To be Discussed
A draft of document on amendments to decree of the Government of the Russian Federation of October 28, 2015 No 1154 “On the Principles of Interchangeability of Drugs for Medical Use”, prepared by the Ministry of Healthcare of the Russian Federation, has been introduced for public discussion.
It is suggested to supplement the Rules for detection of interchangeability of drugs for medicinal use with the following section:
“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.