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” were officially announced.
This regulation does not specify waves and implementation timelines. The laid down rules are effective from 1st August 2022. There is another Government Decree stating that 1st wave will need to be serialized for products in scope produced after 1st July 2022.
Users of the Kazakhstan National Track & Trace System – IS MPT can be representative offices or affiliates of international manufacturers, foreign manufacturer’s trusted representative, MAH, manufacturers and affiliated companies.
Aggregation is carried out in the presence of several levels of nesting:
1) aggregation of the first level – the combination of primary and (or) secondary packages into a transport package;
2) aggregation of the second level – combining transport packages into another transport package of a higher level of nesting.
The full-stack solution covers the whole vertical from level 1 (Hardware) to level 5 (Reporting), complying with the labelling requirements for serialization, aggregation 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 provides an end-to-end solution for complying with all requirements of the Kazakhstan National Track & Trace System – IS MPT.
SoftGroup 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. The system supports all possible statuses and functionality, required by IS MPT.