Italy’s Serialization Update 2025: Key Compliance Changes for Pharma Companies

On 28 January 2025, the Italian Council of Ministers approved a new legislative decree aligning Italy with the EU Falsified Medicines Directive (FMD). This long-awaited update introduces a two-year stabilization period, giving pharmaceutical manufacturers time to transition from the current national traceability system to the EU-compliant serialization model.

For companies operating in Italy, this means critical adjustments in compliance, supply chain processes, and product verification systems.

Key Changes and Deadlines

Transition Period from 9 February 2025 to 8 February 2027

During this phase, pharmaceutical manufacturers can choose between continuing with Italy’s existing system (Bollino Farmaceutico) or switching to EU FMD serialization (unique identifier and anti-tampering label).

After 8 February 2027, full compliance with the EU serialization model will be mandatory.

New Verification and Reporting Rules

• Prescription medicines must carry a unique identifier (UI) and an anti-tampering device (ATD).
• The Italian Medicines Agency (AIFA) and the Ministry of Health will manage a centralized tracking database.
• Pharmacies, wholesalers, and distributors will have new obligations for verifying and deactivating UI codes.

Upcoming Ministerial Guidelines

• Within 30 days of publication in the Official Gazette, the Ministry of Health will release detailed implementation guidelines.
• These will define technical specifications, reporting requirements, and compliance procedures.

Non-Compliance Consequences

• Strict financial penalties apply for failing to serialize medicines, not verifying UI codes, or improper deactivation.
• Fines range from € 10,000 to €150,000 per violation.

What This Means for Pharmaceutical Companies

For Marketing Authorization Holders (MAHs), CMOs, and parallel importers, this is a critical time to prepare. Companies must:

• Assess serialization readiness and decide whether to transition now or later.
• Prepare IT systems to handle the new traceability and reporting requirements.
• Stay informed as AIFA and the Ministry of Health release further implementation details.

How Veritec Can Support You

We provide Serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.

We are well versed with the compliance regulations for various markets and can help you with implementing the Nigerian pharmaceutical serialization requirements as and when the regulations evolve.

Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization and pharmaceutical supply chains.

• Seamless serialization implementation aligned with Italian and EU regulations.
• Flexible integration with existing ERP and other business-critical systems.
• Real-time compliance monitoring to ensure every unit is verified and secure.