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Update on the Regulation and Advertising of Medicines in Russia 

by Irina Anyukhina, Maria Ostashenko

Published: April, 2020

Submission: April, 2020

 



We would like to provide you with an update on some changes in the legal regulation of medicines in Russia made due to dynamic spread of the coronavirus (COVID-19).


On April3rd, 2020, there was enacted a federal law, according to which, licensed pharmacy organizations are permitted to sell remotely (online):


  • Over-the-counter medicines (under the respective procedure to be set by the Russian Government) and
  • Prescribed medicines (only within the emergency, as a temporary measure to be introduced by the Russian Government (if required) until December 31st, 2020).

This new regulation provides for new business opportunities for pharmacy organizations and medicine manufacturers.


At the same time, the Russian Federal Antimonopoly Service (FAS) scrutinizes the advertising of medicines where it is used a reference to therapeutic efficacy against COVID-19.


In particular, in January 2020, an advertisement of the medicine Arbidol, which was released on the radio, stated that the medicine has therapeutic efficacy against 2019-nCoV (COVID-19).


In March2020, FAS found this advertisement illegal, since the medicine’s package leaflet did not contain the information on such therapeutic efficacy. Therefore, FAS issued an order to the advertiser to stop the violation.


Besides, in February 2020, the similar advertisement of the medicine Remantadin at pharmacies was qualified by the regional subdivision of FAS as containing signs of violation due to the same reason. The advertiser removed the advertisement promptly and voluntarily.


Under the Russian law, an advertisement of a medicine is allowed only within the limits of the information contained in a duly approved package leaflet of the medicine. Otherwise, such an advertisement will be deemed illegal and will lead to an administrative fine up to RUB500,000 (approx. USD6,556) for legal entities.


Summarizing the above, we would like to emphasize the following:


  • Although the permission for pharmacy organization to sell medicines remotely (online) is an obvious and expected step towards liberalization, it cannot be actually applied until the respective regulations are adopted by the Government. We recommend monitoring closely the regulations in this area.
  • Taking into account the scrutiny of FAS, pharmaceutical companies should be more careful while advertising medicines, particularly, as a treatment of COVID-19.

 


Footnotes:

For up-to-date legislative news and business-related guidance in connection with COVID-19, please visit our dedicated webpage: COVID-19: What you need to know


We hope that the information provided herein will be useful for you. If any of your colleagues would also like to receive our newsletters, please send them the link to complete a Subscription Form. If you would like to learn more about our Intellectual Property practice area, please let us know in reply to this email. We will be glad to provide you with our materials.



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