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

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 centralised 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 SoftGroup Can Support You

 

SoftGroup’s serialization and track & trace solutions are designed to help pharmaceutical manufacturers meet compliance requirements with minimal disruption. With our expertise in EU FMD regulations and deep understanding of Italy’s evolving system, we support:

  • 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.

 

 

 

Get Expert Guidance on Your Compliance Strategy

 

With the Italian serialization deadline fast approaching, companies must act now to ensure a smooth transition. Whether you’re looking to update your serialization system or need clarity on compliance requirements, SoftGroup is here to help.

 

Contact our experts today to discuss how we can support your compliance journey.  Explore how SATT PLATFORM can support your needs. Contact us today!