Article 57 of Directive 2001/83/EC allows Member States to require additional information on the outer packaging, for example the legal supply category (prescription only or not), price, reimbursement status and national identification numbers. The information is normally kept in a separate box so the rest of the packaging can stay the same across countries. The requirements differ by country, and the European Commission's packaging guideline explains how this works for centrally authorized products.
Why it matters for labeling
One product sold in several EU countries can need a different blue box for each, on top of the same core artwork and the product information in each language. Because the content is national and changes over time, it is a classic place for outdated or mismatched text. The box has to be right for the country the pack is sold in, alongside the information in the SmPC.
Common mistakes
- Using outdated national requirements
- A box that is missing, in the wrong place or too small for the required text
- Content copied from another country's variant
- Translations of national text that haven't been checked