Recall and withdrawal in EMVS – Nordic recommendations

By |2023-01-11T15:54:36+00:00January 10th, 2023|

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. [...]

ICEMVO 2023 Annual Fee – ICEMVO Board decision

By |2022-11-01T14:58:12+00:00November 1st, 2022|

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 [...]

ICEMVO 2022 Annual Fee – a 10% reduction

By |2021-10-21T17:10:43+00:00October 21st, 2021|

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 [...]

Alert investigations – NMVS-Alerts

By |2021-09-16T14:21:11+00:00September 16th, 2021|

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 [...]

ICEMVO CONTACT DURING SUMMER 2021

By |2021-07-16T12:22:16+00:00June 30th, 2021|

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 [...]

ICEMVO 2021 Annual Fee – a 10% reduction

By |2020-10-13T11:53:08+00:00October 13th, 2020|

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 [...]

ICEMVO CONTACT DURING SUMMER 2020

By |2020-07-08T10:32:15+00:00July 8th, 2020|

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 [...]

EMVO – NEW TECHNICAL DOCUMENT ON ALERT AND NOTIFICATIONS

By |2020-07-03T14:53:35+00:00July 3rd, 2020|

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 [...]

ICEMVO 2020 Annual Fee

By |2019-10-18T14:53:56+00:00October 18th, 2019|

18.10.2019 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 [...]

September 30th – ICEMVS stabilisation period comes to an end.

By |2019-10-04T10:58:11+00:00October 2nd, 2019|

1st. October 2019 Stabilisation period granted to end-users of the Icelandic Medicines Verification system (ICEMVS) has come to an end as of September 30th, 2019. End-users in Iceland are now required to record, investigate and potentially report alerts received from ICEMVS and the European Medicines Verification System (EMVS). In case of an alert, the end-user [...]

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