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Regulatory For
Uzbekistan
Uzbekistan Regulatory Requirements
| Regulatory Agency | Primary Regulatory Authority: Ministry of Health of the Republic of Uzbekistan (for medicines). Traceability System Operator: ASL BELGISI / xTrace, operated by CRPT Turon under the State Tax Committee and Ministry of Health enforcement. |
| Regulation Name | Decree No. 737 “On establishing mandatory digital labeling” (20 Nov 2020). Resolution No. 149 “On the introduction of the system of mandatory digital labeling of medicines and medical devices” (approved April 2022, phased rollout rules) |
| Compliance Dates | Deadlines varied by product group (secondary / primary packaging /
|
| Applies to | All human pharmaceutical products manufactured or imported into Uzbekistan under ASL BELGISI digital labeling |
Secondary Packaging
(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)
| Barcode Symbology | GS1 DataMatrix (2D). |
| Barcode Content |
|
| Serial Number Randomization | Randomized, unique per unit |
| Serial Number Reuse | Not permitted. |
| Human Readable Expiry Date Format | YYMMDD / YY/MM/DD format standard (human-readable below DataMatrix). |
| Barcode Data Encoding | GS1 Application Identifiers (DataMatrix) |
| Product Code Notes | GTIN must align with GS1 Uzbekistan prefix and national catalog entry. |
| Free Samples must be marked? | Not explicitly detailed; typical labeling still applies and must include required DataMatrix. No public exemption noted. |
Tertiary Packaging
(A shipper containing one or more secondary packs)
| Barcode Symbology | GS1-128 or DataMatrix (for aggregated shipping units). | |
| Barcode Contents | SSCC, GTIN, batch/lot, expiry (depending on label) | |
Aggregation Data Capture
| Mapping Aggregation Capture? | Yes — linking sellable units to cases and pallets. |
Data Exchange
| Send Unit Data to Government Repository? | Yes |
| Send Unit Data to Third-Party Repository? | Possible for internal industry tools but not mandated. |
| Send Unit Data to Trading Partner? | Commercial exchange expected between partners (internal trade systems). |
| Send Aggregation Data to Government Repository? | Yes |
| Send Aggregation Data to Third-Party Repository? | Possible via internal systems but not regulator-mandated. |
| Send Aggregation Data to Trading Partner? | No Specified |
Authentication
| Who Offers Data Repository for Authentication? | BELGISI / xTrace managed by CRPT Turon. |
| Manufacturers Must Register Shipments in Repository? | Yes — all serialization, movement, and event reporting occurs in ASL BELGISI. |
| Downstream Trading Partners Must Authenticate on Receipt? | Industry practice involves scanning on receipt, but no widely published mandatory authentication requirement for every trading partner outside reporting events — though supply chain scanning is expected. |
| Downstream Trading Partners Must Authenticate on Shipment? | Similar to above — not explicitly mandated as a separate regulatory event. |
Government Reporting
| Manufacturer Activity Reported? | Yes |
| Downstream Trading Partner Activity Reported? | Scanning and movement events may be recorded into the traceability system during distribution. |
Source and Credit: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.
Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.
About Kevision Systems
Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.
Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.
Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.
For Further Information, please contact our Compliance Team at info@kevision.in