Russia: Introduction of Mandatory Drug Labelling Postponed

On 28 December 2019, a law* came into force that postpones the deadline for the introduction of a track and trace system for medicines until 1 July 2020.

Initially, labelling with Data Matrix codes was to become mandatory for drugs for medical use from 1 January 2020.

However, a decision was made to postpone the introduction of the track and trace system because:

  • many market participants were not ready to work under the new conditions;
  • the operator of the marking system (the Centre for the Development of Advanced Technologies) was late in fully issuing cryptographic codes; and
  • it was necessary to test the mandatory marking system on the entire supply chain (from the manufacturer to pharmacies and end consumers).

This postponement is intended to allow market participants to register with the labelling system, install the necessary equipment and adjust their internal procedures related to drug-acceptance procedures and the unloading of medicines.

The new law leaves open the opportunity to store, transport and sell drugs without mandatory labelling until their expiration date if they were manufactured before 1 July 2020.

Another transition period is established for medicines for the expensive treatment of nosologies (e.g. haemophilia or Gaucher disease), which should have already been labelled in accordance with the new requirements from 1 October 2019. Pursuant to the new law, provided that such medicines were manufactured before 31 December 2019, they can be stored, transported and sold without mandatory labelling until their expiration date.

During the transition period, the system will once again be tested before the full-scale start up. In the course of these tests, if functional problems are identified, adjustments will be made to the rules for the functioning of the track and trace system. Another extension of the transition period for the full implementation of the system could also be recommended.

We will monitor the situation and inform you about any changes in the legislation on the track and trace system.

* In Russian