The Ministerial Decree of 20 May 2025, which defines the technical and graphic features as well as the information requirements of the new anti-counterfeiting device for human-use medicines, was published in the Official Gazette on 9 July.

The device is designed to enhance the medicine control system. It is produced on a secure medium and affixed to the part of the packaging chosen by the manufacturer.

The decree aligns with European legislation, in particular Directive 2011/62/EU and Delegated Regulation (EU) 2016/161, which require the implementation of safety features on medicine packaging to enable identification and authentication.

 Manufactured by the Italian State Printing Works and Mint (IPZS), the device is a self-adhesive element measuring 40 mm wide by 25 mm high, with rounded corners (2 mm radius). It is made of security watermarked paper, contains UV-fluorescent fibers, and is free of optical brighteners. It also includes an identification code generated and assigned by IPZS to mark its internal production batch.

The device is intended to remain affixed to the outer packaging of the medicine throughout its shelf life, and is designed to be destroyed or visibly damaged if removal is attempted.
As a security document ("carta valori"), the device is subject to specific management procedures under the responsibility of the marketing authorization holder (MAH).

 

The decree also mandates the inclusion of specific phrases on the medicine packaging depending on its intended use. Examples include “hospital/outpatient use” for products intended for public and private healthcare facilities, or “free sample – not for sale” for those to be provided to doctors as free samples. These statements must be clearly visible and printed with indelible ink.

During the stabilization period—from 9 February 2025 to 8 February 2027, as established by Legislative Decree 10/2025 (which adapts Italian law to Delegated Regulation (EU) 2016/161)—traceability and reimbursement of human-use medicines may also be ensured through the information included in the device. This includes the AIC code, product name, serial number, and the name of the marketing authorization holder.

 The decree entered into force on 9 July 2025, the date of its publication in the Official Gazette.