On January 28, 2025 the Italian government approved a legislative decree (“Decree”) implementing EU regulation 2016/161 through which the European Union has introduced specific measures aimed at fighting counterfeit medicines.

Packaging. Packaging of pharmaceutical products will have to include: (i) a two-dimensional bar code (i.e. “unique identifier”) able to guarantee the authenticity and the identification of the single individual pack of medicinal products; and (ii) an anti-tampering device.

Marketing authorization. Any new or existing marketing authorization (“MA”) requests must include information on the unique identifier and anti-tampering device when it has an impact on the primary packaging, the locking system or the label’s legibility. MA holders must update their MA to ensure full compliance with the new regulation.

Timeline.  The Decree should come into force on February 9, 2025, but its publication in the official Gazette is still awaited. However, the Decree has provided for a transition period between February 9, 2025, to February 8, 2027, where it will be possible to continue using the old “Bollino” system without incurring penalties.

Sanctions.  The manufacturer who does not apply and activate the unique identifier may be sanctioned with an administrative fine ranging from Euro 10,000 up to 60,000 for each batch. An MA holder may be sanctioned with a fine, ranging from Euro 10,000 up to 60,000 for each batch, for trading a medical product lacking an anti-tampering device. Manufacturers, wholesalers, and suppliers of medicines to the public who do not notify immediately to the competent authorities of any case of tampering or counterfeiting may be sanctioned with a fine starting from Euro 20,000 up to Euro 80,000 for each batch.