Starting from July 1, 2024, mandatory serialization of medicinal products will be introduced in Kazakhstan. All medicinal products imported into Kazakhstan must include an identification means—a two-dimensional matrix barcode in the Data Matrix format.

The requirements and method for applying the identification means, as well as the procedure for submitting data to the electronic system for the marking 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 the approval of rules for the marking and traceability of medicinal products and the marking of medical devices.”

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

To add additional packaging with a place for applying the 2D code, an Application for Amendments of type IA B.II.d.8 Change in the design of the primary and secondary packaging marking must be submitted. At this stage, registration of both the current packaging and additional packaging with serialization is allowed.

Cratia provides registration of medicines and pharmacovigilance in Kazakhstan. We have deep knowledge and expertise in local regulation, have necessary experience and resources. To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.