Uzbekistan Pharma Regulatory Compliance: Full Overview

Why Uzbekistan’s Compliance Landscape Demands Attention?

Uzbekistan's pharmaceutical sector has undergone significant regulatory transformation, establishing itself as a critical market in Central Asia with stringent compliance requirements that mirror global best practices. As of 2025, the projected revenue in the pharmaceuticals market is expected to reach US$508.15M with an annual growth rate of 3.59% (CAGR 2025-2029). While local production accounts for nearly 65% of the market, the country remains heavily reliant on imports for essential and innovative medicines.

This presents immense growth potential, but only for manufacturers and exporters who master Uzbekistan's increasingly stringent compliance ecosystem.

But the failure to comply? Expect costly shipment delays, customs rejections, and market access disruptions.

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Serialization Deadlines

The serialization initiative was formally established through Government Decree #737 in November 2020, setting the foundation for a comprehensive regulatory framework. It draws inspiration from the Russian Chestny ZNAK system, with the traceability system developed by 'CRPT Turon' called Asl Belgisi. This strategic alignment enables pharmaceutical companies familiar with Russian serialization requirements to leverage existing knowledge while adapting to Uzbekistan specific nuances. 

Uzbekistan's serialization implementation follows a carefully orchestrated timeline designed to minimize market disruption while recognizing the complexity of supply chain integrations. The initiative was rolled out in three main phases as follows: 

• Phase 1: September 1, 2022

Mandatory implementation began for domestically manufactured pharmaceutical products, allowing local manufacturers to establish operational processes and validate system integration.

• Phase 2: March 1, 2023 z sz

Requirements extended to drugs included in the register of drugs with foreign registrations, recognizing a substantial portion of the imported pharmaceutical market. This phase significantly expanded the scope to include imported pharmaceuticals with recognized foreign registrations, representing a substantial portion of the market.

• Phase 3: February 1, 2025

‍ Encompasses medicines on the list approved by tax authorities and the Ministry of Health.

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Within these phases, specific product groups were assigned their own detailed deadlines for serialization and aggregation: 

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Transitional Period for Pre-Labeled Products:

A 3-year transitional period applies, allowing the sale of products labeled prior to their respective serialization deadlines:

• Group 1: Allowed until August 1, 2025
• Group 2: Until November 1, 2025
• Group 3: Until March 1, 2026
• Group 4: Until February 1, 2028

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How to Prepare for Compliance Reporting?

For successful participation in Uzbekistan's pharmaceutical serialization ecosystem manufacturers and importers must follow the below steps:

1. Acquire an Electronic Digital Signature (EDS): Manufacturers and importers must acquire an electronic digital signature (EDS) from e-imzo.uz by installing the plug-in. EDS of legal entity director becomes crucial for registration and signing agreements.

2. For foreign manufacturers (MAHs), gaining a Taxpayer Identification Number (TIN) from Uzbekistan authorities and a Personal Identification Number of an individual (PINFL) for their representative is necessary before obtaining the electronic signature from an embassy or consulate. 

3. Sign up with ASL Belgisi: 

• Undergo compliance check for software requirements
• Fill out and submit the application form

Following the signup, two agreements will be issued for signatures - Agreement for Connecting the Labeling System and Data Matrix Agreement.

4. Register Manufacturer Information and Product with National Catalog

• Access the National Catalog Module on Asl Belgisi
• For local manufacturers: Access GS1 Uzbekistan
• For foreign manufacturers: Access national GS1 organization in the product’s country of origin
• During registration, GTIN is a mandatory requirement for creating a product card

5. Login into Asl Belgisi, and add credits to the personal account for ordering the marking codes. Each code costs approximately UZS 68 + VAT (~ INR 0.50)

6. Add devices to the Order Management System (OMS) and order the data matrix codes.

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Mastering GS1 Standards for Global Interoperability

For regulatory alignment, adherence to specific GS1 standards is essential:

• GS1 Company Prefix: A unique number assigned to any company, forming the base for creating globally recognized product codes
• GTIN (Global Trade Item Number): The unique code that identifies each product type, essential for serialization and product tracking
• SSCC (Serial Shipping Container Code): A unique identifier for logistics units like cartons or pallets, critical for aggregation and shipment traceability 
• GLN (Global Location Number): A unique number that identifies physical locations or legal entities within the supply chain

To ensure alignment with human-readable standards on product packaging, GTIN is also complemented with information like expiration date, serial number and batch/lot number.

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Breakdown of Regulatory Authority Ecosystem

Uzbekistan's pharmaceutical regulatory ecosystem involves multiple authorities with distinct but interconnected responsibilities. The Ministry of Health serves as the primary regulatory authority for pharmaceutical registration and safety oversight, while the State Tax Committee manages digital marking compliance and enforcement activities.

• Asl Belgisi (ASLLIK BELGISI): National Information System for Digital Labeling and Traceability of Goods. Its primary purpose is to verify the authenticity and quality of products, combat counterfeit goods, and protect consumer health. 
• CRPT Turon: Overarching entity that manages the ASL Belgisi national track and trace system. It provides critical cryptographic elements (verification key and code) that are included in the Data Matrix codes generated through the ASL Belgisi’s OMS.
• Within ASL Belgisi, the Orders Management System (OMS) handles the processing of orders for Marking Codes (KM).
• The IZKM is the programmatic API interface that allows customers to send requests and receive responses from OMS for tasks such as ordering codes, reports on application, aggregation, and withdrawal.

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Deep Dive: Data Matrix Components

Asl Belgisi leverages advanced cryptographic techniques to enhance data security and prevent counterfeiting activities. Every barcode has the following four data points integrated through sophisticated encoding mechanisms:

• GTIN (Global Trade Item Number): This is a 14-digit product code
• Serial Number (SN): This is a 13-character randomized identifier, generated either by CRPT Turon or by a participant in the supply chain.
• Verification Key: This is a 4-character code generated by CRPT Turon
• Verification Code: This is a 44-character code generated by CRPT Turon

Asl Belgisi's OMS system sends DataMatrix codes to manufacturers or importers with the assistance of CRPT Turon. 

Data Matrix and Marking Codes are synonymous. Data Matrix is the physical manifestation of the Marking Code.

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Understanding the Reporting Requirements

Manfacturers/Importers are required to report various event data to ASL Belgisi. The types of reports include:

• Utilization/Application of Marking Codes: Report data on the application of marking codes to individual packaging at the end of production. Report type: UTILISATION
• Aggregation of Marking Codes: Report data of aggregated packages. Each aggregation receives a unique SSCC, forming a hierarchy. Report type: AGGREGATION
• Withdrawal/Dropout/Rejection Report: Report data of products sold to consumers (scanned at the online cash desk) or removed from the supply chain for reasons such as damage, expiration, or destruction. Report type: DROPOUT
• Release into Circulation (Implicit Reporting): Report data on how the product is introduced into the supply chain. 
  
  • For local manufacturers: This occurs after production and quality control
  • For importers: iIt happens after customs clearance
  • The methods can be:
    
    • PRODUCTION: Goods are produced within the country
    • IMPORT: Goods are imported to the country
    • REMAINS (Marking of residues) + COMMISSION: Registering an order on behalf of participants with the role of ‘Wholesale Trade’ or ‘Retail Trade’
    • COMMISSION: Similar to remains, this value can be used when registering an order on behalf of participants with the role of ‘Wholesale Trade’ or ‘Retail Trade’

Simplified View of Data Exchange Methods

Uzbekistan's compliance framework blends digital systems, secure data exchange, and physical product labeling to ensure full traceability. Below is a quick snapshot of the key methods and technologies every manufacturer and exporter should understand.

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Common Compliance Pitfalls & How to Avoid Them

Managing Rate Limits & Throughput

Here’s a quick overview of various limits to keep in mind when sending any requests to Asl Belgisi:

Key Points on Marking Code Orders

• Confirm Receipt: Once marking codes are received, the order needs to be closed to confirm the receipt
• Automatic Closure: Orders with all marking codes registered will close automatically after two days
• No Re-obtaining: Marking codes cannot be fetched again from orders that are already 'Closed'

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Managing Exceptions and Reversals

Asl Belgisi incorporates mechanisms for handling exceptions and managing reversals of product status through reporting various events that remove products from active circulation or indicate issues in the reporting process itself. 

While the system doesn't allow for simple 'Undo' action, it provides clear mechanisms to report these events, ensuring traceability records remain accurate.

How to accelerate access to Uzbekistan market?

Uzbekistan's evolving regulatory landscape reflects a broader global shift toward greater pharmaceutical traceability, product security, and patient safety. While the technical requirements of ASL Belgisi, GS1 standards, and serialization deadlines may seem complex, they are designed to create a more transparent, efficient, and counterfeit-resistant supply chain.

For manufacturers, exporters, and supply chain leaders, success in this market depends on early preparation, a clear understanding of regulatory expectations, and the ability to integrate compliance seamlessly into existing operations. Staying informed, investing in the right systems, and building internal capabilities today will help ensure uninterrupted market access and position your business for long-term success across Central Asia.

Looking to stay ahead of Uzbekistan's evolving compliance landscape?

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

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Frequently Asked Questions (FAQs)

1. What is Uzbekistan’s pharmaceutical serialization system and why is it required?

Uzbekistan uses a national traceability system called ASL Belgisi to digitally label and track pharmaceutical products throughout the supply chain. This mandatory serialization framework improves product authenticity, combats counterfeits, and aligns with global traceability trends.

2. Who must comply with serialization requirements in Uzbekistan?

Both domestic manufacturers and importers of pharmaceutical products must comply. The requirements were phased in over time, with full serialization and reporting now expected for a wide range of products.

3. What are the key serialization deadlines?

Uzbekistan’s serialization rollout followed three main phases, beginning in 2022 for local products, expanding in 2023 to many imported medicines, and extending further in 2025 to approved medicines lists, with transitional sell-through periods for pre-labeled stock.

4. What data must be reported to the ASL Belgisi system?

Manufacturers and importers must report the application of marking codes, aggregation events (linking unit packs to logistics units), withdrawals or rejections, and product releases into circulation via specified event types within the system.

5. Do companies need specific digital identifiers to participate?

Yes. Entities must obtain an Electronic Digital Signature (EDS) and register with the ASL Belgisi system. Foreign companies also require a Taxpayer Identification Number (TIN) and may need local representative credentials before ordering marking codes.

6. What GS1 standards are required in Uzbekistan?

Compliance revolves around GS1 identifiers such as the GTIN (product code), SSCC (serial shipping container code), and others used in DataMatrix barcodes. These are critical for global interoperability and regulatory traceability.

7. What happens if a product enters the Uzbekistan market without compliance?

Non-compliant products risk shipment delays, customs rejections, or market access disruptions, including possible removal from circulation during post-market surveillance.