For years, Italian medicine cartons carried a distinctly national element: the pharmaceutical label known as the bollino. With alignment to European legislation against falsified medicines, the bollino is being phased out. For companies that produce and market medicines, it is the most significant packaging change in years.
What the legislation requires
Directive 2011/62/EU on falsified medicines and Delegated Regulation (EU) 2016/161 introduced two ‘safety features’ on packs across Europe: a unique identifier, encoded in a DataMatrix, and a device showing whether the pack has been opened.
Italy, which had its own bollino-based system, used a derogation. The Ministry of Health decree of 6 March 2025 set the specifications for the new code and started a two-year transition period that ends in February 2027.
What changes, in short
| Before | After the transition |
|---|---|
| National pharmaceutical label | GS1 DataMatrix with a unique identifier |
| National traceability | Verification in the European medicines system |
| No EU tamper-evidence requirement | Anti-tampering device on the pack |
The requirement applies to prescription medicines and some non-prescription medicines specified by EU legislation. During the transition, packs with the bollino and packs with the new code coexist in pharmacies.
Why it is a packaging issue, not just a coding one
The DataMatrix is not something to add at the last minute. It affects the carton architecture, the relationship with printers and packagers, the legibility of mandatory information and stock management. Every decision has to be coordinated between regulatory affairs, production and suppliers.
The space freed up by the bollino is also an opportunity: if rethought carefully, it can make the pack clearer and better organised. If rushed, it risks repeating the same mistakes across dozens of products.
The real challenge: timing
The critical point is not a single carton but the number of products to update before a fixed deadline. A large catalogue needs a plan shared with the whole supply chain, not a last-minute rush.
How we work with our clients
In our pharmaceutical packaging design work, we support companies throughout the move to DataMatrix: from reviewing the catalogue to updated artwork and coordination with packagers and printers. We have handled these steps for years, so our clients do not have to worry about them. For other industry developments, see pharmaceutical packaging trends.
Frequently asked questions
When will the pharmaceutical label disappear in Italy?
The transition period set by the decree of 6 March 2025 ends in February 2027. From then on, new packs of the medicines concerned will use the European DataMatrix.
Which medicines are affected?
Prescription medicines and some non-prescription medicines specified by EU legislation.
Does it apply to food supplements?
No. The system covers medicines. Food supplements follow food labelling rules.
Do all cartons need a redesign?
Not necessarily a redesign, but every product concerned must be updated. It pays to work with people who know both the regulations and the production chain.
Sources
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