Mandatory Medicine Marking in Kazakhstan: Rules for Importers

Mandatory marking of medicines in Kazakhstan took effect on 1 July 2024 and covers 100% of medicines. The system was built in stages: a pilot project started on 1 September 2019 and ended on 31 July 2021, and the first stage was applied to 90 product names on 1 July 2022. The single operator of the marking and traceability system is Tañba, part of Kazakhtelecom. Stocks imported or produced before mandatory marking began do not need to be marked.

The requirements are set out in the Rules for Marking and Traceability of Medicines, approved by Order of the Minister of Health No. ҚР ДСМ-11 of 27 January 2021 and substantially amended by Order No. 22 of 19 June 2024. Under these rules, medicines from third countries may be marked in the third country before import into Kazakhstan, in customs warehouses that are pharmacy (distributor) warehouses, or in pharmacy (distributor) warehouses after customs clearance. For medicines from EAEU member states, the importer must create and electronically sign an import notification and obtain a registration number in the traceability system before crossing the state border.

The marking code uses the GS1 Data Matrix format with four data groups: a 14-digit GTIN, a 13-character serial number, a 4-character verification key identifier and a 44-character verification code. Order of the Ministry of Health No. 134 of 18 July 2023 set the maximum price of one marking code at KZT 2.40 excluding VAT. Consumers can scan the code on the pack with the Naqty Onim app to check authenticity. For suppliers shipping medicines to Kazakhstan, deciding before shipment where the code will be applied is critical.

Source: Tañba (Kazakhtelecom) official marking portal, tanba.telecom.kz; Order of the Minister of Health of the Republic of Kazakhstan No. 22 of 19 June 2024 (Ministry of Justice registration No. 34529); Order of the Ministry of Health of the Republic of Kazakhstan No. 134 of 18 July 2023.