(1201 d 07:32 ago)
Posting: # 21186
Dear all (and esp. our Russian members),
do you understand / can you explain what that means?
Russian President signed Federal Law No. 475-FZ on December 27, 2019, which introduced amendments into several laws, including Federal Law No. 61-FZ "On the Circulation of Medicines" dated 12 April 2010 (Federal Law No. 475-FZ and Law on the Circulation of Medicines). Federal Law No. 475-FZ establishes a new procedure for the medicines' interchangeability. The interchangeability will be determined within the framework of one international non-proprietary name (either chemical or generic name) of the medicine by the Russian Ministry of Healthcare on the basis of an expert commission's report of the relevant expert institution, which will be guided by the criteria established by the Federal Law No. 475-FZ.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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(1201 d 05:47 ago)
Posting: # 21187
❝ do you understand / can you explain what that means?
Firstly: around 5 years ago IB story was started by our government in order to understand whether generics which are present on our market could serve as substitute to reference drug because government buys drugs for Healthcare system. Six points were introduced in order to understand whether drugs are interchangeable:
Then companies started submitting the upgrades for their dossiers (together with BEQ reports). The deadline for this was until 31.12.2016. By the 1.1.18 experts were preparing IB register which was introduced within GRLS system. You can see it here at the bottom of the each page for separate drug if you use search. Now some changes are introduced again in IB procedure however as I understood it is not so critical. At least for me.
Secondly: about BEQ. MoH will evaluate BEQ reports also for 20-years-on-the-market drugs which was not performed before, since such drugs were registered without BEQ study. More information here (sorry, only Russian).