Uzbekistan Pharma Serialization Update: September 1 Deadline & More
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Uzbekistan Pharma Serialization Sept. 1

Uzbekistan Pharma Serialization Update: September 1 Deadline & More

We’ve been following the Uzbekistan pharma serialization rollout as part of our ongoing survey of global pharmaceutical regulations and compliance.

As we wrote in mid-February 2022, the country’s State Tax Committee “extend[ed] the timeframe for the phased introduction of mandatory digital markings” of pharmaceutical products. That announcement, however, didn’t stipulate a new deadline.

So, what’s the latest with Uzbekistan pharma serialization? Let’s take a look.

Uzbekistan pharma serialization and Resolution No. 149

On April 2 of this year, Uzbekistan’s Cabinet of Ministers adopted Resolution No. 149, “On the introduction of a system of mandatory digital labeling of medicines and medical devices.” This established the following labeling deadlines for medicinal products and medical devices:

      • September 1, 2022: products produced with secondary (external) packaging (except for orphan drugs)
      • November 1, 2022: products produced with primary (internal) packaging (provided there is no secondary packaging) and medical agricultural products (except for orphan drugs)
      • March 1, 2023: products and medical products to treat orphan diseases as designated by the Ministry of Health
      • March 1, 2023: drugs included in the register of drugs with foreign registrations, the results of which are recognized in Uzbekistan
      • February 1, 2025: medical products on a list approved by tax authorities and the Ministry of Health

Additionally, there seems to be a grace period for the 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.

More about the labeling requirements

The Uzbekistan traceability system is called ASL BELGISI. It’s managed by CRPT Turon, the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT), which manages Russia’s National Track and Trace Digital System (Chestny ZNAK).

The regulations currently apply to five product categories other than medicines and medical devices: tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks.

Products in every regulated industry 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

To learn more about Uzbekistan pharma serialization, how ASL BELGISI works, and labeling requirements, read our “Uzbekistan Traceability Update” from earlier this year. Keep in mind that we wrote this before the first deadline delay and adoption of Resolution No. 149.

Final thoughts

The Uzbekistan pharma serialization deadlines are upon us — about three weeks away. Since its inception, ASL BELGISI has been a hot topic in the industry, especially in key pharma-producing countries.

India, for example, has taken a keen interest in the requirements. One recent article reported that Indian pharma companies are “looking for more clarity over regulations and technical standards … and looking for a transition period to migrate to digital labeling.” The same article noted several other interesting points:

      • India’s pharma exports to Uzbekistan more than doubled in fiscal year 2020-21.
      • India’s export of pharma products to Uzbekistan totaled $137 million in 2021.
      • Uzbekistan’s pharma market is valued at $1.5 billion.
      • There are opportunities for investment and exports in Uzbekistan’s oncology and dermatology sectors.

The good news is that we can help you navigate Uzbekistan pharma serialization requirements no matter where you’re based — India, Asia, the EU, the UK, Latin America, the United States. We have experts in all of these markets, and rfxcel and Antares Vision Group are committed to ensuring you’re compliant everywhere you do business. Contact us today and schedule a short demo of our award-winning Traceability System and our Compliance Management solution.

 

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