Interchangeability of Drugs: the Procedure to be Specified
To improve legal regulation in the field of drug circulation and implementation of Point 3 of Resolution of the Council of Eurasia Economic Commission of 03.11.2016 No 92 “On specific questions of circulation of medicinal drugs”, FAS of Russia has prepared amendments to the Law on Drug Circulation (61-FZ). The draft of law suggests to introduce a procedure of maintaining a register (list) of interchangeable drugs, circulating in the territory of EEU. For creation of such register it is suggested to use information of a unified register of medicinal drugs approved in its territory. The Ministry of Health of Russia will be responsible for maintenance of the list.
Besides, the draft of law also provides details on the procedure of establishing interchangeability of drugs, including the order of providing information on the drug to the Federal executive organ, to determine interchangeability of drugs, approved according to the rules, effective until July 1, 2015.
The text of the draft of law has been sent to the Russian Ministry of Health and has been uploaded by the Ministry for public discussion which will continue until January 7, 2017.