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Russia Pharmaceuticals Sector Update - February 2021

In this month's 'Russia Pharmaceuticals Sector Update', Julien Hansen, Elena Mikhailovskaia and Pavel Arievich of DLA Piper's Moscow office discuss proposed regulatory changes in Russia regarding medicine labelling requirements and subsidies for medical device and pharmaceutical manufacturers.  

The Russian Ministry of Industry and Trade produced a draft resolution introducing a notification regime for labeling medicines released before 1 February 2021. This is designed to ease the transition to the federal information system for monitoring the circulation of pharmaceutical products under which labelling becomes mandatory for all drugs as of 1 July 2021. This new system is designed to aid the traceability and monitoring of pharmaceutical products through the various stages in the supply chain using a Data Matrix code. Simplified mechanisms for medicines to enter the labeling system are set to be in place until 1 July 2021.

Regulatory changes which introduce subsidies for medical device and pharmaceutical companies are also discussed. Medical device and pharmaceutical companies may now be able to claim compensation for costs associated with the production and sale of products of specific nomenclature classification. The relevant product lists will take into account proposals made by manufacturers, scientific organisations, research centres and government bodies.

Please find the full article here.

Tags

medical devices, pharmaceuticals, regulation, russia, labeling, subsidies, orphan medicines

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