Indonesia
| Regulatory Agency | National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan — BPOM) — the authority that oversees pharmaceutical serialization and traceability in Indonesia | ||||||||
| Regulation Name | Peraturan BPOM Nomor 22 Tahun 2022 – “Penerapan 2D Barcode dalam Pengawasan Obat dan Makanan” (Implementation of 2D Barcode in Drug and Food Monitoring). | ||||||||
| Compliance Dates |
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| Applies to | Domestic and imported pharmaceutical medicines, including prescription, OTC, traditional medicines, cosmetics, supplements & processed foods under BPOM regulations. |
| Barcode Symbology |
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| Barcode Contents | Identification Barcode QR Code
* Authentication Barcode QR Code/2D Datamatrix
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| Serial Number Randomization | Not Specified |
| Serial Number Reuse | Not Specified |
| Human Readable Expiry Date Format | Must appear on packaging per GS1/DataMatrix standards (e.g., YYMMDD), consistent with serialization best practice. |
| Barcode Data Encoding | GS1 standard encoding (DataMatrix & QR) for serialized DM. |
| Product Code notes | |
| Free Samples must be marked? | Not Specified |
| Barcode Symbology |
GS1-128 recommended for logistic/aggregation levels per GS1 aggregation standards. |
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| Barcode Contents |
SSCC (serial shipping container code) on cases & pallets to link parent-child. |
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Parent-Child Mapping Aggregation Capture? | Mandatory for serialized products under authentication requirements |
| Send Unit Data to Government Repository? | Yes: Unit serialization data must be reported to BPOM via TTAC (Track & Trace Anti-Counterfeit Control) System. |
| Send Unit Data to Third-Party Repository? | Not explicitly required outside BPOM’s system; third-party repositories may be used by companies but are not mandated by regulation. |
| Send Unit Data to Trading Partner? | Yes |
| Send Aggregation Data to Government Repository? | Yes |
| Send Aggregation Data to Third-Party Repository? | Optional: Industry may store in external partners, but not explicitly mandated. |
| Send Aggregation Data to Trading Partner? | Common in supply chain best practices; not a strict BPOM rule |
| Who Offers Data Repository for Authentication? | BPOM’s TTAC System is the centralized government repository for serialization reporting and authentication. |
| Manufacturers Must Register Shipments in Repository? | Yes |
| Downstream Trading Partners Must Authenticate on Receipt? | Downstream partners (distributors/wholesalers) are expected to scan and report product receipt to TTAC. |
| Downstream Trading Partners Must Authenticate on Shipment? | Yes |
| Master Data Upload? | Master product data (GTIN, NIE, batch, expiry) must be uploaded into BPOM’s TTAC system as part of serialization setup. |
| Manufacturer Activity Reported? | Yes: Activation, packing, distribution, and return/recall events must be reported. |
| Downstream Trading Partner Activity Reported? | Yes: Receipts, shipments, returns, and distribution events are part of TTAC reporting. |
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For Further Information, please contact our Compliance Team at info@kevision.in
