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В соответствии с п. 1 ст. 64 Федерального закона от 12.04.2010 № 61-ФЗ "Об обращении лекарственных средств" лекарственные препараты, находящиеся в обращении на территории Российской Федерации, подлежат мониторингу безопасности в целях выявления возможных негативных последствий их применения, предупреждения пациентов и их защиты от применения таких препаратов.