Drugmakers can label products in Russian warehouses; report

Foreign pharmaceutical companies importing drugs into Russia will be able to label them at customs warehouses in the country to comply with new traceability rules, according to media reports.

The Pharma Letter reports (subscription required) that Russia’s Prime Minister Mikhail Mishustin has approved the provision to facilitate drug imports.

Drugmakers are having to adapt to the new Chestny ZNAK labelling requirements, which require medicines and various other product types sold in Russia to carry labels with a unique, serialised code to allow them to tracked through the supply chain.

There have been concerns that delays in compliance with the new requirements could lead to imports of some essential medicines being delayed, leading to shortages.

Russia medicine traceability requirements apply to all medicines, including over-the-counter medicines, and came into effect officially on July 1, with relationship between individual medicine pack and case (aggregation) also recorded.

The system aims to ensure citizens have access to high-quality, safe and effective medicines, make it easier to spot and withdraw substandard and falsified medicines from the market, and ensure transparency and fair competition in drug supply.