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 fueled the sale of counterfeit drugs. To overcome this, the government of Kazakhstan has planned to establish mandatory labeling and tracking of drugs by 2023 with a phased approach. Kazakhstan’s milestone is to implement 100% of Serialization by 2023.

Key Upcoming Dates

  • May 2022 – The ministry has identified 93 products and would begin the mandatory product serialization for them. This is 1% of all drugs
  • October 1, 2022: Mandatory serialization for 20% of all drugs

  • January 2023 – The estimated start of mandatory data reporting with serialization and the same product scope.
  • April 1, 2023: Mandatory serialization of at least 80% of all drugs
  • July 1, 2023: Serialization of 100% of medicines

Chronology Of The Regulation Development

  • September 2015 – The Health Ministry of Kazakhstan issues guidelines on product labeling 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.

Kazakhstan Serialization And Traceability Guidelines

  • The first step in Kazakhstan Serialization is to provide information about the products for labeling 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 Serialized Labeling

The mandatory digital labeling 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.

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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, 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. Please use the references below to follow the updates at the source.

https://www.gov.kz/memleket/entities/dsm?lang=en

About CosmoTrace

Our entire team at CosmoTrace has kept up with all the changing updates and is aware as well as equipped to navigate through the relevant requirements. Our goal is to help manufacturers operating in the Kazakhstan market achieve serialization compliance.  We can assist your business prepare for all the upcoming deadlines with complete Serialization Project Management and Implementation. If you have questions or would like to know more about the Kazakhstan serialization regulations, just get in touch and we can assist.