intensive and limited studies undertake this step. There is no standardised process, and few studies that report harm assessment provide adequate methods to allow for study replication. Studies typically mention that a clinical review panel classified patient harm and provide a reference to a classification tool. Moreover, in many studies it is unclear whether potential or actual harm was classified as studies refer only to ‘error severity’. The tools used to categorise the severity of patient harm vary widely across studies and few have been assessed for inter-rater reliability and criterion validity. In this paper, we describe the systematic process we undertook to synthesise the defining elements and strengths, while mitigating the limitations, of existing harm classification tools to derive the Harm Associated with Medication Error Classification (HAMEC). This new tool provides a harm classification for use across clinical and research settings. The provision of an explicit process for its application and guiding category descriptors are designed to reduce the risk of misclassification and produce results that are comparable across studies. As the World Health Organisation embarks on its international safety challenge of reducing medication-related harm by 50%, accompanying methodological advances are required to measure progress.