Mandatory labeling of drugs

The federal state information system for monitoring pharmaceuticals for medical use from the manufacturer to the final consumer has been developed and implemented in accordance with the order of the President of the Russian Federation dated February 4, 2015 No. Pr-285.

On December 27, 2019, Federal Law No. 462-FZ “On Amending the Federal Law“ On the Circulation of Medicines ”and the Federal Law“ On Amending the Federal Law “On the Circulation of Medicines”, which postponed the implementation of mandatory labeling of medicines for medical use on July 1, 2020

Medicinal products for medical use manufactured before July 1, 2020 are subject to storage, transportation, dispensing, sale, transfer, use without identification means until their expiration date.

From January 1, 2020, manufacturers of medicines have the right to apply identification means to the medicinal product, and they must submit information about applying identification means to the monitoring system. The fee for providing marking codes is charged from July 1, 2020.

The main stages of connecting to the system:

From January 1 to February 29, 2020, all participants in the drug turnover are required to register in the labeling system.

Until February 15, 2020 – medical institutions (hospitals, clinics, other institutions licensed for medical activity), as well as drug circulation entities that dispense drugs free of charge or with a prescription discount, which have not yet submitted an application to the System Operator for disposal registrar – must do this.

Until May 1, 2020, drug trafficking participants (manufacturers and importers) must apply for a registrar of emissions.

From July 1, 2020, the transfer of information on labeled drugs to the monitoring system is mandatory for all participants in the turnover.