The European Falsified Medicines Directive (EU-FMD) entered into force on 9th February 2019. However, Italy, Belgium, and Greece were granted a six-year exception because they already had mechanisms in place for validating and tracing pharmaceutical items. Italy has employed the Bollino System for both OTC and prescription medicines since 2002; nonetheless, the deadline for implementing FMD in accordance with EU markets is February 9, 2025.
The following was published in the Italian Gazette on 21st February 2024: “Delegation to the Government for the Transposition of European Directives and the Implementation of Other Acts of the European Union – European Delegation Law 2022-2023,” effective March 10, 2024. The article specifies how and when Italy must comply with European serialisation.
- The Government is delegated to adopt, within 12 months of the date of entry into force of this law, one or more legislative decrees to adapt national legislation to the provisions of the specified Delegated Regulation.
- Provide specific and progressive measures aimed at implementing, by February 9, 2025, the affixing of the unique identifier and tamper-evident security features on pharmaceutical packaging.
- Ensure that manufacturing companies have enough time to comply with the effective date of 9th February 2025.
- Adapt and reconcile existing national regulations with the terms of the EU Delegated Regulation, and expressly repeal incompatible national rules.
- Stipulate that, under a special arrangement, the business NMVO Italia (formed on the 17th of January by the Associations representing the Producers and the Distribution Chain) will use the Istituto Poligrafico dello Stato to create the national archive.
At this moment, it is unclear how serialisation will be implemented, as well as if the current Bollini system would be phased out for prescription drugs or kept for OTCs. Additional practical guidance from AIFA and the Ministry of Health is planned.
