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NMVO ITALIA

Highlights

An updated set of the most frequently asked questions received from pharmaceutical supply chain stakeholders is available

October 23, 2026

This section will be regularly updated, expanded, and revised to reflect evolving regulations, guidance from National Competent Authorities, and technical or operational updates to the National Medicines Verification System (NMVS).

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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

Work instructions No. 2 for phase 2 of the NMVS pilot project, issued pursuant to Article 13, paragraph 4, of Legislative Decree No. 10 of 6 February 2025, have been published on the Ministry of Health website

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π’π­πšπ«π­ 𝐨𝐟 𝐭𝐑𝐞 𝐞𝐧𝐫𝐨π₯π₯𝐦𝐞𝐧𝐭 𝐟𝐨𝐫 𝐏𝐑𝐚𝐬𝐞 𝟐 𝐨𝐟 𝐭𝐑𝐞 ππŒπ•π’ 𝐏𝐒π₯𝐨𝐭 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.

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Onboarding page for wholesalers authorized to distribute pharmaceutical products in Italy

June 3, 2026

Onboarding page for authorized Wholesalers

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Official communication to Marketing Authorization Holders, On-Boarding Partners and Parallel Importers

June 1, 2026

Following a notification from the EMVO (European Medicines Verification Organization)...

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Italian NMVS officially connected to the EMVS (EU-HUB) production environment

May 11, 2026

Italian NMVS officially connected to the EMVS (EU-HUB) production environment. As of today, May 11, 2026,

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Serialization Italy – AIFA resolution on the procedures for granting Marketing Authorisations (AIC) and on the modalities for fulfilling the obligations set out in Article 4 of Legislative Decree No. 10 of 6 February 2025, including those relating to imported and parallel-distributed medicines

July 18, 2025

The resolution containing the "Application Instructions" regarding the regulatory obligations for holders

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Serialization Italy – Decree on the "Dispositivo realizzato su supporto di sicurezza carta valori" published in the Official Gazette

July 10, 2025

The Decree regulating the technical and graphic characteristics of the "dispositivo realizzato su supporto di sicurezza carta valori" has been published in the Italian Official Gazette.

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Serialization Italy – β€œData Matrix” Decree Published in the Official Gazette

March 10, 2025

The ministerial decree regulating the technical specifications of the unique identifier β€œData Matrix” has been published in...

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