Russia: Changed procedure for determining drug interchangeability [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2020-02-21 13:20 2a02:8388:6bc2:ce80:856f:1d4e:74d9:7171 – Posting: # 21186
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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.

In terms of their content, the criteria have not changed. However, some new definitions have been implemented into the Law on the Circulation of Medicines (e.g "therapeutic equivalence of medicines", "bioequivalence of medicines" etc.) for the purposes of administration of the process of determining medicines' interchangeability.

Moreover, the Federal Service for Surveillance in Healthcare (Rosdravnadzor) may order both the holder of marketing authorization for that medicine and the holders of marketing authorizations for interchangeable medicines to make changes into the instruction on use (patient leaflet), if it is necessary based on a pharmacovigilance data.

A new separate registry for interchangeable medicines will be created. The registry will be open and each internet user will have access to it.


Cheers,
Helmut Schütz
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