Everything MAHs, CMOs, and Parallel Distributors need to prepare for the Italian NMVO enforcement phase.
Prepare for Italy’s transition to EU FMD serialization requirements
Italy is entering a critical transition phase toward full alignment with the EU Falsified Medicines Directive.
From 9 February 2025 to 8 February 2027, Italy applies a stabilization period for the application, activation, verification, and deactivation of the Data Matrix. During this period, pharmaceutical companies must prepare their packaging, serialization data, systems, and operational processes for the new traceability requirements.
For Marketing Authorization Holders, manufacturers, CMOs, and supply chain partners, this transition affects more than packaging artwork. It requires reliable data management, system readiness, partner coordination, and clear compliance workflows.
SoftGroup supports pharmaceutical companies with validated serialization, aggregation, and traceability solutions designed for regulated markets.
What is changing in Italy?
Italy is aligning its national medicines traceability framework with the European verification model introduced by the EU Falsified Medicines Directive and Commission Delegated Regulation (EU) 2016/161.
The EU framework requires safety features on the outer packaging of medicinal products, including a unique identifier and an anti-tampering device. The unique identifier enables the verification of the authenticity and identification of an individual pack, while the anti-tampering device helps verify whether the packaging has been opened or altered.
For Italy, this transition includes the use of a 2D Data Matrix code containing key serialization data, while maintaining Italy-specific requirements during the stabilization period.
Key requirements for pharmaceutical companies
Pharmaceutical companies placing medicines on the Italian market need to prepare for several operational and data requirements.
Packaging and artwork readiness
Medicine packaging must support the required Data Matrix and safety feature configuration. This may require artwork updates, packaging line adjustments, validation activities, and coordination with packaging suppliers.
Serialization data management
The Data Matrix must include essential product and pack-level data, including:
- Product code / GTIN
- Serial number
- Batch number
- Expiry date
- AIC code for the Italian market
This makes master data accuracy, serial number management, and system control essential for reliable compliance.
System and process readiness
Companies must ensure that their internal systems can manage serialization events, product master data, batch data, pack status updates, verification processes, and partner data exchange.
NMVO Italia onboarding
Marketing Authorization Holders need to complete the onboarding process with NMVO Italia. This includes company registration, payment of the entrance fee, contract signature, and annual fee payment where applicable.
Transition planning before February 2027
The stabilization period gives companies time to complete implementation, validation, onboarding preparation, and operational alignment before the transition period ends on 8 February 2027.
How SoftGroup supports Italy traceability compliance
SoftGroup provides end-to-end serialization, aggregation, and traceability capabilities for pharmaceutical companies preparing for Italy’s transition.
Serialization and aggregation at production level
SoftGroup supports packaging operations with serialization and aggregation solutions designed for regulated pharmaceutical production.
Our solutions cover printing, verification, rejection handling, rework processes, aggregation, and data exchange with enterprise systems.
Centralized serialization management
SATT PLATFORM enables centralized management of product data, batch data, serial numbers, production events, and compliance workflows across lines, sites, and partners.
This helps pharmaceutical companies maintain control over serialization data and reduce manual handling across operational processes.
Partner and system integration
SATT PLATFORM supports integration with ERP, WMS, CMOs, MAHs, logistics partners, and external systems.
This enables reliable data flow across the supply chain and supports better coordination between internal and external stakeholders.
Authority reporting readiness
SoftGroup helps companies prepare accurate, structured, and compliant serialization data for national traceability requirements and the European verification system.
The platform supports controlled data exchange, data consistency, and operational visibility across compliance processes.
Expert support through the transition
SoftGroup supports pharmaceutical companies through implementation, validation, onboarding preparation, and operational alignment.
Our team combines regulatory understanding with practical serialization experience, helping companies prepare for Italy’s requirements with confidence and control.
Why early preparation matters
Italy’s transition affects several parts of pharmaceutical operations:
- packaging and artwork
- line-level serialization
- master data management
- partner communication
- system integration
- verification processes
- compliance reporting readiness
Companies that prepare early can reduce the risk of packaging rework, incomplete serialization data, delayed onboarding, verification issues, and operational pressure close to the 2027 deadline.
SoftGroup helps pharmaceutical companies build the right serialization foundation before compliance requirements become operational blockers.
Prepare your Italy compliance roadmap
Italy’s stabilization period is already active. Use the time before 8 February 2027 to assess your packaging, data, system, and partner readiness.
SoftGroup can help you evaluate your current setup, identify operational gaps, and prepare a structured roadmap for Italy traceability compliance.
