[Blog] Uzbekistan Pharma Aggregation – the first deadline is officially from May 2023
From May 1st, the medicines from Group 1 will face the mandatory requirements for aggregation.
On the first day of May, also came the first deadline for the aggregation of medicines in Uzbekistan. Pharma Track and trace requirements for the Uzbekistan market are a hot topic for quite a time. In 2022 Uzbekistan’s Cabinet of Ministers adopted Resolution No. 149 which announced the deadlines for serialization of the four groups of medicinal products. This year the authorities introduced the official aggregation requirements and the respective deadlines.
The products that must be in compliance with the aggregation requirements are from Group 1 – medicinal products with secondary (external) packaging (except orphan drugs).
The requirement is to place a Uniquely Identified Serialized Shipping Container Code (SSCC). The code must include:
- Application identifier – the first “00” must always be present in the code.
- Extension Digit – in this case, the extension digit “1” may mean that it is an SSCC pallet.
- Company Prefix. – the GS1 company prefix should be replaced with the TIN of the importer.
- Serial reference number – this is the serial number of the batch (generated by the participant of the goods turnover).
- Check Digit
The labels must include the Manufacturer Plant, Product name, GTIN, Lot number, Expiry date, Number of cartons (Quantity), and Number of cases.
Separate terms are established for the four groups of medical products which are as follow:
- Group 1 – from May 1, 2023;
- Group 2 – from August 1, 2023;
- Group 3 – from December 1, 2023;
- Group 4 – from December 1, 2025.
Our experts want to remind you that an official transitional period is issued. Within 3 years from the date of mandatory labeling the relevant group – is allowed to sell medicines and medical devices manufactured before the date of mandatory labeling without labeling:
- Group 1 – to August 1, 2025;
- Group 2 – to November 1, 2025;
- Group 3 – to March 1, 2026;
- Group 4 – to February 1, 2028.