Russian President Vladimir Putin signed the Federal law from 03.08.2018 No. 323-FZ “On amendments to certain legislative acts of the Russian Federation on the circulation of biomedical cell products.”
The law clarifies certain provisions of the Federal law “On biomedical cell products”:
– the definition of “biomedical cell product” (BMKP) is supplemented with the fact that the composition of this product, along with the recent state registration of medicinal preparations for medical use can be included in the state register of medicines of the pharmaceutical substance;
– it is established that for carrying out of examination of quality BMKP will be required, including samples of pharmaceutical substances;
– determines that the list used in the manufacture BMKP components must be disclosed the data on pharmaceutical substances, and in the state register BMKP along with the names of drugs included in the BMTP will have to specify the names of pharmaceutical substances;
– expands the composition of the registration dossier for BMCP.
In addition, it establishes that the activity BMKP will be licensed, which requires changes to the Federal law “On licensing separate types of activities”.
In addition, according to the law the state control in the sphere of circulation BMKP becomes an integral part of state control in the sphere of health protection (relevant provisions are supplemented by Federal laws “About bases of health protection of citizens in the Russian Federation” and “On protection of rights of legal entities and individual entrepreneurs when exercising state control (supervision) and municipal control”).