The Government of the Russian Federation has proposed to withdraw high-tech medicines subject to registration under the rules of the EAEU and transplantation items from the Federal Law No. 180 on biomedical cellular products (BMCP). The corresponding document has been posted in the electronic database of the State Duma.
Registration of BMCP will no longer be compulsory for theor import. The requirements for other import conditions, including confirmation of conformity and a set of documents for import, will also be canceled.
BMCPs for individual use, produced by clinics for specific patients in the medical organization in which the product was prescribed, will also not require registration. The Government will have the right to establish a special procedure for the circulation of such products, including the rules for granting permission for their production and use.
These changes will provide conditions for the innovative development of Russian medicine and healthcare amid sanctions, the explanatory note says, according to FV. In addition, the bill expands the concept of a biomedical cellular product to include products containing cells that have not been cultured and/or modified.