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MIL OSI Translation. Region: Russian Federation –

Decree of January 31, 2022 No. 73

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Decree of January 31, 2022 No. 73

The simplified workflow in the drug labeling and traceability system will now be in effect on a permanent basis. The resolution to this effect has been signed.

Under the simplified procedure, pharmacies and distributors are not required to wait for drug acceptance confirmation from suppliers in order to balance these drugs and put them on sale. The information is automatically confirmed by the labeling system itself by checking the product code and participants’ data. Thus, recipients of batches of medicines are not affected by errors or delays on the part of their suppliers. In general, the simplified procedure increases the speed of drug transactions for all market participants and reduces the risk of drug shortages in pharmacies.

This procedure for working in the drug labeling and tracking system was introduced in November 2020 due to the increased demand for medicines and taking into account the epidemiological situation. It was supposed to be valid until February 1, 2022.

At the same time, from July 1, 2021, the simplified procedure does not apply to medicines that are imported into Russia. This functionality is no longer in demand by companies. In most cases, importers receive timely import confirmations from marketing authorization holders or owners and can then sell them.

The phased introduction of the labeling system began in Russia in 2016. A unique digital code applied to products during labeling allows each buyer to make sure that he has a legally produced high-quality product in front of him. It also makes it possible to trace the entire path of the goods – from the manufacturer or importer to the final consumer.

The signed document amendedDecree of the Government of December 14, 2018 No. 1556.

EDITOR’S NOTE: This article is a translation. Apologies should the grammar and or sentence structure not be perfect.

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