Milestones of the Russian Labeling System

| By | Drug Circulation, Drug Label

The Russian Government has established the particularities of implementing a system of digital labelling and tracking of medicinal products. Taking into account the successful launch of the labeling of the drugs that took part in the Seven Nosologies Program from October 1, 2019, the Russian Government signed the Proposition No. 1954 of December 31, 2019. This document defines the optimal regime to prepare all participants of the drug product circulation for the date of mandatory labelling of all drugs. The Resolution shall come into force on the date of its publication.

The milestones of the connection to the labelling system are the following:

  • From January 1 to February 29, 2020 inclusive, all participants of the drug circulation must register in the labelling system.
  • By February 15, 2020, medical institutions (hospitals, polyclinics, other institutions with a license for medical activity) which have not yet applied to the system operator for obtaining a departure record (a device that records the fact of drug departure) must do so.
  • By May 1, 2020, drug circulation participants (manufacturers and importers) have to make an application to receive an emission recorder
  • From July 1, 2020, there will start a prohibition on production and import of unlabeled medicinal products. The transmission of the information about circulation of labeled medicines to the labeling system is mandatory for all participants of the drug circulation. The sale of the unlabeled drugs that entered into circulation before July 1, 2020 is allowed until their expiration date.

Those manufacturers of medicines who have been integrated into the system and are ready to start labeling from January 1, 2020 will receive digital codes free of charge until July 2020. This solution was proposed by the operator of the Center for Development of Advanced Technologies, which will defray to deforcement expenses and is supported by the Government of the Russian Federation.

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