Key Dates in Uzbekistan

  • November 20, 2020: Decree #737 was published by Uzbekistan Government which focused on implementing serialization for Pharmaceuticals, tobacco, alcohol, soft drinks, and appliances by 2022.
  • June 1, 2021: 6-month pilot project for serialization was started.
  • April 2, 2022: A resolution was published that describes the introduction of mandatory labeling for 4 product groups which are largely consisting of medicines. Phase wise implementation of Group 1 (Non-orphan medicines) has been published.
    • Phase 1 - May, 2022: Initial preparation for complying with the regulation
    • Phase 2 - July, 2022: Focusing on serialization readiness - product, artwork, production lines and other items to be in place and validated.
    • Phase 3 - Sep, 2022: Mandatory labeling to be done on secondary packaging
    • Phase 4 - Dec, 2022 - May 2023: Aggregation to become mandatory
    • Phase 5 - 2023 - 2025: Removing unmarked medicines from the market

Introduction

CRPT Turon is managing the Track & Trace system for Uzbekistan with the objective of guaranteeing consumers the authenticity and declared quality of the purchased products which are being imported or produced in the territory of the Republic of Uzbekistan. The traceability system developed by CRPT Turon is called ASL BELGISI.

CRPT Turon is very similar to the Russian Track & Trace system which is managed by Russia’s Center for Research in Perspective Technologies (CRPT). Like the Russian model, consumers in Uzbekistan can also download the mobile app to scan the products and for reporting the suspected products and their feedback about the system. However, the acquisition of crypto code will differ in case of CRPT Turon as crypto codes only have prepaid option as compared to the pay upon utilization option in case of Russia.

Registration

The MAH/ Manufacturer, Importer, Wholesaler, Retail Trade enterprise or medical organization and association need to apply to the official website of the “CRPT TURON” LLC for registering themselves. The participants need to describe the goods in the catalog of labeled goods and the access to the system for getting the codes and reporting them back is granted only after the approval of the application.

The Applicant (Holder) of the Marketing Authorization can be a legal entity, both resident and non-resident of Uzbekistan and is not required to establish a representative office or company in Uzbekistan. However, the Applicant must establish and maintain a local pharma co-vigilance system.

Standards for Labeling & Barcode

Regarding the serialization requirements, marking of medicines is carried out in the form of a two-dimensional barcode according to GS1 Data Matrix Standards:

  • GS1 Global Trade Item Number (GTIN) (14 digit) - AI (01)
  • Serial Number (13 digit) - AI (21)
  • Verification key (4 digit) - AI (91)
  • Verification code (44 digit) - AI (92)

Human Readable Standards:

  • GS1 Global Trade Item Number (GTIN) (14 digit) - AI (01)
  • Expiration Date (YYMMDD format) - AI (17)
  • Serial Number (13 digit) - AI (21)
  • Batch or Lot Number - AI (10)

secondary---Copy-(2)-1

For aggregation, the required identification code of the package, SSCC (Serial Shipping Container Code) must be provided in GS1 -128 linear code format and 2D in some cases.

Traceability requirements

In order to trace the movement of goods throughout the supply chain, unique Data Matrix code is important to be assigned to all the products. These codes can then be scanned by the retailers or pharmacies to find the authenticity of the product. The end consumers can also use the ASL BELGISI app to check the product’s legitimacy.

CRPT Turon has also specified a few additional points to regarding the traceability requirements to help movement of serialized goods inside the Republic of Uzbekistan:

  • All the packs which are manufactured before the deadline can still be imported within 6 months as per their original packaging. However, it is important to apply the digital marking to such packs.
  • All the packs which were imported or produced in the Republic of Uzbekistan before the deadline can continue to be sold until their shelf lives, but this should not exceed 3 years from the introduction of marking.
  • There were also discussions about importing the goods in the Republic of Uzbekistan which were initially serialized for Russian market. However, more information and confirmation regarding this should be taken in advance.

The approved concept of Track & Trace in Russia which arguably has the world’s toughest supply chain requirements will act as an important step for implementing the serialization and traceability regulations in Uzbekistan.

How can CosmoTrace help?

We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing 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 with implementing the serialization project to meet the deadlines.

As Serialization Consulting & Implementation Experts, our focus is on delivering the absolute best serialization support by offering long-term serialization and sustainability strategies and providing forward-thinking industry solutions.

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, partners 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.

References

CRPT TURON - Главная (crpt-turon.uz)

To learn more about CosmoTrace visit www.cosmotrace.com. Follow us on LinkedIn and Twitter for Serialization and industry related updates.

Need a helping hand in ensuring smooth operations in your serialization efforts.

CosmoTrace can help you manage the end-to-end Serialization project for Uzbekistan traceability requirements

Contact us for a free consultation