kazakhstan traceability requirements

[Blog] Action plan for labelling and traceability of medicines in Kazakhstan


In July 2023 the Republic of Kazakhstan announced a comprehensive strategy for introducing labeling and traceability of medicines.







The aim is to enhance transparency, accountability, and efficiency in the pharmaceutical sector. The plan uses a series of organized actions, including changing rules, sharing data, and giving industry benefits, to create a strong system that makes sure medicines are identified, tracked, and traced correctly from start to finish.


This initiative reflects Kazakhstan’s commitment to advancing healthcare standards and promoting sustainability within the industry.


Here are the main topics from the action plan.



Laws and regulations for labeling and traceability of medicines


The first topic discusses the introduction of laws and regulations to label and trace medicines in Kazakhstan. This plan involves different steps and measures to make sure medicines can be identified and tracked properly. It is being worked on by different parts of the government, most primarily by the Ministry of Health.


Measures with a deadline of October 2023


  • Approve mandatory labelling and traceability stages with appropriate lists
  • Information submission to ЕЭК (Eurasian Economic Commission) in stages and lists
  • Introduce changes to incentives for purchasing equipment for applying Control Identification Data
  • Reregistration time reduction for labeling layouts: Introduce amendments and additions to Order No. KR DSM-11.



Measures with a deadline of November 2023


  • Changes to Rules for Labeling and Traceability of Medicines: Introduce amendments and additions.
  • Consider changes to the Code of the Republic of Kazakhstan “On Taxes and Other Obligatory Payments to the Budget.”


These actions collectively demonstrate Kazakhstan’s efforts to enhance the identification, traceability, and transparency of medicines, aligning with industry standards and promoting healthcare improvements.


The provided information outlines a series of strategic steps and collaborative efforts being undertaken in Kazakhstan’s pharmaceutical sector now.


Central to these initiatives is the enforcement of laws and regulations about the labelling and traceability of medicines.




Issues of equipping participants in the labelling of medicines with equipment


The second topic is about giving equipment to different groups involved in labelling medicines in Kazakhstan. These groups need to have the right tools to do their jobs well. This includes medical organizations, manufacturers, distributors, pharmacies, and other organizations. The plan is to provide equipment like scanners and other tools. They are working together with different parts of the government to make this happen. The aim is to improve the process of labelling medicines and ensure that everyone has what they need to work effectively.


The following participants should be equipped until December 2023


  • Equipping pharmacy organizations with 2D Scanners
  • Equipping medical organizations with required equipment (2D scanner).
  • Equipping manufacturers with serialization and aggregation Equipment
  • Equipping distributors with aggregation equipment, DCT, and 2D scanners
  • Equipping other organizations working with labelled medicines


The preparation of customs warehouses for medicines labelling should be finished by July 2024.


Collaborative preparations involving the Ministry of Finance, Ministry of Health and Kazakhtelecom JSC (as agreed).




Integration of traceability processes of labelled drugs within the guaranteed volume of medical care / compulsory health insurance


Integrating traceability processes for labelled medicines within Kazakhstan’s guaranteed medical care and compulsory health insurance involves carefully planned actions.


This action plan consists of a comprehensive approach that involves multiple steps and collaborations:



Approval of interaction business processes


The approval of business processes highlights the coordination between different information systems, including those of medical organizations, warehouses, and the Operator’s IS (Information System for Labeling and Traceability of Goods). This alignment ensures seamless communication for accurate traceability.


The deadline for it is July 2023.



Working group composition approval for information system integration


The formation of a working group signifies a collaborative effort to integrate information systems relevant to healthcare delivery. This integration includes the Ministry of Health’s information system, the Operator’s IS, and systems related to medical organizations, warehouses, and compulsory health insurance.


The deadline for it is also July 2023.



Traceability experiment for labelled medicines


The traceability experiment involves labelled medicines supplied for guaranteed medical care. It encompasses the entire lifecycle from supply to storage and transportation by service providers. The experiment aims to validate the effectiveness of traceability within real-world scenarios.


The deadline for it is September 2023.



Testing traceability of medicine movement to patients


The testing phase evaluates the traceability of medicine movement specifically to patients. It involves the participation of various systems, including the Ministry of Health’s information system and the Operator’s IS. This step ensures that the traceability process extends to the point of patient care.

The deadline for it is December 2023.


The action plan contains some more measures, concerning the interaction and modification of Medical and Accounting Information Systems and the integration of Operator’s IS.


Source: https://www.gov.kz/