Pharma Compliance Guidelines: Kazakhstan

Kazakhstan: A Growing Pharma Powerhouse in Central Asia

Kazakhstan’s pharmaceutical sector is rapidly emerging as a strategic growth market in Central Asia. Projections for 2025 place total pharmaceutical revenues at approximately US$ 492 million, with the oncology segment alone representing $85.8 million, and a projected 5.0% compound annual growth rate (CAGR) through 2029. Backed by government-led healthcare reforms and a strong push for local manufacturing, Kazakhstan aims to meet 50% of domestic drug demand by 2025. There is no doubt that it is becoming a critical node in the global life sciences supply chain.

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The Journey Toward Serialization

The serialization initiative began in 2015 when it introduced requirements for labeling and data exchange via a centralized traceability system. A pilot program was launched from September 2019 to July 2021, with over 40 industry participants, including local manufacturers, distributors, and pharmacies. The system, based on the IS MPT platform and GS1 standards, initially mandated serialization for 93 product SKUs starting August 2022. Gradual thresholds were introduced: 20% of SKUs by October 2022, 60% by January 2023, 80% by April 2023, aiming for complete coverage by July 2023. 

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Updated Timelines: A Phased Approach 

In light of operational hurdles and industry readiness, Kazakhstan's government revised its serialization rollout timelines. Under the updated plan:

• All prescription drugs must be serialized by January 1, 2025
• Over-the-counter (OTC) drugs by July 1, 2025

Priority continues to be placed on critical and high-risk categories (oncology, antibiotics, and immunosuppressants), which remain under mandatory tracking. These revised deadlines provide Manufacturers with additional time to align IT systems, streamline reporting processes, and comply strictly with regulatory requirements.

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Understanding the landscape: Beyond the basics

Company Registration & Digital Signature

For any pharmaceutical company aiming to operate within Kazakhstan, a critical first step is establishing a formal presence within the country by registering as a legal entity and participant with the IS MPT. This registration is more than a formality. It grants the necessary legal standing to interact with the national traceability system. 

Furthermore, secure access and submission of data to the IS MPT are exclusively facilitated through a Electronic Digital Signature (EDS). This EDS acts as a secure digital identity, binding all electronic submissions to the responsible entity and ensuring data integrity and non-repudiation, a cornerstone of Kazakhstan's digital governance. It is imperative to obtain this digital signature as part of your market entry process.

For general information on company registration and obtaining an EDS in Kazakhstan, refer to the official Electronic Government of the Republic of Kazakhstan portal.

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GS1 Standards Adoption

IS MPT system fundamentally relies on GS1 Standards, making GS1 membership and the correct application of below identifiers a mandatory requirement. 

• Global Trade Item Numbers (GTINs): Every unique product SKU (Stock Keeping Unit) destined for the Kazakhstan market must be assigned a unique 14-digit GTIN
• Global Location Numbers (GLNs): All relevant physical and legal entities involved in the pharmaceutical supply chain in Kazakhstan, including manufacturing sites, warehouses, distribution centers, and even points of dispensing, must be identified with unique 13-digit GLN
• Serial Shipping Container Codes (SSCCs): For aggregated logistical units, such as cases, bundles, or pallets, the use of 18-digit SSCCs is crucial. These unique serial numbers enable the tracking and tracing of product groupings, simplifying logistical movements. 

For more details on GS1 standards and to obtain necessary identifiers, visit the official GS1 Kazakhstan website.

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Regulatory Authority Ecosystem

Kazakhstan’s compliance mandates originate from the Committee of Medical and Pharmaceutical Control, part of the Ministry of Healthcare of the Republic of Kazakhstan, that manages and implements state policy, as well as state control and supervision. ‍

• Information System for Marking and Traceability of Goods (IS MPT) stands as the backbone of this framework. It is officially operated by Kazakhtelecom JSC, a major state-owned telecommunications company. The IS MPT functions as the central digital repository, meticulously tracking every marked product from its point of production or import through various distribution stages, and ultimately to its final dispense, ensuring complete transparency. 
• IS MPT relies on several interconnected components and distinct data flows to manage the entire marking and traceability process. At its core is the Order Management System (OMS) which serves as the primary digital interface where manufacturers and importers initiate and manage their essential requests, most notably the orders for unique Crypto Codes and other digital markers. It's through this system that all code emission orders are submitted and their lifecycle tracked, providing a centralized point of interaction for clients.
• ‍CEDM (Centralized Electronic Document/Data Management): While not always highlighted as a standalone interface for direct client interaction, CEDM represents the system's robust backbone for managing and processing all critical digital documents and data streams exchanged within the traceability ecosystem. This is essential for the secure reception, storage, and retrieval of various submitted reports (like utilization or aggregation reports), system confirmations, and other crucial digital artifacts generated throughout the product's journey.

Continuous compliance in Kazakhstan is heavily reliant on the stability and uptime of the IS MPT system itself, alongside your own robust internet connectivity and secure communication channels. Any disruptions in these external or internal connections can directly impact your ability to receive codes, submit mandatory reports, and move products through the supply chain, potentially leading to significant operational halts and compliance breaches.

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Data Matrix Components and the Crypto Advantage

At the heart of Kazakhstan's pharmaceutical traceability system is the Data Matrix code – a compact, two-dimensional barcode capable of encoding a significant amount of product information in a small space. Kazakhstan's mandate focuses on a specific set of core identifiers directly embedded on the code:

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Data Exchange Methods

The digital backbone of Kazakhstan's compliance involves direct, programmatic system-to-system communication. The primary and most efficient method for interacting with the IS MPT for all required reporting is via API (Application Programming Interface). These APIs typically leverage RESTful or SOAP architectures, facilitating the exchange of structured data in XML or JSON formats for EPCIS payloads and other system interactions. 

Robust security protocols, including HTTPS/TLS encryption and reliance on authentication tokens (e.g., OAuth 2.0 or proprietary tokens generated via initial authentication using EDS), are fundamental to ensuring the secure and integrity-protected transfer of sensitive serialization data between your L4 system and the IS MPT.

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Core Reporting Requirements

Manufacturers and importers are obligated to digitally communicate every critical event related to their serialized products to the national system. This comprehensive data submission ensures full traceability and maintains a real-time digital twin of the physical supply chain. The core report types vital for this continuous data flow include:

• Emission Order Reports: This marks the crucial initiation phase. Here, manufacturers formally request and receive unique Crypto Codes and associated serial numbers directly from the IS MPT for their specific pharmaceutical products. This report confirms the intent to produce and mark a certain quantity of goods.
• Commissioning/Utilization Reports: Once the ordered codes are physically applied to individual product packs on the production line, these reports inform the IS MPT that the products have been "commissioned" and are now actively entering the supply chain. This confirms the successful serialization and readiness for distribution, linking the physical product to its digital identity.
• Aggregation Reports: As individual product packs are grouped into bundles, cases, or pallets for logistics, aggregation reports establish the hierarchical relationships between these serialized units. 
• Exception/Dropout Reports: Critical for maintaining data accuracy and system integrity, these reports communicate any anomalies or changes in status for serialized codes. This includes instances where codes are rendered unusable (e.g., due to printing errors, damage, or quality control sampling), or when products need to be formally decommissioned from the active supply chain for reasons like destruction or recall.

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Managing IS MPT Rate Limits & Throughput

For high-volume manufacturers and importers, successfully integrating with the IS MPT demands sophisticated throughput management. The IS MPT imposes specific API rate limits for various interactions, particularly for crucial processes like code emission requests and bulk report submissions. 

Overlooking these technical constraints can lead to API request rejections, system timeouts, and critical bottlenecks on your production lines. Implementing intelligent queueing mechanisms, retry logic with exponential backoff, and asynchronous processing within your serialization solution is essential to manage these limits and ensure continuous, uninterrupted operations without overwhelming the IS MPT or your L4 systems.

Exception Handling & Reversals

In any complex supply chain process, exceptions are inevitable. A robust serialization solution must offer clear technical protocols for exception handling and reversals. This includes defining automated or semi-automated processes for managing errors, submitting corrections, and invalidating erroneous data within the IS MPT.  The ability to receive immediate, granular error feedback from the system is crucial for rapid technical resolution and compliant reconciliation of scenarios like product returns, re-labeling, or re-packaging.

The following table summarizes the technical protocols for exception handling and reversals within the OMS and IS MPT:

Mastering Complexity for Continuous Market Access

Navigating the complexities of Kazakhstan's IS MPT, with its unique Crypto Codes and demanding EPCIS reporting, certainly presents a significant technical and operational challenge. Understanding these end-to-end requirements is crucial for your Supply Chain Operations, ensuring seamless market access and robust compliance. While the intricacies may seem daunting, achieving full compliance is entirely manageable with the right strategic approach and a truly capable serialization partner.

AltiusHub specializes in transforming these complexities into seamless compliance, providing tailored solutions that address the specific needs of MAHs and Importers navigating Kazakhstan's pharmaceutical landscape. We empower your team to meet every regulatory demand with confidence and efficiency, safeguarding your operations and market presence.

Ready to discuss your specific Kazakhstan compliance needs?

Contact us today to speak with an expert or request a personalized consultation.

https://www.altiushub.com/book-a-demo

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