Welcome to the latest edition of the EMVS Community Newsletter!
In this issue, we delve into the importance of data quality and why it’s critical for the success of the EMVS. You’ll also hear from the General Managers of Greece and Italy, who share insights into their onboarding journeys. Finally, we wrap up with key highlights from EMVO’s General Assembly and the recent FMD Workshop, both held in May.
Content
- Data Quality
- On-boarding update from Greece
- On-boarding update from Italy
- EMVO’s annual Statutory General Assembly
- FMD Workshop
Data Quality
Continuing in the strive towards Good Data Quality within the EMVS, EMVO is proceeding with the analysis and the monitoring of the Completeness and Correctness of the Product Master Data (PMD) and the Product Pack Data (PPD).
Wondering why we need Good Data Quality in the EMVS? Check this out
Thanks to the great effort from the On-Boarding Partners (OBPs), solicited by the numerous EMVO’s activities in 2024/early 2025 including EMVO’s communication, EMVO’s workshops and implementation of technical mandatory field in the EU Hub, the Completeness of the data elements required by the Commission Delegated Regulation (EU) 2016/161 reached the highest levels from the implementation of the EMVS! (see in Figure 1 the evolution of the Product Codes containing the specified data element).
Thank you all for your dedicated actions!
Figure 1 Overview of the completeness of the PMD data that were made technically mandatory at the end of Jan 2025.
Encouraged by these positive results and confident that the same can be achieved for the Correctness of the EMVS Product Master Data (PMD), EMVO launched, in the first quarter of 2025 the first communication directed to the OBPs whose product codes (PC) were detected as containing incorrect data. Following this activity, OBPs are engaging with EMVO and correcting the identified issues; the numbers are already evolving positively!
Curious about the evolution of the quality of the EMVS PMD Data, follow here the monthly updates! Curious about the most frequent mistakes?
- 83,000 product codes contain what we have identified as bad data, that is 25% of all codes;
- “Product name” is the most common field with bad data, followed by “Common name”;
- For many codes, the “product name” field is missing the strength (and sometimes the pharmaceutical form). Barring exceptions, please be reminded that the “product name” field should contain the (invented) name, strength and pharmaceutical form!
What else should you know?
- EMVO is planning a second round of communication about incorrect data in May 2025
- Join us at the next FMD workshop if you want to know more about tips on how to correct the data evolution of the EMVS Data Quality
On-boarding update Greece
Written by Ioanna Kontomanolopoulou (General Manager)
Greece has made significant strides in connecting end-users to the HMVS, with a total of 10,881 users successfully integrated.
This includes 10,507 private pharmacies, 135 public hospitals, 148 wholesalers, and 91 private hospitals.
Currently, the system remains in the tolerance phase to accommodate both the authenticity tape and the 2D code.
While this transition period has brought certain challenges—such as technical issues and the configuration of scanning equipment—we are working diligently in collaboration with IT providers to address these matters.
Furthermore, we maintain ongoing communication with end users to offer guidance, resolve concerns, and ensure a smooth transition. This support has been instrumental in facilitating adaptation to the new system.
Additionally, Greece is leveraging this tolerance period to establish sustainable and effective communication channels between end-users and OBPs/MAHs.
The overarching goal is to eliminate the potential for errors both in the decommissioning process and in reimbursement.
This collaborative approach highlights the unique and distinguishing character of the Greek NMVO’s system compared to other European NMVOs.
On-boarding update Italy
Written by Marcello Matarrelli (General Manager)
We are pleased to bring you the latest update on Italy’s journey toward full compliance with the Falsified Medicines Directive (FMD). In the following news, you will find a concise overview of key milestones and essential steps for Marketing Authorization Holders to complete their onboarding with NMVO Italia.
Stabilization Period
What’s Happening During the Stabilization Period (until 8 February 2027): Continued Use of the Old “Bollino”
You may continue to use the current “bollino” for batch releases throughout the Stabilization Period, ensuring a safe, controlled, and thoroughly tested adoption of the new regulation.
Connection to the EU Hub
The Italian National Medicines Verification System (NMVS) is expected to connect to the EU Hub during the IOT window in October 2025.
Performance Qualification Testing (“Pilot Phase”)
Immediately following connection, a Pilot Phase will begin with a select group of end-to-end supply-chain participants (from manufacturers to pharmacies). Subject to confirmation by National Competent Authorities (NCAs), this phase is planned to run until Spring 2026.
Progressive Roll-Out in “Hypercare” Mode
NMVO Italia will progressively open the system to all remaining actors in Hypercare mode, under detailed rules to be agreed with the NCAs. This phase will continue through end of 2026.
Full, Stable Go-Live
By early 2027, the FMD system adoption should be flawless, complete, and stable.
Onboarding to NMVO Italia
To ensure smooth setup and operations during the Stabilization Period, it is essential that all Marketing Authorization Holders (MAHs) for the Italian market complete their onboarding to NMVO Italia as soon as possible.
Who Must Onboard: Each MAH registered in the Italian market for medicines within the scope of FMD.
Fees: All MAHs must pay an Entrance Fee (collection already underway) followed by Annual Fees.
Onboarding Agreement (contract between NMVO Italia and each MAH): The standard agreement will be distributed in the coming days and is identical for all MAHs.
Next Steps:
MAHs already contacted are kindly asked to complete onboarding as soon as possible. If you have not yet been contacted, please write to: onboarding@nmvo-italia.it .
NMVO Italia Business Partner Head, Mauro Salvadori, will follow up promptly.
EMVO Statutory General Assembly 2025 – A Successful Gathering
EMVO is proud to share the successful conclusion of its 2025 Statutory General Assembly, chaired by our President, Ilaria Passarani, with support from the General Manager Kai Mjaanes as Secretary.
This annual milestone offered a valuable opportunity to reflect on progress and reaffirm our shared commitment to the European Medicines Verification System (EMVS).
We were honoured to welcome Rainer Becker, Director of Medical Products and Innovation at DG SANTE, European Commission, who underscored the achievements made in combating falsified medicines over six years of FMD implementation and emphasized the growing strength of our collaboration.
Additionally, Ruth Mifsud, a Senior Data Consultant from Data Reply UK offered key insights into leveraging data for smarter monitoring and decision-making.
We also welcomed Margriet Keijzer, the new Director representing Affordable Medicines Europe to the EMVO Board, alongside the continued support of the rest of EMVO’s Directors Nathalie Moll (EFPIA), Adrian van den Hoven, Medicines for Europe, and Bernd Grabner, GIRP.
A sincere thank you to the entire EMVS Community for your unwavering dedication to securing the legal supply chain and protecting patients across Europe.
EMVO’s FMD Implementation Workshop May 19, 2025
EMVO successfully hosted its first FMD Implementation Workshop of the year on May 19, welcoming nearly 400 participants to the fully online event! A heartfelt thank you to all OBPs, NMVOs, and Stakeholders who took the time to join us, contribute valuable feedback, and pose thought-provoking questions. Your engagement continues to drive the success and relevance of these workshops.
If you missed the event or would like to revisit the discussions, we invite you to explore the recording below:
Looking ahead, SAVE THE DATE for our next hybrid FMD Workshop happening on 21 October 2025, both in Brussels and online! Expect lively discussions, interactive sessions, and a chance to connect over a delicious networking lunch. Stay tuned for the registration link—coming soon!