News2017-11-30T17:52:47+00:00

NEWS

Alert investigations – NMVS-Alerts

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 .

ICEMVO CONTACT DURING SUMMER 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): +354 660 3707

ONBOARDING OF END USERS
Requests will be handled as soon as possible and with regards to ICEMVO personnel availability during summer. If urgent, please send an email to info@lyfjaaudkenni.is

EMVO HELPDESK
Email: helpdesk@emvo-medicines.eu

ICEMVO 2021 Annual Fee – a 10% reduction

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

The amount of the Annual Fee (operational cost of ICEMVO divided by number of contracted MAH’s) may fluctuate from time to time.

ICEMVO 2021 Annual Fee has been decided by ICEMVO Board of Directors. ICEMVO is happy to inform that there is an overall 10% reduction to the fees from the current year. This is made possible due to reduction in 2021 operational costs and higher number of MAH participating than originally foreseen.

ICEMVO 2021 Annual Fee:

  • 4,410 € for MAH with IDM 2020 sales turnover above 80,000 €
  • 1,350 € for MAH with IDM 2020 sales turnover below 80,000 €
  •    405 € for MAH with IDM 2020 sales below 16,000 €.

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

ICEMVO CONTACT DURING SUMMER 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 (mobile): +354 660 3707

ONBOARDING OF END USERS
Requests will be handled as soon as possible and with regards to ICEMVO personnel availability during summer. If urgent, please send an email to info@lyfjaaudkenni.is

EMVO HELPDESK
Email: helpdesk@emvo-medicines.eu

EMVO – NEW TECHNICAL DOCUMENT ON ALERT AND NOTIFICATIONS

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 alerts for Potential Suspect Falsification packs and may assist with the design of processes and procedures for investigation and handling of potential suspect falsification packs and other scenarios where suspicious activity is detected. Link to Letter of Annoncement

 

ICEMVO 2020 Annual Fee

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

The amount of the Annual Fee (IT-cost and operational cost of ICEMVO divided by number of MAH’s) may fluctuate from time to time.

ICEMVO 2020 Annual Fee has been decided by ICEMVO Board of Directors. There is no change to the fees from the current year, except for the addition of a new group for MAH with annual sales below 16,000€, as recorded in IDM on December 31st 2019.

ICEMVO 2020 Annual Fee:

  • 4.900€ for MAH with IDM 2019 sales turnover above 80,000€
  • 1.500€ for MAH with IDM 2019 sales turnover below 80,000€
  • 450€ for MAH with IDM 2019 sales below 16,000€.

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

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