New Regulations for Medicines Safety in Italy
On February 7, 2025, Legislative Decree No. 10 was published in the Official Gazette, entering into force on February 8, 2025. This measure aligns Italian legislation with the European Falsified Medicines Directive (FMD) and introduces significant measures to ensure the safety of medicines.
What Changes?
Unique Identifier: Human-use medicines must carry a unique identifier encoded in a two-dimensional barcode, mandatory for prescription-only drugs.
Anti-Tampering System: All medicines must have an anti-tampering system to prevent fraud.
Verification and Registration: Manufacturers, wholesalers, and pharmacies must verify the authenticity of unique identifiers and register them.
Transition Period: A 24-month transition period allows companies to adapt to the new regulations.
Impact and Prospects
The decree represents a significant step forward in protecting public health and provides certainty to the pharmaceutical supply chain. During the transition period, the new traceability system and the traditional pharmaceutical sticker will coexist, with the goal of further improving the safety and integrity of medicines.