uzbekistan traceability system

[Blog] Uzbekistan is on the way to mandatory serialization of pharmaceutical products

Uzbekistan is one of the countries in the CIS region that work quite proactively on improving the quality of healthcare in different stands and developing traceability system.

 

 

The Ministry of Health of the Republic of Uzbekistan’s governmental body participates in implementing programs regarding the licensing of pharmaceutical activities, state registration, and quality control of medical devices.

 

In November 2020 Uzbekistan Government published Decree #737, “Establishment of obligatory digital labelling”, which required the serialization for tobacco, alcohol, pharmaceuticals, soft drinks and appliances. In May this year, the Cabinet of Ministers has adopted a resolution “On measures to implement pilot projects to expand the list of goods subject to mandatory digital marking”. According to the newly approved resolution, from 1st of June 2022, the digital marking of medicines and medical products is mandatory.

 

 

Uzbekistan Traceability System

 

The traceability system is developed by “CRPT Turon” and is called “Asl belgisi” (Uzbek translation of “Chestny znak” system used in Russia). If you are MAH/ Manufacturer, Importer, Wholesaler, Retail Trade enterprise or medical organization/ association, you must apply to the official website of the “CRPT TURON” LLC. If the application complies with the requirements, the participant will receive a personal account and access to the Uzbekistan system.

 

 

Regulatory Requirements

 

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

 

  • GTIN – 14-digit character, with an application identifier (01)
  • Individual serial number – 13-digit character or alphanumeric sequence with an application identifier (21)
  • Crypto key – 4 characters with an application identifier (91)
  • Crypto signature – 44 characters with an application identifier (92)

 

Furthermore, there are additional requirements regarding serialization, which include the use of ASCII encoding, error detection and correction function DataMatrix ECC 200, ISO/IEC 16022:2006 “Information technology” and digital identification.

 

As for aggregation, the required identification code of the transport package, SSCC number (Serial Shipping Container Code), must be provided in the form of a one-dimensional barcode following the ISO 15394:2009 “Packaging – Barcode and two-dimensional symbols for shipping, transport and receiving labels” with an application identifier (00).

 

 

Timeline

 

November 20, 2020 – Decree #737 “Establishment of Obligatory Digital Labelling” was published

May 30, 2021 – Resolution No. 322 was issued by the Uzbekistan Government

June 1, 2021 – Start date of the pilot project

February 1, 2022 – Date of commencement of gradual introduction of compulsory digital marking (mandatory serialization)

 

 

If you need any assistance or consultation regarding the Uzbekistan traceability system and serialization requirements, our experts are a click away >>

 


Sources:

https://www.who.int/health-laws/countries/uzb-en.pdf

https://www.uzpharm-control.uz/en/

Pharma Serialization, Aggregation and Track and Trace Software by SoftGroup

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