Barcode labelling guidelines (Rx)
Implementation guidelines for barcode labelling of prescription drugs
医療用医薬品へのバーコード表示の実施要項
Summary
Which GS1 barcodes go on which packaging unit of prescription drugs (dispensing unit such as PTP sheet or vial, sales unit, original case), and which data (GTIN, expiry, batch, quantity) must be encoded.
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Key labelling requirements (3), transition and timeline notes, related documents and CSV export are available to testers.
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Relevance by packaging component
| Component | Relevance | What it concerns |
|---|---|---|
| CartonOuter packaging / folding carton | D Direct | |
| LabelImmediate container label (bottle, tube, large vial, bag) | D Direct | |
| Blister / foilBlisters, strips, sachets, lidding foil | D Direct | |
| Small unitSmall immediate packaging: ampoule, small vial, cartridge, pen | D Direct | |
| LeafletPackage leaflet / PIL, package insert, prescribing information, Medication Guide | – | |
| DeviceIntegral or co-packaged device and its instructions for use | – | |
| Shipper / caseTertiary packaging: shipping case, homogeneous case, pallet | D Direct | |
| e-LabellingElectronic product information, QR / 2D-code linked content | – |
packart.dev summary, not a quotation of the source. Confirm requirements in the official text before regulatory use.