v. 19 – Q3 2021

Market Executive Summary Objective is full Track and Trace system – assumption is that Kazakhstan will be synchronized with the Russian system. February 2019 National pilot project to be organized by KZ Telecom. Implementation by Ministry of Finance (not Ministry of Health) with monthly discussions taking place involving the industry. Companies, especially international ones, are invited to take part in the pilot project.

Following EAEU rules for medicines registration and assessments (from 2018).
March 23, 2019: Agreement of EAEU countries on medicines labeling by identification means.

2019: Strong position of Kazakhstan is not to use crypto code protection, but the decision still has not been taken regarding the final decision on which example to follow: on Russia or EU.

August 2019: EAEU meeting to uniform serialization norms among member countries according to Russia example. Further discussions have been foreseen.

November 17, 2020: Kazakstan government considers start of Mandatory serialization from 01/01/2022

All medical products must be registered at MoH, but there is no requirement for the use of GS1 standards. The use of GTIN barcodes for medical products identification is not mandatory.

95% of pharmaceutical products are numbered with GTIN-13 or GTIN-8.

Pilot operated by KZ Telecom is finalized by July 31, 2021, the project included all stakeholders of supply chain.

Regulations will follow best practice from Russian and European model.

Key Dates
  • September 2015: Guidelines on product marking and labelling, and on access to the portal and uploading of data have been published to support implementation (following the Law N 227, from Apr 16, 2015)
  • November 2015: GS1 Kazakhstan has been mandated by the MoH to run a pilot for a national drugs traceability system
  • 2019 – July 31, 2021: Serialization Pilot (tests in 2018/2019)
  • 2020/2021: Start of labelling of newly produced and imported products (voluntary)
  • January 27, 2021: Order KP DCM -11, Guidelines for Medicinal products traceability and serialization issued
  • July 31, 2021: Pilot is finalized and guidelines are issued:
    • July 1, 2022: Mandatory serialisation for approved list of 93 medicines (1% from all drugs);
    • October 1, 2022: Mandatory serialisation for 20% of all drugs;
    • April 1, 2023: Mandatory serialisation of at least 80% of all drugs;
    • July 1, 2023: Serialization of 100% of medicines

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