In the execution of the decrees of the Russian Federation Government dd. 05.09.2019 No.1986-r “On allotting to the Ministry of Industry and Trade of the Russian Federation the Budgetary Allocations from the Reserve Fund in 2019” and dd. 25.09.2019 No. 2170-r “On the Import to the RF of Unregistered Psychotropic Medications for the Purpose of Providing Children with Medical Care for Vital Indications in 2019” (hereinafter as the Decrees) on the import to the territory of the Russian Federation of unregistered medications containing psychotropic substances, FSUE "Moscow Endocrine Plant” of the Ministry of Industry and Trade of Russia (hereinafter as the Enterprise) with the help of the Ministry of Industry and Trade of Russia has imported psychotropic medications non-registered in the territory of the Russian Federation with the INNs - Diazepam, Midazolam, Clobazam in dosage forms intended for children use.
As part of the organisation of own production of the imported drug products, the Enterprise, together with the Ministry of Industry and Trade of Russia has introduced into production the medicinal products “Midazolam, solution for oromucosal (buccal) use” and "Diazepam, solution for rectal administration”.
At present, the pharmaceutical products manufacturing process is fully developed, additional equipment has been procured and installed.
The Enterprise has started conducting authorization clinical studies of the specified pharmaceutical products.
The clinical studies are performed in strict compliance with GMP requirements.
Gaining the marketing authorizations for the specified pharmaceutical products is scheduled for QIV of 2020.
Comment type is not specified in the component properties.