In the EU, most prescription medicines must carry a unique identifier and an anti-tampering device on their outer packaging, under the framework set out in Directive 2001/83/EC and Delegated Regulation (EU) 2016/161. Examples include a tamper-evident seal or a perforated closure. In the US, most OTC products need tamper-evident packaging under 21 CFR 211.132, with a statement on the label describing the feature.

Why it matters for labeling

The device is a physical feature, but the label has to work with it: artwork has to leave space for the seal, and in the US the statement about the tamper-evident feature has to be present and accurate. If the packaging changes, the feature and the statement have to be checked again.

Common mistakes

  • A label statement describing a feature the new pack no longer has
  • Artwork changes that move or cover the seal area
  • Assuming the EU requirement applies to OTC products, which are usually exempt unless specifically listed
  • Forgetting to re-check after a packaging change

Sources