Here’s a detailed overview of Kazakhstan’s serialization regulations:

1. Centralized System: Information System for Labeling and Traceability of Goods (IS MPT)

• Kazakhstan uses a centralized national tracking system called IS MPT (Information System for Labeling and Traceability of Goods), operated by Kazakhtelecom JSC.
• All movements of serialized medicines must be recorded in this system, providing real-time oversight and regulatory control from the manufacturer to the patient.
• The IS MPT issues the unique codes and manages their lifecycle.

2. Mandatory Digital Labeling with Data Matrix Codes:

• All pharmaceutical products must bear a 2D Data Matrix barcode. This code is cryptographically protected.
• The Data Matrix code must contain four key data elements:
  • GTIN (Global Trade Item Number): 14 numeric characters (GS1 Application Identifier 01).
  • Serial Number: 13 alphanumeric characters (GS1 Application Identifier 21). This is a randomized unique identifier for each unit.
  • Crypto Key: 4 alphanumeric characters (GS1 Application Identifier 91).
  • Crypto Code: 44 alphanumeric characters (GS1 Application Identifier 92).
• The crypto key and crypto code are specific to the Eurasian Economic Union (EAEU) and are issued by the IS MPT system.
• Human-readable information (GTIN, Serial Number, Batch/LOT, Expiration Date) must also be present on the packaging.

3. Scope and Phased Implementation:

Kazakhstan has adopted a phased approach to full serialization:

• Until July 1, 2024: Mandatory labeling of 100% of all drugs (meaning applying the Data Matrix code). Medicines manufactured before this date can circulate without serialization until their expiry.
• From July 1, 2024:
  • Full traceability (serialization) for drugs purchased by a single distributor (primarily for government procurement, representing about 40% of the market).
  • Mandatory labeling applies to all medicines manufactured or imported into Kazakhstan after this date.
• From January 1, 2025: Serialization of all prescription medicines (approximately 30% of the market).
• From July 1, 2025: Serialization of all over-the-counter (OTC) medicines (approximately 30% of the market).
• By mid-2025, Kazakhstan aims to achieve full traceability for all pharmaceuticals.

4. Aggregation:

• Aggregation is mandatory in Kazakhstan. This involves establishing a hierarchical relationship between individual serialized units and their parent packaging (e.g., bundles, cases, pallets).
• Each level of packaging must be labeled with a unique SSCC (Serialized Shipping Container Code) of GS1-128 codes assigned by the manufacturer.
• This hierarchical serialization practice enables granular-level tracking and tracing and needs to be reported to the IS MPT system.

5. Process and Reporting Flow:

The serialization and traceability process generally involves these steps:

• Code Request: Manufacturers/importers order unique serial numbers with crypto codes from the IS MPT (or its Order Management Station – OMS) based on their production/purchase plan.
• Code Application: The received codes are applied as Data Matrix codes to individual consumer packages during production.
• Aggregation: Packages are aggregated into cases and pallets, and each level is labeled with its SSCC, maintaining a parent-child relationship.
• Data Reporting (Market Release): The full hierarchy of serialization data must be reported to the IS MPT before the shipment can be customs-cleared or released to the market.
• Supply Chain Movements: Manufacturers, distributors, and retailers are required to register and report product movements (receipt, shipping, inventory changes) to the IS MPT.
• Deactivation/Withdrawal: At the point of sale (pharmacy) or dispense (medical institution), the Data Matrix code is scanned, and the product is officially removed from circulation in the IS MPT.
• Consumer Verification: Consumers can use a mobile app called “NAQTY ÓNIM” to scan the code on the package, verify authenticity, and learn more about the product. There’s also a “NAQTY SAUDA” app for retailers to scan products in and out, especially for those without dedicated scanners.

6. Exemptions:

Certain categories of products may be exempt from serialization, including:

• Active Pharmaceutical Ingredients (APIs)
• Radiopharmaceuticals manufactured directly in healthcare organizations
• Exported medicines
• Samples (for clinical studies, registration, or exhibition without sale)
• Medicines compounded in pharmacies
• Medicinal plant raw materials
• Advanced Therapy Medicinal Products (ATMPs) for individual use
• Medicines for humanitarian assistance

Key Stakeholders Affected:

• Marketing Authorization Holders (MAHs)
• Domestic Pharmaceutical Manufacturers
• Foreign Pharmaceutical Manufacturers exporting to Kazakhstan
• Importers
• Wholesalers and Distributors
• Pharmacies
• Medical Institutions

Compliance Considerations:

• System Integration: Companies need robust serialization solutions capable of generating, applying, and managing unique codes, performing aggregation, and integrating with the IS MPT for data exchange.
• Crypto Code Management: Understanding and handling the crypto key and crypto code elements is crucial, as they are central to the Kazakhstani and EAEU systems.
• Phased Rollout: Adhering to the specific timelines for different product categories and market segments is essential.
• Bilingual Labeling: In addition to serialization, general labeling requirements in Kazakhstan typically require information in both Kazakh and Russian languages.