Canine leishmaniosis (CanL) is a major zoonosis transmitted by sand flies which can potentially cause severe fatal disease in humans and dogs. The disease is endemic in southern Europe and there are concerns about its introduction into the non-endemic areas of the European Union (EU). The objectives of this work were to investigate the efficacy of different control measures using a systematic review (SR), assess the role of dogs in the spread of Leishmania Infantum (L. infantum) in the EU and evaluate potential mitigation measures using simulation modelling, and evaluate the impact of the disease in endemic areas. The SR evaluated the effectiveness and safety of control measures for CanL using 23 clinical trials conducted on a total of 5861 dogs. Significant benefits were observed in the intervention groups for a number of vaccine types, deltamethrin collars, spot-ons, and prophylactic medication with domperidone. However, these results require confirmation in adequately powered well designed randomised controlled trials. The results of the stochastic simulation modelling suggest that there is a high risk of endemicity for disease-free EU regions with presence of a competent vector and where infected dogs are introduced. When evaluated individually and at a high level of implementation, the best mitigation measures in decreasing order of effectiveness were: repellent, vaccine, prophylactic medication and insecticide. Some combinations of mitigation measures showed a joint effect higher than the effect of individual measures. Test and exclusion of positive dogs moving into non-endemic areas was effective for low numbers of imports, but its benefits diminished as the number of imported dogs increased, given the low sensitivity of the diagnostic test used. The results of the impact assessment suggest clinical CanL is a common diagnosis in endemic parts of the EU. The estimated percentage of practice-attending dogs with a veterinary diagnosis of CanL by country was as follows: France 0.71%, Spain 3.71%, Portugal 2.92%, Italy 4.25% and Greece 7.80%. CanL can have a significant impact on the welfare of affected dogs and economic implications for owners, both for prevention and treatment. It is estimated that the use of preventative collars in these five countries cost dog owners €54 million in 2012 alone. The incidence of clinical human leishmaniosis is much lower than CanL, with reported data suggesting between 20 and 380 hospital admissions per country per year. Costs relating to hospital fees and time off work may amount to approximately €4.5million/year in Spain, Portugal, Italy and Greece. The current economic crisis is likely to have an adverse impact on the prevention and control of CanL.