QRD templates (human)
QRD product information templates for human medicines (SmPC, labelling, package leaflet)
Summary
The mandatory structure and standard headings for the product information of centrally authorised products, used widely in national procedures too. Annex IIIA defines the numbered particulars for each packaging level.
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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 | 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 | – |
packart.dev summary, not a quotation of the source. Confirm requirements in the official text before regulatory use.