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Concerns are Exaggerated

18 may 2017 10:01

Recently reports with a reference to the European Business Association (EBA) on the imminent deficiency of imported drugs because of compulsory labeling, have emerged in mass media.

However, these concerns are exaggerated. According to the Ministry of Healthcare of the Russian Federation and Roszdravnadzor, the Russian national labeling system standards are equivalent to international standards (in particular, ISO standards 16022 (Data Matrix) for data carrier (control (identification) sign) and GS1 for identification of products), used in the same way as globally. They are used to implement a pilot project.

A notion that “international colleagues will not manage to adjust to the new rules” is also groundless. Everyone, including EBA, is aware, that a delegated normative act (EU) 2016/161 of October 2, 2015, will be effective in the territory of the EU as of February 09, 2019. It will use a Data Matrix bar code, suitable for automatic reading, with a function of recognition and correction of mistakes, equivalent or stricter than Data Matrix ECC200, as a unique identifier (Standard of International Standardization Organization / International Electrotechnical Commission (ISO/IEC) 16022:2006).

Therefore, the standards used in the Russian Federation are NOT different from European standards. Our international colleagues will NOT have to adjust. It will be the EU requirements that everyone will have to adjust to. The statement that “labels are different, as the Russian labels contain information on the product price and TN VED”, is also not correct.

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