Kazakhstan Compliance

The Kazakhstan Compliance™ solution enables Marketing Authorization Holders (MAHs) and Importers to comply with the Order of the Minister of Health of the Republic of Kazakhstan for KR DSM-11, on regulation of trading activity and determine procedure for marking and traceability of medicines in the Republic of Kazakhstan.

MAHs and Importers use the Kazakhstan Compliance solution to meet the reporting requirements for Kazakhtelecom JSC, the traceability operator. Kazakhstan Compliance generates reports for regulated products as they move through the supply chain and submits those reports to the Government systems. The Ministry of Health has established the Order Management Station (OMS) and Information System Center for Electronic Documentation of Labeled Goods (IS CEDM) to enable the traceability of pharmaceuticals.

• TraceLink automatically submits Aggregation and Utilisation reports to the OMS once they are generated.
• MAHs must download and submit Transfer of CI to Importer report manually to IS CEDM once it is generated.

The following versions are available:

• Kazakhstan Compliance, solution version 3.0.0 Help Center (including documentation for the Kazakhstan Compliance, version 2024.3.0 app)

  This Help Center is a preview of the Kazakhstan Compliance, solution version 3.0.0 release. The final Help Center will be available on the Validation date.

• Kazakhstan Compliance, solution version 2.0.0 Help Center (including documentation for the Kazakhstan Compliance, version 2024.2.0 app)