Because the foil is small, EU law allows reduced particulars on blisters that are placed in an outer carton: at least the name of the medicine, the marketing authorization holder, the expiry date and the batch number (Article 55 of Directive 2001/83/EC). If a blister is not in an outer carton, the full outer packaging particulars apply to it. The blister is usually printed on the foil, and each cavity may be perforated so that single doses can be torn off. See also unit dose.
Why it matters for labeling
The foil is primary packaging that is designed and approved separately from the carton, often by a different team or supplier. The two have to stay consistent: name, strength, batch and expiry, and any pack-specific details. Variable data such as the batch number and expiry date is printed on or embossed into the foil during packaging, where legibility is harder than on a carton.
Common mistakes
- Foil artwork not updated when the carton changes
- Batch or expiry date that is hard to read after embossing or sealing
- Missing minimum particulars on the foil
- Information cut off when a dose is torn from the strip