Subject to Discussion
A draft of document on making amendments to the resolution of the Government of the Russian Federation of October 28, 2015 No 1154 “On Procedures of Detecting Interchangeability of Drugs for Medicinal Use”, prepared by the Russian Ministry of Healthcare, has been presented for discussion.
It is suggested to supplement the Rules of determining interchangeability of medicinal drugs with the following clause:
“In case of unavailability of the reference drug with the quality, efficacy and safety proven based on results of preclinical and clinical trials of drugs, newly authorized drugs based on own preclinical and clinical trials of drugs in circulation in the Russian Federation are considered to be equal to reference drugs”.
The public discussion will continue to October, 6.