PMD Act
Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act)
医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律
Summary
Japan's medicines law. It lists the items on containers and wrappers, requires precautions information, and since the 2019 amendment replaces the paper package insert for prescription drugs by electronic information reached through a GS1 code on the package, with barcode display mandatory.
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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 | – | |
| Small unitSmall immediate packaging: ampoule, small vial, cartridge, pen | D Direct | |
| LeafletPackage leaflet / PIL, package insert, prescribing information, Medication Guide | D Direct | |
| DeviceIntegral or co-packaged device and its instructions for use | – | |
| Shipper / caseTertiary packaging: shipping case, homogeneous case, pallet | – | |
| e-LabellingElectronic product information, QR / 2D-code linked content | D Direct |
packart.dev summary, not a quotation of the source. Confirm requirements in the official text before regulatory use.