A special recording procedure for certain securities will be in effect until the end of 2025
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07.02.2024
MAJOR AMENDMENTS HAVE BEEN MADE TO THE LAW ON THE CIRCULATION OF MEDICINES
Amendments have been made to the Law on the Circulation of Medicines aimed at bringing its provisions into compliance with international treaties and acts that constitute the law of the EAEU.
From 2025, government services in the area of circulation of medicines will be provided in the form of electronic document management using the Uniform State Health Information System and the Unified Portal of State and Municipal Services.
The circulation of medicines is being transferred to a registry model - thus, the registration certificate of a drug will be not only a document, but also an entry in the State Register of Medicines and Medical Products confirming the fact of registration (from January 1, 2025 registration certificates on paper will no longer be issued).
The specifics of introducing certain groups of medicinal products into civil circulation will be established.
A ban is introduced on the use of information on the results of preclinical and clinical trials of drugs for commercial purposes and submitted by the applicant for registration of the drug, without the applicant’s consent for six years from the date of registration of the generic in the Russian Federation.
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