Kazakhstan: Pharma serialization and track and trace

[Blog] Kazakhstan introduced the mandatory serialization and traceability requirements

The government of Kazakhstan is working on the implementation of a pharma track & trace for the serialization of all medicines

 

 

 

 

In 2018, the journey of Kazakhstan towards building a traceability system started. In the next 3 years, the government constantly worked and planed the pharmaceutical track and trace process for serialization of all medicines. At the beginning of 2021, the Kazakh Ministry of Health published a pilot guideline for product marking and traceability.

Over the last week’s regular session where issues of labeling and traceability were discussed, Mr. Mamin summarized:

“The introduction of a system of labeling and traceability of goods allows protecting the Kazakhstani market from counterfeit and low-quality products, preserving the health of citizens, increasing the competitiveness of domestic producers in the EAEU market…”.

It is obvious that Kazakhstan is taking serious actions and product labeling is one of the main goals in their future development plans.

 

More about the regulatory framework

 

Regarding the implementation of serialization of medicines, the Kazakh Ministry of Health has been focused on the GS1 Standards. The latest unofficial and unconfirmed information about the timeline is as follows:

 

  1. July 1, 2022 – mandatory serialization for 1% of all drugs on the market (93 medicines in total)
  2. October 1, 2022 – mandatory serialization for 20% of the medicines
  3. January 1, 2023 – mandatory serialization for 60 % of all drugs
  4. April 1, 2023 – the volume of mandatory serialized drugs must be 80%
  5. July 1, 2023 – 100% mandatory serialization of all drugs

 

The responsibility for marking the medicine is for:

 

  • If the product is manufactured in Kazakhstan – the manufacturer
  • If the product is manufactured abroad, including in the EAEU countries – the importer

 

Serialization process

 

According to the framework, when the information for the product is entered into the system for labeling, it generated the Data Matrix code. The Data Matrix will be encrypted and will contain digital information about the manufacturer/ importer, the batch number as well as other necessary product data.


Sources:

https://www.primeminister.kz/en/news/ukimet-tauarlardy-tanbalau-zhane-kadagalau-maselelerin-karady-171030

https://www.mondaq.com/dodd-frank-consumer-protection-act/1105440/labelling-of-goods-in-the-republic-of-kazakhstan