Italy’s Pharmaceutical Updates: Serialization and Regulatory Changes on the Horizon
Italy has long been a leader in pharmaceutical safety, with its unique systems for verifying and tracking medicinal products. However, with the full rollout of the European Union’s Falsified Medicines Directive (EU-FMD) and new documentation requirements, the pharmaceutical landscape in Italy is about to undergo significant changes. These updates, set to be implemented over the next few years, will bring Italy’s system into closer alignment with EU-wide standards while maintaining some of its own distinct practices.
The Bollino System: A Unique Approach to Medicine Tracking
Italy’s pharmaceutical serialization journey began in 2002 with the introduction of the Bollino system, a national initiative that guarantees the authenticity of medicines and tracks each individual pack. Unlike most other European countries, Italy has had a state-mandated labeling system where the government prints and issues Bollino stickers. These stickers, which are placed on medicine packaging, include vital information such as the A.I.C. code (a unique authorization number issued by the Italian Medicines Agency, A.I.F.A.) and a serial number (UID) to uniquely identify the product.
The Bollino system’s major strength lies in its centralized database, which is connected to Italy’s National Health Information System (NHIS). This allows authorities to trace every medicinal product through the supply chain, ensuring the prompt identification of counterfeit medicines and offering valuable insights when dealing with adverse effects. With the database, even small incidents such as counterfeit drugs or side effects can be traced back to a specific product, allowing for immediate corrective actions.
EU-FMD: A Major Shift in Italy’s Pharmaceutical Regulations
While the Bollino system has worked well in Italy, the full adoption of the EU-FMD by February 9, 2025, will bring significant changes. Under the EU-FMD, all EU member states are required to introduce a standardized system for serialization, and Italy will need to transition to this global standard. This means replacing the current Italian-specific A.I.C. code and UID with a Global Trade Item Number (GTIN), batch number, expiry date, and a randomly generated serial number, which will all be transmitted to the EU hub for verification.
For pharmaceutical manufacturers, this shift will require adopting the GS1 standard, a globally recognized system for product identification. Companies that already supply medicines to other EU markets will likely have an easier transition, as they are already familiar with GS1 standards. However, companies that have only sold medicines within Italy may face a longer adjustment period, particularly for artwork, labeling, and production line changes.
The rollout will be gradual, with an interoperability period from now until 2028, followed by a transition phase running until 2033. During this time, Italy will use a dual-labeling system, where both the GS1 data matrix and the Bollino label will be used in parallel for products on the market. This allows for a smoother transition and ensures that products already in circulation can remain traceable while Italy adapts to the new system.
New Mandate for Updated Product Documentation
In addition to serialization updates, Italy is also introducing a new documentation requirement for pharmaceutical companies. By November 9, 2024, all companies must submit updated versions of their Package Leaflet and Summary of Product Characteristics (SmPC) for their medicines. This update is part of Article 78 of Italy’s Drugs Code and ensures that patients and healthcare providers have access to the most current information about each medicinal product.
These updated documents must include any new safety warnings, dosage instructions, contraindications, and adverse effects that have been discovered since the last update. The move is in line with the EU’s broader regulatory framework, ensuring that Italy’s pharmaceutical documentation stays consistent with European standards and reflects any new scientific findings or regulatory changes.
Compliance and Penalties: What Pharmaceutical Companies Need to Know
Pharmaceutical companies must ensure that they meet the November 9, 2024 deadline for submitting updated leaflets and SmPCs. This requires coordination between regulatory, legal, and medical departments to ensure that all information is accurate, up-to-date, and compliant with AIFA’s requirements. Companies that fail to comply may face penalties, including the suspension of marketing authorizations for affected products.
This move by AIFA aims to ensure greater transparency in the pharmaceutical industry, helping healthcare providers deliver accurate advice and allowing patients to better understand their treatment options. By keeping medicinal product documentation current, Italy is reinforcing its commitment to safety, efficacy, and informed use of medicines.
The Road Ahead for Italy’s Pharmaceutical Industry
As Italy moves forward with the full adoption of the EU-FMD and other regulatory updates, pharmaceutical companies will need to stay on top of both national and EU-wide requirements. While the transition will present challenges, especially for those accustomed to the Bollino system, it also offers an opportunity to enhance traceability, security, and patient safety.
The dual-labeling period through 2033, combined with the updated documentation requirements, represents a significant effort to harmonize Italy’s pharmaceutical practices with broader EU goals. For manufacturers, staying ahead of these changes will be crucial to ensuring compliance and maintaining the trust of both regulators and patients.
Italy’s approach is a reminder that, in the ever-evolving landscape of pharmaceutical safety and regulation, staying current with new directives is essential not just for legal compliance, but for improving patient outcomes and fostering greater transparency across the healthcare sector.
