Dear Colleague
As you know, CPNI has been issuing updates relating to the EU Falsified Medicines Directive (FMD) which imposes legal obligations aimed at helping to prevent entry of falsified medicinal products into the supply chain. The Delegated Regulation was implemented in all EU Member States on 9 February 2019 and is still a legal requirement in Northern Ireland.
SecurMed has written to you recently advising that they will be implementing a new version of the UKNI Medicines Verification System (UKNI MVS) in April 2022.
This requires a change in the software and scanner system you use to connect to it. SecurMed indicates that your software supplier has been informed of this and should have implemented (or be preparing to implement) the relevant changes to update their End User software for continuation of your access to the UKNI MVS.
If your software and scanner system is not up to date when the new system is rolled out, you will no longer be able to access the UKNI MVS and you will not be able to remain compliant with FMD requirements.
ACTION
Contractors are advised to:
- Check with your software supplier to ensure that you have the updated version of your FMD software installed (or will have it installed by April 2022). You should ask your software supplier to confirm that your NMVS software is, or will be, compatible with NMVS Core 1.10.
If you have any queries, please raise them with your software supplier in the first instance.
Kind regards – Mike
SENT ON BEHALF OF
PROF. MIKE MAWHINNEY
Head of Regulatory Affairs