Community code (Directive 2001/83/EC)
Directive 2001/83/EC on the Community code relating to medicinal products for human use
Summary
The core EU law for the labelling of human medicines. It lists the particulars of the outer and immediate packaging, the reduced particulars for blisters and small immediate packaging units, and the content and order of the package leaflet.
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Key labelling requirements (6), 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 | C Context | |
| 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.