Reason for the Change
The Safety Features Regulation, the final part of the Falsified Medicines Directive, came into force in the UK on 9th Feb 2019. The UK system that is used to carryout the checks on the individual packs in the UK as it is scanned throughout various points in the supply chain is the UK National Medicines Verification System. The system sends alert messages in circumstances that the data on the pack of a medicine gives cause for concern for its authenticity.
What is changing?
A change is to be made to the wording of the 11 Alert messages and 1 related system message produced by the UK NMVS. The changed messages are listed in the attached document.
Both the “Description” and “Short Description” are being amended to make them more understandable. The alerts themselves are not being changed and will operate in exactly the same way as now. The Arvato codes (example NMVS_FE_LOT_03) associated with the alerts will stay the same.
When is the change happening?
The functionality to change these messages has been made possible in the latest release of the system, within the last week. It is important to make this change quickly as system usage is growing rapidly. The change will be made effective on Sunday 17th March 2019.
What you need to do?
Software Suppliers: Review your solution to ensure this change is effective through to the end user. We believe that the vast majority of solutions send the message from the UK NMVS straight through unchanged to the end user. A check for field length limitations would be appropriate. If your software alters the wording, you may consider amending it using the additional clarity provided in this change.
End Users: It may be appropriate for you to amend your Operating Procedures to reflect this new wording.
Industry Associations and Professional Bodies providing guidance material: It may be appropriate for you to amend your guidance material to reflect this new wording.