A Complete Guide to Kazakhstan Pharma Serialization

An update on July 2024 timelines

On amendments to the Decree of the Government of the Republic of Kazakhstan dated September 10, 2020 No. 568 “On determining the list of goods subject to labelling. The Government of the Republic of Kazakhstan decided to make the following change to the Decree of the Government of the Republic of Kazakhstan dated September 10, 2020 No. 568 “On determining the list of goods subject to labelling”.

In the List of goods subject to labelling, determined by the said resolution paragraph three of the note should be stated as follows:

“From July 1, 2024 – mandatory labelling for medicines manufactured since July 1, 2024, packaged in dosage forms (including medicines in the form of transdermal systems) or forms or packaging for retail sale, except medicines and vaccines used in veterinary medicine”.

This resolution comes into effect upon the expiration of sixty calendar days after the day of its first official publication.

The Original Draft in Russian Language:

The English Translation of the above:

COMPARISON TABLE

The draft resolution of the Government of the Republic of Kazakhstan “On amending the Decree of the Government of the Republic of Kazakhstan dated September 10, 2020 No. 568 “On determining the list of goods subject to labelling”

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)

Central reporting system: IS MPT

As in other EAEU and CIS countries, products must be labeled 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”:

1. The manufacturer applies a code to every package and sends them to a distributor.
2. The distributor receives and scans the products, and then sends them to the retailer (e.g., a store or supermarket).
3. The retailer receives the new (legal) batch of goods, scans the codes, and sells the products.
4. At checkout, the cashier scans each code (either with a scanner or using the NAQTY SAUDA app) and it’s withdrawn from circulation.
5. 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.

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.

Reference

https://legalacts.egov.kz/npa/view?id=15063356

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.

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, 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.