BackgroundSmuggling health goods given the importance and critical nature of health services should be undeniably addressed and controlled by all countries. This issue is especially more widespread in developing countries with more damaging consequences. This paper therefore aims to identify and analyze the challenges of preventing smuggling of health goods in Iran.MethodWithin this qualitative study, we conducted face-to-face, semi-structured interviews with 30 purposefully recruited key informants and stakeholders in the detection, prevention, and combating of health goods smuggling. Each interview was analyzed thematically, using an inductive approach to generate codes, then categorized and presented in the form of main themes and sub-themes. Maxqda 11 assisted in coding, analysis, and data management.ResultsThree main themes emerged representing the challenges of prevention of smuggling in Iran in the areas of anti-smuggling policy development, including categories of inefficient policy and plan, and failure to reach agenda; policy implementation; categorized into actors, resources and instruments, and implementation guarantee; and finally monitoring and evaluation; including, procedures and practices, and the role of surveyors.ConclusionPrevention of smuggling health goods proves to be a highly complex, challenging, and multi-faceted practice. Therefore, strengthening policy-making, regulatory frameworks, and facilitation functions about smuggling, counterfeiting, and corruption should be promoted in parallel.