Welcome on NMVO Italia
Ensuring Medicine Safety & Traceability
Highlights
The work instructions dedicated to the phase 2 of the NMVS pilot project are now available on the website of the Ministry of Health
July 31, 2026
Disponibili le istruzioni operative dedicate alla fase 2 del progetto pilota NMVS sul sito del...
Read more𝐒𝐭𝐚𝐫𝐭 𝐨𝐟 𝐭𝐡𝐞 𝐞𝐧𝐫𝐨𝐥𝐥𝐦𝐞𝐧𝐭 𝐟𝐨𝐫 𝐏𝐡𝐚𝐬𝐞 𝟐 𝐨𝐟 𝐭𝐡𝐞 𝐍𝐌𝐕𝐒 𝐏𝐢𝐥𝐨𝐭 𝐏𝐫𝐨𝐣𝐞𝐜𝐭
June 4, 2026
Following the conclusion of Phase 1 of the NMVS Pilot, NMVO Italy announces the launch of Phase 2 of the NMVS Pilot Project starting from June 2026.
Read moreOnboarding page for wholesalers authorized to distribute pharmaceutical products in Italy
June 3, 2026
Onboarding page for authorized Wholesalers
Read moreThe European Falsified Medicines Directive – FMD
Directive 2011/62/EU (Falsified Medicines Directive – FMD) specifically addresses the issue of counterfeiting in the pharmaceutical sector by establishing safety measures for the end-to-end identification of each individual pack of medicine in Europe. Delegated Regulation (EU) 2016/161 implemented this directive by creating a system to prevent falsified medicines from entering the legal supply chain.
Safety Features
Introduces the 2D Data Matrix code and the anti-tampering device as tools for verifying the authenticity of medicines.
Patient Protection
The measures apply to all prescription medicine packs, except for specific exemptions outlined in the Regulation.
Alert System
Provides an effective alert management mechanism to ensure the delivery of safe medicines and prevent disruptions in the supply chain.
THE ROLE OF NMVO ITALIA
NMVO Italia is the organization responsible for the implementation and management of the National Medicines Verification System (NMVS) in accordance with European and Italian regulations. Legislative Decree 10/2025 defines the role and functions of NMVO Italia, which is in charge of implementing and managing the National Repository containing information on the safety features of medicines. The role of NMVO Italia is essential to ensure the safety and integrity of the pharmaceutical supply chain in Italy.
Key Responsibilities:
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NMVS Implementation
Manages and coordinates the national infrastructure for the verification and authentication of prescription medicines.
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Monitoring and Security
Ensures the proper functioning of the system, preventing the distribution of falsified medicines.
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Regulatory Compliance
Collaborates with Italian and European regulatory authorities to ensure adherence to the provisions of Delegated Regulation (EU) 2016/161.
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Data Management and Interoperability
Ensures the integration of the system with European and national platforms and the proper flow of data among the various actors in the supply chain.
Objectives and Mandate
The main objectives of NMVO Italia
01 / Safety
– Ensure the authenticity of medicines through a verification system based on unique identifiers
– Prevent the distribution of falsified medicines, protecting patient health
– Guarantee continuous monitoring of the pharmaceutical supply chain through advanced technologies
02 / Prevention
– Combat the illegal trade of medicines through real-time pack verification
– Reduce the risk of unintentional dispensing errors, improving the reliability of the distribution chain
– Promote training and awareness among industry operators for proper system management
03 / Compliance
– Ensure adherence to Delegated Regulation (EU) 2016/161 and European medicines safety legislation
– Collaborate with national health authorities (Ministry of Health and AIFA) to guarantee compliance with current regulations
– Provide ongoing support to stakeholders for the integration and effective use of the verification system
