Pharma

Pharma serialization
in Kazakhstan

Regulator
Joint-stock company ‘Kazakhtelekom’
System
IS MPT (markirovka.ismet.kz)
Traceability
Incomplete, applies to pharmaceuticals set out by the Decree of the Kazakhstan Republic Government of April’25’2022 # 242. The list of pharmaceuticals will be extended further.
Branding
Standard GTIN - 14 digits, Serial Number - 13 digits, cryptographic part: verification key provided by the system operator – 4 digits and verification code generated by the system operator -44 digits.
What is required
to start serialization:
What is required
to start serialization:
List of local abbreviations
IS MPT – Information system of goods serialization and traceability
OMS – Order management system
DMC – DataMatrix code
CW – Customs warehouse
Further development timeline
The 1st stage of mandatory
serialization July 01’2022
Pharma serialization in Kazakhstan
Reporting process
For local manufacturers
Order of the DataMatrix codes
The manufacturer orders unique serial numbers with cryptic codes for each unit according to the production plan via the OMS.
1
Utilization of DataMatrix codes
In case the code is utilized in the manufacturing process, serial numbers are coded in DataMatrix format for further utilization on separate retail packages. After the production process completion, the information on this stage is sent to OMS. At the end of production data on the completion of this stage are transferred to OMS. After the data transfer is completed the serialized products are deemed to have released in circulation.
2
Aggregation
Units can be aggregated into factory packings and transportation packings which are aggregated to pallets. Each aggregation receives its own unique SSCC GSI-128 code assigned by the manufacturer; codes comprise hierarchies. Each DataMatrix code with hierarchical structure is saved in a private repository and transferred to OMS.
3
Dispatch to a new owner
Serialized goods in transportation packings and aggregated to pallets are sent by the manufacturer further along the supply chain. Each serialized packing is scanned, unique codes are entered into the Act of Transfer and Acceptance, the latter being sent to IS MPT. In the process of accepting the serialized consignment, a receiver scans each transportation unit or packing to check their compliance to the inbound Act of Transfer and Acceptance. Ownership is transferred after signing the Act of Transfer and Acceptance with EDS. The title transfer is registered with the IS MPT.
4
Withdrawal from circulation
As the serialized packings are sold in retail stores, the DataMatrix code is scanned for the consumer, the unique serial numbers are entered into the electronic cash receipt, subject to subsequent transfer to the IS MPT via a fiscal data operator. As such, the goods are withdrawn from circulation by virtue of a sale. It is also possible that the goods may be withdrawn as they move down the supply chain due to damage, expiration, destruction etc. All the relevant changes are entered into the repository and are uploaded to the IS MPT.
5
Inspection of the product by the end consumer
Any consumer may scan the DataMatrix code via a mobile app called NagtyOnim, so as to check the authenticity of the product and learn about its origin.
6
Reporting process
For importers
Order of the DataMatrix codes
An importer/ manufacturer representative orders unique serial numbers with crypto codes for each unit in accordance with the production plan. Serial numbers and crypto codes are ordered through the OMS. Further, ordered serial numbers are sent to the manufacturer for marking the goods.
1
Utilization of DataMatrix codes
If serialization is done in the course of production, the serial numbers are coded in the DataMatrix format with a view to subsequently applying them to individual consumer packaging. At the end of production data on the completion of this stage are transferred to OMS.
2
Aggregation (optional)
Units can be aggregated into factory packings and transportation packings which are aggregated to pallets. Each aggregation receives its own unique SSCC GSI-128 code assigned by the manufacturer; codes form hierarchies. Each DataMatrix code with hierarchical structure is saved in a private repository and transferred to OMS.
3
Serialization at the Custom Warehouse
Serialization the good and its aggregation can be done at the Customs Warehouse. A complete hierarchy of codes is to be uploaded to OMS before the goods go through the customs clearance.
4
Imports
An importer or a customs broker applies a freight customs declaration (FCD) to the Committee of state revenues of the Ministry of finance of the Republic of Kazakhstan. The Committee clears the goods and authorizes the import of goods into the Republic of Kazakhstan. After the serialized goods pass through customs the importer upload a specialized report to the IS MTP, which constitutes of the product release in circulation.
5
Dispatch to a new owner
The manufacturer delivers serialized goods in packings and on pallets to the next partner in the supply chain. Each serialized packing is scanned, the unique codes are entered into the Act of transfer and acceptance and are then transferred to the IS MPT. In the course of acceptance of the serialized goods receiver scan each transportation unit or package to check that the codes correspond to those entered into the Act of transfer and acceptance. Ownership is transferred after the execution by the consignee of the Act of transfer and acceptance. The title transfer is registered with the IS MPT.
6
Withdrawal from circulation
As the serialized packages are sold in retail stores, the end consumer may scan the DataMatrix code, the unique serial number is entered into the electronic cash receipt, subject to subsequent transfer to the IS MPT via a fiscal data operator. As such, the goods are withdrawn from circulation by virtue of a sale. It is also possible that the goods may be written off as they move down the supply chain due to damage, expiration, destruction etc. All the relevant changes are entered into the repository and are uploaded to the IS MPT.
7
Inspection of the goods by the end consumer
Any consumer may scan the DataMatrix code via a mobile app called NagtyOnim, so as to check the authenticity of the product and learn about its origin.
8
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