SoftGroup Solution successfully passed through the certification process by the Kazakhtelecom

 

 

 

 

 

 

SoftGroup is constantly expanding its portfolio of services, directed at the progressive development of solutions in compliance with new and emerging regulations. This month our SoftGroup® SaTT Solution was officially certified by Kazakhtelecom. The full-stack solution covers the whole vertical from level 1 (Hardware) to level 5 (Reporting), complying with the labelling requirements for serialization and reporting certain events to the national system – IS MPT. SoftGroup® SaTT Solution provides comprehensive functionalities to meet Kazakhstan`s complex regulatory requirements and to fulfil supply chain participants` needs.

 

SoftGroup® SaTT Kazakh Hub Gateway provides a connection and data exchange between Kazakhstan National Track & Trace System – IS MPT and all supply-chain participants (MAHs, Manufacturers, Importers, Wholesale trade enterprises, etc.). The solution allows requesting and receiving the cryptographic protection (crypto key and crypto signature for each serial number upload the final batch data) and publishing the serialization and aggregation reports concerning Article 7-2/12.04.2004 “About regulation of trade activity” and determining the procedure for marking and traceability of medicines in the territory of the Republic of Kazakhstan, Order No. KR DSM -11/27.01.22 “For the approval of rules for labelling of medicines and medical devices” of the Minister of Health and social development of the Republic of Kazakhstan. The system supports all possible statuses and functionality, required by IS MPT.

 

 

Background

 

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

 

In June 2022, amendments to the order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021, No. KR DSM-11 “On Approval of the Medicines and Medical Devices Labeling Guidelines” was officially announced.