Republic of Kazakhstan: Overview of Serialization and Traceability Requirements

The pharmaceutical industry has no shortage of challenges – regulatory scrutiny, patent cliffs, R&D productivity, and most of all, the complex supply chain. Drugs and medications go through several changes of hands: from manufacturers to repackagers, to the dispensaries, and finally, to the patients. This long chain facilitates the easy entry of counterfeit drugs and the diversion of legitimate ones.

Cost-cutting pressures, demand for generics, drug shortages and increased online buying have further fuelled the sale of counterfeit drugs.

The problem is especially severe in former Soviet republics, where the presence of counterfeit drugs in the supply chain is more pronounced than in other countries. The share of counterfeit drugs in the Republic of Kazakhstan is estimated at 10-12%, meaning one out of 10 drugs sold is fake.

To counter this predicament, the government of Kazakhstan has planned to introduce mandatory labelling of drugs and a tracking system by 2023. Here’s everything pharmaceutical manufacturers and packagers in Kazakhstan need to know about track-and-trace developments.

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CHRONOLOGY OF THE REGULATION DEVELOPMENT

September 2015 – The Kazakhstan government issued guidelines on product labelling and marking. It also stipulated requirements regarding accessing a centralized portal and uploading data for proper implementation.

November 2015 – Kazakhstan’s Ministry of Health mandated GS1 Kazakhstan to run a pilot project for the national drug traceability system.

2019 – GS1 Kazakhstan launched the pilot project. The tests for the pilot were conducted in 2018-2019.

2020/2021 – 2020 marked the beginning of the labelling program for imported and newly produced products. Initially, the program was voluntary.

August 8, 2021 – The Ministry of Health proposed 93 products for the initial serialization phase, which will begin in May 2022.

May 2022 – Expected start of mandatory product serialization for the 93 products.

January 2023 – Anticipated start of compulsory data reporting, alongside serialization, for the same product scope.

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GUIDELINES FOR SERIALIZED LABELS

In May 2022, Kazakhstan will start implementing the compulsory digital labelling of drugs. For the first implementation stage, the Ministry of Health has proposed 93 products.

Fortunately, many pharmaceutical companies have already grown accustomed to the labelling process, thanks to the pilot project conducted by the government. One Kazakh importer, two distributors, four pharmaceutical manufacturers, eight medical institutions, five pharmacies and the state-run distributor SK-Pharmacy LLP participated in the project.

Almost 100,000 packages of drugs and medical products have been digitally labelled since September 2019, which marked the project’s inception.

The compulsory digital labelling system ensures transparent circulation of medicines and quality control throughout their life cycles. In addition, manufacturers and importers can also monitor the pharma supply chain, anticipate and prevent drug shortages and bar the entry of counterfeit drugs.

According to the framework of this project, the first step is to enter information about the products into the system for labelling and traceability of goods. The system then generates a Data Matrix code for each product, which contains digital information about the manufacturer or importer, the batch number and other data necessary to control the movement of the product. Also, the Data Matrix code is encrypted, leaving no room for forgery.

The use of GTINs as per GS1 standards is not yet mandatory.

GUIDELINES FOR AGGREGATION

The final stage for a complete pharmaceutical track-and-trace program is end-to-end aggregation. This is a hierarchical serialization model in which each level of packaging (carton, pallet, and container) is assigned a unique serial number, facilitating granular-level tracking and tracing. The airtight system doesn’t leave any room for counterfeiting or other illegal activities.

Kazakhstan’s Ministry of Health has only released guidelines for serialization and labelling requirements. Any information about future aggregation plans is yet to be revealed. Will Kazakhstan opt for aggregation? Only time will tell.

 

 

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