Russian standards of drug labeling system are not different from European ones

| By | Drug Marking, Roszdravnadzor
0
1479

The standards of the national labeling system in Russia are not different from those used in Europe, as the international standards (in particular, ISO standards 16022 (Data Matrix) for data carrier (control (identification) label) and GS1 for product identification) are used in the pilot labeling project.

Any concerns that “foreign colleagues may not be able to reconfigure their activities in time for the new rules” have no grounds. The Association of European Businesses should be well aware that, on February 9, 2019, a delegated regulation (EU) 2016/161 of October 2, 2015 will come into effect on the territory of EU to adopt, as a unique identifier standard, a machine-readable Data Matrix bar code with the recognition and error correction feature that is equivalent to or higher than in Data Matrix ECC200 (the International Organization for Standardization / International Electrotechnical Commission (ISO / IEC) standard 16022:2006). Therefore, the standards used within the Russian Federation are NOT different from those used in Europe, and foreign colleagues do not have to reconfigure their activities for them; they need to reconfigure their activities in accordance with EU requirements.