Introduction
Kazakhstan as in the rest of the world, is in the fight against counterfeiting in order to protect the health of its citizens. The problem of tracking counterfeit drugs in former Soviet republics has become tedious with the former unorganized approach. Kazakhstan faces issues of having a high number of counterfeit drugs. demand for generics, drug shortages, and, increased online buying have further fuelled the sale of counterfeit drugs. To overcome this, the government of Kazakhstan is planning to establish mandatory labelling and tracking of drugs by 2024 with a phased approach. Kazakhstan’s milestone is to implement 100% of Serialization by 2025.
Key Dates
- Stage 1 Until July 1, 2024: Mandatory labelling of 100% of drugs.
- Stage 2 From July 1, 2024: Serialization of drugs purchased by a single distributor.
- Stage 3 From January 1, 2025: Prescription drugs (about 30%) have to be traceable and labelled
- Stage 4 From July 1, 2025: Serialization of no-prescription drugs (about 30%)
Data elements: data matrix code
- 14-digit product code (i.e., Global Trade Item Number, or GTIN) (GS1 Application Identifier 01)
- 13-character randomized serial number (21)
- 4-character verification key (91)
- 44-character verification code (92)
Aggregation: not required
Central reporting system: IS MPT
As in other EAEU and CIS countries, products must be labelled with a DataMatrix code with four data points. The maximum cost of one code will be 2.68 tenge ($0.0056) without VAT.
Every code goes through the same five steps during its “lifetime”:
- The manufacturer applies a code to every package and sends them to a distributor.
- The distributor receives and scans the products, then sends them to the retailer (e.g., a store or supermarket).
- The retailer receives the new (legal) batch of goods, scans the codes, and sells the products.
- At checkout, the cashier scans each code (either with a scanner or using the *NAQTY SAUDA app) and it’s withdrawn from circulation.
- Consumers can use the NAQTY ÓNIM app to learn more about the product.
* NAQTY SAUDA mobile application to accept and withdraw marked goods from circulation (primarily for participants who are unable to purchase scanners).
* NAQTY ÓNIM mobile application for the public to participate in the system.
Chronology Of The Regulation Development
September 2015 – The Health Ministry of Kazakhstan issues guidelines on product labelling and accessing a centralized portal for uploading data.
November 2015 – The Ministry of Kazakhstan instructs GS1 Kazakhstan to implement a pilot project for the national drug traceability system.
2019 – GS1 Kazakhstan starts the pilot project and executes tests.
2020/2021 – The labeling program is started which also voluntarily included imported and newly produced products. The pilot is finalized and guidelines are issued
August 8, 2021 – The Health Ministry shortlists 93 products for implementing the first phase of serialization starting in May 2022.
June 5, 2022 - The Health Ministry amended its traceability rules issued in 2021 with the new rules into effect from August 1, 2022.
June 23, 2023 - Phased approach not only by product groups, but by the participant's role in the supply chain was suggested in an industry meeting with KZ’s MoH.
As per the decree 931 signed in October 2023; July 1, 2024 onwards it is mandatory to label medicines that are imported into the Republic of Kazakhstan and or produced on the territory of Kazakhstan, packaged in dosage forms or in forms of packaging for retail sale. With this especially the foreign manufacturer has to be ready with their side of compliance reporting.
Kazakhstan Serialization And Traceability Guidelines
The first step in Kazakhstan Serialization is to provide information about the products for labelling and traceability of goods.
An encrypted Data Matrix code for each product is then generated by the system which contains information about the manufacturer or importer, the batch number and other information necessary for the product’s movement.
Guidelines For Serialized Labelling
The mandatory digital labelling system enforced by the Kazakhstan ministry ensures the transparent supply chain of medicines, which in turn ensures quality control throughout the life cycle of these medicines. In addition, manufacturers and importers can monitor the pharma supply chain for the movement of these drugs and because of this transparency, they can anticipate and prevent drug shortages as well as the circulation of counterfeit drugs.
Aggregation Guidelines
The final stage for a complete pharmaceutical track-and-trace program is following up the serialization with end-to-end aggregation as well. This hierarchical serialization practice involves updating each level of packaging detail such as carton, pallet, and container with a unique serial number, facilitating granular-level tracking and tracing. This approach will strengthen the anti-counterfeiting measures.
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients manage end-to-end serialization projects and prepare them for the existing and upcoming regulations across the globe.
We are well-versed in the compliance regulations for various markets and can help you with implementing the Kazakhstan pharmaceutical serialization requirements.
Our team of experts strategizes and plans end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences, and brand integrity.
References
Please use the references below to follow the updates at the source.
https://www.gov.kz/memleket/entities/dsm?lang=en
Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, or partners and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions.
