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 amount 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 has planned to establish mandatory labelling and tracking of drugs by 2023 with a phased approach. Kazakhstan’s milestone is to implement 100% of serialisation by 2030.
Key upcoming dates
- May 2022: The ministry has identified 93 products and would begin the mandatory product serialisation for them. This is 1% of all drugs
- October 1, 2022: Mandatory serialisation for 20% of all drugs
- January 2023: The estimated start of mandatory data reporting with serialisation and the same product scope
- April 1, 2023: Mandatory serialisation of at least 80% of all drugs
- July 1, 2023: Serialisation of 100% of medicines
Chronology of the regulation development
- September 2015 – The Health Ministry of Kazakhstan issues guidelines on product labelling and accessing a centralised 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 labelling programme is started which also voluntarily included imported and newly produced products. The pilot is finalised and guidelines are issued
- August 8, 2021 – The Health Ministry shortlists 93 products for implementing the first phase of serialisation starting in May 2022.
Kazakhstan serialisation and traceability guidelines
- The first step in Kazakhstan serialisation 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 pertaining to the movement of the product.
Guidelines for serialised 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 serialisation with end-to-end aggregation as well. This hierarchical serialisation 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.
Disclaimer
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