The rollout of Uzbekistan serialization requirements will continue on schedule as spring 2023 approaches. Let’s take a look at the requirements, what happened last year, and what to expect for this year’s deadlines in March and May.
What are the Uzbekistan serialization requirements?
Uzbekistan traceability system is called ASL BELGISI. It’s managed by CRPT Turon, the equivalent of the Center for Research in Perspective Technologies (CRPT), which manages Russia’s National Track and Trace Digital System (Chestny ZNAK).
Today, the Uzbekistan serialization requirements apply to seven product categories: medicines; medical devices; tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks. Regulated products must be labeled with DataMatrix codes that include four data points:
- A 14-digit product code (i.e., Global Trade Item Number, or GTIN)
- A 13-character randomized serial number generated by CRPT Turon or a supply chain participant
- A four-character verification key generated by CRPT Turon
- A 44-character verification code (i.e., crypto code) generated by CRPT Turon
Product packaging must also have the following human-readable information:
- Serial number
- Expiration date in YY/MM/DD format
- Batch number or lot number
Key dates in 2022
It’s been a little more than a year since Uzbekistan’s State Tax Committee extended the schedule for the “phased introduction of mandatory digital markings” of pharmaceutical products.
We’re also approaching the 1-year anniversary (April 2) of Resolution No. 149, which established the labeling deadlines for four groups of medicinal products and medical devices. There were two deadlines in 2022:
- September 1: Products produced with secondary (external) packaging (except for orphan drugs)
- November 1: Products produced with primary (internal) packaging (provided there is no secondary packaging) and medical agricultural products (except for orphan drugs)
March and May 2023 Uzbekistan serialization requirements
Resolution No. 149 stipulates two labeling deadlines for March 1:
- Products and medical products to treat orphan diseases as designated by the Ministry of Health
- Drugs included in the register of drugs with foreign registrations, the results of which are recognized in Uzbekistan
As with the 2022 deadlines, it seems that Resolution No. 149 established a grace period for mandatory labeling in two circumstances:
- Products that were produced domestically within 90 days of these deadlines do not have to be labeled and may be circulated.
- Products that were imported within 180 days of these deadlines do not have to be labeled and may be circulated.
And on May 1, the law requires full track and trace and aggregation with Serial Shipping Container Codes (SSCCs) on tertiary packaging. A customs aggregation code (AIC) for imported products and aggregation code for locally manufactured products is already required. The AIC has 25 digits: a 14-digit tax identification number (TIN) for businesses or personal identification number (PINFL) for individuals; the date the AIC was generated by ASL BELGISI (6 digits in DDMMYY format); and a random 5-digit security code generated by ASL BELGISI.
The Uzbekistan serialization requirements mean that pharma companies that want to do business in the country have a long list of items to check off their compliance to-do list, including generating and managing serial numbers, obtaining crypto codes from CRPT Turon, and monitoring packing lines to ensure compliance with the requirements.
The good news is that we can help you navigate the requirements. Contact us today and schedule a short demo of our compliance management solution, which takes the guesswork out of compliance by automatically sending reports to regulators, adapting to changes in laws, and updating your partners. Our digital supply chain experts will help you evaluate your needs and work directly with you to design a solution customized for your business.
And sure to bookmark our blog and check back for more updates about Uzbekistan serialization requirements and requirements in other Commonwealth of Independent States nations and members of the Eurasian Economic Union.
Published Feb. 27, 2023