Kazakhstan Medicines Compliance

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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.

Reporting Requirements 

Operation
Data to Report
When to Report
Serial Number Generation
GTIN, Batch, Qty
Before packaging to obtain or generate serials
Commission
GTIN, Serial, Batch, Expiry
At packaging line
Aggregation
Parent SSCC and Child Serials
When forming cases or pallets
Shipment Dispatch
Sender, Receiver, SSCC or Serial List
Before dispatch
Receiving
Serial or SSCC List
At warehouse or distributor receipt
Import Clearance
Full serial list and shipment details
Before customs release
Returns
Serial status
When returned
Decommission
Serial and reason
When destroyed, expired or written off
OperationData to ReportWhen to Report

Commission 
Aggregation 
Shipping 

GTIN, Serial, Batch, Expiry  
Parent SSCC, Child Serials  
Sender GLN, Receiver GLN, SSCC or Serial List
During packaging before shipment 
When creating cases or pallets 
Before dispatch 
ReceivingImport Clearance
Supply to Pharmacy
GTIN, Serial, Batch, Expiry  
Parent SSCC, Child Serials  
Sender GLN, Receiver GLN, SSCC or Serial List
During packaging before shipment 
When creating cases or pallets 
Before dispatch 
Returns 
Decommission 
Serial status and reference 
Reason and serials 
When return is approved 
When product is destroyed or removed 

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.

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.

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

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

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.

,kThe system links reported events to the secure serialized codes printed on medicine packs.

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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

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Lead Pharmacist, Pioneer Pharmacy Services

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EPCIS Data Encoder,Capital Wholesale Drug
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