The pharmaceutical industry is growing and advancing every day. With advancements in technology, counterfeiters are also getting smarter. Hence, to get ahead of them, the pharmaceutical industry is preparing itself through track and trace system implementation. The problem of counterfeiting prevails more in underdeveloped and developing countries. Hence, the Kazakhstan government planned to take steps against this plight and introduced a plan for labeling and tracking drugs by 2023 with a phased approach.
The journey of the traceability system of Kazakhstan started in 2018. After planning and working on serialization and traceability systems for three years, the government, in 2021, published a pilot guideline. The government has made it mandatory to register all pharmaceutical and medical products with the Kazakh Health Ministry. The MoH developed a system named ISPMT – Information System for Products Marking and Traceability for observing traceability in the product supply chain. Now, the government is ready to implement the system permanently and by July 1, 2023, 100% mandatory serialization of all drugs.
The use of GTIN as per GS1 standards for the labeling process is not mandatory. To start the labeling process, the product information must be entered into the system. The system will generate an encrypted data code containing the details of manufacturers and importers, batch numbers, serial numbers, and other necessary information. The barcode labeling at the primary level is exempted until further notice.
On Secondary Level ::
- For the medicinal product, 2D barcode with following data elements should be applied to secondary level packaging (on primary packaging, if secondary level is not available)
- GTIN – AI(01) – a product code of the consumer packaging consisting of 14 digits
- Serial Number – AI(21) – an individual serial number of the consumer packaging consisting of 13 characters (digits, Latin uppercase and lowercase letters, as well as special characters)
- Verification Key Identifier Code – AI(91) – an identifier (individual serial number) of the verification key consisting of 4 characters (digits, Latin uppercase and lowercase letters, as well as special characters)
- Verification Code values – AI(92) – the value of the verification code consisting of 44 characters (digits, Latin uppercase and lowercase letters, as well as special characters)
On Tertiary Level ::
- The identification code of the transport (tertiary) packaging represents a one-dimensional (1D) barcode in Code 128 format as per ISO/IEC 15418-2013, with a unique identifier of the transport packaging in the form of a Serial Shipping Container Code (SSCC code).
- In some Brand owner 2D Code is also required
After the completion of the serialization process, the final step to strengthen the track and trace is end-to-end aggregation. In this step, each level of packaging is updated with details such as carton, pallet, and container with a unique serial number and data posting to National Hub.
Kevision Systems, part of the Kevin group, is a leading provider of complete solutions and services to protect your products and supplies. We are also a leading Solutions Provider for Vision-Based Inspection Systems for products, especially in the Healthcare, Food & Beverage as well as Automobile Industries. With Global Trade becoming seamless, the need for increased security & traceability of products is imperative for product authenticity. Kevision partners with clients to provide a robust & secure solution to meet product & client safety as well as regulatory compliance.