ICEMVS stabilisation period ended September 30th 2019.
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 cannot 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).
The European Commission publishes and regularly updates a Question and Answers document to facilitate consistent implementation of the new safety feature requirements across Europe.
EMVO has prepared a Knowledge Database for manufacturers and MA holders who need to connect to the EU Hub.
For further information please contact email@example.com