Italy is late in complying with an important European regulation on drug packaging, in particular on the so-called pharmaceutical stampswhich guarantee that medicines have not been tampered with or counterfeited. The result is that starting from February 9, 2025medicines used by millions of Italians could disappear from pharmacy shelves.
In fact, the Government has not yet specified how it will implement the European regulation, which has been active for almost 10 years but for which Italy had received an exemption. The associations of drug manufacturers and pharmacists have been asking the ministries for clarification for months, but the procedures are blocked and the times to update the manufacturing lines are very tight.
Dozens of drugs could disappear in February
In 2011 the European Union approved a directive requiring all member states to equip themselves with a single system against drug counterfeiting and tampering with packaging. In 2016 this directive becomes a regulation and therefore binding for all member countries, with two exceptions. Italy and Greece had in fact just introduced their own anti-counterfeiting system, which is working very well. The EU therefore gave them more time to comply: until February 9, 2025.
Italy uses the so-called pharmaceutical stampa label that is also applied on the boxes of over-the-counter medicines and which guarantees their traceability. The new rules, however, include three innovations:
- The printing of a two-dimensional barcode called Datamatrix on each box
- The creation of a national medicines archive linked to the European one
- Placing a seal on each box of medicines
The Datamatrixwhich must be read with special tools, allows all operators in the sector, from manufacturers to pharmacists, to know where a drug comes from and what its expiry date is. The national archiveby cross-referencing the data with the European one, guarantees that the drug has not been counterfeited. The seal finally ensures that the box has not been tampered with.
All points still to be clarified in the Government decree
However, Italy is seriously late in adapting to these rules. Giorgia Meloni’s Government approved it in August a legislative decree containing general principlesbut more precise indications are lacking. To stimulate a dialogue with the executive, the entire Italian pharmaceutical supply chain has joined forces in the NMVO (National Medicines Verification Organisation). At the moment, however, there are still significant obstacles:
- The legislative decree has not yet been confirmed by Parliament. If this does not happen by the beginning of March, it will lapse
- It is not clear whether the seal to be placed on the packages will be provided by the State or whether it can be purchased on the market
- There is no plan on how to manage old packaging: however, their sale entails fines of up to 80 thousand euros
This uncertainty has not allowed producers to adapt the lines, which are not ready for the changes necessary to manufacture the new packages. The NMVO has asked for a transition period of up to two years to adapt. However, it is not clear whether the Government can grant this extension: the risk is that from 9 February pharmacies will no longer be able to sell even very common medicines.
