Kazakhstan has introduced a Pharmaceutical Traceability System (PTS) to ensure the safety and authenticity of medicines in its market. The legislation mandates serialization and tracking of all pharmaceutical products to prevent counterfeit drugs, ensuring consumers receive only authentic and safe medicines while enhancing public health. Additionally, the system improves supply chain transparency and aligns Kazakhstan with Eurasian Economic Union (EAEU) regulations, facilitating trade and regulatory cooperation. However, challenges include high implementation costs, the need for technical upgrades in medical organizations, and the risk of medicine shortages if the system is not fully integrated. Efforts are being made to address these issues, including collaboration with Kazakhtelecom JSC to enhance the traceability system.
Scope of the PTS legislation
All pharmaceutical products must have a unique identifier (Data Matrix code) that includes:
- GTIN (Global Trade Item Number)
- Serial Number
- Crypto Key & Crypto Code
Kazakhstan’s Pharmaceutical Traceability System enables end-to-end tracking of medicines, ensuring seamless monitoring from the manufacturer to the patient while enhancing safety, transparency, and supply chain integrity. To achieve this, all medicine movements must be recorded in Kazakhstan’s national tracking system (IS MPT), operated by Kazakhtelecom JSC, providing real-time oversight and regulatory control.
Manufacturers, distributors, and retailers are required to register and report product movements, ensuring compliance with the country’s pharmaceutical regulations. Looking ahead, Kazakhstan plans to introduce aggregation requirements for multiple packaging levels, to further improve supply chain efficiency.
Implementation Timeline
- Until July 1, 2024: Mandatory labeling of all drugs.
- From July 1, 2024: Serialization required for state-procured medicines (40% of the market).
- From January 1, 2025: Serialization extended to all prescription drugs (30% of the market).
- From July 1, 2025: Serialization applied to over-the-counter (OTC) medicines (30% of the market).
By mid-2025, Kazakhstan aims to achieve full traceability for pharmaceuticals, strengthening its healthcare system and protecting consumers from illicit medicines.
How Can SNI Help You?
SNI’s Pharmaceutical Traceability System for Kazakhstan simplifies and optimizes the pharmaceutical tracking and order process. It begins by extracting the necessary data from any ERP system, which is then used to generate an order.
Once the order is generated, it is directly submitted to the government platform for processing. The government responds with a status update, including a serial number. This response is automatically captured and updated in the SNI system, providing you with real-time tracking information.
After the serial number is received, it is sent back to your ERP system as part of a list. This allows for full traceability and ensures that you can monitor the status of the pharmaceutical product throughout its lifecycle. The manufacturing process continues smoothly, including packaging, with all the necessary information readily available to keep operations on track.
Finally, once the manufacturing and packaging processes are complete, aggregate reports are submitted to the government platform. This final step ensures that your business is fully compliant with regulatory requirements and provides a complete, auditable record of the entire process.
With SNI’s Pharmaceutical Traceability System, your operations will remain efficient, transparent, and in compliance with the necessary regulations, providing you with a streamlined and reliable approach to pharmaceutical traceability.