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Unauthorized by the Right Holder

Some amendments will be made to the Federal Law No 61-FZ of 12.04.2010 “On Drug Circulation”. The amendments were prepared and offered by the Ministry of Health to facilitate the procedure of marketing authorization of generic drugs.

It is suggested to introduce an amendment to Clause 18 of the Federal Law “On Drug Circulation”. It should be reminded, that currently according to Part 18, Clause 18 FZ No 61-FZ of 12.04.2010 “On Drug Circulation”  any information on preclinical and clinical trials provided by the applicant may be used for the purpose of marketing authorization, including reference drug study reports, irrespective of the fact of publication, on condition of acceptance by the right holder of the reference drug.

If the proposed amendment is approved and included into the law, it will enable to use information on results of preclinical and clinical trials of medicinal drugs without approval of the reference drug rights owner in the Russian Federation for the purpose of marketing authorization of drugs. However, it only refers to the information which is publicly available and published in open sources, including specialized printed publications or web-sources.

Public discussion of the document will continue to December 29, 2016.

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