Kazakhstan
| Regulatory Agency | Ministry of Healthcare of the Republic of Kazakhstan (Committee for Medical and Pharmaceutical Control) and the national track & trace system IS MPT – Information System for Labeling and Traceability of Goods operated by Kazakhtelecom JSC oversee pharmaceutical serialization compliance. |
| Regulation Name |
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| Compliance Dates |
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| Applies to |
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(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)
| Barcode Symbology | 2D GS1 DataMatrix (cryptographically protected). |
| Barcode Content |
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| Serial Number Randomization | Yes – randomized unique identifier. |
| Serial Number Reuse | Not permitted (each pack unique). |
| Human Readable Expiry Date Format | Standard human-readable expiry date included below the DataMatrix (e.g., YYYY-MM-DD). |
| Barcode Data Encoding | GS1 Application Identifiers (AI 01, AI 21, AI 91, AI 92). |
| Product Code Notes | Unique GTIN required per SKU; allocated per GS1 standards and recorded in IS MPT. |
| Free Samples must be marked? | No explicit exemption in primary regulation; free samples would typically require serialization and labeling when sold/removed from production context |
(A shipper containing one or more secondary packs)
| Barcode Symbology | GS1-128 SSCC for case/pallet marking (aggregation units). | |
| Barcode Contents | SSCC, possibly aggregated GTIN with hierarchical parent links recorded in the system. | |
| Parent-Child Mapping Aggregation Capture? | Yes – parent/child relationships captured and reported. |
| Send Unit Data to Government Repository? | Yes – units reported to IS MPT (serialization, commission, movement). |
| Send Unit Data to Third-Party Repository? | Possible – internal systems, not regulator-mandated. |
| Send Unit Data to Trading Partner? | Yes – commercial exchange between partners as required for supply chain operations. |
| Send Aggregation Data to Government Repository? | Yes – aggregation hierarchy reported to IS MPT. |
| Send Aggregation Data to Third-Party Repository? | Possible – internal to company systems. |
| Send Aggregation Data to Trading Partner? | Yes – commercial exchange for logistics. |
| Who Offers Data Repository for Authentication? | IS MPT (national aggregator managed by Kazakhtelecom JSC). |
| Manufacturers Must Register Shipments in Repository? | Yes – serialized units and movements are registered in IS MPT. |
| Downstream Trading Partners Must Authenticate on Receipt? | Yes – distributors and pharmacies scan codes and record receipt events in IS MPT at handover. |
| Downstream Trading Partners Must Authenticate on Shipment? | Yes – movements between partners are scanned and reported. |
| Manufacturer Activity Reported? | Yes – serialization issuance, commissioning, shipments reported. |
| Downstream Trading Partner Activity Reported? | Yes – receiving, shipping, and sales events recorded. |
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For Further Information, please contact our Compliance Team at info@kevision.in
