Safety features (Delegated Regulation 2016/161)
Commission Delegated Regulation (EU) 2016/161 laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use
Summary
Implements the Falsified Medicines Directive: a unique identifier in a GS1 DataMatrix with human-readable data, and an anti-tampering device, on the packaging of prescription medicines (with listed exceptions) and listed non-prescription medicines.
More in the full catalogue
Key labelling requirements (4), 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 | C Context | |
| Small unitSmall immediate packaging: ampoule, small vial, cartridge, pen | – | |
| 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 | C Context | |
| 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.