Malaysia
| Regulatory Agency | National Pharmaceutical Regulatory Agency (NPRA) Under the Ministry of Health Malaysia. |
| Regulation Name | Drug Registration Guidance Document (DRGD) – labeling and registration rules NPRA Product Barcode & Traceability Requirements |
| Compliance Dates | Barcode (GTIN) requirement: Implemented for registered pharmaceutical products over the past decade (mandatory GS1 barcode on outer packaging). No nationwide mandatory serialization (unique serial number per pack) requirement as of current regulations. |
| Applies to | All registered pharmaceutical products (prescription and OTC) marketed in Malaysia. Applies to manufacturers, importers, and Marketing Authorization Holders (MAHs). |
| Barcode Symbology | GS1 1D (EAN-13) or GS1 DataMatrix (depending on packaging configuration) |
| Barcode Content | GTIN (product identifier only) |
| Serial Number Randomization | Not required (no mandatory serialization) |
| Serial Number Reuse | Not applicable |
| Human Readable Expiry Date Format | As per NPRA labeling rules (typically MM/YYYY or DD/MM/YYYY) |
| Barcode Data Encoding | GS1 GTIN standard |
| Product Code Notes | GTIN must be registered with GS1 Malaysia and linked to NPRA registration. |
| Free Samples must be marked? | Yes – must be labeled “Free Sample – Not for Sale” per labeling regulations |
| Barcode Symbology | GS1-128 (SSCC) – if used for logistics | |
| Barcode Contents | SSCC or GTIN (logistics use) | |
| Parent-Child Mapping Aggregation Capture? | Not required |
| Send Unit Data to Government Repository? | No |
| Send Unit Data to Third-Party Repository? | Optional (company systems only) |
| Send Unit Data to Trading Partner? | Commercially optional |
| Send Aggregation Data to Government Repository? | No |
| Send Aggregation Data to Third-Party Repository? | Optional |
| Send Aggregation Data to Trading Partner? | Commercially optional |
| Who Offers Data Repository for Authentication? | None (no national serialization repository) |
| Manufacturers Must Register Shipments in Repository? | No |
| Downstream Trading Partners Must Authenticate on Receipt? | No |
| Downstream Trading Partners Must Authenticate on Shipment? | No |
| Manufacturer Activity Reported? | No |
| Downstream Trading Partner Activity Reported? | No |
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For Further Information, please contact our Compliance Team at info@kevision.in
