FiMVO Finnish Medicines Verification Organisation

📢 Important Update: Disconnection of UKNI System from the EU Hub On 18 December 2024, the European Commission published the Notice of Application for the Windsor Agreement, confirming that the regulation will take effect on 1 January 2025. As a result, we officially confirm that the disconnection of the UKNI system from the EU Hub is planned for 31 December 2024, at 23:00 GMT. 🔴 Key Information for OBPs: 💠 After this date, uploading Product Master Data (PMD) with the market "GB" will no longer be possible. Doing so will result in A-16 data validation errors (#A16) and A-22 "Market not found" errors (#A22). 💠 OBPs must update their multi-market packs by removing the market "GB" from designated markets before 1 January 2025 to avoid system errors. 💠 Updates to the PMD can be done by editing the last version of the affected data. For further details, refer to Version 4 of EMVO’s Q&A on the Disconnection of Northern Ireland from the EMVS, which provides more clarification on the decommissioning of packs to Northern Ireland. You can access the document here: 🔗 https://lnkd.in/eZjFa8Un #EMVO #EMVS #FMD #FightFakes 💉💊

FiMVO on Christmas Break 23.12.2024 – 6.1.2025 🎄 🎅🏼 The FiMVO office is open only with limited resources from December 23rd to January 6th. We provide support regarding urgent issues during the holiday season on business days. The FiMVO team wishes you a Merry Christmas and Happy New Year! ❤️

🌟 Season’s Greetings from #EMVO! 🌟 We’re delighted to share the holiday edition of our #EMVS Community Newsletter, packed with key updates and exciting news as we look ahead to 2025.   🎄 What’s Inside: 🔹 A recap of the most pressing EMVS topics. 🔹 A heartfelt farewell to our General Manager, Andreas Walter, and a warm welcome to his successor, Kai Mjaanes. 🔹 Updates on EMVO’s Board, including the election of our new President, Ilaria Passarani. 🔹 Highlights from the FMD Workshop held in October, focusing on collaboration and key system advancements. 🔹 A sneak peek at EMVO’s new website – a fresh start for the new year!   As we reflect on the progress made this year, we’re looking forward to an exciting new chapter for the EMVS Community in 2025.   💌 From all of us at EMVO, we wish you and your loved ones a joyous holiday season filled with peace, happiness, and success in the year to come!   ✨ Don’t miss the full newsletter for more details. https://lnkd.in/et75SFrn #EMVO #EMVS #FMD #FightFakes 💉💊

💌 Newsletter 4/2024 As the year 2024 is coming to its end, it is also time for this year's last newsletter. Topics: ❄️ EMVO: Master Data Guide – New version is now available ❄️ Deployment of the EU Hub Release 1.16 in the production environment ❄️ Last call for PO numbers for 2025 ❄️ Nixit (Northern Ireland Exit): UKNI will be disconnected from the EMVS 1st of January 2025 ❄️ Products and batches not in scope of the Falsified Medicines Directive (FMD) ❄️ Recall and withdrawal in EMVS – Nordic recommendations ❄️ FiMVO on Christmas break 23.12.2024 – 6.1.2025 Have a read: https://lnkd.in/d_KU_7YD Subscribe to the newsletter: https://lnkd.in/gt3NnUUN

💌 Uutiskirje 4/2024 Vuoden viimeisiä päiviä viedään ja sitä myötä on myös aika vuoden viimeiselle uutiskirjeelle. Siinä aiheina: 📍 Ilmoita organisaatiossa tai toimipisteessä tapahtuvista muutoksista tarpeeksi ajoissa FiMVOlle 📍 Syksyn käyttäjäkoulutuksen 31.10.2024 materiaali saatavilla 📍 ”Nixit” eli Pohjois-Irlannin järjestelmän irrottaminen EU:n lääkevarmennusjärjestelmästä 📍 Lääkevarmennusjärjestelmässä ylläpidettävä listaus valmiste-eristä, jotka eivät kuulu lääkevarmennuksen piiriin 📍 Pohjoismaiden yhteinen suositus poisvetojen ja myyntilupien peruuttamiseen lääkevarmennusjärjestelmässä  📍 Fimea: Kun lääkkeessä havaitaan virhe, tärkeintä on minimoida riskit 📍 FiMVO joulutauolla 23.12.2024 – 6.1.2025 Lue uutiskirje täältä: https://lnkd.in/d5in7-Cc Ja täältä voit tilata uutiskirjeen: https://lnkd.in/gt3NnUUN

📢 Invitation for Greek and Italian Onboarding Partners (OBPs) The European Medicines Verification Organisation (EMVO) invites Greek and Italian OBPs to begin their On-Boarding process to the EU Hub. This is an essential step for ensuring compliance and smooth integration. To assist you in getting started, EMVO is hosting a series of online workshops to guide you through the process and answer any questions. 🗓 Workshop Schedule: 💠 January 9th, 2025 | 14:00 - 15:30 CET 🔗 https://lnkd.in/eM6K-Xf3 💠January 16th, 2025 | 14:00 - 15:30 CET 🔗 https://lnkd.in/eGXrT94X 💠January 23rd, 2025 | 14:00 - 15:30 CET 🔗 https://lnkd.in/e99x6_dK 💠January 30th, 2025 | 14:00 - 15:30 CET 🔗 https://lnkd.in/ead-UE5y For more details and important next steps, refer to this article: 🔗 https://lnkd.in/ejZM9RqC Start your on-boarding today to ensure a smooth transition to the EU Hub! #EMVO #EMVS #FMD #FightFakes 💉💊

💰 EMVO has published the NMVO Fee Models Overview for 2025 on the EMVO website The NMVO Fee Models Overview Table and the NMVO Fee Models Overview Presentation can be consulted ➡️ in the “NMVO” section of the Documents Overview area in the Knowledge Database (https://lnkd.in/dtv-HB8K) ➡️ on our website (https://lnkd.in/d8CjQKqK) Please note that the 2025 fees for some NMVOs are not confirmed yet. EMVO will publish an updated overview in due time.

🚨 Important Update from EMVO: EU Hub Release 1.16 Deployment 🚨 We are pleased to announce that the Interoperability Test (IOT) has been successfully completed, and the official deployment of the EU Hub Release 1.16 in PRD is scheduled for 25 January 2025. Here are the key details: 🔧 Deployment Start: 08:00 CET on 25 January 2025 ⚙️ Ready for Use: Approx. 23:00 CET on 25 January 2025 ⏳ Downtime Window: 09:00 – 23:00 CET Key Changes: As part of Release 1.16, some existing fields in the Product Master Data (PMD) and Product Pack Data (PPD) will become mandatory. Please note that if these mandatory fields are not properly filled, you will not be able to upload data to the EU Hub after 25 January.  🗓️                                                                📄 For more information on the required actions, please refer to Version 4 of the Q&A Document on “PMD Introduction of additional mandatory fields.” 👉 https://lnkd.in/eZ4va9ej   📌 Feel free to reach out with any questions or consult the letter below!

FiMVO office is closed on Friday 6th of December 2024 🕯️ We'll be celebrating Finland's Independence day and we'll get back to work on Monday! Hyvää itsenäisyyspäivää!

In the Nordic countries the risk from falsified medicines is real, but only when you buy your medicine from unauthorised and illegal sources. If you buy your medicine from an approved pharmacy, you can be confident that your medicine is authentic. The Nordic NMVOs provide secure, straightforward and supportive systems for verifying medicines. The system alerts if a falsified medicine should turn up and warns if medicines already dispensed or destroyed are dispensed. The system can also be used to ensure that packs from recalled batches never reach the patient. This results in an additional quality control in the medicine handling process. Together we help to make sure every individual can have confidence in their medicine. The Nordic NMVOs have recently updated our “Nordic Best Practice” on how to do a Recall or Withdrawal through the EMVS, check it out: In English: https://lnkd.in/drbRF8WG Suomeksi: https://lnkd.in/dTQNtaEv #FightTheFakesWeek2024 #FTFweek #fakemeds #SFs #StopFakeMeds #FightTheFakes