By the Decree of the Government of the Russian Federation of June 30, 2021 No. 1069 “On Amendments to the Regulation on the Monitoring System for the Movement of Medicinal Products”, this period was determined until February 1, 2022. Thus, the simplified procedure for working in the medicinal product labeling and tracking system in Russia is prolonged for another 7 months.
Under the simplified procedure, pharmacies and distributors are not obliged to wait for a confirmation of medicinal product acceptance from suppliers in order to put them on balance and start selling. The medicinal product information is automatically confirmed by the labeling system by checking the product code. The date of submission of information to the monitoring system is the date of submission of information and subjects of medicines circulation. It’s expected that this will increase the speed of medicinal product operations for all participants, and reduce the risks of shortages in pharmacies.
At the same time, from July 1, 2021, the simplified procedure no longer applies to medicinal products that are imported into Russia from foreign countries. This is due to the fact that in most cases, importers receive confirmation of the import of medicinal products from the holders of registration certificates in time.
On the official website of the Government, the extension is justified as follows: “Given the increased demand for medicines and the epidemiological situation, the simplified regime will be in effect until February 1, 2022, so that recipients of medicinal product consignments do not depend on errors or delays on the part of their suppliers. Such a procedure increases the speed of operations with medicinal product s for all participants, reduces the risks of medicinal product shortages in pharmacies, which is especially important in a pandemic".
Recall that mandatory medicinal product labeling was introduced on July 1, 2020. Until July 1, 2021, a simplified mode of work with labeled medicinal products was determined. However, numerous representatives of pharmaceutical associations have repeatedly indicated the need to extend the validity of the simplified procedure.
August 11, 2021