EMVS Community Newsletter – Holiday Bulletin 2024

Welcome to the holiday bulletin edition of our EMVS Community Newsletter!

In this special holiday edition, we would like to remind you about the most urgent and pressing EMVS topics. Additionally, we are saying goodbye to our General Manager Andreas Walter and warmly welcome his successor – Kai Mjaanes. We also inform you of the changes within EMVO’s Board and the election of EMVO’s new President – Ilaria Passarani.

We hope this edition is valuable and prepares you for the start of a new, exciting year for the EMVS Community!

We wish you and your loved ones a joyous holiday season filled with peace and happiness!


Get Ready for the Upgrade: Additional Mandatory Fields in the PMD & PPD Explained

With the deployment of the EU Hub Release 1.16 in the PRD Environment, additional fields in the Product Master Data (PMD) and Product Pack Data (PPD) will become mandatory. As of 25 January 2025, failure to properly complete these fields will prevent data uploads to the EU Hub. We kindly urge all OBPs to review and address these requirements promptly to ensure compliance. Detailed guidance on the actions required and an overview of the additional mandatory fields can be found in Version 4 of the Q&A Document on “PMD Introduction of Additional Mandatory Fields” available here.

The deployment of Release 1.16 will begin at approximately 08:00 CET on 25 January 2025, with the system becoming operational at around 23:00 CET the same day. A downtime window is planned between 09:00 CET and 23:00 CET on the deployment date.

To help OBPs prepare for these changes, EMVO organized four workshops – two for OBPs and two for Connection Providers. Recordings of these sessions are available below:

OBPs Workshops: 29th October recording here & 25th November recording here

Connection Providers Workshops: 31st October recording here & 28th November recording here

Please note: uploading the required information into the EU Hub before the release of a medicinal product for sale or distribution is mandatory under the Commission Delegated Regulation (EU) 2016/161 (Art 33).

Disconnection of Northern Ireland from the EMVS (NIXIT)

On 18 December 2024, the European Commission published the notice of application related to the Windsor agreement confirming that the Regulation will apply from the 1 January, 2025. Please refer to the notice here.

Consequently, we can officially confirm that disconnection of the UKNI system from the EU Hub will take place at 23H00 GMT on 31 December 2024. From this date, uploading Product Master Data (PMD) with the market “GB” as a designated market will no longer be possible, resulting in an A-16 data validation error (#A16) and an A-22 “Market not found” error (#A22) will be added to the response. If an end-user tries to verify/(undo) decommission UKNI single market legacy packs in their possession after 1 January, 2025, the EMVS will respond with a message notifying the end-user that the UKNI system no longer exists.

To avoid system errors and disruptions in the OBPs’ product data uploads, OBPs must update the PMD of their multi-market packs by removing the market “GB” from the designated markets as of 1 January 2025. OBPs can remove the market “GB” by updating the last version of the affected PMD.

For more details on the necessary updates, please refer to the newly available Version 4 of EMVO’s Q&A on the Disconnection of Northern Ireland from the EMVS here.

Greece & Italy Connection to the EMVS

The on-boarding deadline of 9 February 2025 is fast approaching, and both Greece and Italy are making significant efforts to meet it.

Latest news on Greece:

The Greek NMVO (Hellenic Medicines Verification Organisation, HMVO) welcomed its new General Manager, Ioanna Kontomanolopoulou, on 18 November. Ioanna and EMVO are keeping regular contact to ensure speedy connection to the EMVS and provide the necessary support to the NMVO.

Regarding Data Matrix specifications, it is important to highlight that there are no additional requirements/specifications than the four elements already included in the Data Matrix. Although the National Health Reimbursement Number (NHRN) is required from the Greek authorities, the NHRN will not be used as a fifth element in the Data Matrix. However, manufactures will be required to provide it electronically during the Product Master Data (PMD) upload.

Should you have any questions related to the on-boarding of Greece, please feel free to directly approach HMVO at hmvo@hmvo.gr.

Latest news on Italy:

NMVO Italia has appointed Mauro Salvadori as its new Business Partner Head to oversee the onboarding of MAHs and collaborate with EMVO on operational matters. Several meetings took place already during which a detailed discussion regarding the onboarding strategy for MAHs and OBPs was discussed.

Progress is currently limited due to delays in national legislation. The decree, expected in December this year, will provide the technical specifications (including any Data Matrix specifications) and clarity needed for further steps, including system connection and onboarding activities.

In the meantime, EMVO is actively engaging with new Greek and Italian OBPs to speed up their on-boarding via the OBP Portal, ensuring a swift and smooth connection to the EU Hub.

Should you have any questions related to the on-boarding of Italy, please feel free to directly approach NMVO Italia onboarding@nmvo-italia.it.

New Greek & Italian OBPs – Next steps for a smooth EMVS connection:

If you are a newly registered Greek and/or Italian OBP or you still need to initiate the on-boarding to the EU Hub, we have prepared a set of useful materials which aim to assist you in the best possible way. Additionally, to assist you in getting started, EMVO is hosting a series of online workshops to guide you through the process and answer any questions. Please find all the materials below:

  • Begin the On-boarding Process: If your company will act as the On-boarding Partner (OBP), start by completing the registration form here.
  • Review the Guidelines: Carefully read EMVO’s on-boarding guideline here, which provides a detailed description of each step in the process.
  • Explore Training Resources: Familiarise yourself with the OBP Portal by watching EMVO’s instructional videos available here.
  • Consult the Q&A Document: Refer to EMVO’s comprehensive Q&A document here, “On-boarding of New Greek & Italian On-boarding Partners (OBPs) to the EU Hub & Actions for Existing OBPs” for answers to common questions.
  • Join a Workshop: Register for one of EMVO’s on-boarding workshops to walk through the process together, learn to navigate the OBP Portal, and get your questions answered.
    • Thursday, 9 January from 14:00 to 15:30 CET – register here
    • Thursday, 16 January from 14:00 to 15:30 CET – register here
    • Thursday, 23 January from 14:00 to 15:30 CET – register here
    • Thursday, 30 January from 14:00 to 15:30 CET – register here

EMVO Welcomes New General Manager: Kai Mjaanes to Succeed Andreas Walter

EMVO is pleased to announce that Kai Mjaanes, currently leading NOMVEC in Norway, will take on the role of General Manager of EMVO. Kai will succeed Andreas Walter, who is retiring at the end of this year. Kai’s appointment marks an important transition for EMVO as the organisation looks to build on the strong foundations laid under Andreas’ leadership.

A Legacy of Leadership: Farewell to Andreas Walter

Andreas Walter has been with EMVO since its inception, guiding the organisation through its formative years and playing a pivotal role in creating and implementing the European Medicines Verification System (EMVS). Under his leadership, EMVO has navigated numerous challenges and capitalised on key opportunities, transforming into a pioneering, stakeholder-led initiative now recognised and respected across the pharmaceutical sector.

EMVO sincerely thanks Andreas for his dedication, vision, and tireless efforts. His leadership has been instrumental in shaping EMVO into the robust and successful organisation it is today. We look forward to formally thanking Andreas for his farewell later this year and celebrating his achievements and contributions.

Andreas Walter states:

“… I also want to warmly congratulate my successor, Kai Mjaanes, on his appointment as EMVO’s new General Manager. Kai brings a wealth of experience and expertise, making him the ideal person to lead EMVO into a bright future. As I prepare to leave EMVO on 31 December 2024, I take comfort in knowing that the organisation is in capable hands. It has been a privilege to work alongside such dedicated colleagues, and I am certain the future of the EMVS will be long and exciting. Thank you all for your hard work, and I wish my successor and the Board every success!”

Introducing Kai Mjaanes, The New General Manager

Kai Mjaanes is no stranger to the Falsified Medicines Directive (FMD) and the EMVS community, joining the sector in 2017. Since 2018, he has served as Managing Director of NOMVEC and NoMVO, overseeing the successful implementation and ongoing operation of Norway’s National Medicines Verification System.

With a diverse background in the pharmaceutical industry, Kai brings extensive experience from wholesalers and pharmacy organisations. His qualifications include a Norwegian Air Force Academy degree, an MBA, and further project management, finance, and logistics certifications. This broad expertise makes him exceptionally well-suited to lead EMVO through its next chapter.

Strengthening Cooperation Across Europe

As EMVO moves forward with this leadership transition, it remains committed to deepening its collaboration with National Medicines Verification Organizations (NMVOs). The partnership with NMVOs has been a cornerstone of EMVO’s success in implementing the EMVS, and with Kai at the helm, we are confident that this cooperation will only continue to grow.

We look forward to this new chapter under Kai’s leadership and we are excited about EMVO’s future as it continues to ensure the safety and security of the European pharmaceutical supply chain!

Changes to EMVO Board of Directors

After a successful General Assembly meeting held on 12 December 2024, EMVO would like to congratulate EMVO’s Board Members for the renewal of their 2-year mandate and their appointment in new functions within the Board.

More specifically, Ilaria Passarani has been re-elected as EMVO’s Director representing PGEU and has also been appointed as the new EMVO President.
Adrian van den Hoven has been re-elected as Director representing Medicines for Europe & appointed as the new EMVO Vice-President.
Bernd Grabner has been re-elected as EMVO’s Director representing GIRP & appointed as the new EMVO Treasurer.
Nathalie Moll has been re-elected as EMVO’s Director representing EFPIA.
Olga Ruppert has been re-elected as EMVO’s Director representing Affordable Medicines Europe.

Ilaria Passarani, EMVO’s new President and Director representing PGEU, states:

“I’m deeply honoured to be elected as President of EMVO. The European Medicines Verification System represents a collective commitment to protecting public health and a shared responsibility of all the actors involved to guarantee that every patient in Europe is protected from the risks posed by falsified medicines.

This is a crucial moment for EMVO as we continue to advance the security and integrity of the pharmaceutical supply chain. I look forward to working closely with EMVO stakeholders to further strengthen our collaboration and to position the EMVS as a model of trust, safety, efficiency, and reliability”.

We wish good luck to the Board in the new year!

FMD Workshop October 2024 – Recap

On October 9th, 2024, EMVO hosted the FMD Implementation Workshop in Brussels. The event brought together all members of the EMVS Community and focused on the progress and ongoing challenges of implementing the Falsified Medicines Directive (FMD).

The workshop provided a valuable platform for sharing updates on key developments, with some highlighted topics outlined below.

IT Updates and New Tools

The event began with an IT update covering crucial advancements in the EMVS infrastructure, such as the upcoming EU Hub Release 1.16, the OBP Portal Migration, and the European Alert Management System (EAMS).

Product Master Data & Data Quality

Another key session focused on Product Master Data and Data Quality, led by Alice Borghi, Tracy Slosse, and Athanasios Kantarelis of EMVO. The presenters underscored the importance of accurate and high-quality product data in maintaining the effectiveness of the EMVS. They introduced ongoing initiatives to improve data submission standards and addressed questions from participants during an interactive Q&A session.

Disconnection of Northern Ireland from the EMVS

In light of recent regulatory changes under the Windsor Framework, IMVO and SecurMed led a detailed discussion on Northern Ireland’s disconnection from the EMVS. The discussion covered adjustments to the EU Hub and NMVS, clarifying the next steps for maintaining system integrity in this transitional period.

Trends in Medicinal Product Falsification

Gudrun Gallhoff from the European Commission (DG SANTE) presented findings from the recent study on falsified medicinal products. Her presentation emphasised the trends observed in falsification activities across Europe and discussed measures being implemented under Directive 2011/62/EU. The insights shared helped underline the ongoing need for a robust and responsive verification system to protect the supply chain.

Best Practices for Alert Prevention and Management

The workshop concluded with a session by Alice Borghi on best practices for Alert Management. Participants were encouraged to adopt strategies for preventing and efficiently managing alerts, focusing on improving stakeholder collaboration to ensure prompt action and resolution of potential risks.

Closing Remarks

The event wrapped up with closing statements from Andreas Walter, General Manager of EMVO, and co-chair Kristina Von Sydow (e-VIS), both emphasised the importance of continued collaboration among the community to strengthen the fight against falsified medicines. They thanked participants for their contributions and encouraged ongoing dialogue to address the evolving challenges in FMD implementation.

FMD Workshops in 2025 – save the date!

EMVO is organising two FMD workshops in the new year. The workshops are currently planned on:

  • 19 May 2025 – fully remote
  • 21 October 2025 – hybrid event (Brussels & online)

Stay tuned for more information about the events in the new year!

A New Year, A New Look: Explore EMVO’s Redesigned Website

EMVO’s new leadership for the coming year and beyond marks a wonderful opportunity for a fresh start, reinforcing our commitment to continuously improving our services and enhancing your experience.

That’s why we are thrilled to already introduce our revamped website. With a streamlined layout, modern look, and improved user-friendly navigation, our new platform is tailored to better serve your needs.

While the final touches are still being made, you can still refer to our old website where you can find all the relevant documents.

This launch marks the beginning of an ongoing evolution. Future updates will continue to bring even more enhancements, ensuring the website remains an invaluable resource for all users.

Please explore EMVO’s new website by following this link – https://emvo-medicines.org.

Happy Holidays

As the holiday season approaches, EMVO would like to extend our heartfelt gratitude for your partnership and collaboration throughout 2024. Looking ahead to 2025, we remain committed to working together towards continued success.

We wish you and your loved ones a joyous holiday season filled with peace and happiness.