To Agree on the Terms
The Ministry of Healthcare of the Russian Federation has prepared and presented for public discussion a draft of law regulating the principles of interchangeability of approved drugs.
According to the document a commission of experts at the Federal state budgetary institution will determine the interchangeability of approved drugs, according to an assignment of the Russian Ministry of Health, including those based on application of the holder or owner of marketing authorization certificate before December 31, 2017.
The draft of law specifies the term “reference drug”. It will enable extension of the new term from the drugs being approved to the drugs that have already been approved before the law “On making amendments to clause 4 of Federal Law “On Drug Circulation” came into force and recognize the expiry of certain provisions of legislative acts of the Russian Federation” and included into state drug registers.
Public discussion of the document will continue to May 12, 2016.