Russia Introduces Mandatory Drug Labeling

Starting from July 1, 2020, all pharmaceutical products for medical use in Russia will have to be labelled in accordance with the federal information system for monitoring the circulation of pharmaceutical products. In order to meet the requirements, each pharmaceutical product will have a unique identifier on its packaging, a Data Matrix code, containing information such as the products’s serial number, expiration date, consignment number and manufacturer’s name, thus enabling the monitoring of each product’s circulation from the manufacturer to the end user.

This system intends to minimize the presence of counterfeit and low-quality medicines in the market, control the prices of medicines and prevent the illegal trade of medicines initially provided to hospitals and other institutions free of charge. The online sale of certain pharmaceuticals was recently allowed in Russia, so the new system will also allow consumers to check the origin of the drug they are buying online.

The drug monitoring system was introduced by the Federal Law No. 425-FZ of December 28, 2017, which brought changes to the Federal Law ‘On Circulation of Medicines’. It was first intended to enter into force on January 1, 2020, but the entry into force was postponed until July 1, 2020 by further amendments to the Federal Law ‘On Circulation of Medicines’ introduced on December 27, 2019.

In order to comply with the new requirements, all entities involved in the trade of medicines (including pharmaceutical companies, hospitals, importers and pharmacies) must obtain the technical equipment for creating the codes and for recording the information that will be tracked by the federal information system. Because of the COVID-19 pandemic and the delays it has caused in the entire sector, many companies are arguing that they have not been able to obtain the necessary equipment and are asking for a delay in the implementation of the new system.

It is uncertain whether the delay will be granted, but the sanctions for failure to comply with the new labelling requirements include fines of up to EUR 3,850 (USD 4,200) and the seizure of counterfeit products. Unlabeled medicines produced before July 2020 may be stored, shipped, sold and used until their expiration date.

By: Julia Zhevid

For more information, please contact Julia Zhevid at our Russia office.