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

NEWS

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

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

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 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).

ICEMVO 2019 Annual Fee

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

Verification of medicines in Iceland from 9th February 2019 – initial stabilisation period or ‘use and learn’ phase

08.02.2019

The following national approach to the initial operation of the medicines verification system in Iceland has been announced today.

The Icelandic Medicines Agency has been working closely with the ICEMVO to monitor progress in the implementation of the new safety feature requirements across all sectors. Notwithstanding the significant work undertaken to date and given the complexities associated with setting up the medicines verification system impacting all stakeholders in the medicines supply chain across Europe, it is anticipated that the initial period of operation will identify issues as the new system comes into effect Europe-wide.

Following discussions at a national and European level with stakeholder representatives, it has been decided to adopt a pragmatic approach to the implementation of the Delegated Regulation (and the associated statutory instrument) after the go live date, to ensure the continuity of safe supply of medicines to patients while all parties gain a better understanding of the new system. This means that:

  1. All medicinal products released by MAHs for the Icelandic Market after Feb 9th should bear the safety features as required i.e. a tamper proof seal and 2D barcode
  2. During the initial period of operational stabilisation, the system will be considered to be in ‘use and learn’ phase. Therefore wholesalers, pharmacies and hospitals should scan medicines bearing the safety features and if an alert or any other unexpected message is flagged, should continue to supply packs to patients in accordance with their existing procedures, unless they have overriding concerns that a falsified medicine is involved.
  3. All alerts generated by FMD system in pharmacies, wholesalers and hospitals, upon scanning a pack during this ‘use and learn’ phase will be forwarded by the system to the ICEMVO, the IMA and the pharmaceutical companies so that they can be investigated and monitored.
  4. Notwithstanding the above, if a pharmacist or wholesaler has reason to believe that packaging has been interfered with, based on their examination of the anti-tampering device on the pack, they must report their concern to the IMA (as a suspected quality defect via the usual reporting mechanisms) and not supply the pack.

During this period, the alerts generated will be analysed by the IMA and ICEMVO to determine why they are occurring and develop appropriate protocols for their resolution. Manufacturers (and marketing authorisation holders (MAHs)) will also be involved in the investigation of alerts generated against their products. The stabilisation period will be from February 9th to September 30th. This approach will ensure that medicines continue to be provided to patients without delay and also ensure that all stakeholders, manufacturers, wholesalers, pharmacists and other healthcare professionals work to build confidence in operating the new safety system.

Formal notification of this agreed national approach has been issued today to pharmacists, wholesalers, MAHs and manufacturers by the IMA (only in Icelandic). ICEMVO is very appreciative of the careful consideration given to the matter by the authorities in Iceland and we will continue to work closely with them over the coming months to maximise the learnings about the system during this ‘use and learn’ period.

ICEMVO activities regarding alerts

All communications with ICEMVO about alerts should be emailed to alerts@lyfjaaudkenni.is. MAHs registered with us are asked to nominate a contact point for ICEMVO to liaise with when we have queries about alerts relating to their products.

New EMVO system to provide information on status of EU Hub and national system.

The European Medicines Verification System Information (EVI) has been launched by EMVO to provide information on downtimes and known issues with the EU Hub and all the national systems (including the Icelandic system). You can consult the EVI and subscribe for updates by clicking here.

Contacts in ICEMVO 

 Type of query Email address
Queries re MAH fees, MAH onboarding, invoices, MAH agreements, etc. info@lyfjaaudkenni.is
Queries relating to end-user (pharmacy, hospital, wholesaler) registration with ICEMVO info@lyfjaaudkenni.is
Queries relating to alerts alerts@lyfjaaudkenni.is
All other queries*

*Queries about EMVO onboarding and uploading pack data to EU Hub, should be directed to EMVO Helpdesk

(Tel.: +372 611 90 44, e-mail: helpdesk@emvo-medicines.eu)

info@lyfjaaudkenni.is
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