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 € for MAH with sales turnover between 41,000 € to 142,000 € (2024 OCT MAT)
• 303 € for MAH with sales below 41,000 € (2024 OCT MAT)

For any further information please contact ICEMVO via email info@lyfjaaudkenni.is

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 MAHs continue to pay lower fees. This reflects the Board committment to not create barriers for entry to market for medicines in Iceland.

ICEMVO 2024 Annual Fee:

• 3,160 € for MAH with sales turnover above 142,000 € (2023 SEPT MAT)
• 970 € for MAH with sales turnover between 41,000 € to 142,000 € (2023 SEPT MAT)
• 290 € for MAH with sales below 41,000 € (2023 SEPT MAT).

For any further information please contact ICEMVO via email info@lyfjaaudkenni.is

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. When the systems functionality is handled correctly the EMVS also adds security and quality to the supply chain by preventing withdrawn or recalled packs from reaching patients without causing unnecessary disruptions in the distribution.

The Nordic NMVOs govern the national medicines verifications systems in the Nordic countries:

• e-VIS – e-Verifikation in Sverige 
• FiMVO – Finnish Medicines Verification Organisation
• ICEMVO – Icelandic Medicines Verification Organisation
• Nomvec – Norwegian Medicines Verification Company
• DMVO – Danish Medicines Verification Organisation

Nordic recommendations:

Recall and withdrawal in NMVS Nordic recommendations

If you need additional information, please contact info@lyfjaaudkenni.is for questions regarding Icelandic procedures.

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 IDM 2022 sales turnover between 16,000 € to 80,000 €
• 329 € for MAH with IDM 2022 sales below 16,000 €.

For any further information please contact ICEMVO via email info@lyfjaaudkenni.is

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 based on actual cost of running the ICEMVO short and long term.

ICEMVO 2022 Annual Fee has been decided by ICEMVO Board of Directors and there will be an overall 10% reduction to the fees from the current year.
ICEMVO 2022 Annual Fee:

• 3,969 € for MAH with IDM 2021 sales turnover above 80,000 €
• 1,215 € for MAH with IDM 2021 sales turnover between 16,000 € to 80,000 €
• 365 € for MAH with IDM 2021 sales below 16,000 €.

For any further information please contact ICEMVO via email info@lyfjaaudkenni.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 for NMVOs, OBPs, MAHs, NCAs and End Users.

NMVS-Alerts is designed as a collaboration platform for all involved FMD stakeholders, NMVS Alerts supports the necessary escalation and alert investigation procedures.

In addition to the alerts database, stakeholders can ask for and exchange helpful information such as documents, photos or remarks. Log information is tracked through the entire alert investigation process using NMVS Alerts whilst the End User stays anonymous towards MAHs and OBPs.

For further information, please contact ICEMVO at info@lyfjaaudkenni.is.

For general information about NMVS-Alerts, please visit NMVS-Alerts  homepage .