Kazakhstan Regulatory Serialization Updates

(An Official publication of PharmaSecure)

November’ 21: The government has issued version 4 of the draft instructions for mandatory serialization to pilot participants, who have been providing feedback.

October ‘21: Latest unofficial timelines and scope:

• July 1, 2022 –  Marking only for 93 drugs. The latest list includes the registration number and manufacturer. 
• October 1, 2022, The label has been expanded to just 20% of pharmaceutical products. 
• January 1, 2023, 60% labelling and traceability of pharmaceutical products. 
• April 1, 2023 Labelling and traceability expanded to 80% of pharmaceutical products.
• July 1, 2023 Labelling and traceability have been expanded to 100% of pharmaceutical products.

October ‘21: 

The Ministry of Trade and Integration of Kazakhstan has sent a letter to the EAEU (Eurasian Economic Union) with July 1, 2022, as the deadline for the initial phase of mandatory labelling.

• July 1, 2022 –  Display of 93 drugs only. The latest list includes the registration number and manufacturer. 
• October 1, 2022, The label has been expanded to just 20% of pharmaceutical products. 
• January 1, 2023, 60% labelling and traceability of pharmaceutical products. 
• April 1, 2023 Labelling and traceability expanded to 80% of pharmaceutical products.
• July 1, 2023 Labelling and traceability have been expanded to 100% of pharmaceutical products.

October ‘21: 

Discussions are underway with Kazakhtelecom to accept signatures from companies outside Kazakhstan

September ‘21: 

Kazakhtelecom updated its website with further information on the regulatory serialization schedule and changed the more general deadline for mandatory labelling to 2022. Previously, this was listed as Phase 1 January 2022.

July ‘21: 

The information shows a phase-wise implementation of traceability, with 93 products being serialized in May 2022 and reported for the same product scope in January 2023. 

May ‘21: 

Kazakhtelecom has published a roadmap on its website that includes the text “Stage 1” next to the mandatory labelling requirement stated for January 2022. 

April ‘21: 

Kazakhtelecom publishes its traceability deadline on its website of January 2022. However, this page did not mention any of the latest legislation. Also, it also seemed like the start of the pilot project has been delayed.

February ‘21 

The Kazakhstan  Ministry of Health had published guidelines for its drug labeling and traceability pilot project, where they had mentioned that the system will be operated by Kazakhtelecom. 

The serialization requirements included the crypto code and how to obtain it, the requiremnts stated by the MOH looks much like the requirements of the Russian Federation. It is unclear whether it will reach the same level of complexity as Russia, as no detailed description of the traceability event is given. GS1 reported that the pilot would be completed in March 2021.