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Background. The risk management plan is the one of main documents of pharmacovigilance system – a document focuses on the planning of pharmacovigilance activities and minimization of risks. As the use of herbal medicines has increased, so too have the reports of suspected toxicity and adverse events. As many herbal products on the market have not been thoroughly tested for their pharmacology and toxicology, pharmacovigilance has paramount importance in detecting unwanted reactions. One of the herbal preparations widely used to support the cardiovascular system under stress, neurocirculatory dystonia, cardiac neurosis, in the complex treatment of arterial hypertension, angina pectoris, arrhythmia is a complex medicinal product Carvelis, oral drops, solution. The active pharmaceutical ingredients of the drug are: extract from a mixture of hawthorn leaves, flowers and fruit (Сrataegi folii cum flore, fructus extractum); herb extract of canine nettle (Leonuri herbae extractum); melissae herbia extract Melissae herbae extractum); valerian root extract (Valerianae radix extractum). Objective. Сritical analysis of current scientific data on the benefit/risk ratio of a complex herbal medicine with sedative and cardioprotective effects. Results. Pathophysiological and epidemiological characteristic of following nosological forms have been analyzed: stress, neurocirculatory dystonia, cardiac neurosis, arterial hypertension, angina pectoris, arrhythmia. Current data on phytopreparation safety and estimation benefit/risk ratio have been generalized. Available clinical data were analyzed for individual phytocomponents or its combinations. Conclusions. The prevalence, seriousness and severity of the course of all manifestations of neurocirculatory dystonia, stress, nervous excitement, heart neurosis, especially with disproportionate approaches to the treatment of these diseases, is a serious medical and social problem. Given the proven efficacy of the use of Carvelis preparation components, and also that the risks are predictable, and their occurrence can be countered, and if they occur it can be effectively suppress with other drugs, the benefit of using the phytopreparation prevails above the risks.