The EU-FMD process currently generates over 2.5 million system alerts every month that pharma manufacturers need to deal with.
Even though the level of alerts has dropped from the scary double-digit percentage figures seen in the early days, it is still running at above 1% of transactions, which is a huge amount.
EU Alert Management is going to remain a critical topic for the foreseeable future and every pharma manufacturer connected to the system must be ready to monitor and deal with the sheer magnitude of these alerts.
And the issue might be about to get worse before it gets better. Here’s why…
Many markets function on a stabilisation period, at the grace of the relevant National Competent Authorities (NCAs). This period means pharmacists can dispense a pack even when the EMVS has alerted they regard it as a false alarm. However, these stabilisation periods are ending. Ignoring the ‘do not dispense’ message by the system will not be an option soon.
The next wave of dispensing partners going live in the system will worsen the situation, as more and more end-users and their systems are onboarded. This will increase the rate of alerts.
So, disregarding alerts is definitely not a possibility. Every alert is a potential falsified product that could threaten a patient’s life.
Once the stabilisation period ends and regulators are starting to enforce the obligations, every marketing authorisation holder needs to ensure that they have a reliable GxP process in place and expert support to manage their alerts in a controlled, documented and timely way.
That’s where we come in. Excellis are pleased to announce our new Excellis Service Bureau Alert Management Service. The facility provides a robust and reliable managed service that scales and configures to your needs and helps you discharge your duty, in conjunction with your internal teams and pre-existing processes.
Find out more about our Alert Management Service in our recent webinar.
Download it via our Knowledge Base here: https://excellishealth.eu/knowledge-base/