kyrgyzstan pharma serialization requirements

Key dates in Kyrgyzstan:

• Phase 1 for medicines is March 2023 to July 2023.

• • • 28 medicines (all dosages and packaging)
    • 18 manufacturer-specific medicines
  • Phase 2 for medicines is July 2023 to November 2023.
    
    
    • 11 medicines (all dosages and packaging)
    • 107 manufacturer-specific medicines
  • Phase 3 for medicines is November 2023 to March 2024.
     
    • 169 medicines (all dosages and packaging)
  • Phase 4 for all medicines is March 2024 to June 2024.

A 2-year transition period is laid down, meaning that serialized products with any country labeling will be allowed for 2 years.

Click here to download the most updated medicine list issued by MoH: http://pharm.kg/upload/%D0%BF%D1%80%D0%B8%D0%BA%D0%B0%D0%B762_compressed.pdf

Responsibility for completing serialization rests with the importer

• Coding requirements: GS1 data matrix including GTIN + SN + ASCII separator.
• Batch expiration date and aggregation are optional.
• Products carrying a Crypto Code from other countries are accepted.
• Product must be serialized before certification (stickers are acceptable)
• Alfa Telecom CJSC: National Authority that generates and issues labeling codes.
• National system: АИС «Маркировка товаров» / АИС MT
• Kyrgyz platform: Teksher

Those who wish to be users of the system must have a valid Kyrgyz license and a permanent local establishment.

The Kyrgyz central platform: Teksher

1. Manufacturers & Importers have to be registered in GS1 Kyrgyzstan – http://gs1kg.org/
2. Registration to Kyrgyz HUB – Teksher – https://main.teksher.kg/about.html
3. Sign a contract with Alfa Telecom CJSC
4. Sign a contract with a solution provider

Introduction:

Kyrgyzstan, officially known as the Kyrgyz Republic, stands as a post-Soviet nation and a member of the Eurasian Economic Union (EAEU), alongside Russia, Belarus, Armenia, and Kazakhstan. The country is witnessing a rapid evolution in its pharmaceutical market, where foreign-manufactured products hold a prominent position.

To address the need for enhanced traceability of pharmaceutical products within the Kyrgyz Republic, the President, guided by articles 13 and 17 of the Constitutional Law of the Kyrgyz Republic, has made significant decisions within the Cabinet of Ministers:

• Launching a phased introduction of a comprehensive drug traceability system, encompassing products produced, imported, and sold within the territory of the Kyrgyz Republic.
• Approval of the Traceability Procedure for medicinal products.
• Entrusting the Department of Medicines and Medical Devices with the responsibility for implementing and maintaining drug traceability systems, operating under the Ministry of Health of the Kyrgyz Republic.

The phased plan outlines specific deadlines, prohibiting wholesale and retail sales of traceable medicines from the list without the registration of digital marking codes in the IP EBD. Medicines imported or produced within the Kyrgyz Republic are permitted in circulation until their shelf life expiration, adhering to the specified deadlines for traceability system implementation.

The Ministry of Health will oversee a centralized database, and it is mandatory for all key supply chain entities to register in the system. Plans are in place to implement GS1 standards for serialization, aggregation, and barcoding. Alfa Telecom CJSC has been appointed by the Ministry of Health as the National Authority responsible for generating and issuing labeling codes. The national system, known as АИС «Маркировка товаров» / АИС MT, will facilitate this robust traceability initiative.

Coding Requirements

Product Identification:

• 2D Data matrix Coding requirements:
  
  • GS1 data matrix including GTIN + SN + Verification code (cryptotail).
  • Batch expiration date and aggregation are optional.
• HNI (Human-readable): GTIN + Serial Number (SN) + Batch number + Expiry date.
• Products carrying a Crypto Code from other countries are accepted.
• Product must be serialized before certification (stickers are acceptable).

Responsibility for completing serialization rests with the importer.

The identified types of serialization are Internal marking (into the Kyrgyzstan territory) and external (cross-border for EAEU countries) marking:

• External marking: External (cross-border) marking is voluntary for import to the EAEU countries
• Internal (mandatory) marking: Mandatory on the territory of the Kyrgyz Republic.

The circulation of non-labeled products is prohibited according to the current legislation.

Printing designations (labels) of the above elements when applying human-readable information is not Regulated.

Applied to the package A two-dimensional barcode meets the following specifications:

• Compliance with ISO/IEC 16022:2006 (Data Matrix bar code symbology specification);
• Applied with class level quality C or higher in accordance with ISO/IEC 15415:2011, ISO 22742:2005.
• Function used recognition and correction of errors not lower than Data Matrix ESS200.
• Applied to a flat white surface with sufficient contrast.
• Sustainability ensured sealing for fading before the end of the shelf life of the medicinal product when compliance with storage conditions.
• When using stickers, it is impossible to separate the sticker from the packaging without it Damage.

How can CosmoTrace help?

We provide serialization consulting, implementation & integration services to help our clients manage end-to-end serialization projects and prepare them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you to implement the serialization requirements.

Our team of experts strategizes and plans end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences, and brand integrity.

References

The procedure for ensuring the traceability of medicines (to the Resolution of the Cabinet of Ministers of the Kyrgyz Republic dated February 9, 2023 No. 53) (minjust.gov.kg)

НаСайтПриказДЛО.pdf (pharm.kg)

Disclaimer

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.