11.11.2024 ICEMVO 2025 Annual Fee for Marketing Authorisation Holders has been decided by ICEMVO Board of Directors. The decision reflects the Board continued committment to not create barriers for entry to market for medicines in Iceland. ICEMVO 2025 Annual Fee: 3,317 € for MAH with sales turnover above 142,000 € (2024 OCT MAT) 1,017 € [...]
16.10.2023 ICEMVO 2024 Annual Fee has been decided by ICEMVO Board of Directors and, as was the case for previous year, there will be an reduction in fees, compared to current year. Additionally, sales categories by turnover, as presented in Icelandic Drug Market (IDM, SEPT MAT), have been revised and increased to ensure that smaller [...]
10.1.2023 The Nordic NMVOs have jointly published recommendations on how pharmaceutical companies, wholesalers and pharmacies best handle a recall or withdrawal through the EMVS to further add efficiency, quality and value to the supply chain as well as strengthen patient safety. The European Medicines Verification System safeguards the supply chain and patients from falsified medicines. [...]
28.10.2022 ICEMVO 2023 Annual Fee has been decided by ICEMVO Board of Directors and, as was the case for the 2022 fees, there will be an overall 10% reduction compared to the current year. ICEMVO 2023 Annual Fee: 3,572 € for MAH with IDM 2022 sales turnover above 80,000 € 1,094 € for MAH with [...]
21.10.2021 The ICEMVO annual flat fee is charged per market authorization holder to cover, inter alia, the annual costs of the operation and further development of the ICEMVS, costs inherited from the European Medicines Verification Organization and all necessary and legally compulsory activities of the ICEMVO. The level of the annual flat fee contribution is [...]
16.09.2021 ICEMVO has introduced NMVS-Alerts as the preferred tool to handle alert investigation in Iceland. As a result of the EU FMD regulation, various alerts are created due to the detection of falsified packs or due to procedural or technical errors. The management of these FMD alerts in high numbers can be a significant challenge [...]
16.07.2021 ICEMVO office is closed from July 19th to July 28th, however monitoring of alerts is maintained. The best method to get in touch with ICEMVO during summer is to send an email. Alert Related Questions Email: alerts@lyfjaaudkenni.is General and Technical Questions Email: info@yfjaaudkenni.is Contracts and Fees (MAH) Email: info@lyfjaaudkenni.is Website: https://lyfjaaudkenni.is/ Telephone (mobile): +354 [...]
13.10.2020 The ICEMVO annual flat fee is charged per market authorization holder to cover, inter alia, the annual costs of the operation and further development of the ICEMVS, costs inherited from the European Medicines Verification Organization and all necessary and legally compulsory activities of the ICEMVO. The level of the annual flat fee contribution is [...]
08.07.2020 CONTACT The best way to get in touch with ICEMVO during summer is to send an email. Our office is closed from July 13th to August 4th but monitoring activity of alerts is maintained. Alert Related Questions Email: alerts@lyfjaaudkenni.is General and Technical Questions Email: info@yfjaaudkenni.is Contracts and Fees (MAH) Email: info@lyfjaaudkenni.is Website: https://lyfjaaudkenni.is/ Telephone [...]
03.07.2020 A new document, EMVO_0402_EMVS Alerts & Notifications, is now available to OBPs. It can be found in the Technical Info Pack on the OBP Portal. The document describes alerts and notifications emanating from the European Medicines Verification System (EMVS). It can be used to help identify the triggers that cause the EMVS to issue [...]