Russia Pharmaceuticals Sector Update - February 2021

Possible new requirement to label medicines released before 1 February 2021

The Russian Ministry of Industry and Trade has proposed introducing a notification regime for labelling medicines released before 1 February 2021. Such draft resolution of the Russian Government was prepared at the initiative of the Ministry but has not yet been adopted.

Such proposal has been made in order to more smoothly transition to a new system for tracing the events in the turnover of medicines. Specifically, it has been taken into account that medicines introduced into turnover before 1 February 2021 may be at different stages in the chain of their traceability.

Simplified mechanisms for medicines to enter the system of labelling medicines are set to be in place until 1 July 2021. Until then, participants in the process of circulating medicines are not obliged to wait for suppliers to confirm the acceptance of medicines in order to undertake further operations (acceptance and further sale) with medicines; and upon the import of medicines into Russia, importers do not need to wait for confirmation of import from the marketing authorisation holders.

Representatives of the Centre for the Development of Advanced Technologies (the official labelling operator) believe that the pharma industry has increased the quality of work with the medicine labelling system and will painlessly switch to the usual course of work after the simplified regime ends.

Source: tass.ru

Clarification of rules for granting subsidies to manufacturers of medical devices and pharmaceuticals

In accordance with the new version of Resolutions No. 1463 and No. 1464 of the Government of the Russian Federation of 16 November 2019, starting from 2021, organisations producing types of products included in lists of strategic areas drawn up by the Ministry of Industry and Trade of Russia will be eligible to claim compensation for costs associated with the production and sale of competitive medical devices and medicines.

These lists should be drawn up in relation to medical devices – by their types in accordance with the nomenclature classification; andwith regard to drugs – by the main classes of diseases and conditions, including socially significant, prevailing causes of disability and mortality in the population, or diseases that pose a danger to others, as well as those used for pathogenetic treatment of rare (orphan) diseases.

When drawing up the lists, proposals from interested government bodies, scientific organisations and national medical research centres, and manufacturers will be taken into account.

For each strategic area specified in the lists, the Ministry of Industry and Trade of Russia will annually establish the maximum amount of subsidies within the total budgetary allocations communicated to the Ministry for these purposes.

At the moment, the lists of strategic areas have not yet been drawn up.