Non-prescription herbal preparations in Russia are traditionally in high demand among the population. In this regard, pharmacovigilance, the audit system, inspection and examination of the safety of medicinal products based on herbal raw materials are of great importance.

Among the sedatives of natural origin, widely used in everyday life and in stressful situations, more than 80% of the drugs in the pharmacy range fall into the over-the-counter category. Consumers appreciate the safety of their use compared to synthetic products. Valerian officinalis (Valeriana officinalis L.), a member of the Valerianaceae family, is a well-known medicinal plant whose biologically active substances have a proven sedative, anxiolytic and cardiotropic effect. In accordance with the State Register of Medicines (hereinafter – GRLS), as well as taking into account the experience and practice of pharmacovigilance, the audit system, inspection and examination of the safety of medicinal products based on plant raw materials, valerian rhizomes with roots are used for the manufacture of infusion, tincture, thick extract; raw materials are part of the sedative collection No. 2 and No. 3, sedative collection No. 2, gastric collection No. 3. Valerian tincture is used as a monopreparation and as a component of lily of the valley-valerian drops, Zelenina drops, dental drops, Bellavamen, Bromenval, Valocormid, Valemidin® , Gastroguttal®, Cardiovalen. The extract is available in the form of tablets, and is also a component of the preparations Sanason Lek, Persen®, Persen®forte, Persen® Night, Novo-Passit®, etc.

Thanks to a well-functioning pharmacovigilance system, a system of audit, inspection and examination of the safety of medicinal products based on herbal raw materials, a significant amount of data has been collected. As a result, valerian medicinal raw materials and preparations based on it are included in the European Pharmacopoeia and many national pharmacopoeias: Austria, Australia, Belgium, Great Britain, Germany, Italy, France, Canada, Russia, USA, Switzerland. No less popular among the population is the multicomponent drug Corvalol of sedative and antispasmodic action, dispensed without a doctor’s prescription, which contains phenobarbital, chemically synthesized ethyl ester of α-bromisovaleric acid (ethyl bromisovalerianate) and peppermint leaf oil.