Issued under Art. 13(4) of Legislative Decree No. 10 of 6 February 2025, by the Directorate General for Medical Devices and Pharmaceuticals.
Context. Italy is in the stabilisation period during which the national medicines verification system (NMVS) under EU Delegated Regulation 2016/161 is being phased in. Phase 1 of the pilot is finished; the Ministry, AIFA and NMVO Italia are now launching phase 2 to test the system under real operating conditions, focused on unique identifier management and on actual circulation of packs carrying the "Annex B" security device introduced by the Ministerial Decree of 20 May 2025.
What phase 2 does differently. Phase 1 used non-saleable products with hand-picked participants at every link of the chain. Phase 2 puts real saleable medicines on the market. NMVS is connected to the European EMVS hub in the production environment, not a test environment.
Objectives: confirm that MA holders can upload unique identifiers to EMVS; confirm pharmacies can work with the Annex B device; surface operational problems and uncovered or ambiguous use cases before the hypercare phase; and measure real-world performance, speed and reliability of EMVS/NMVS.
Timing. Started July 2026, with duration set by NMVO Italia together with the competent authorities. A structured results report goes to the authorities in November 2026 and is then shared across the supply chain. After the pilot, the system opens to all actors, still in controlled "hypercare" mode. The paper security device stays valid until the stabilisation period ends on 8 February 2027; IPZS has made 100,000 devices available.
Participants. Only manufacturers / MA holders, on a voluntary basis: DIFARMED, HCS BV, Zentiva Italia, and Dompé. Four products are in scope Ganfort eye drops, Olmesartan HCS 20 mg, Ezetimibe Zentiva, and OKI 80 mg granules chosen for high volume and fast turnover so they clear the market quickly. Hospital-dispensed products are excluded.
Pack configuration: Data Matrix unique identifier (DM 6 March 2025) + Annex B paper security device replacing the bollino farmaceutico + anti-tampering device.
Roles across the chain:
- Manufacturers/MAHs normal GMP release, upload UIs to EMVS, and decommission every serial in EMVS before the pack enters distribution ("upstream decommissioning"). Lots produced must be reported to NMVO Italia.
- Depositaries and wholesalers nothing new. No Data Matrix scanning, unless a depositary separately agrees with an MAH to test decommissioning.
- Pharmacies and healthcare facilities scan the Annex B device instead of the bollino for dispensing and reporting. Explicitly no scanning, verification or decommissioning of the Data Matrix.
Other provisions. Theft or loss must be reported to law enforcement with products, lots and the unique identifiers shown on Annex B. Movement data and SSN supply values, including production waste, continue to flow to the central traceability database (BDC) under the DM of 15 July 2004. Participation requires a signed adhesion form accepted by NMVO Italia, and phase 1 instructions still apply where not superseded.
One point worth flagging if you write about this: because all serials are decommissioned upstream and no downstream actor scans the Data Matrix, phase 2 is not testing the verification transaction at the point of dispense. It tests EMVS data upload by MAHs and the operational handling of the paper device, with real packs in the real chain as the risk-controlled way to get there