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.

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

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

1st. October 2019

Stabilisation period granted to end-users of the Icelandic Medicines Verification system (ICEMVS) has come to an end as of September 30^th, 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 is advised to:

• • Record the event in line with users operating procedure on deviations.
  • User should exclude any technical scanning errors or other local software issues that might have triggered the alert. User should also check for known pack or batch issues caused by EMVO Onboarding partner (OBP) and registered with ICEMVO.
  • ICEMVO can provide support to rule out technical issues and facilitate flow of information between end-user and OBP.
  • End-user should take a picture of the pack and 2D-barcode, put it aside and evaluate further need for investigation (e.g. has the seal been tampered with, does the pack look suspicious?).
  • If technical errors have been excluded and information about the pack-alert is not received from OBP with-in two working days, the respective wholesaler shall be notified. Information to be provided to the wholesaler includes product code (GTIN, PC number), serial number (SN), expiry date and Unique Alert ID. It´s very important not to initiate a return procedure of the product without first consulting the respective wholesaler.
  • In the case that a possible falsification can not be ruled out after consulting wholesaler and MAH/OBP representative in Iceland, a formal notification of a suspected falsified product should be sent to the Icelandic Medicines Agency (IMA).

04.03.2019

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

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

ICEMVO 2019 Annual Fee has been decided by ICEMVO Board of Directors. It will be EUR 4.900 for MAH with IDM sales turnover above 10 m ISK (80k EUR) and EUR 1.500 for MAH with IDM sales turnover below 10 m ISK (80k EUR).

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