Plasma law was accepted in Russian Federation2022-07-13
The Federal law from 28.06.2022 № 204-Federal law «About changes into some laws of Russian Federation», which became a result of ending of Law project № 106588-8 «About changes into certain legal acts of Russian Federation » (in the part of state regulation plasma collection for medicines manufacturing)». This ends phase of changes of approval added to Federal law (FL) № 125 from 20.07.2012 «About blood and its components donation».
The Government of Russian Federation was the main initiator of making changes into the law. Main goal of the suggested changes is to make Russian law in accordance with requirements of Eurasian economical union and make the process of plasma distribution for clinical using and medicines manufacturing more transparent (definition «Plasma for fractionation» will be added).
Thanks to published law blood donation centers will be able to send collected donor plasma straight to pharmaceutical manufactures and manufactures of medicines will get an ability to storage and transport plasma intended for fractionation.
Important change became an amendment to allow plasma import for fractionation to Russian Federation according to custom rules of EAEU.
Also, important amendment was added to the sphere of organization and equipment centers of donations (plasma collection). Manufactures of medicines get a possibility to conclude Agreement about joint development infrastructure of subject circulation donor blood and its components, based on its manufacturers can guaranty providing their manufactures necessary plasma for fractionation in change of investments into infrastructure of donations centers.
Accepted edits will become affected from the 1st October of 2022.