Pharmaceutical Revolution: the New Label Arrives
Italy an excellence, among the safest countries
The familiar pharmaceutical excise stamp — the security feature developed by the Istituto Poligrafico e Zecca dello Stato that for years helped Italy achieve the world’s lowest rate of counterfeit medicines (0%, compared with a global average of 6–7% and a European average close to 1%) — is getting a new look.
In implementing European legislation aimed at harmonising pharmaceutical packaging security requirements across the European Union, Italy has adopted a new solution that complies with EU requirements while preserving the Institute’s role as guarantor and maintaining the country’s exceptionally high security standards.
The new European regulation requires medicine packaging to include a unique identifier (Data Matrix code) and an anti-tampering device, a physical security feature that varies according to the type of packaging. In addition to these two elements, Italy will introduce a third security feature.
Produced by the Istituto Poligrafico e Zecca dello Stato on State security paper, this additional device will ensure anti-counterfeiting protection, pharmaceutical safety, and the necessary measures to combat fraud against public finances.
Furthermore, the Institute will be responsible for developing and managing the National Repository on behalf of NMVO (National Medicines Verification Organisation), the non-profit organisation established by associations representing the pharmaceutical supply chain. The repository records the unique identifiers of prescription medicines and plays a key role in ensuring the integrity and traceability of the pharmaceutical system.
