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:
- 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
- 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.
- 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.
- 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 email@example.com. 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, firstname.lastname@example.org|
|Queries relating to end-user (pharmacy, hospital, wholesaler) registration with ICEMVOemail@example.com|
|Queries relating to firstname.lastname@example.org|
|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: email@example.com)