Gedeon Richter launched early drug labeling for Russian market - Information portal

Gedeon Richter launched early drug labeling for Russian market

09 Декабря 2019, 10:29
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Gedeon Richter launched early drug labeling for Russian market

Gedeon Richter demonstrated the readiness of its production lines to label medicines for the Russian market. Starting from the beginning of 2020, the procedure will become mandatory for all pharmacy manufacturers in Russia. The company produced the first commercial batch of ‘Panangin concentrate for solution for infusion’ labeled with a digital code compliant with the requirements of Russian laws. The event was attended by representatives of the Ministry of Industry and Trade of the Russian Federation, the Federal Service for Supervision of Healthcare, the Russian-Hungarian Intergovernmental Commission for Economic Cooperation, professional associations, as well as the Center for the Advanced Technologies Development (CRPT).

Gedeon Richter is among the pioneers of the Russian drug serialization pilot. Currently, producers of pharmaceuticals for Russia are appropriately equipped and ready to produce tablets, capsules, ointments and solutions in packages marked with the DataMatrix code. Besides, the event participants could see the readiness of the company's packaging facility for aggregation, i.e. packing batches in large boxes bearing the respective information. This is especially important for the production of large volumes of drugs.

Natalia Volovich, Deputy Director and Head of Registration Department at the Representative Office of Gedeon Richter OJSC (Hungary) in Moscow says: “Today, the labeling process using identification materials with cryptographic protection was demonstrated for Panangin at one of our high-speed packaging lines. This medicine, which is included in the list of vital drugs, is in great demand by Russian doctors and patients. That was a symbolic start of the full involvement in the serialization project of all the company’s product lines that produce drugs for the Russian market in Hungary, Romania, Poland, Germany and, of course, in Russia. Gedeon Richter is technically capable of labeling its products. However, we are concerned, along with the entire pharmaceutical industry in Russia, with the finalizing of the development of the last-level software, the so-called “Russian module”of SAP. 

The pilot drug labeling project was launched on February 1, 2017, to become mandatory for drugs from the list of “7 high-cost nosologies” in Russia since October 1, 2019. For other drugs in Russia, this innovation will become effective from January 1, 2020. The marking includes a two-dimensional Data Matrix code applied directly to the product wrapping or product label. The code contains detailed product data such as the name, manufacturer, production date, time and place.

Dmitry Alkhazov, Director General of Operator-CRPT says: “The well-coordinated teamwork of Gedeon Richter and Operator-CRPT allowed us to broaden the list of pharmacy manufacturers that started production of commercial batches of drugs before the start of mandatory labeling. We will continue to establish conditions that will allow not only manufacturers, but also all other stakeholders, to enjoy the most comfortable entry into the regime of mandatory labeling.”

The participants in the event, which is taking place at Gedeon Richter’s headquarters these days, also discussed the experience of serialization in the European Union, critical points in the Russian module, regulatory requirements and procedures, the preparedness of importers and customs. Currently, the introduction of product labeling is underway not only in the pharmacy sector, but in other industries as well.

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