Government of the Russian Federation Resolution No. 1069 dated June 30, 2021, "On Amending the Regulations on the System for Monitoring the Movement of Medicinal Products for Medical Use," extended this regulatory deadline until February 1, 2022. Consequently, the Russian Government extended the simplified operational procedure within the pharmaceutical track and trace system for an additional seven months.

Under the simplified procedure, pharmacies and distributors do not need to wait for suppliers to confirm receipt of medicinal products before recording them on their balance sheets and initiating sales. The track and trace system automatically verifies product data by validating the product code. The system deems the date on which pharmaceutical market participants submit data to be the official date of information submission. Regulators expect this measure to accelerate pharmaceutical operations for all supply chain participants and mitigate the risk of drug shortages in pharmacies.

However, effective July 1, 2021, the simplified procedure no longer applies to medicinal products imported into Russia. This change reflects the fact that importers generally receive timely import confirmations from marketing authorization holders or owners.

The official website of the Government provides the following rationale for the extension: “Given the increased demand for medicines and the epidemiological situation, the simplified regime will remain in effect until February 1, 2022, ensuring that recipients of pharmaceutical shipments do not depend on supplier errors or delays. This procedure accelerates pharmaceutical transactions for all participants and reduces the risk of drug shortages in pharmacies, which is particularly vital during a pandemic.”

As a brief background, mandatory pharmaceutical labeling took effect on July 1, 2020. Regulators originally established the simplified regime for track and trace compliance until July 1, 2021. However, numerous pharmaceutical associations repeatedly emphasized the critical need to extend the simplified framework.