USA Serialization System

Serialization

Required - YES

Aggregation

Required - YES

Key Milestones

  • November 20, 2020 – The Government of Uzbekistan issued Decree #737, mandating the implementation of serialization for pharmaceuticals, tobacco, alcohol, soft drinks, and appliances by 2022.
  • June 1, 2021 – A six-month pilot project for serialization commenced.
  • April 2, 2022Resolution #149 was published, introducing mandatory labeling for four product groups, primarily consisting of medicines. A phased implementation plan for these product groups was later released.

Phase wise implementation of these medicine group was published.

Scope

Deadlines for Serialization

Deadlines for Aggregation

Group 1

Medicinal products with secondary packaging

September 1, 2022

May 1, 2023

Group 2

medicines with primary packaging

November 1, 2022

August 1, 2023

Group 3

Medicines and medical devices for orphan diseases

 Medicines included in the register of medicines with foreign registrations, the results of which are recognized in Uzbekistan

March 1, 2023

December 1, 2023

Group 4

Medical products according to the list determined by the Ministry of Health

February 1, 2025

November 1, 2025

Introduction

CRPT Turon is the designated authority managing Uzbekistan’s national Track & Trace system, aimed at ensuring the authenticity and declared quality of both imported and domestically produced goods. This traceability system, known as ASL BELGISI, allows consumers to verify products using a dedicated mobile app and to report any suspected counterfeits or provide feedback.

Uzbekistan’s model closely mirrors the Russian Track & Trace system, which is overseen by the Center for Research in Perspective Technologies (CRPT) in Russia. Similar to its Russian counterpart, Uzbekistan’s ASL BELGISI app enables product verification through scanning of unique crypto codes. These codes are paid for upon utilization.

Registration Process

To participate in the serialization system, the following stakeholders must register via the official CRPT Turon website:

  • Marketing Authorization Holders (MAHs)
  • Manufacturers
  • Importers
  • Wholesalers
  • Retail Trade Enterprises
  • Medical Organizations and Associations

Participants are required to categorize their goods in the catalog of labeled products. Access to the system for obtaining and reporting codes is granted only upon application approval.

Notably, foreign MAHs must establish a representative office or legal entity within Uzbekistan to fulfill requirements related to pharmacovigilance, as outlined in Resolution #149.

Standards for Labeling and Barcodes

Serialization of medicines in Uzbekistan requires the use of GS1 Data Matrix barcodes in the following format:

Machine-Readable (Data Matrix):

  • GTIN (14 digits) – AI (01)
  • Serial Number (13 digits) – AI (21)
  • Verification Key (4 digits) – AI (91)
  • Verification Code (44 digits) – AI (92)

Human-Readable Format:

  • GTIN (14 digits) – AI (01)
  • Expiry Date (YYMMDD) – AI (17)
  • Serial Number (13 digits) – AI (21)
  • Batch/Lot Number – AI (10)

Aggregation Requirements:
For packaging and shipment purposes, products must include a Serial Shipping Container Code (SSCC) using the GS1-128 linear code format, and in some cases, a 2D code. 

Traceability Requirements

To ensure product traceability throughout the supply chain, each item must be assigned a unique Data Matrix code. These codes allow retailers and pharmacies to verify authenticity, while consumers can use the ASL BELGISI app for product validation.

Additional Guidelines from CRPT Turon:

  • Products manufactured before the mandatory marking deadline can be imported within six months in their original packaging; however, digital marking must be applied.
  • Products imported or produced prior to the deadline may continue to be sold until the end of their shelf life, not exceeding three years from the date of serialization enforcement.
  • There have been discussions about allowing goods serialized for the Russian market to be imported into Uzbekistan. However, further clarification and approval from authorities is recommended.

Uzbekistan’s adoption of a serialization system inspired by Russia’s stringent Track & Trace framework represents a significant move toward enhanced supply chain transparency and consumer safety.

How VariTec Can Support Your Serialization Journey

At VariTec, we specialize in serialization consulting, implementation, and integration services, supporting clients through every stage of their serialization projects. Our goal is to ensure your organization is fully prepared for both current and emerging global regulatory requirements.

With deep expertise in global compliance standards, including Uzbekistan’s pharmaceutical serialization regulations, we offer tailored solutions to help you navigate complex compliance landscapes with confidence.

Our team of seasoned experts brings together extensive experience in product serialization, pharmaceutical supply chains, life sciences, and brand protection. We design and execute end-to-end strategies that align with your business objectives while ensuring full regulatory compliance.

CONCLUSION: In today’s evolving global landscape, traceability is more than a regulatory requirement — it’s a strategic imperative. Our advanced solutions help your organization achieve seamless compliance, end-to-end transparency, and the highest standards of pharmaceutical safety.
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