Kazakhstan Medicines Compliance

ISMPT National Track and Trace System

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Global Regulations

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Labelling

Products are required to display information in writing.

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Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

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Aggregation

The packaging hierarchy of products is required to be identified and documented.

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Central repository

The traceability documentation is required to be centralized in a unique system.

Summary

Kazakhstan requires all medicines to be tracked through a national system called ISMPT. The objective is to protect patients, reduce counterfeit medicines, and improve visibility across the pharmaceutical supply chain. All medicines sold or imported into Kazakhstan must carry a secure serialized code and must be reported as they move from manufacturing to pharmacies. Serialization, aggregation, and movement reporting are mandatory.

Labelling Requirements 

Each medicine pack must carry a 2D DataMatrix barcode issued through the national system.

The barcode includes:

  • Product identifier
  • Unique serial number
  • Secure verification element (commonly referred to as crypto)
  • Batch or lot number
  • Expiry date

The secure element helps confirm that the code is genuine and has not been copied or reused.

Outer cartons and pallets must also be labeled to support shipment tracking.

Regulatory Timeline 

  • 2019 – Kazakhstan begins implementing medicine traceability.
  • 2020 to 2021 – Serialization and secure marking become mandatory.
  • 2022 – Aggregation and movement reporting enforced.
  • Current state – Full compliance required across the supply chain.

Reporting Requirements 

Reporting Requirements Table
Operation
Data to Report
When to Report
Commission
GTIN, Serial, Batch, Expiry
During packaging
Crypto Code Application
Crypto and verification codes
When applicable
Aggregation
Parent SSCC with Child Serials
When building cases or pallets
Shipment Dispatch
Sender, Receiver, SSCC or Serial List
Before goods leave the facility
Receiving
SSCC or Serial List
At warehouse or distributor receipt
Import Clearance
Serial list and shipment data
Before customs release
Sale or Supply
Serialized supply event
At pharmacy or hospital level
Returns
Serial and return status
When returned
Decommission
Serial and reason
When destroyed, expired or removed

Operational Timelines for Industry 

  1. Register company and product information in ISMPT.
  1. Obtain secure serialized codes for medicines.
  1. Print DataMatrix codes on individual packs.
  1. Aggregate packs into cartons and pallets.
  1. Report shipments before goods move.
  1. Confirm receipt at each supply chain location.
  1. Report supply, returns, or withdrawals as they occur.

Reporting Hub

  • All reporting is done through Kazakhstan’s national marking and traceability platform (ISMPT).
  • Manufacturers, importers, distributors, and logistics providers must register in the system and report supply chain activities.
  • The system links reported events to the secure serialized codes printed on medicine packs.

Aggregation Requirements 

Aggregation is mandatory in Kazakhstan.

Individual packs must be correctly linked to cartons and pallets before shipment.

Accurate aggregation supports efficient verification during transport, customs checks, and distribution.

Common Errors to Avoid 

  • Treating Kazakhstan as a simple barcode-only requirement.
  • Missing the secure verification element in the code.
  • Printing codes that cannot be validated.
  • Incomplete aggregation before shipment.
  • Late or missing shipment reporting.
  • Mismatch between physical products and reported data.

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LSPedia didn’t just provide software; they ensured we were fully compliant. Anytime we had questions, the LSPedia team knew DSCSA inside and out and guided us step by step. That level of expertise made a huge difference during audits. Thanks to their expert team our audit was smooth and successful

Hussein Salman
Lead Pharmacist, Pioneer Pharmacy Services

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EPCIS Data Encoder,Capital Wholesale Drug
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