Serialization of medicines in Kazakhstan

On June 28, 2024, amendments were approved to the Resolution of the Government of the Republic of Kazakhstan No. 568 “On the determination of the list of goods subject to labeling,” according to which batches of medicinal products produced from July 1, 2024, are subject to mandatory serialization (labeling with an identifier).

The packaging of the medicinal product must include an identifier – a two-dimensional matrix barcode in the Data Matrix format. The requirements and method of applying the identifier and the procedure for submitting data to the electronic system of labeling and traceability of goods are approved by the Order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021, No. ҚР ДСМ-11 “On approval of the rules for labeling and traceability of medicinal products and labeling of medical devices.”

Obtaining labeling codes for imported medicinal products is performed by registration certificate holders, manufacturers, their authorized representatives and/or branches (subsidiaries), or importers. The 2D code is applied directly during production or by sticker.

Please note that to include the 2D Data Matrix on the packaging, an application for variations must be submitted to the regulatory body, assessed, and approved.

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