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

Therefore, Marketing Authorization Holders and On-Boarding Partners (OBPs) are invited to undertake the preparatory activities necessary to comply with the standards required for serialization in Italy (uploading of Product Master Data, artwork development).

Regarding the actual release of batches featuring the security elements required during the stabilization period (Decreto Legislativo 10/2025, art. 13, comma 4, and art. 6 of the Decreto del Ministro della Salute of May 20, 2025) — specifically the GS1 Data Matrix, the Dispositivo di Sicurezza "Allegato B", and the anti-tampering device — interested parties shall adhere to the operational instructions to be issued by the “Tavolo Tecnico di Monitoraggio” (established by the Decreto del Ministro della Salute of March 4, 2025). These guidelines will be responsible for regulating, in detail, the procedures for placing products on the market during the stabilization period.

Furthermore, it is specified that the release of batches with the aforementioned characteristics will initially be managed within a dedicated pilot, named “Pilota Fase 2”.The enrollment of Marketing Authorization Holders for this specific phase will be coordinated with the support of pharmaceutical industry trade associations. Further updates and details will be made available through the official channels of the Ministero della Salute (Ministry of Health) and NMVO Italia.