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NMVS Pilot - Phase 1

Within the framework of the activities carried out by Ministry of Health and the Italian Medicines Agency (AIFA) during the stabilization period (February 2025 – February 2027), NMVO Italia proposed a Pilot Project defined during the periodic alignment meetings with the various institutional stakeholders involved. 

This pilot project's primary objective was to field-test the adoption of the new regulation through a step-by-step verification process along the entire pharmaceutical supply chain, in order to highlight—prior to full national deployment—any potential issues and use cases not adequately covered by current legislation. In this initial phase, among the entities authorized to dispense medicines, only community pharmacies were included; the analysis of dispensing phases within healthcare facilities or other specific cases will be the subject of dedicated further study with representatives of the Regions and Autonomous Provinces.

The pilot project was planned in the second half of 2025 with the contribution and participation of all relevant public stakeholders, such as:

  • Minisitry of Health
  • Italian Medicines Agency (AIFA)
  • Ministry of Economy and Finance - Ragioneria Generale dello Stato (MEF-RGS)
  • Ministry of Enterprises and Made in Italy (MIMIT)
  • Istituto Poligrafico e Zecca dello Stato (IPZS);
  • Nucleo Carabinieri Nas di AIFA;
  • representatives of the Regions and Autonomous Provinces.

 

On July 17, 2025, the informative kick-off meeting for the 'Pilot Phase' of the implementation of the new regulation took place, involving:

  • over 15 Manufacturers, including 1 parallel importer (national and multinational);
  • over 15 Logistics Supply Chain Operators (providing end-to-end process coverage);
  • IT Service Providers – Sogei and IPZS (also in their role as Dispositivo Supplier);
  • all competent authorities – Ministry of Health, AIFA, MEF (RGS), Regions, NAS, MIMIT

 

The plan provided for an initial phase involving the controlled release into the supply chain of 24 batches of non-saleable packs (approximately 68,000 serialized units across 8 different pharmaceutical forms)., whose final destination was disposal via destruction or donation to the Banco Farmaceutico (Pharmaceutical Bank), in accordance with the instructions of the respective MAHs (Marketing Authorisation Holders). Upon completion of Phase 1, all packs were decommissioned to enable final data reconciliation on the NMVS. Phase 2 involves the use of a smaller number of batches—this time saleable—along with the completion of commercial transactions. Participation in the Pilot, which was on a voluntary basis, was facilitated by Trade Associations, who followed the project as privileged observers and will be able to use its findings to better support their members.

All participants covered their own costs and any supply contributions for the first phase, each for their respective part. For Phase 2, as it involves saleable products, standard commercial transactions are followed.

Specific Objectives of the Pilot Project

The primary objective of the Pilot Project was to verify, step-by-step, the usability and reliability of the new system along the entire supply chain. Specifically, the Pilot aimed to:

  • Test the NMVS (National Medicines Verification System)—i.e., the national infrastructure for the verification and authentication of prescription medicines—in terms of functionality, speed, and reliability;
  • evaluate the level of readiness of supply chain actors regarding serialization processes;
  • Identify and propose solutions to operational criticalities prior to the adoption of the new system on a national scale.
  • Validate the application processes of the new Dispositivo di Sicurezza in Carta Valori ('Annex A' and 'Annex B') and of the Data Matrix code.

The Pilot Phases

The Pilot is structured into two phases, following an evolutionary path that ensures maximum operational continuity:

  1. Phase 1 – completed (January 2026 – April 2026): involved the use of medicines manufactured in accordance with GMP standards, but not intended for sale, fitted with the experimental «Annex A» Dispositivo di Sicurezza in Carta Valori. The packs were identified by the mandatory marking "CONFEZIONE GRATUITA FASE PILOTA VIETATA LA VENDITA" (abbreviated as 'FP' for small-sized packaging). Patient dispensing and prescription management were purely simulated within test environments; pharmacies connected directly to the NMVS via a web interface (GUI), without integration with management software or the NHS (SSN) dispensing workflow. Alert management processes were not tested, as the National Alert Management System (NAMS) was not available for the Pilot.
  2. Phase 2 – ongoing, scheduled for completion by the end of 2026 : involves the use of saleable medicines and other distribution scenarios. The packs included in this phase feature the security features provided for during the stabilization period for serialized products (GS1 Data Matrix, Dispositivo di Sicurezza in Carta Valori 'Annex B' , Anti-tampering device).Phase 2 – ongoing, scheduled for completion by the end of 2026: involves the use of saleable medicines and other distribution scenarios. The packs included in this phase will feature the security features provided for during the stabilization period for serialized products (GS1 Data Matrix, State Security Paper 'Annex B' Security Feature, Anti-tampering device).

The Supply Chain and stakeholders involved

The project was based on voluntary participation involving the entire pharmaceutical value chain, ensuring a diverse representation of all supply chain stakeholders:

  • Manufacturing: a selected sample of pharmaceutical companies responsible for serialising and uploading the codes to the European Hub and, consequently, to the national repository.
  • Logistics (logistics service providers and wholesalers): a selected sample of logistics operators who tested handling, verification, and storage procedures in compliance with the Delegated Regulation.
  • Pharmacies: a selected sample of community pharmacies, chosen by trade associations to ensure geographical and organizational diversity (urban, rural, municipal, and private, using different management systems), which performed the verification, dispensing, and cancellation (Undo) of Unique Identifiers.
  • Final destination of medicinal products: Assinde S.r.l. participated for testing waste disposal processes, and the Banco Farmaceutico Foundation participated for managing donations of selected medicinal products used in the Pilot.
 
Participations were collected with the support of the respective Trade Associations. Below is the list of actors involved in the Pilot:
  

Manufacturers / Parallel Importers / Marketing Authorisation Holders (MAHs)

  1. Abiogen Pharma S.p.A.
  2. Alfasigma S.p.A.
  3. CHIESI FARMACEUTICI S.p.A.
  4. DOC Generici S.r.l.
  5. Dompé farmaceutici S.p.A.
  6. EG S.p.A.
  7. Difarmed S.L.U
  8. A. Menarini IFR S.r.l.
  9. Laboratorio Guidotti S.p.A.
  10. Pfizer Italia S.r.l.
  11. Sanofi S.r.l.
  12. So.Se.PHARM S.r.l.
  13. Teva Italia S.r.l.
  14. Ratiopharm GmbH
  15. Mylan S.p.A.
  16. Viatris Italia S.r.l.
  17. Zentiva Italia S.r.l. 
 
Logistic providers
 
  1. DHL SUPPLY CHAIN ITALY S.p.A.
  2. Kuehne + Nagel S.r.l. con unico socio (Depositario non attivo nelle attività del Pilota)
  3. UPS Healthcare Italia S.r.l.
  4. Euromed Pharma Service S.r.l.
  5. Chiapparoli Logistica S.p.A.
  6. Logista Pharma Italia S.r.l
 

Wholesalers and Intermediate Distribution

  1. Unifarma Distribuzione S.p.A.
  2. Alliance Healthcare Italia Distribuzione S.p.A.
  3. Farvima medicinali S.p.A.
  4. FARLA SOCIETA’ COOPERATIVA
  5. Comifar Distribuzione S.p.A.
  6. FederFARMA.CO S.p.A
  7. VIM S.r.l.
  8. Q Farma S.p.A.
  9. Farmacentro Servizi e Logistica Società Cooperativa
  10. D.M. Barone S.p.A.

The Medicines of the Pilot

Below is the list of medicines selected for the Pilot. The products chosen for the pilot were selected from among those not in a state of shortage and not belonging to high-cost categories or strictly hospital-only dispensing.

 

AIC Code
MedicineMarketing Authorization Holder
prodotto
035215033METFONORM
“1000 MG COMPRESSE RIVESTITE CON FILM ” 60 COMPRESSE DIVISIBILI		Abiogen
Pharma SpA
019655051 BENTELAN
“1 MG COMPRESSE EFFERVESCENTI” 10 COMPRESSE		Alfasigma
S.p.A.
023103132 CLENIL
“800 MICROGRAMMI SOSPENSIONE PER NEBULIZZATORE” 20 FIALE DA 2 ML		CHIESI
FARMACEUTICI S.p.A
049156019MAGALDRATO
DOC “800 MG SOSPENSIONE ORALE IN BUSTINA” 40 BUSTINE DA 10 ML IN
PE/AL/PET		DOC
Generici S.R.L
A028511095 OKI
“80 MG GRANULATO PER SOLUZIONE ORALE” 30 BUSTINE BIPARTITE		Dompé
farmaceutici S.p.A.
A042005013LEVOTUSS
TOSSE “60 MG/ML GOCCE ORALI, SOLUZIONE” FLACONE DA 30 ML		Dompé
farmaceutici S.p.A.
029036050METOPROLOLO
EG “100 MG COMPRESSE” 50 COMPRESSE		EG
S.p.A.
034667042FLUOXETINA
EG STADA “20 MG COMPRESSE ORODISPERSIBILI” –  28 COMPRESSE		EG
S.p.A.
050937010GANFORT
300 MCG/ML / 5MG/ML COLLIRIO,SOLUZIONE – USO OFTALMICO -CONTENITORI MONODOSE
(LDPE) 0,4 ML – 30 CONTENITORI MONODOSE (LDPE)		Difarmed
S.L.U
027309018 PRAVASELECT
“20 MG COMPRESSE” 10 COMPRESSE		A.
Menarini IFR s.r.l.
033006014 TOTALIP
“10 MG COMPRESSE RIVESTITE CON FILM” 10 COMPRESSE IN BLISTER
PA/AL/PVC-AL		Laboratorio
Guidotti s.p.a.
014159040MEDROL
“16 MG COMPRESSE” 20 COMPRESSE		Pfizer
Italia Srl
A02399013LASIX
“25 MG COMPRESSE”30 COMPRESSE		Sanofi
s.r.l.
A027161052TRIATEC
«2,5 MG COMPRESSE» 28 COMPRESSE IN BLISTER PVC/AL		Sanofi
s.r.l.
049260019MATIC
“800 MG GEL ORALE” 40 BUSTINE DA 10 ML IN PE/AL/PET		So.Se.PHARM
S.r.l. 
037819036CETERIS
“10 MG/ ML GOCCE ORALI, SOLUZIONE” FLACONE DA 20 ML		So.Se.PHARM
S.r.l.
036257020GENTAMICINA
TEVA ” 0,1 % CREMA ” TUBO 30 G		Teva
Itala S.r.l.
033617022TAMOXIFENE
RATIOPHARM «20 mg  compresse  rivestite 
con  film»  20 compresse in blister PVC/PVDC/Al		Ratiopharm
GmbH
037398029SIMVASTATINA
MYLAN GENERICS “20 MG COMPRESSE RIVESTITE CON FILM” 10 COMPRESSE IN
BLISTER AL/PVC/PVDC		Mylan
S.p.A
040486134BISOPROLOLO
MYLAN “5 MG COMPRESSE RIVESTITE CON FILM” 28 COMPRESSE IN BLISTER
PVC/AL		Mylan
S.p.A
035046034TERAFLUSS
“2 MG COMPRESSE” 30 COMPRESSE DIVISIBILI		Viatris
Italia s.r.l
026675013DILTIAZEM
MYLAN GENERICS ITALIA “60 MG COMPRESSE”50 COMPRESSE		Mylan S.p.A
043277110ROSUVASTATINA
ZENTIVA “10 MG COMPRESSE RIVESTITE CON FILM” 28 COMPRESSE IN
BLISTER AL/AL		Zentiva Italia Srl
037593302SIMVASTATINA
ZENTIVA “40 MG COMPRESSE RIVESTITE CON FILM” 28 C0MPRESSE IN
BLISTER PVC/PE/PVDC/AL		Zentiva Italia
Srl 

Governance and Monitoring

NMVO Italia exercised overall coordination and monitoring of data and goods flows, organizing weekly alignment meetings with single points of contact (SPOCs) representing manufacturers, logistics operators, competent authorities, trade associations, and waste management entities. The results of Phase 1 were compiled into a structured report that was approved by the Competent Authorities prior to dissemination across the entire supply chain, in order to promote maximum sharing of best practices and use cases identified during the Pilot, as well as to recommend the corrective actions required for the successful transition to the definitive FMD system.

Key Results of Phase 1

Il Pilota ha consentito di testare l’intero ciclo di serializzazione: dal caricamento dei dati sull’EU Hub alle linee di produzione, dall’onboarding degli operatori logistici ai sistemi L4, dalla dispensazione in farmacia allo smaltimento, fino alla reportistica del NMVS. Il sistema NMVS ha gestito correttamente le operazioni previste (verifica, dispensazione, annullamento) quando ha ricevuto i dati nel formato atteso. Le evidenze, comprese le criticità rilevate, costituiscono la base documentale per le azioni correttive e i miglioramenti da implementare in vista di febbraio 2027.

  • Marketing Authorisation Holders (MAHs): 17 companies, 18 manufacturing sites, approximately 68,000 serialized units across 24 batches. Fifteen out of 17 MAHs uploaded the pilot batch data to the EU Hub prior to shipment; in the two cases where data was not uploaded, the NMVS correctly flagged the anomaly ("pack not found"), providing a useful test case for the protocols to be followed. On the packaging lines, the main causes of rejection were print quality, Data Matrix readability, and the detection of the experimental «Annex A» Security Feature. Furthermore, some MAHs reported that machinability tests, conducted on a limited number of lines and packs, are not statistically representative and will need to be extended to a broader sample.
  • Logistics service providers and wholesalers: Data Matrix scanning and NMVS operations (primarily verification, as well as dispensing, export, sampling, and their corresponding cancellations) were successfully executed across all designated workstations, with no systemic criticalities identified. Key areas requiring attention relate primarily to the complexity of the onboarding process (credential management, Legitimacy Check, baseline testing of L4 software) and response times for bulk operations.
  • Pharmacies: 29 pharmacies recorded approximately 5,600 system operations between April and May 2026. The criticalities observed were mainly related to the configuration of barcode scanners for reading the Data Matrix (which can compromise the reading of the national vignette/sticker) and the resulting reliance on manual entry. The results refer to a standalone web-based test: integration with pharmacy management software and the National Health Service (SSN) workflow were not validated.

Actions Taken Following Phase 1

  • Dispositivo di Sicurezza 'Carta Valori' (Annex A): at the request of manufacturers, the layout was updated in December 2025 to include a control 'notch'; following the outcomes of Phase 1, it was further revised to incorporate the logos of the Ministry of Health and IPZS, as well as a barcode returning the value 'MdS', in order to optimize its detection on production lines.
  • Onboarding of logistics service providers and wholesalers: NMVO Italia has set up a dedicated page on its website, featuring the request form, downloadable training SOP, detailed insights, and FAQs.
  • Barcode scanners: NMVO Italia has initiated discussions with leading scanner manufacturers; the list of compatible devices is available on the dedicated information page of the portal. Users accessing the NMVS via GUI must apply a specific configuration to the barcode scanner.
  • Pilot FAQ: the Competent Authorities addressed the questions arising during the activities by publishing the FAQs on the official website of the Ministry of Health (Annex 2 below).

References and Documents

On 6 March 2026, Operational Instructions No. 1 pursuant to Article 13(4) of Legislative Decree No. 10 of 6 February 2025 dedicated to the Pilot project were published on the Ministry of Health website, together with the two related annexes available at the following links:

Operational Instructions: Istruzioni operative

Annex 1 – List of Medicinal Products: Allegato 1 – Elenco medicinali 

Annex 2 – FAQ: Allegato 2 – FAQ

The Phase 1 Results Analysis Report is available (in Italian) at the following link: Report esiti Fase 1 Pilota NMVS

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