Kyrgyzstan Serialization and Traceability Compliance

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Global Regulations

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Labelling

Products are required to display information in writing.

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Lot Level Traceability

Products are traceable as part of uniquely identified lots.

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Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

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Central repository

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

Summary

Kyrgyzstan has implemented a national pharmaceutical serialization and traceability framework as part of the Eurasian Economic Union (EAEU) digital marking initiative. The system is designed to improve medicine supply chain transparency, prevent counterfeit medicines, and enable regulatory monitoring of pharmaceutical distribution.

The national system requires medicines to carry serialized DataMatrix codes that allow regulators and supply chain participants to track pharmaceutical products from manufacturing or import through distribution and dispensing.

Kyrgyzstan operates its digital marking system through the State Tax Service marking platform, which forms part of the broader national digital product labeling program. Pharmaceutical products must be registered in the marking system, and serialized identifiers must be applied before products are placed on the market.

The framework is aligned with international identification standards and supports electronic reporting of supply chain events across the pharmaceutical distribution network.

Labelling Requirements 

Medicines distributed in Kyrgyzstan must include a 2D DataMatrix barcode applied to the secondary packaging.

The DataMatrix must follow the national digital marking requirements and typically contains the following elements:

  • Product identification code
  • Unique serial number
  • Batch number
  • Expiry date

These identifiers allow each pharmaceutical package to be uniquely identified and verified within the national traceability system.

The barcode must be printed on the packaging in accordance with national labeling and marking standards. Human readable information on the packaging must correspond to the encoded barcode data.

Regulatory Timeline 

2019–2020
Kyrgyzstan began implementing national digital marking initiatives aligned with broader EAEU digital product labeling strategies.

2021
Pilot programs for digital marking and traceability were introduced across regulated product categories, including pharmaceuticals.

2022 onward
The serialization and traceability system has been progressively implemented for medicines within the national digital marking framework.

Reporting Requirements 

Operation
Data to Report
When to Report
Code Registration
Product information and marking codes
Before manufacturing or import
Commission
Serialized DataMatrix identifiers
During packaging or import preparation
Import Reporting
Shipment data and serialized identifiers
Before product distribution
Distribution
Sender and receiver information with serialized data
When products move between supply chain participants
Receiving
Confirmation of serialized products received
At warehouse or pharmacy receipt
Dispensing
Serialized pack information supplied to patient
At dispensing stage
Decommission
Serial numbers and removal reason
When products are destroyed or withdrawn

Supply chain participants must report product movement within the national marking system to ensure complete traceability.

Operational Timelines for Industry 

  • Register pharmaceutical products and obtain necessary approvals before import or manufacturing.
  • Register products in the national digital marking system.
  • Apply serialized DataMatrix codes during manufacturing or before import into Kyrgyzstan.
  • Report supply chain transactions through the national marking platform.
  • Maintain traceability records and support regulatory verification activities.

Reporting Hub

Traceability reporting in Kyrgyzstan is managed through the national digital marking and traceability system operated by the State Tax Service.

The platform enables supply chain participants to interact with the system through electronic services and APIs.

Participants interacting with the platform include:

  • Manufacturers
  • Importers
  • Distributors
  • Pharmacies
  • Healthcare institutions

The system supports:

  • Registrtion of product codes
  • Generation and registration of serialized identifiers
  • Reporting of supply chain transactions
  • Verification of medicine authenticity

Aggregation Requirements 

The Kyrgyzstan marking system primarily focuses on unit level serialization using DataMatrix codes.

Aggregation at case or pallet level is not explicitly mandated in the publicly available regulatory guidance. However, pharmaceutical manufacturers may implement aggregation internally to improve logistics efficiency and supply chain operations.

Common Errors to Avoid 

  • Failure to register pharmaceutical products in the digital marking system before market entry.
  • Incorrect generation or formatting of DataMatrix codes.
  • Mismatch between printed serialized identifiers and reported traceability data.
  • Incomplete reporting of supply chain transactions.

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EPCIS Data Encoder,Capital Wholesale Drug
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