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Pharma (Kazakhstan)

September 1, 2019 – July 31, 2021 the experiment on labeling of medicines lasted.

Labeling is introduced for medicines manufactured from July 1, 2022 (90 items). The first stage – serialization.

Proposed Timeframe:

  • 1 July 2022 –Introduction of labelling for approved 93 of medicines (1% from all drugs)
  • 1 October 2022 -expansion list of drugs at least for 20%
  • 1 January 2023 -expansion of the list of drugs at least for 60% and starting traceability of marked drugs
  • 1 April 2023 -expansion list of drugs at least for 80%
  • 1 July 2024 – Implementation of full traceability

The most current information about the timing of mandatory labeling, legislative acts, technical documentation, as well as the beginning of the experiment of new product groups you can find on the websites of our partners: Naqty Onim and QazMarka.

Kazakhstan Track&Trace regulations for the pharmaceutical market

Kazakhstan Track&Trace regulations for the pharmaceutical market
1

The manufacturer orders unique serial numbers with crypto codes for each trade item in accordance with the production plan to order management system (OMS).

2

In case of a direct printing scenario, these serial numbers are passed to manufacturing facilities, where they are encoded into Data Matrix codes and applied to individual consumer packages during production. The packages are placed into cases and other forms of containers and are then further aggregated into pallets. Each level of the container is labeled with a unique SSCC of GS1-128 codes assigned by the manufacturer. Codes are associated with a parent/child structure.

At the end of production: Each serialization code with a hierarchical structure is stored in a private repository and transferred with additional attributes, such as expiration date, to OMS. After the data transfer, the serialized products are considered released to the market and also reflect the structure of the box/pallet nesting.

3

At any given point in the supply chain, product aggregation can be changed. When this happens, it is reflected in the repository and reported to CEDM/EDO. Likewise, products can be written off for various reasons, such as damages, expiration, or shortages.

4

After the serialized goods are picked and packed in new cases and pallets they are dispatched from the importer to the next supply chain partner. Each serialized container is scanned, unique codes are edited into Act of Acceptance and sent to the CEDM/EDO.

5

During acceptance of labeled serialized products, the wholesaler scans each shipping unit or package to verify upon Act of Acceptance. A Corrective Act of Acceptance is issued to resolve discrepancies. Change of ownership takes place after the Act is signed by the recipient's electronic signature. Ownership of the goods is recorded in the CEDM/EDO. 

6

In the retail store, a DataMatrix code is scanned, unique serial numbers are included in the electronic cash register receipt, which through fiscal data operator is sent to the CEDM/EDO.

7

Any consumer can scan a Data Matrix code with a phone app NaqtyOnim to verify the authenticity of the product and learn more about its origin.

Kazakhstan Track&Trace import regulations for the pharmaceutical market

Kazakhstan Track&Trace import regulations for the pharmaceutical market
1

The importer orders unique serial numbers with crypto codes for each produced trade item based on the production/purchase plan. The serial numbers and crypto codes are emitted by the OMS system. Then, the ordered serial numbers are transferred to the manufacturer for products serialization.

2

In case of a direct printing scenario, these serial numbers are passed to manufacturing facilities, where they are encoded into Data Matrix codes and applied to individual consumer packages during production. The packages are placed into cases and other forms of containers and are then further aggregated into pallets. Each level of the container is labeled with a unique SSCC of GS1-128 codes assigned by the manufacturer. Codes are associated with a parent/child structure.

3

Each hierarchically structured serialization code is stored in a private repository and transmitted to OMS with additional attributes, such as expiration date.

4

Alternatively, the serialization process can take place at a warehouse outside Kazakhstan or at the customs warehouse. The full hierarchy has to be reported to OMS before the shipment can be customs-cleared.

5

The importer or the customs broker submits a customs declaration (GTD) to the State Revenue Committee Ministry of Finance of the Republic of Kazakhstan. Which clears the shipment and allows its import into Kazakhstan.

6

After customs control, the importer submits a Market Release Report to the CEDM/EDO, which is the entry of the serialized goods into circulation.

7

After the serialized goods are picked and packed in new cases and pallets they are dispatched from the importer to the next supply chain partner. Each serialized container is scanned, unique codes are edited into Act of Acceptance and sent to the CEDM/EDO.